Regulatory Systems
on Ensuring Access to Quality Medicines

Country Reports

Japan International Corporation of Welfare Services (JICWELS)－ 203 －

Contents
1. AZERBAIDZHAN………………………２０７
2. BRAZIL………………………………２２３
3. FIJI………………………２４１
4. INDIA…………………………２５５
5. INDONESIA………………………２６７
6. IRAQ………………………………２８９
7. MYANMAR………………………３０５
8. SAMOA………………………３１７
9. THAILAND……………………………３３７
10. UGANDA………………………３５１
11. VENEZUELA………………………３６７
12. ZAMBIA………………………３８１
13. LAOS………………………４０１－ 205 －

Regulatory Systems
on Ensuring Access to Quality Medicines

AZERBAIDZHAN－ 207 －

Azerbaijan Republic

Analytical Expertise Centerof the Ministry of Health1

Structure of state system of pharmaceutical regulation
2

in Azerbaijan Republic
Ministry of Healthof Azerbaijan
Republic

Analytical
Expertise Center

Innovation and
Supply Center

Managing aparate

Pharmacovigilance
sectorQuality
management
sector

Sanitary andQuarantine
Inspection

Service sectors

Legal sector

Department ofRegistrationexpertise of
medicines

Department ofImport-expertise of
medicines－ 209 －

Department of
Quality Control
Laboratory ofMedicines

Department ofState Inspection ofPrivatePharmaceutical
Organizations

Department ofRelation with
Pharmaceutical
Organization

3

Analytical Expertise Center
Analytical Expertise Center
is a National Medicines
Regulatory Authority whichis established in 2007 andsubordinates to MoH. Main
responsibility of the Center
is to provide society withhigh quality, safe andeffective medicines.

4

Pharmacovigilance sector
I have been working as a pharmacovigilance specialist since January,2017 and involved in below mentioned activities : formulation of sector legislation
 tracing, recording, evaluating, archiving adverse drug reactions, transmitting information
to the UMC of the WHO; examining the official websites of World Health Centers minimizing the risk by monitoring the warnings on pharmaceutical safety investigating security-related applications by registering owners
 taking the necessary measures, by investigating Risk Management Plans (RMP) andPeriodic Safety Update Reports (PSUR); preparation of a list of medicines under additional monitoring; delivering of information to healthcare professionals;
 taking the necessary measures to promote the spontaneous data transmission byhealthcare professionals for the best application of pharmacovigilance system;－ 210 －

5

Roles and Position of Pharmacists in the
Azerbaijan Republic Prepare, obtain , store, secure, distribute, administer, dispense, and disposeof medical products
 Provide effective medication therapy management
 Maintain and improve professional performance Contribute to improve effectiveness of the healthcare system and publichealth Counsel patients
 Ensure patients' safety
 Educate health provider colleagues

6

Roles and Position of Pharmacists in the
Azerbaijan Republic
Generally, pharmacists working in these areas: Pharmaceutical companies (distributors)
 Warehouses
 National Regulatory Authority
 Public and private hospital pharmacies
 Private and state pharmacies－ 211 －

7

Good Practices
 In Azerbaijan Republic established national framework of quality standards
and guidelines (GMP,GSP,GPP and GDP) Minimum national standards established for these activities.
 Developed guidelines and Standard Operating Procedures (SOPs) has
prove to be a good practice to achieve uniformity of the performance of a
specific function
 State pharmacy where I was working as pharmacist all procedure
operated under (GSP and GPP) guidelines and SOP`s developed
according these standards
 Azerbaijan provides changes in the Law on Medicines and going toapprove of new national regulations for pharmacovigilance activities which
will be harmonized to European Union (EU) system. After approval we aregoing to develop national GVP guidelines .

8

Difficulties/Lessons Learned from Past Experience Unavailability of effective pharmacovigilance regulatory framework Challenges to set up a national database system for pharmacovigilance inAnalytical Expertise Center Human resource capacity constraints
 Education – need to increase the professional skills of existing staff as well
as experience exchange with other countries for a new successful
collaborations.
 Medical Dictionary for Regulatory Activities (MedDRA) should be translated
in to the native language for improvement of ADR (Adverse drug reaction)
reporting culture.

－ 212 －

My interests

9Japanese pharmaceutical affairs and the quality risk
management for post marketing. Post marketing
safety measures of drugs on the market.
Pharmaceutical approval system in Japan.
GMP process and clearance of manufacturers .

Thank you !

ferid16710@gmail.com
www.pharma.az－ 213 －

Regulatory Systems on Ensuring Access to Quality Medicines （JFY 2018）
Name:

FARID HASANOVCountry:

AZERBAIJAN

Organization/Department/Division: Analytical Expertise Center/Pharmacovigilance① Organizational Chart

Goverment of
Azerbaijan Republic

Managing aparate

Analytical ExpertiseCenterInnovation and
Supply Center

Service sectors

Supporting
departments

Pharmacovigilance
sector

Department ofRegistrationexpertise of
medicines

Department of"Single Window"

Quality management
sector

Department ofImport-expertise of
medicines

Department ofGeneral services

Legal sector

Department of
Quality Control
Laboratory ofMedicines

Department of
Finance

Department of State
Inspection of Private
Pharmaceutical
Organizations

Department ofPurchasing

Department ofRelation with
Pharmaceutical
Organization

Department ofSecurity

Ministry of Health of
Azerbaijan Republic

Ministry of
EconomyTariff (Price)
Council

Sanitary andQuarantine
Inspection

Baku City Drug
Administration

Pharmaceutical andMedical Industry
Association

Department of IT1－ 214 －

 The Ministry of Healthcare of Azerbaijan Republic, also known as Ministry of Health of Azerbaijan
Republic is a governmental agency within the Cabinet of Azerbaijan in charge of regulating the healthcare
system in Azerbaijan Republic.
 Ministry of Economy- issues licenses, permits, certificates and other documents for various
entrepreneurial activities.
 Tariff (Price) Council- in compliance with relevant legislation regulates prices of pharmaceuticals.
 İnnovation and Supply Center - The Innovation and Supply Centre under the MOH organizes
procurement for medicines determined by the MOH. Organizes supply of medicines and medical supplies
on the basis of the requirements of government healthcare institutions. Participate in determining the needsof medical equipment, instruments, apparatus, devices, devices based on the order of medical institutions.
 Sanitary and Quarantine Inspection – issues permission certificate for food supplements and hygiene
products.
 Baku City Pharmacy Administration – state pharmacies which is located in capital city (Baku)
subordinates to this administration.
 Pharmaceutical and Medical Industry Association – state pharmacies which is located in out of capital
city subordinates to this association.
 Analytical Expertise Center – the initiative of the Ministry of Health, for strengthening of state control
over the quality, efficiency and security and emerging issues in the activities of the participants in order toregulate the pharmaceutical market. Analytical Expertise Center was established in 2007. Main
responsibility of the Center is to provide society with high quality, safe and effective medicines.
 Pharmacovigilance sector - sector's main activity is systematic monitoring of adverse drug reactions andrisk-benefit balance to ensure the safe use of the medicines, gathering information, registering, evaluating,archiving, establishing contacts between the parties and taking the necessary measures to minimize thedamage caused by drugs.
 Department of Registration-expertise of medicines - The State Department of Registration of theAnalytical Expertise Center of the Ministry of Health acts as a structural unit.
In accordance with his duties, performs the following functions:
1. Implementation of state registration of medicines;
2. Approval of the state registration of medicinal products (extension);
3. Recall of state registration of medicinal products (cancellation);
4. Addition of changes to files and documents of registered medicines;
5. Holding of the state register of medicinal products that passed state registration in the territory of the
Republic of Azerbaijan;
6. Preparation of regulatory documents related to the circulation of medicinal products;
7. Elucidation of belonging to medicinal products of products received for State Registration;
 Department of Import-expertise of medicines – Controls the import of medicines and medical goods inthe territory of the Azerbaijan Republic.

－ 215 －

 Department of Quality Control Laboratory of medicines – The Laboratory of Quality Control of
Medicinal Preparations (LQCMP) of the Analytical Expertise Center, used in the world practice of somecountries, as well as in Azerbaijan, was established to control the quality of drugs imported legally andillegally into our Republic and with the goal of protecting the health of the population.
 Department of State Inspection of Private Pharmaceutical Organizations – is responsible for
periodically inspection of private organizations where pharmaceutical activities are performing.
 Department of Relation with Pharmaceutical Organization - The main purpose of the department's
activity is to control the safety and quality of medicines in circulation in the territory of the Republic ofAzerbaijan. Also, evaluates of compliance of pharmaceutical enterprises with the requirements ofnormative-legal acts on the basis of appeals received from the Ministry of Health.
② Legislation on pharmaceutical administration◆National Level
・ Law on “Protection of Population Health” June 26, 1997 administered by the Ministry of Health・ Law on “Medicinal Products” December 12, 2006 administered by the Ministry of Health・“Regulation of State Registration and Register Compilation of Medical Products” July 13, 2007
administered by the Ministry of Health・ Law on “Licenses and Permits” March 3, 2016 administered by the Ministry of Economy◆Local Level
・ Decision of Board of MoH of Azerbaijan Republic on approval of some normative legal acts
regulating pharmaceutical activity administered by the Ministry of Health Requirements for manufacturing, carriage and strorage of medicines.
 Requirements for wholesale of medicines Requirements for Pharmacies and Rules on sale of medicines from pharmacies.

・Rules for state Registration and registery of medicines adminstered by the Ministry of Health.

◆PIC/S member: No③ Regulatory Services◆Pharmaceutical Manufacturing
・ There are 4 licensed pharmaceutical manufacturers in Azerbaijan. In 2018, domestic manufacturers held 3.8%of the market share by value produced. Azerbaijan Republic imports 96.2% of all pharmaceutical and medical
devices used in the country. Domestic manufactures are certified by a manufacturing license; this is the national
analogue of GMP. There are no multinational pharmaceutical companies that manufacture medicines locally.

－ 216 －

Manufacturing capabilities are presented in table below:
Research and Development for discovering new active substancesNo

Production of pharmaceutical starting materials (APIs)No

The production of formulations from pharmaceutical starting material

Yes

The repackaging of finished dosage forms

Yes

・ Decision on approval of some normative legal acts regulating pharmaceutical activity(Requirements for manufacturing, carriage and strorage of medicines) administered by the Ministry of
Health◆Drug Import/Export
・ Ministry of Economy issues licenses to wholesalers and importers for drug importing and exporting.
Wholesalers and importers who are permitted by the Ministry of Economy are allowed to conduct import andexport of pharmaceuticals and medical devices. Beside of private sector, government too import pharmaceuticals
and medical devices for the public sector. For the public sector drugs are imported mainly through the İnnovationand Supply Center, which is responsible in distributing drugs and related items to government sector hospitals.
Legal provisions exist requiring authorization to import medicines. Laws exist that allow the sampling ofimported products for testing. Legal provisions exist requiring importation of medicines through authorized portsof entry. Regulations or laws exist to allow for inspection of imported pharmaceutical products at authorized
ports of entry, one sample from each imported batch is inspected. All the drug imports to Azerbaijan Republicshould be registered under Department of Registration-expertise of medicines established under AEC of the
Ministry of Health and all drug importers are held responsible for ensuring that all drugs that are brought to the
Azerbaijan Republic are manufactured in accordance to GMP.
・

Law on “Licenses and Permits” March 15 , 2016 administered by the Ministry of Economy

・Law on “Medicinal Products” December 12, 2006 administered by the Ministry of Health◆Marketing Authorization
・ In Azerbaijan, legal provisions require marketing authorization (registration) for all pharmaceutical productson the market, however exceptions/waivers for registration do exist. Medicines for humanitarian purposes, rare
medicines, medicines used to cure diseases that require specific treatment and WHO prequalification medicines
without public registration in Azerbaijan may be imported only for non-commercial use. Mutual recognitions
mechanisms are not in place. Explicit and publicly available criteria exist for assessing applications formarketing authorization of pharmaceutical products. By 01.06. 2018, there were 4,449 pharmaceutical products
registered in Azerbaijan. There are legal provisions requiring the Medicines Regulatory Authority (MRA) to
make the list of registered pharmaceutical products publicly available and update it regularly. This register is
updated every year. The updated list can be accessed through http://www.pharma.az. Medicines are always
registered by their INN (International Non-proprietary Names) or Brand name + INN. Legal provisions requirea fee to be paid for Medicines Market Authorization (registration) based on applications and the registration fee
for applications can be accessed through http://www.pharma.az.

－ 217 －

・Law on “Medicinal Products” December 12, 2006 administered by the Ministry of Health・Regulation of State Registration and Register Compilation of Medical Products approved by decreeof the Cabinet of Ministers, on July 13, 2007 №108 administered by the Ministry of Health◆Drug Distribution (including drug selection, procurement, sale)・Public Sector Procurement - Public sector procurement in Azerbaijan is both centralized and decentralized.
Public sector request for tender documents and public sector tender awards are publicly available. Procurement
is based on the prequalification of suppliers. The Innovation and Supply Centre under the MOH organizes
procurement for medicines determined by the MOH for the capital and medicines for all programs (programs
available on www.health.gov.az only in Azeri) for the country and carries out centralized tendering. Regions of
Azerbaijan organize local procurement for medicines.
・Public Sector Distribution-The government supply system department in Azerbaijan has a Central Medical
Store (CMS) at National Level which is under the Innovation and Supply Centre. There are no public
warehouses in the secondary tier of the public sector distribution. Medical goods are directly delivered from
CMS to health facilities. There are national guidelines on Good Distribution Practices (GDP). A licensing
authority that issues GDP licenses exists. The licensing authority does accredit public distribution facilities. The
CMS is GDP certified by this licensing authority, it is not ISO certified.
・Private Sector Distribution-Legal provisions exist for licensing wholesalers and distributors in the private
sector. To obtain a license as a wholesaler or a distributor it is necessary to comply with the national GDP. A listof GDP certified wholesalers and distributors exist in the private sector.
・Selection and rational use of medicines - A National Essential Medicines List (EML) exists. Selection of
medicines for the EML is undertaken through a written process. A mechanism aligning the EML with theStandard Treatment Guidelines (STGs) is in place. All the public health facilities have a copy of the EML andthe STGs. There is a public or independently funded national medicines information center providing
information on medicines to prescribers, dispensers and consumers. There is a national program or committee,
involving government, civil society, and professional bodies, to monitor and promote rational use of medicines.
・ Decision of Board of MoH of Azerbaijan Republic on approval of some normative legal acts
regulating pharmaceutical activity administered by the Ministry of Health.
 Requirements for manufacturing, carriage and strorage of medicines.
 Requirements for wholesale of medicines Requirements for Pharmacies and Rules on sale of medicines from pharmacies.

◆Medicine Safety (post-marketing)・In Azerbaijan, the Pharmacovigilance Department of the Analytical Expertise Center of the Ministry of Healthis responsible for the safety of drugs and does post marketing surveillance. Analytical Expertise Center
Pharmacovigilance sector's main activity is systematic monitoring of adverse drug reactions and risk-benefit
balance to ensure the safe use of the medicines, gathering information, registering, evaluating, archiving,
establishing contacts between the parties and taking the necessary measures to minimize the damage caused bydrugs.

－ 218 －

・At the present time, Azerbaijan provides changes in the Law on Medicines and will approve new national
regulations for pharmacovigilance activities which will be harmonized to European Union (EU) systemadministered by the Ministry of Health.
◆Relief System for Adverse Drug Reactions
・In an event of an adverse drug reaction (such as serious, expected, unexpected and ineffectiveness) a healthcare
professional, MAH or the patient can report the details of adverse drug reactions (ADR) to the National PV
located at Analytical Expertise Center of MOH, where details of adverse drug reactions are collected fromgovernment hospitals and government medical institutions, private medical institutions and from the patients.
・At the present time, Azerbaijan provides changes in the Law on Medicines and will approve new national
regulations for pharmacovigilance activities which will be harmonized to European Union (EU) systemadministered by the Ministry of Health.
④ Drug Pricing
・Tariff Council in compliance with relevant legislation establish prices of pharmaceuticals. In 2015, the it
adopted the mechanism which determines the prices for medicines that passed state registration and includes
methods for calculating wholesale and retail prices for the medicines. The Tariff Council identifies base prices
by referring to at least 5 out of 10 references countries (Turkey, France, Italy, Spain, Portugal, Greece, Poland,
Hungary, Bulgaria and Slovenia). In determining the cost of medicines, the Council relies on the lowest priceestablished in these countries. The Ministry of Economy controls observance of established prices.
 “Procedure for regulation of prices of state registered medicines and implementation of monitoring overthese prices” approved by Order No. 209 of the Cabinet of Ministers of the Republic of Azerbaijan dated
June 3, 2015.
 “Instructıons on the methods of calculation of medicine prices” approved by Decision No. 4 of the Tariff(price) Council of the Republic of Azerbaijan dated July 21, 2015.
 Annex No. 1 to "Instructions on the methods of calculation of medicine prices" approved by Decision
No. 4 of the Tariff (price) Council of the Republic of Azerbaijan dated July 21, 2015.
 Annex No. 2 to "Instructions on the methods of calculation of medicine prices" approved by Decision
No. 4 of the Tariff (price) Council of the Republic of Azerbaijan dated July 21, 2015.
⑤ Statistic Data
1.

Number of pharmacists

5180(2018)

2.

Number of GMP inspector (National & Local)

7(2018)

3.

Number of pharmaceutical manufacturers / manufacturing sites

4(2018)

4.

Number of traditional medicine manufacturers / manufacturing sites0(2018)

5.

Number of pharmaceutical importers and wholesalers

101(2018)※All participants. Please describe the following general information as much as you know.

⑥

Education and License of Pharmacists in your country－ 219 －

（１） Number of years in primary, secondary and high school education
Primary

4

years

Secondary

5

years

High school

2

years

（２） Number of years / weeks in the following categories during university or college
University / college:

4/3

years

Professional education:

NA

years

Practical training:

NA

years

Duration of training by each facility:

NA

years

Hospital pharmacy:

4

weeks

Community pharmacy:

4

weeks

Pharmaceutical company:

4

weeks

Others:NA

weeks

Age at graduation:

23

years old

In Azerbaijan, there is a strategic plan for pharmaceutical human resource development in place.
This strategic plan, "Guidelines to certification of persons carrying out medical and pharmaceuticalactivities”, was approved by Ministry of Health in 2010. There are two key points in the document.
Firstly, pharmacists that have not continuously carried out activity within their specialty for over 5 years
may be involved in pharmaceutical activity after having passed training in corresponding educational
facilities. Secondly pharmacists who work in drugstores are obliged to undergo training within capacity
building facilities at least once in five years.

（３）Are there any national examinations for pharmacists in your country?
Yes

No

Academic Exams

days

Clinical Exams

days

√

（４）Which of the followings must you fulfill to obtain a pharmacist's license?
* If practical training is mandatory, give the subjects and training period.
Practical training is mandatory to obtain a pharmacist's license
The training period is one (1) month. Practical training consists of the training at the designatedsites by which supervisors will sing a log book that is issued to intern pharmacists at the beginning of
the training and provide a report whether or not the intern pharmacist completed the training
satisfactorily.

（５）Number of pharmaceutical university or college graduates:－ 220 －

University graduates:

72-78 / per year approx.

College graduates:

30-36 / per year approx.

The alumni's placement rate (%)
a. Hospital:

26%

b. Community Pharmacy:54%

c. Government Organization:

8%d. Enterprise:

10%

e. Others:

2%⑦ Side effect report
All healthcare professional, MAH`s and the patients are enjoined to report the details of adverse drug
reactions (ADR) to the National PV center. In AEC website there is downloadable ADR form which any
healthcare professional or patient can accomplish and submit the ADR form to the office of the agency via post
office or fax. Beside of that, right now we are on process to design a user-friendly application for online reporting
ADRs. All adverse drug reaction reports collecting, evaluating, analyzing and submitting WHO global ICSR
database (VigiBase) by pharmacovigilance experts at national PV center. When a severe side effect case isoccurred in a medical institution, healthcare professional who is in charge for reporting, must report and inform
national PV within 24 hours about ADR. After evaluation procedure if there is any issues according serious
adverse drug reaction, AEC is establishing contacts between the parties and taking the necessary measures tominimize the damage caused by drugs. Also at national PV center pharmacovigilance specialist sends report via
web based program (VigiFlow) to WHO-UMC global ICSR database (VigiBase).

－ 221 －

Regulatory Systems
on Ensuring Access to Quality Medicines

BRAZIL－ 223 －

Brazilian Health Regulatory Agency
ANVISANathalie Dias Kuwabara

 ANVISA was established by Federal Law
9.782/99.
 ANVISA’s headquarter is located in Brasília,Brazilian capital.
 Currently ANVISA has approximately 2.200
employees working throughout the country,
most of them located in Brasília.
1－ 225 －

2

REGULATION FIELDS

3－ 226 －

1. Introduction of the work
General Office of Good Manufacturing Practices Inspections
Health Regulation Specialist
Regulatory services that I´m engaged in: Good Manufacturing Practices inspections in pharmaceuticalcompanies, both national and international;
 Review of GMP regulations and guidelines; Activities related to monitoring the quality of medicines in themarket and investigation of deviations; Revision of current regulations in Brazil in order to update themaccording to the best practices all over the world.
4

Roles and position of pharmacists in Brazil:
In the public medical care system, pharmacists are responsible for:
 Management of the pharmacy (including storage) Acquisition of medicines Efficient distribution
Besides that, the pharmacists also have a role in the care programs, giving orientation about theuse of medicines to the population, taking part in the community health education and monitoringof effectiveness of treatment.
•

Recent atributions: Clinical attributions: pharmaceutical consultation, requisition and evaluation of laboratory
tests in order to assure if the treatment is going fine, development of pharmaceutical careplan.
 Pharmaceutical prescription: only non medical prescription medicines.
5－ 227 －

Roles and position of pharmacists in Brazil:
Pharmacies: Formulation of medicines
 Dispensation
Pharmaceutical companies: pharmacists take roles in almost every department, including: production, QC, QA,
engineering, marketing, R&D, etc.

6

2. Good Practice
Graduation: Industrial Pharmacy
Specializations: Health Surveillance; MBA – Administration;
Pharmaceutical Technology.
7 years working for pharma companies(QC and QA)
Anvisa since 2014
 Variations after Marketing Authorizations
 GMP Inspections

7－ 228 －

3. Difficulties/Lessons Learned from Past Experience Complex distribution chain of medicines in Brazil
 Harmonization of GMP knowledge over thecountry and with the rest of the world8

4. My interests(1)Quality during distribution of medicines(2) Post marketing monitoring(3) Identification of substandard and falsified
medicines

9－ 229 －

Regulatory Systems on Ensuring Access to Quality Medicines （JFY 2018）
Name: Nathalie Dias KuwabaraCountry: Brazil
Organization/Department/Division: Anvisa/ GMP Inspection Office① Organizational Chart−Please attach the organizational chart of pharmaceutical administration at national/state & local levels aboutpharmaceutical administration in your country.
−Please briefly describe each role and responsibility on pharmaceutical administration.

Created in 1999 by Law 9.782, the Brazilian Health Regulatory Agency (Anvisa) is an administrative
independent and financially autonomic governmental regulatory agency, connected to the Ministry of
Health.
Anvisa has its legal mandate to regulate all sectors related to products and services that may affect thehealth of Brazilian population. The ANVISA competence covers the health products regulation as well as
the economic regulation of the market.
The General Office of Good Manufacturing Practices (GGFIS) is responsible for the inspections inpharmaceutical and medical devices industries all over the world. It’s also responsible for coordinating theinspections in the industries inside Brazil. This department is also responsible for the monitoring of any
kind of deviations related to medicines, Active Pharmaceutical Ingredients, medical devices, cosmetics,
sanitizers and food.
Pharmacists work mostly with medicines and APIs subjects, mas there are pharmacists working in－ 230 －

every department inside the General Office.

② Legislation on pharmaceutical administration−Please briefly bulletined major laws/acts◆National Level

Law 6360/1976 – provides for the Health Surveillance that the medicines, drugs, and the API, cosmetics &sanitizing and other products are subjected, and gives other provisions.
Decreet 8077/2013 – regulates the activities described in the Law 6360/1976.
Law 5991/ 1973 – provides for the sanitary control for sale of medicines, drugs, API and correlates, andgive other provisions.
Law 6437/1977 – define sanitary infractions to the federal law and relative penalties
Law 8080/1990 – define the Unified Health System in Brazil
Law 9782/1999 – establish the role and responsibilities of Anvisa and define the National Health
Surveillance System◆Local Level

According to the decentralized principle of the Unified Health System in Brazil, the States andMunicipalities should follow the national legislation and may establish supplementary and complementary
legislations.
◆PIC/S

Anvisa is not a PIC/S member yet, but in 2010 Brazil formalized the intention to become a member and it
is expected in 2018/2019 an assessment by the PIC/S delegation in order to determine whether Anvisa canbecome a member.
③ Regulatory Services−Please describe pharmaceutical regulatory services of your country in response to each topic described below.
−It is recommended to add supplemental information such as systems, regulations, responsible administrators,
since you are expected to explain them to other participants.
◆Pharmaceutical Manufacturing
・Systems, Regulations, etc.

According Resolution RDC nº 16/2014, all companies that intend to store, distribute, pack, ship, import,
export, extract, fractionate, purify, manufacture, transform and/or transport drugs and drug products forhuman use must require an operation permit (autorização de funcionamento - AFE), issued by Anvisa. Thispermit is granted upon proof of compliance to technical and administrative requirements listed in the
resolution.
Another document issued by Anvisa for drug product’s manufacturers is the good manufacturing
practices (GMP) certificate. The minimum regulatory requirements for manufacture of drug products aredescribed in Resolution RDC nº 17/2010, which also guides the inspections to verify compliance with theprinciples of GMP. The GMP inspection team is generally composed for two inspectors who evaluate－ 231 －

technical items throughout all the company departments, such as warehouse, utility sections (for example,
HVAC, and water for pharmaceutical use), manufacturing, and quality control. An inspection can get three
results: satisfactory, on-demand, and unsatisfactory. As a result of a satisfactory GMP inspection thecompany is granted a certificate (CBPF) valid for two years.
Within Anvisa’s structure, the General-office of GMP Inspection (GGFIS), subordinated to the boardof Control and Health Monitoring (DIMON), is responsible for granting or denying operation permits and
GMP certificates. The performance of inspections to verify compliance with the principles of GMP within
Brazilian territory is delegated to state and municipal government. National government - Anvisa - is
responsible for inspecting manufacturers located outside Brazil.
Conducting inspections to verify compliance with the principles of good clinical practices is
responsibility of the Clinical Research Coordenation (COPEC), subordinated to the General-office of Drugs
and Biological Products (GGMED).
※Example: Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice◆Drug Import/Export

All products regulated by Anvisa must obtain the agency´s consent to be imported, according to
Resolution RDC nº 81/2008. The companies which intent to import those products also must be authorized.
The petitions are made through an electronic system (SISCOMEX) and Anvisa’s department responsible
for supervise import and export activities of regulated products is the General-office of ports, airports andborders (GGPAF).
As defined by Law 6.360/1976, imported drug products must be approved at its country of origin andmust be registered by Anvisa before being made available for sale. The regulatory requirements for approvalof an imported drug product are the same as those for medicines manufactured in Brazil, provided by
Resolution RDC 60/2014, except by the request of declaring the commitments made with anotherregulatory agencies about conduction of complementary studies (non clinical and clinical) for new drugs.
As an exception, an individual is allowed by Resolution RDC 28/2011 to import non approved drug
products, provided they are intend for personal use only, and not for sale.
Import and export of banned substances, defined in regulation Portaria 344/1998 are forbidden.
Concerning drug export there is specific regulation, RDC 62/2016, only for narcotics, and psychotropic
drugs export, which require an export authorization. Besides that, Anvisa issues export certificates tocompanies that require this document for its products registered in Brazil.
◆Marketing Authorization

For granting a marketing authorization, the holder should prove that the medicine meets the Agency
requirements related to quality, safety, efficacy and administrative aspects.
Regulatory actions take place before the application submission (eg. BPF approval and approval ofclinical trials design for trials conducted in Brazil), during the assessment of the application (efficacy, safety,
quality and administrative reports assessments) and after marketing authorization (eg. pharmacovigilance,
post approval quality changes and register cancelation).
Anvisa establish several categories of medicines, according to medicines’ properties and origin, andfor each category there is specific legislation and requirements. Currently, medicines are categorized as－ 232 －

new synthetic medicines, generic medicines, brand generic medicines, herbal medicines, biologic
medicines, radiopharmaceuticals, homeopathic and dynamized medicines and specific medicines. The
process described below will focus on actions related to assessment of new synthetic medicines applications
for marketing authorization.
The current legislation for new marketing authorizations and register renewal of new synthetic,
generic, and branded generic medicines is Resolution RDC nº 60/2014.
Several departaments of the General-office of drugs and biological products (GGMED) are involved
in application assessment. Before application submission, the marketing authorization holder may request
a pre submission meeting with Anvisa reviewers to discuss technical aspects of the data, especially when
there is specific or unusual issues. For new synthetic medicines, application submission is made through anelectronic system called Eletronic Register System.
The safety and efficacy data of the new synthetic drug is analyzed by the office of safety and efficacy
assessment of new synthetic medicines (GESEF). This office is responsible for the analysis of non-clinicaland clinical trials reports and also for ensuring product information compliance with critical non-clinicaland clinical findings. The reviewer conduct its individual assessment of the dossier and write a detailed andconclusive report about new register, renewal and post-marketing applications of synthetic medicines.
Depending on data complexity, an ad hoc expert assessement may be requested. Anvisa counts with thesupport of three council of experts in different therapeutical areas that work as consulters for the regulatory
decision making process.
The office of assessment of pharmaceutical technology (GRMED) reviews the chemical,
manufacturing, and controls documentation of the dossier. This includes the drug master file of the active
pharmaceutical ingredient (API) used, the drug product production report, the quality control report,
analytical method validation, stability studies, and for generic or branded generic, pharmaceuticalequivalence studies. The requirements for analytical method validation are provided by resolution RE nº
166/2016; the resolution RE nº 1/2005, approved the Guideline for conducting stability studies of drug
products; and the pharmaceutical equivalence studies are regulated by resolution RDC nº 31/2010. GRMED
is responsible for suggesting the approval or rejection of the petition, based on its own review of quality
documentation and on GESEF’s reports about safety and efficacy.
Before marketing authorization, it is also required a pharmacovigilance plan, which is analyzed by
Pharmacovigilance Office (GFARM). When it is identified a notable risk for the new drug, the agency
requires a risk management plan with complementary actions for risk minimization.
In case of doubts or unanswered question about the dossier Anvisa may send an electronic
requirement questioning the applicant about the issue. The applicant has 120 days to explain the questions,otherwise the new drug application will be rejected.
※Example: Good Quality Practice◆Drug Distribution (including drug selection, procurement, sale)

In Brazil everybody citizen have the right to have access to free health services, including access to free
medicines, through the Unified Health System (Sistema Único de Saúde – SUS), set up in 1988 by theConstitution. This is a decentralized system, in which the municipal and state governments have theresponsibility for the management and financing of the health care. There is a budget shared by the federal,－ 233 －

state and municipal governments.
Medicines acquisition is not part of Anvisa legal responsibilities. Once the medicine is approved andmarketed, the drug selection, procurement and distribution to population through public health service isan attribution of the Ministry of Health (MoH).
CONITEC (National Comission of Health Technology Assessment for the Unified Health System) is acollegiate permanent commission that is part of MoH structure. CONITEC objective is support the MoH
on decisions related to incorporation, exclusion or change of health technologies adopted by SUS.
CONITEC should follow some directives such as adopting rational criteria and efficacy, efficiency andeffectiveness parameters adequate for the health necessities and incorporate health technologies relevant
for the citizens and the health system, based on a cost effectiveness positive relationship. CONITEC should
also review the National Relation of Essential Medicines (RENAME).
CONITEC is composed of a plenary that takes technical decisions and an executive-secretariat that
handles the administrative procedures. Anvisa must designated a nominee for being part of the CONITEC
plenary, among other twelve members from MoH secretaries and other public health related authorities (e.g.
National Council of Medicine). Moreover, when necessary, CONITEC may request information for Anvisa
about product register status, indications, caracteristics, data about market monitoring, pharmacovigilance,
among other relevant information.
CONITEC must issue reports explaining the decisions basis considering at least:- Scientific evidences about efficacy, accuracy, effectiveness and safety of the medicine, product orprocedure under assessment, that where considered by the authority responsible for their register orauthorization;- Comparative economic analyses of benefits and costs in relation to the already available healthtechnologies- Impact of the incorporation of the health technology on SUS.
CONITEC reports and decisions are subject of a public consultation and, depending on the relevanceof the theme, a public audience may be conducted to gather more contributions. After the final decision of
new technology incorporation, the legal deadline to offer this in SUS is up to 180 days.
Anvisa issue Certificates of Good Distribution or Storage Practice for medicines, devices and active
pharmaceutical ingredients companies in Brazil. The companies that do the transportation of medicines also
must have a permit to work and follow good transport practices.
◆Medicine Safety (post-marketing)

The main national regulations in pharmacovigilance are RDC 04/2009, which regulates how thepharmacovigilance should be done by the marketing authorization holders and RDC 36/2013, which
establishes rules for the patient’s safety in health care system.
The post-marketing pharmacovigilance is made mainly by the voluntary reporting of adverse events(AEs) by health practitioners and by patients. A web form is available at ANVISA’s website for bothpractitioners and patients. The adverse events’ reports are also collected by the ombudsman service.
The health surveillance reporting system is called Notivisa, which is an electronic system developedby Anvisa to receive notifications of incidents, adverse events and technical complaints related to products
and services under sanitary surveillance.

－ 234 －

Some examples of adverse events that could be notified through Notivisa are: adverse event during asurgical procedure, adverse reaction to a medicine, medication error that caused harm to patient and adverse
event to a cosmetic product; some examples of technical complaints that could be notified through Notivisa
are: product suspected of quality deviation, product without a valid license, counterfeit product andpharmaceutical company working without an operation permit.
The notifications received through Notivisa may be used for:- Underpin the National Health Surveillance System (SNVS) to identify adverse reactions orunpleasant product effects;- Improve the knowledge about product effects and, as appropriate, change the recommendations ofuse;- Promote actions for public health protection through regulation of marketing products in the country.
Notifications records are available for Anvisa and the sanitary authorities of states and municipalities.
Notifications are assessed based on its severity, predictability (expected or unexpected event), causal
relationship between the event and the product and associated risk related to the adverse event or technicalcomplaint.
Different sanitary actions may be adopted depending on this analyses, such as, pooling notifications
until receive more information or other notifications, set up an investigational process, inspect the places
involved in the adverse event or technical complaint notification, collect samples for fiscal analyses,
elaboration and dissemination of alerts and reports, changes in product labels, restrictions on use or
marketing, prohibition of lots or cancellation of product register.
※Example: Good Pharmacovigilance Practice◆Relief System for Adverse Drug Reactions

When important adverse drug reactions are detected, after Anvisa’s evaluation, the warnings are
published at Anvisa’s website and the marketing authorization holders must send a letter to the healthpractitioners. This letter is sent to medical associations, to hospitals and institutions that are member of asentinel network and they are also published at Anvisa’s web page.
Anvisa is looking for another ways of spreading such important information in order to be closer tothe patients such as using social network media, for example, facebook page.
④ Drug Pricing−Please describe about price control and drug price mechanism at public sector in your country.

In Brazil drug product manufacturers must follow the requirements established by law 10.742/2003 to
set and adjust their products’ prices. This law created the Drug Market Regulation Chamber (Câmara deRegulação do Mercado de Medicamentos – CMED), an inter-ministerial organ responsible for the economic
regulation of Brazilian pharmaceutical market, and settled a maximum price for medicines, based on anindex. The index considers inflation, market share, and raw material costs of a product.
Anvisa holds the position of Executive Secretariat in the CMED, monitor the price of drug products
commercialized in Brazil, and oversees the settling of prices for new drug products. The agency publishes
a list with the maximum prices allowed for drug products sold directly to the consumer by drugstores andpharmacies.

－ 235 －

CMED also created a mandatory minimum discount (price-cap) applied for pharmaceutical distributers
and manufacturers when selling medicines to public administration. Local government generally acquire
drug products through electronic trading, and performs annual drug acquisition, among other strategies topromote resource optimization.
⑤ Statistic Data
−Please answer the following questions (if the number is not applicable, please give an answer to the best of
your knowledge).
−Put the year of the presented data as well if it's available.
1.

Number of pharmacists

203.600 (2016)

2.

Number of GMP inspector (National & Local)

3.

Number of pharmaceutical manufacturers / manufacturing sites

1342 (2018)

4.

Number of traditional medicine manufacturers / manufacturing sites

not available

5.

Number of pharmaceutical importers

444 (2018)

6.

Number of pharmaceutical wholesalers

4761 (2018)~ 25 (2018) – local amount not available※Hospital pharmacy only⑥

Information on your hospital pharmacy（１） Organization chart of the pharmaceutical department or the pharmacy to which you belong
a. Number of section chiefs:
b. Number of deputy chiefs:
c. Number of managers:（２） Number of staff
a. Number of pharmacists:
b. Number of clinical pharmacists:
c. Number of technicians:（３） Number of the kinds of drugs managed in your pharmacy or hospitala. Oral medicine:b. Injections:c. Medicines for external use:
（４） Number of prescriptions dealt in your pharmacy per day
a. For inpatients:
b. For outpatients:（５） Equipment of the pharmacy in your hospitala.

Does your hospital have a dispensary room?
If "Yes", how large is it?
Yes

b.

㎡

No

Does the pharmacy have a clean room or laminar flow hood?

－ 236 －

Yes

/

No

If "Yes", please describe it in detail
Detail:c.

Does the pharmacy have computers?
Yes

/

No

If "Yes", what is the purpose of using them.
Purpose:d.

Do you implement Therapeutic Drug Monitoring (TDM : Therapeutic Drug Monitoring) in yourHospital?
Yes

e.

/

Do you prepare TPN (Total Parental Nutrition)
Yes

f.

No

/ No

Can you use Internet at the pharmacy?
If "Yes", what is the purpose of using it.
Yes

/

No

Purpose:※All participants. Please describe the following general information as much as you know.

⑦

Education and License of Pharmacists in your country

I don’t have this kind of data available.
（１） Number of years in primary, secondary and high school education
Primary

5

years

Secondary

4

years

High school

3

years

（２） Number of years / weeks in the following categories during university or college
University / college:

minimum 4000 hours

Professional education:

years

Practical training:

minimum 800 hours

Duration of training by each facility:

years

Hospital pharmacy:

weeks

Community pharmacy:

weeks

Pharmaceutical company:

weeks

Others:weeks

Age at graduation:

years old

－ 237 －

The time for training in each field of knowledge of Pharmacy is divided in the following way:I - drugs, cosmetics, medicines and pharmaceutical care: minimum 60% of 800 hours;
II – clinical, genetic, toxicological and food analysis: minimum 30% of 800 hours;
III – institutional and regional specificities: minimum 10% of 800 hours.
（３）Are there any national examinations for pharmacists in your country?
Yes
Academic Exams

days

Clinical Exams

days

No. In Brazil we don’t have any specific exam for pharmacists.
（４）Which of the followings must you fulfill to obtain a pharmacist's license?
* If practical training is mandatory, give the subjects and training period.
Described in item 2 above.
* If practical training is optional, give the reasons.
(i.e. Training is necessary to prepare for the national examination)（５）Number of pharmaceutical university or college graduates:~ 18000

people / per year (around 529 universities or colleges in Brazil)

The alumni's placement rate (%)

I don’t have this data available.

a. Hospital:%b. Community Pharmacy:%c. Government Organization:%d. Enterprise:%e. Others:%⑧ Side effect report
Please describe the flow of reporting system (from a medical institution to an administrative agency), when asevere side effect case is occurred in a medical institution. Describe specifically the rule and responsibility ofeach organization (an administrative agency / a medical institution), and their collaboration/cooperation.

The marketing authorization holder receives the AEs reporting from healthcare providers, patients andthe population in general and then must send the serious adverse events (SAE) reported by healthcare
providers to Anvisa (by NOTIVISA system). Serious adverse events occuring in Brazil involving case ofdeath or risk of death, must be reported to the regulatory agency in up to seven days after the MAH
acknowledged it, and in up to 15 days the others SAE (RDC nº 04/2009).
The agency will begin the analysis of the reporting of SAE in up to 15 days, and, in case of death, in
up to five days. After this evaluation, Anvisa may ask for label revision, spread regulatory measures adopted,
share the pharmacovigilance information with other offices in Anvisa, and search for other AEs occurredin the Sentinel Network Hospitals.

－ 238 －

About 50% of the AE’s reporting is from the Sentinel Network, a group of hospitals coordinated by
ANVISA that act strongly in the reporting of AEs. In a lesser quantity, the AEs reports come from the MAH
and the health care providers.
The responsibility is shared between Anvisa and the MAH in detecting and preventing AEs. The
healthcare providers’ reporting, on the other hand, is voluntary.

－ 239 －

Regulatory Systems
on Ensuring Access to Quality Medicines

FIJI－ 241 －

Country: Fiji
Organization: Medicines Regulatory Authority(Ministry of Health & Medical Services)

Name: Ilisabeta May Pesamino
Principal Pharmacist

Bula !!

Population: 898,760 (2016)1－ 243 －

Permanent Secretary for Health

Chief Pharmacist

Director‐FPBSManager

Principal Pharmacist x 3 ‐Institutional Pharmacy
Services

Principal Pharmacist x 2 ‐Medicines Regulatory
Authority

Principal Pharmacist ‐Essential Medicines
Authority

Logistics Management
Unit

Principal Supply Officer ‐Procurement & Supply
Operations

Manager
Finance/Administration

Senior Accounts Officer ‐Bulk Purchase Scheme

National Biomedical
Coordinator

Senior Pharmacist

Admin Support Staff

Senior Pharmacist x 2

Logistic Officers x 3

Senior Supplies Officer

Clerical Officers x 2

Packers

Biomedical engineers x 2

Telephone Operator
Supervising Pharmacist

Supplies Officer

Cleaners
Drivers
Labourers

Pharmacy Technician

Stores Officer I

Intern Pharmacist

Stores Officer II

2

Packers

Pharmaceutical Division Organisational Structure

Permanent
Secretary for
HealthChief Pharmacist

Institutional
Pharmacy Service

Product Approvals

Medicines
Regulatory
Authority

Director ‐FPBS

Essential
Medicines
Authority

Logistic
Management
Unit

Compliance & Inspection

Admin
Support
Officer3－ 244 －

Procurement &SupplyOperations

Admin &
Finance

Bulk
Purchase
Scheme1. Regulatory Services• Fiji imports all its medicines & medical supplies• One manufacturer – TGA certified, export market• Product/Manufacturer Evaluation- COPP, COA,
cGMP
• Import Authorisation/Export Authorisation –permits for narcotics, psychotropic, precursor
chemicals• Licensing & Registration of Importers, wholesalers& retailers• Inspection & Investigation – handle complaints• Product testing – overseas test facilities• Pharmacovigilance – ADR reporting
4

Roles and positions of pharmacists in
Fiji
Public HealthPharmacists

RetailPharmacists• Dispensary service – Outpatient & Inpatient• Clinical Pharmacy (Ward bed‐side service)• Medicine Information• Inventory management• Dispensary service• Medicine Information• Primary health care/Over‐the‐counter medicine prescribing & advice• Referrals to physicians when necessary• Regulatory services – product assessment, licensing & registration of importers,
import/export authorisation, inspection, sample testingFiji• Essential medicine – medicine selection & quantification, EML & treatment
Pharmaceutical guidelines, promoting/awareness on rational drug use, & Anti‐microbial resistance& Biomedical
Services5－ 245 －

2. Good Practice - Achievements

Achievements
 able to set a standard for the quality of
medicines for the Fijian population
Medicines (PIC/S)
Vaccines (UNICEF)
Ongoing projects: for the same objectives
Drug Registration – private sector
Develop regulations/policies/guidelines
Capacity building

6

Solutions for past problems
Learn a lot from other country practices e.g.
Australia, New ZealandMaintain a network of mentors andprofessionals to assist
 based on existing regulations, guidelines andprocesses
Conduct research7－ 246 －

3. Difficulties/Lessons Learned from Past Experience

Major Challenges

 lack of resources & necessary skills
 government systems & processes –contribute to delays in passing of regulations
 politics/funding – affect decision making
when it comes to quality of medicinesincreasing use of traditional & complementary
medicines & practices in Fiji; needing a different
level of skills & regulations
8

4. Things to take back!
(1) Learn more about how Japan conducts
its regulatory services in all areas i.e. Premarketing evaluation, Marketing
Authorisation, Post-marketing surveillance,
Pharmacovigilance(2)Identify which concepts would beapplicable or can be contextualised to suit
the Fiji setting(3) Learn also from other participating
countries & their practices
9－ 247 －

Part I:INFORMATION SHEETRegulatory Systems on Ensuring Access to Quality Medicines （JFY 2018）
Name: Ilisabeta May Pesamino
Country:FijiOrganization/Department/Division: Ministry of Health & Medical Services① Organizational Chart−Please attach the organizational chart of pharmaceutical administration at national/state & local levels
about pharmaceutical administration in your country.
Organisation Structure of the Fiji Pharmaceutical & Biomedical Services (FPBS)& the Medicines Regulatory Authority (MRA)

Permanent
Secretary for
HealthChief
Pharmacist
Institutional
Pharmacy
Service

Medicines
Regulatory
Authority

Product Approvals

Director FPBS
Essential
Medicines
Authority

Logistic
Management
Unit

Procurement& Supply
Operations

Admin&
Finance

Bulk
Purchase
SchemeCompliance &Inspection
Admin
Support
Officer−Please briefly describe each role and responsibility on pharmaceutical administration.
The Medicines Regulatory Authority comes under the responsibility of the Chief Pharmacist who reports directly to
the Permanent Secretary, Ministry of Health & Medical Services. The unit is based at the Fiji Pharmaceutical &Biomedical Services Centre, which is under the responsibility of the Director FPBS, responsible for the Supply
Chain Management System.
The Chief Pharmacist is also responsible for 2 other major services; the Institutional Pharmacy Service which is thedispensary service at all public health facilities in the country and the Essential Medicines Authority, which looks－ 248 －

after medicine selection & quantification, development of the Essential Medicines List & Standard Treatment
Guidelines, and implementation of activities to promote Rational Drug Use and reduce Anti-Microbial Resistance.
Medicines Regulatory Authority
There are only 3 staff members in the Medicines Regulatory Authority:
1. Principal Pharmacist – Product Evaluation
The position is responsible for product evaluation, manufacturer & supplier assessment and issuing import& export authorisations. Fiji relies on the assessment carried out by other national regulatory authorities as
our unit is under-resourced. Fiji only accepts products that are from PIC/S countries and if the products are
manufactured outside PIC/S countries, then the manufacturing plants must be GMP certified by a PIC/S
member country, or WHO, UNICEF, & other partners.
2. Principal Pharmacist – Compliance/Inspection
The position is responsible for ensuring compliance to legal requirements by all pharmaceutical importers
through regular inspections, handling and investigating complaints. The position also ensures that at least
10 random samples are sent abroad for testing annually, since Fiji does not have any testing facility.
3. Admin Support Officer
This officer provides all the administrative support such as issuing of licences and permits, communication& banking.
※Hospital pharmacy only

−Please briefly describe the role of pharmacist in medical care system in your country. If possible, focus on theposition of the pharmacist in medical institutions.
② Legislation on pharmaceutical administration−Please briefly bulletined major laws/acts◆National Level
・Medicinal Products Act 2011administered by Ministry of Health & Medical Services
・Pharmacy Profession Act 2011administered by Ministry of Health & Medical Services◆Local Level
・Public Hospitals & Dispensaries Act administered by Ministry of Health & Medical Services
・Medicinal Products Act 201 administered by Ministry of Health & Medical Services◆PIC/S
Yes

OR

No √

If yes, joined when
③ Regulatory Services−Please describe pharmaceutical regulatory services of your country in response to each topic described below.
−It is recommended to add supplemental information such as systems, regulations, responsible administrators,
since you are expected to explain them to other participants.

－ 249 －

◆Pharmaceutical Manufacturing
・Systems, Regulations, etc.
・Medicinal Products Act 2011administered by Ministry of Health & Medical Services

・

National Medicinal Products Policy 2013 administered by Ministry of Health & Medical Services

There is only 1 manufacturing company in Fiji called Douglas Pharmaceuticals and it is certified by Therapeutic
Goods Administration (TGA) Australia. However the Ministry of Health & Medical Services through its Medicines
Regulatory Unit issues annual manufacturing licence based on valid GMP certification by TGA. Douglas
Pharmaceuticals mostly manufacture for the export market. Fiji imports all of its medicines that are manufactured& certified by PIC/S member countries.
※Example: Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice◆Drug Import/Export
・Systems, Regulations, etc.
・Medicinal Products Act 2011 & Drafted Medicine Registration Regulations administered by the Ministry of
Health & Medical Services.
・In Fiji, all pharmaceutical importers are licensed. There are 72 registered pharmacy businesses, 19 registeredwholesalers which are eligible to import medicines at the moment. However we are also currently developing ourprocesses, to issue Import Licences only to pharmacy business that actually do importation, as some only retail butpurchase stock from other registered wholesalers. Export licence is issued mostly for narcotics to our neighbouring
Pacific Island Countries. Most of these countries import their own pharmaceuticals directly from overseas suppliers
but may import from Fiji if necessary during an emergency.
◆Marketing Authorization
・Systems, Regulations, etc.
・Medicinal Products Act 2011administered by Ministry of Health & Medical Services
Fiji is currently developing its Drug Registration System, software has been purchased and a number of
products have been provisionally registered however the system has not been fully utilized yet due to many reasons
such as limited resources and technical skills to effectively implement and maintain the system. For the public
sector health facilities, all imports are approved by the Medicines Regulatory Unit which is based at the Fiji
Pharmaceutical & Biomedical Services. The Fiji Ministry of Health only imports medicines that have been
manufactured by plants that have been GMP certified by a regulatory body in a PIC/S country or has beenregistered in a PIC/S country. Fiji uses the “Prequalification system’ to prequalify manufacturers.
※Example: Good Quality Practice◆Drug Distribution (including drug selection, procurement, sale)・Systems, Regulations, etc.
・Drug selection is carried out by the Fiji National Medicines & Therapeutics Committee which is also
administered by the Ministry of Health & Medical Services. The committee comprises of physicians from all
medical disciplines such as Internal Medicine, Surgery, Obstetrics & Gynecology, Peadiatrics and Microbiology.
Other smaller disciplines are also represented. Medicine procurement in the public sector is carried out by the
Finance & Procurement division of the ministry, after evaluation and assessment by the technical teams. Only
registered medicine retailers are allowed to sell medicines. Supermarkets may sell general sale medicines andvitamins. There is still however a lot to do to improve in this area.

－ 250 －

◆Medicine Safety (post-marketing)・Systems, Regulations, etc.
・As part of our quality assurance activities, we send a minimum of 10 samples for laboratory testing annually.
We normally used the TGA test facility, but we have also used Health Science Authority in Singapore. Last year
alone we tested over 23 samples, out of which 7 products were confirmed to be below acceptable quality standards
and had to be recalled. This allowed us to relook at our product selection process. There isn’t any regulation
specifically targeted at Post-Marketing but it can be looked at.
※Example: Good Pharmacovigilance Practice◆Relief System for Adverse Drug Reactions
・Systems, Regulations, etc.
There is no National Pharmacovigilance Centre in Fiji but all reports of Adverse Drug Reactions are reported
on a yellow form which is then sent to the Medicines Regulatory Unit or the Essential Medicines Unit. There
still needs to be some improvement and development in this important area, There is a lot of underreporting by
clinicians and also the patients/customers which is probably due to lack of awareness and knowledge on theimportance of Pharmacovigilance.
④ Drug Pricing−Please describe about price control and drug price mechanism at public sector in your country.
Medicines or drugs are supplied free of charge in all public health facilities. There are a total 224 of publichealth facilities in Fiji. These include 3 tertiary/referral hospitals & 2 specialist hospitals whilst the rest include
smaller primary health care hospitals, health centers and nursing stations. The public can access free medicines
as long as they are seen by an in-house physician.
In the private sector, there is a list of price-controlled medicines, containing 70 medicines. The prices are fixedby the Fijian Competition & Consumer Commission which is an in dependent statutory body responsible whichseeks to protect consumers and businesses from restrictive and unfair trade practices.
There is also a government initiative called the Free Medicines Program, whereby 142 medicines canbe accessed free of charge from either the public sector or private sector pharmacies.

⑤ Statistic Data
−Please answer the following questions (if the number is not applicable, please give an answer to the best of
your knowledge).
−Put the year of the presented data as well if it's available.
1.

Number of pharmacists

200(2018)

2.

Number of GMP inspector (National & Local)

0 (2018)

3.

Number of pharmaceutical manufacturers / manufacturing sites

1(2018)4.

Number of traditional medicine manufacturers / manufacturing sites

0(2018)5.

Number of pharmaceutical importers

19(2018)

6.

Number of pharmaceutical wholesalers

19(2018)－ 251 －

※Hospital pharmacy only⑥

Information on your hospital pharmacy（１） Organization chart of the pharmaceutical department or the pharmacy to which you belong
a. Number of section chiefs:
b. Number of deputy chiefs:
c. Number of managers:（２） Number of staff
a. Number of pharmacists:
b. Number of clinical pharmacists:
c. Number of technicians:（３） Number of the kinds of drugs managed in your pharmacy or hospitala. Oral medicine:b. Injections:c. Medicines for external use:
（４） Number of prescriptions dealt in your pharmacy per day
a. For inpatients:
b. For outpatients:（５） Equipment of the pharmacy in your hospitala.

Does your hospital have a dispensary room?
If "Yes", how large is it?
Yes

b.

㎡

No

Does the pharmacy have a clean room or laminar flow hood?
Yes

/

No

If "Yes", please describe it in detail
Detail:c.

Does the pharmacy have computers?
Yes

/

No

If "Yes", what is the purpose of using them.
Purpose:d.

Do you implement Therapeutic Drug Monitoring (TDM : Therapeutic Drug Monitoring) in yourHospital?
Yes

e.

/

No

Do you prepare TPN (Total Parental Nutrition)
Yes

/ No

－ 252 －

f.

Can you use Internet at the pharmacy?
If "Yes", what is the purpose of using it.
Yes

/

No

Purpose:※All participants. Please describe the following general information as much as you know.

⑦

Education and License of Pharmacists in your country（１） Number of years in primary, secondary and high school education
Primary

8

years

Secondary

5

years

High schoolyears（２） Number of years / weeks in the following categories during university or college
University / college:

years

Professional education:

4

Practical training:

years
1

Duration of training by each facility:year
1

Hospital pharmacy:

52

years
weeks

Community pharmacy:

weeks

Pharmaceutical company:

weeks

Others:weeks

Age at graduation:

22

years old（３）Are there any national examinations for pharmacists in your country?
Yes√
Academic Exams

1

Clinical Exams

day
2

days

No
（４）Which of the followings must you fulfill to obtain a pharmacist's license?
* If practical training is mandatory, give the subjects and training period.
Practical training after obtaining Bachelor’s degree in Pharmacy in mandatory and is taken in 52
weeks. There are 7 competence standards that must be completed successfully including a research
project. The 7 competence standards are:
1. Practice pharmacy in a professional manner
2. Promote the rational and optimal use of medicines
3. Provide primary healthcare
4. Apply management and organisation skills
5. Research and provide information
6. Dispense medicines
7. Prepare pharmaceutical products (non-sterile)－ 253 －

* If practical training is optional, give the reasons.
(i.e. Training is necessary to prepare for the national examination)（５）Number of pharmaceutical university or college graduates:
20 people / per year
The alumni's placement rate (%)
a. Hospital:

90%

b. Community Pharmacy:

10%c. Government Organization:%d. Enterprise:%e. Others:%⑧ Side effect report
Please describe the flow of reporting system (from a medical institution to an administrative agency), when asevere side effect case is occurred in a medical institution. Describe specifically the rule and responsibility ofeach organization (an administrative agency / a medical institution), and their collaboration/cooperation.
Reporting of Adverse Drug Reaction can be made by any health practitioner or a patient through a medical
professional. An ADR form is filled at the facility and then sent to the pharmacy department of that facility or
to the nearest Medicine Information Pharmacist at the Tertiary Hospital, and subsequently to the Medicines
Regulatory Authority in Suva.

Severe Side Effect/ADR (reported by patient/carer/consumer)↓
Pharmacist at nearest HF (or other medical staff if no pharmacist available)↓
Medicines Information Pharmacist (at the Tertiary Hospital)↓
Medicines Regulatory Authority (MRA)

The report is analysed to determine if it is an administration error, a normal side effect of the drug or a productquality issue. If product quality is suspected, the MRA would look at severity of the event and either quarantine
the product or advise to use other batches. Since there is no testing facility in Fiji, Fiji sends all its testing
requirements to TGA in Australia. Test results would determine next course of action.

－ 254 －

Regulatory Systems
on Ensuring Access to Quality Medicines

INDIA－ 255 －

Regulatory Systems on Ensuring Access to
Quality Medicines (JFY2018)
No. J18‐04225
Presentationby
Navdeep Rinwa (D1802792),
Joint Secretary in the Department ofPharmaceuticals,
Government of Indiath
13 July,2018 at JICA Tokyo

Introduction of my work
• Member of the Indian Administrative Service• Joint Secretary to the Government of India in the
Department of Pharmaceuticals• Worked in the Department of Health & Family Welfare
just before the present posting• Policymaking, International Cooperation, CMD of IDPL,PMBJP scheme, Review against decisions of NPPA, Pricing
of Drugs• Schemes for promotion of the pharmaceutical Industry• Handling FDI proposals in Pharmaceuticals and Medical
Devices－ 257 －

Good Practices• Fixation of Ceiling Prices under DPCO
• PMBJP Scheme• First Nationwide Drug Survey conducted• CDSCO declared as functional National
Regulatory Authority by WHO• Streamlining of the Clinical Trial Process• Intelligence cell set up in CDSCO

Good Practices‐continued• Establishment of Pharmacovigilance system
made mandatory for all MAH since 2016
• IPC made the 6th WCC for Pharmacovigilancein Public Health Programmes and Regulatory
services for the entire globe.
• Establishment of NIPERs• E‐Governance adopted in CDSCO• Setting up of Public Relations Office in CDSCO－ 258 －

Challenges• Regulation of Medical Devices• Pricing of Patented Drugs• Popularization of Unbranded
Generics• Upgrading all manufacturing
units to WHO GMP standards－ 259 －

Regulatory Systems on Ensuring Access to Quality Medicines ( J1804225)
Inception Report : Part-I (INFORMATION SHEET)Name of the Participant : Navdeep Rinwa
Participant’s Country : India
Working as a Joint Secretary in the Department of Pharmaceuticals

Regulatory Control over Drugs
Drugs fall under the Concurrent list of the Constitution of India. Drugs are regulated under
the Drugs and Cosmetics Act,1940, which is a Central Act, administered by both the Central
and State Governments, and it is extended to the whole territory of India.

The regulatory control over the import, manufacture, distribution and sale of drugs,
cosmetics and notified medical devices in the country is exercised under the provisions of theDrugs and Cosmetics Act, 1940 & the Drugs and Cosmetic Rules, 1945.
The manufacture, sale and distribution of drugs in the country is primarily regulatedby the State Drug Control Authorities appointed by the State Governments while control overdrugs imported into the country and introduced for the first time is exercised by the Central
Government through CDSCO.
The objective of the drug regulatory system is to ensure availability of safe, effective
and quality drugs, cosmetics and medical devices based on scientific excellence and best
possible regulatory practices.

CENTRAL DRUGS STANDARD CONTROL ORGANIZATIONThe Central Drugs Standard Control Organization (CDSCO) headed by the Drugs
Controller General (India) is the Central Authority for regulating the quality of drugs
marketed in the country under the Drugs and Cosmetics Act, 1940. This organization comes－ 260 －

under the administrative control of the Ministry of Health and Family Welfare (MoHFW),
Government of India

1. ORGANIZATION
Organizational Chart:

Central Drugs Standard Control Organization
Drugs Controller General (I)HEAD QUARTER• New Drugs• Clinical Trials• Imports• Biological• Medical
Devices•Export•QC• Pharmco.Vig•Legal etc

ZONAL
OFFICE (6)• GMP Audits• Enforcement• Draw drug
Samples

SUB ZONAL
OFFICE (6)•GMP Audits•Coordination
with States

PORT OFFICE(14)•Import•ExportLABORATORY(8)• Testing ofDrugs•Validation of
Test protocols

The Drugs Controller General (India) is the head of Central Drugs Standard Control
Organisation (CDSCO). The CDSCO with its Headquarters in New Delhi has 06 Zonal
offices, 06 Sub-Zonal offices, 07 Central Drugs Testing Laboratories and 09 Air Port & 14
Sea port Offices (Including Inland Container Depots) as given below:－ 261 －CDSCO (HQ) – DELHIZONAL OFFICES (6)• North Zone-Ghaziabad• East Zone-Kolkata• West Zone-Mumbai• South Zone-Chennai• Zone-Hyderabad• Zone-Ahmedabad

SUB- ZONAL OFFICES (6)• Sub Zone-Bangalore• Sub Zone-Jammu• Sub Zone-Goa• Sub Zone-Indore• Sub Zone-Baddi• Sub Zone-Guwahati

LABORATORIES (7)• CDL-Kolkata• CDL CRI-Kasauli• CDTL-Mumbai• CDTL-Chennai• CDTL-Hyderabad• RDTL-Chandigarh• RDTL-Guwahati

SEA PORTS (14)• Mumbai• Nava Sheva• Chennai• Tuticorin• Cochin• Kolkata• Kandla• Hazira• Goa• Vishakhapatnam• Krishnapatanam• Tughlkabad (ICD)• Patparganj (ICD)• Kodhiyar (ICD)

AIR PORTS (9)• Delhi• Mumbai• Chennai• Kolkata• Hyderabad• Bengaluru• Ahmedabad• Goa•
Vishakhapatnam
Responsibilities of the CDSCO:Approval of New Drugs /Medical Devices
Import of Drugs/Medical Devices/ Cosmetics
Clinical Trials
Standards for Drugs
Amendments to Act and Rules
Pharmacovigilance
Responsibilities of the State Drug controllers:－ 262 －

License for Manufacture, Sale and Distribution of Drugs
Monitoring quality of Drugs and Cosmetics
Investigations and Prosecutions

2. Legislation on Pharmaceutical Administration
National Level: The regulatory control over the import, manufacture, distribution
and sale of drugs, cosmetics and notified medical devices in the country is exercised under
the provisions of the Drugs and Cosmetics Act, 1940 & Rules, 1945.
Local Level: The manufacture, sale and distribution of drugs in the country is
primarily regulated by the State Drug Control Authorities appointed by the State
Governments while control over drugs imported into the country and introduced for the firsttime is exercised by the Central Government through CDSCOPICS – India is not a member of PICS.
3. Regulatory Services Pharmaceutical Manufacturing:
Systems, Regulations: Good Clinical Practices, GMP, GLP, Pharmacovigilance, New DrugApprovals are administered by Central Level.
GLP, GMP, License for Manufacture, Sale and Distribution, Monitoring quality of Drugs
and Cosmetics, Investigations and Prosecutions are primarily administered at State Level.
 Drug Import/Export:
Drug import/export are regulated at central level i.e by CDSCO
 Marketing Authorization:
New Drugs: Central Level
Generic Drugs: State Level－ 263 －

Monitoring of Quality of drugs by both Centre and State level Drug Distribution: Administered at State Level
 Medical Safety (Post Marketing: Pharmacovigilance) by Central Level.
 Relief Systems for Adverse Reactions: At present there is no relief system inexistence .
4. Drug Pricing:Drugs have been declared as one of the essential commodities under the Essential
Commodities(EC) Act. The EC Act is administered under the department of Consumer
Affairs and Public Distribution. The EC Act empowers concerned departments to issue
control orders in respect to commodities declared as essentil commodities under the EC
Act. Accordingly, the department of pharmaceuticals has issued the drugs (prices control)
order (DPCO) to regulate the prices of medicines. The department of pharmaceuticals has
entrusted the task of regulating the prices of drugs to the National Pharmaceutical Pricing
Authority(NPPA), an autonomous body under the Department of Pharmaceuticals,
Ministry of Chemicals and Fertilizers, Government of India.
Mechanism of Price Control


Unlike the DPCO,1995, which adopted a cost-based approach for price fixation in
respect of scheduled drugs, the DPCO,2013 adopts a market-based approach for pricefixation.



The National List of Essential Medicines (NLEM), 2015, is adopted as the primarybasis for determining essentiality, and is accordingly incorporated in the First
Schedule to the DPCO, 2013, which constitutes the list of scheduled medicines for the
purpose of price control.



Third, the price control is applied to specific formulations with reference to the
medicine (active Pharmaceutical ingredient), route of administration/dosage form andstrength as contained in the First Schedule.



Under the market-based approach, the ceiling price of a scheduled drug is determinedby first working out the simple average of price to retailer (PTR) in respect of all
generic versions of that particular drug formulation having a market share of 1 percent
and above, and then adding a notional retailer margin of 16 percent to it.

5. Statistical Data:－ 264 －

S. No.

Subject

Number (Approx.)

I

Number of Pharmacists:

II

Number of GMP Inspectors (National and Local):

1,750

III

Number of manufacturers/manufacturing sites:

10,000IV

Numberoftraditional
manufacturers/manufacturing sites

9000

V

Number of Pharmaceutical Importers:

3,500

VI

Number of pharmaceutical wholesalers

2,00,000

10,00,000

medicine

6. Education and License of Pharmacists in India
There are four distinct levels of pharmacy education in India namely, diploma, graduate
degree, post graduate degree and doctorate. A host of pharmacy education programmes areavailable in India at these four levels. Diploma in Pharmacy (D Pharm), Bachelor of
Pharmacy ( B Pharm), Master of Pharmacy ( M Pharm), Master of Science in Pharmacy [MS(Pharm)], Master of Technology in Pharmacy [(MTech (Pharm)], Doctor of Pharmacy (DPharm), and Doctor of Philosophy in Pharmacy (PhD). The entry point for D Pharm, B
Pharm and Pharm D programmes is after completion of 12 years(5 primary, 7 secondary and2 higher secondary) of school education in science. The D Pharm programme consists of 2
years of didactic course work followed by 500 hours of practical training to be completed
within three months in either a hospital or a community setting. The B Pharma programme
consists of 4 years of study in a college affiliated with a university. The B Pharm degree
holders can complete M Pharm degree in 2 years, the second year of which is devoted toresearch leading to a dissertation in any pharmaceutical discipline. A PhD degree inpharmacy involves minimum three years of study and research. The Pharm D programme isof 6 years duration including one year of internship. The pharm D (post baccalaureate)programme involves three years of study. The syllabus of the all these courses is mainly
focused to cater to the needs of the pharmaceutical industry. The pharmacists with UG and
PG qualification prefer working in industry rather than a community pharmacy due to better
salaries and therefore most of the community pharmacists in India are diploma holders.
At present, 1075 educational institutions with annual admission capacity of 64935 students
for Diploma in pharmacy course and 1113 institutions with annual admission capacity of－ 265 －

1,91,591 students for degree in pharmacy are approved by the Pharmacy Council of India.
India is one of the few countries that allow candidates earning both, a 2 year diploma as well
as a 4 year degree programme in in pharmacy to practice as an independent pharmacist－ 266 －

Regulatory Systems
on Ensuring Access to Quality Medicines

INDONESIA－ 267 －

Drug Regulatory Authority
Badan Pengawas Obat dan Makanan(Badan POM)
(National Agency Of Drug and Food Control – NADFC)

Republic of Indonesia
DEWI NOPITASARI
Japan, Juli 2018

Vision and Mission
VISION

Safe Food and Medicine to Improve Public Healthand National Competitiveness.
MISSION

1. Intensifying Risk‐based Drug and Food Control

System to protect public health
2. Encouraging Self Reliance of Bussiness Actors inensuring Drug and Food Safety andstrengthening partnership with stakeholders
3. Enhancing NADFC institutional capacity.

－ 269 －REGULATORY FUNCTION
Assessment anddevelopment of national
policy in the field of drug
and food control

Coordination offunctional activities
in conducting NADFC
duties.

Enforcement ofspecific policies in thefield of drug and foodcontrol.

Monitoring, providing
mentoring andcoaching forgovernment agencies
activities in the field of
drug and food control.

Implementation guida
nce and generaladministrative
services

ORGANIZATION STRUCTURE
NADFC Chairperson

Principal Inspector

Inspector I

Deputy of Drug, Narcotic, Psychotropic,
Precursor, and Addictive Substance Control

Permanent Secretariat

Inspector II

Deputy of Traditional Medicine, HealthSupplement, and Cosmetic Control

Bureau of Legal andOrganization

Bureau of Planningand Finance

Deputy of Processed Food Control

Bureau of
Cooperation

Bureau of General Affairs
and Human Resources

Deputy of Law Enforcement

Directorate of Drug, Narcotic, Psychotropic,
Precursor, and Addictive SubstanceStandardization

Directorate of Traditional Medicine, HealthSupplement and Cosmetic Standardization

Directorate of Processed FoodStandardization

Directorate of Pacification

Directorate of Drug Registration

Directorate of Traditional Medicine, HealthSupplement and Cosmetic Registration

Directorate of Processed Food
Registration

Directorate of Drug and Food Intelligence

Directorate of Drug, Narcotic, Psychotropic,
and Precursor Production Control

Directorate of Traditional Medicine, andHealth Supplement Control

Directorate of Low and Medium Risk
Processed Food Control

Directorate of Drug and Food
Investigation

Directorate of Drug, Narcotic, Psychotropic,
Precursor Distribution Control

Directorate of Cosmetic Control

Directorate of High Risk and New
Technology of Processed Food Control

Directorate of Safety, Quality, and ExportImport Control of Drug, Narcotic,
Psychotropic, Precursor, and Addictive
Substance

Centre of Drug and Food Information

Directorate ofCommunity and Industries Empowerment

Centre of Human Resources Development

Centre of National Quality Control
Development of Drug and Food

－ 270 －

Bureau of Public Relation andStrategic Support

Provincial Offices(33 technical units)

Centre of Drug and Food Research andStudiesDepartment
Directorate of Drug, Narcotics, Psychotropics, Precursors and Addictive
Substances Control, NADFC, consists of 4 Sub Directorates:
1. Safety Control of Narcotics, Psychotropics, and Precursors
2. Export and Import Control of Narcotics, Psychotropics, and Precursors
3. Tobacco Products Control
4. Quality, Information & Promotion Control of Narcotics, Psychotropics,
and Precursors
•
•
•
•
•
•
•
•

Preparing materials for policy‐making and policy implementation in the field ofquality, promotion, and drug information control
Preparing norms, standards, procedures, criteria, technical guidance andmaterials supervision in the field of quality, promotion, and drug information
control
Preparing guidance of drug sampling
Evaluating drug testing results from regional offices and taking follow up actions
Evaluating report of drug promotion and label control from regional offices andtaking follow up actions
Evaluating drug promotion/advertisement prior to publication
Evaluating CAPA submitted by pharmaceutical manufacturers
Providing national report of quality, information and promotion control

Job Tenure
Joined with NADFC since 2010  Placed in Directorate ofDistribution Control of Therapeutic Products

Evaluator of Drug Promotion Control and GDP Inspector (2010‐
Feb 2018)

Drug and food inspector‐second level (since 2015)

Moved to Directorate of Safety, Quality and Export Import
Control of Drug, Narcotics, Psychotropics, Precursors andAddictive Substances) in March 2018  Evaluator of Drug
Promotion and Labelling Control－ 271 －

Roles and Position of Pharmacists inIndonesia
1.

Undertaking pharmaceutical work in procurement of pharmaceutical preparations in
production facility, distribution facility and pharmaceutical care facility  ensuring thesafety, quality, benefits and efficacy of Pharmaceutical Preparation

2.

Undertaking pharmaceutical work in production of pharmaceutical preparations 
ensuring compliance with the GMP (responsible person in production, QC, and QA
Departement)

3.

Undertaking pharmaceutical work in distribution of pharmaceutical preparations 
ensuring compliance with the GDP (responsible person in drug distribution facility)

4.

Undertaking pharmaceutical work in pharmaceutical care  ensuring compliance withthe pharmaceutical care standard (responsible person in Pharmacy, Hospital Pharmacy
Installation, Community Health Center, Clinic, Drug Store, Shared Physician Practice)In undertaking pharmaceutical work, pharmacist shall ensure and maintain theimplementation of Quality Management System

Good Practices
Drug Promotion & Label/Information Control• Providing online database of
drug promotion approval as
reference for regional offices• Giving assistance topharmaceuticalmanufacturing &regional offices• Providing online system forsubmission of drug
advertisements approvalDrugpromotion
control after
publication

Drugpromotion
approval

Awareness &knowledge ofpharmaceuticalmanufacturing
and regional
offices

Guidance－ 272 －

• Providing regulation on
guidance of drug
advertisements

CURRENT ISSUE & CHALLENGE
Current Issue
Changing trend of drug
promotion/advertising from traditional
media to online media including on social
media

Challenge‐ Needs regulation for law enforcement‐ Needs infrastructure and human resources
for monitoring‐ Needs collaboration with otherministry/agency i.e. Ministry ofCommunication and Informatics

Interest and Expectationa. Acquiring information about:•

The regulatory management in Japan for access to quality medicines including thesystem of quality, information/label and promotion control•

The actual operations both in governmental and medical institutions for ensuring
quality of medicines•

Utilization of information technology in Japan in quality, information/label andpromotion control including online drug promotion

b. Doing observation at pharmaceutical company and pharmacy
Through this programme, I hope to be able to:‐ Improve my knowledge in roles of Regulatory System on Ensuring Access to Quality
Medicines.
‐ Improve the system of online drug promotion control－ 273 －

Regulatory Systems on Ensuring Access to Quality Medicines (JFY 2018）
Inception ReportName: Dewi Nopitasari

Country: Indonesia

Organization/Division: National Agency of Drugand Food Control (NADFC) / Directorate of
Safety, Quality, and Export-Import Control ofDrug, Narcotic, Psychotropic, Precursor andAddictive Substance

National Agency of Drug and Food Control Republic of Indonesia (NADFC) is assigned and functioned
as national regulatory authority on pharmaceutical administration in Indonesia.
Vision of NADFC: Safe Food and Medicine to Improve Public Health and National Competitiveness.
Mission:
1. Intensifying Risk-based Drug and Food Control System to protect public health
2. Encouraging Self Reliance of Bussiness Actors in ensuring Drug and Food Safety andstrengthening partnership with stakeholders
3. Enhancing NADFC institutional capacity.
Organizational Chart
The organizational chart of NADFC at national & provincial offices (Attachment 1).
Organization of Directorate Of Drug Registration (Attachment 2).
Legislation on Pharmaceutical administration
In national level, legislation on pharmaceutical administration is conducted by Indonesia NADFC,
under The Deputy of Drug, Narcotic, Psychotropic, Precursor, and Addictive Substance Control. The
technical implementation of drug control locally is conducted by NADFC regional offices in 33
provincesIndonesia has become a PIC/S member No.41, effective since 1st July 2012.
Regulatory services
Regulatory services for pharmaceutical product are conducted by NADFC, under the Deputy of Drug,
Narcotic, Psychotropic, Precursor, and Addictive Substance Control, which responsible for theadministration of:Pharmaceutical manufacturing
Administered by : Directorate of Drug, Narcotic, Psychotropic, and Precursor Production Control
Standard: Indonesia GMP Code 2012 Edition－ 274 －

Drug import/export system
Administered by : Directorate of Safety, Quality, and Export-Import Control of Drug, Narcotic,
Psychotropic, Precursor and Addictive Substance (Sub-Directorate of ExportImport Control of Drug, Narcotic, Psychotropic, and Precursor)
Standard: Regulation of the Minister of Health and Head of NADFC Regulation on Export
and Import of Narcotic, Psychotropic, and Pharmaceutical Precursor
Merketing authorization
Administered by : Directorate of Drug Registration
Standard: Regulation of the Minister of Health on Drug Registration, Head of NADFC
Regulation on Criteria and Procedure of Drug Registration
Drug distribution
Administered by : Directorate of Drug, Narcotic, Psychotropic, Precursor, and Addictive SubstanceDistribution Control
Standard: Indonesia GDP Code 2012 Edition, Head of NADFC Regulation on the Procedureof GDP licensing

Medicine safety (post-marketing)
Administered by : Directorate of Safety, Quality, and Export-Import Control of Drug, Narcotic,
Psychotropic, Precursor and Addictive Substance (Sub-Directorate of Safety
Control of Drug, Narcotic, Psychotropic, and Precursor)
Standard: Regulation of the Minister of Health on Pharmaceutical Industries, Head of
NADFC Regulation on the Implementation of Pharmacovigilance for
Pharmaceutical Industry

Relief System for Adverse Drug Reactions
None

Drug Pricing
Drug pricing policy is regulated and controlled by Minister of Health

Statistic Data
1. Number of pharmacists: ± 70.000 (2018)
2. Number of GMP inspector (National & Local): 111 personal (2018)
3. Number of pharmaceutical manufacturers / manufacturing sites: 210 (2017)
4. Number of traditional medicine manufacturers / manufacturing sites: ± 80 (2017)
5. Number of pharmaceutical importers: ± 185 (2017)
6. Number of pharmaceutical wholesalers: ± 2200 (2018))
Education and License of Pharmacists in your country
1. Number of years in primary, secondary and high school education
Primary : 6 years－ 275 －

2.

Secondary : 3 years
High school : 3 years
Number of years / weeks in the following categories during university or college
University / college: 3.5 -4 years
Professional education: 1 years (including practical training in national regulatory agency,
hospital pharmacy, community pharmacy, and pharmaceutical company)
Age at graduation: 23-24 years old

3.

Are there any national examinations for pharmacists in your country?
Yes, consist of academic exam (1 day) and practical exam (1 day)

4.

Which of the followings must you fulfil to obtain a pharmacist's license?
Practical training is necessary to prepare for the national examination

Side Effect Report
The monitoring system of side effect report conducted by NADFC consists of :1. Spontaneous reporting from health care professionals using Yellow Form (post mail to NADFC),
email to pv-center@pom.go.id or online reporting (http://e-meso.pom.go.id)
2. Report from pharmaceutical industries in the form of:- spontaneous reporting/CIOMS Form (using post mail to NADFC, email to pvcenter@pom.go.id or online reporting (http://e-meso.pom.go.id),- PSUR/PBRER , scientific publication and study reports (RMP), regulatory action in othercountry, and Marketing Authorization Holder action in other country (using post mail to
NADFC or email to pv-center@pom.go.id).
The rule and responsibility for side effect report as follows:
1. Regulatory and pharmaceutical industy are collaborating in managing risk in term of risk-benefit
ratio for population
2. Healthcare professionals and healthcare facilities manage risk in term of risk-benefit ratio forpatients
3. Patients manage risk in term of personal values－ 276 －

Attachment 1
The organizational chart of NADFC at national & provincial offices

NADFC Chairperson

Permanent
Secretariat

Principal Inspector

Inspector I

Inspector II

Bureauof LegalandOrganizati

BureauofPlanning
andFinance

Bureauof
Cooperation

Bureau ofGeneralAffairs and
HumanR

Deputy of Drug,
Narcotic, Psychotropic,
Precursor, andAddictive SubstanceControl

Deputy of Traditional
Medicine, HealthSupplement, andCosmetic Control

Deputy ofProcessed FoodControl

Deputy of Law
Enforcement

Directorate of Drug,
Narcotic,
Psychotropic,
Precursor, andAddictive SubstanceStandardization

Directorate of
Traditional Medicine,
Health Supplement
and Cosmetic
Standardization

Directorate ofProcessed FoodStandardization

Directorate ofPacification

Directorate of
Traditional Medicine,
Health Supplement
and Cosmetic
Registration

Directorate ofProcessed Food
Registration

Directorate of Drugand FoodIntelligence

Directorate of Drug,
Narcotic,
Psychotropic, andPrecursor Production
Control

Directorate of
Traditional Medicine,and HealthSupplement Control

Directorate of Low
and Medium Risk
Processed FoodControl

Directorate of Drugand Food
Investigation

Directorate of Drug,
Narcotic,
Psychotropic,
Precursor Distribution
Control

Directorate of
Cosmetic Control

Directorate of High
Risk and New
Technology ofProcessed FoodControl

Directorate of Drug
Registration

Directorate of Safety,
Quality, and ExportImport Control of Drug,
Narcotic, Psychotropic,
Precursor, and Addictive
Substance

Centre of Drug andFood Information

Directorate ofCommunity andIndustries
Empowerment

Centre of Human
Resources
Development

Centre of National
Quality Control
Development of Drug

－ 277 －

Bureau of
PublicRelation andStrategic
StProvincial
Offices(33 technicalunits)

Centre of Drug andFood Research andStudiesSection of Export Import
Evaluation of Drugs

Subdirectorate of Export Import Control
of Drugs, Narcotics, Psychotropics, andPrecursors

Section of Promotion andInformation Control of Drugs,
Narcotics, Psychotropics, andPrecursors

Section of Quality Control ofDrugs, Narcotics, Psychotropics,
and Precursors

Subdirectorate of Quality,
Information and Promotion Control ofDrugs, Narcotics, Psychotropics, andPrecursors

Directorate of Safety, Quality, and Export
Import Control of Drugs, Narcotics,
Psychotropics, Precursors, and Addictive
Substance

Section of Export Import
Evaluation of Narcotics,
Psychotropics, and Precursors

Attachment 2

Section of Promotion andAdvertisement Control of Tobacco
Product

Section of Label Control ofTobacco ProductSubdirectorate of Tobacco Products
Control

Organization of Directorate of Safety, Quality, and Export-Import Control of Drugs, Narcotics, Psychotropics, Precursor and Addictive Substances

Subdirectorate of Safety Control ofDrugs, Narcotics, Psychotropics, andPrecursors

Section of Safety Surveillance ofDrugs, Narcotics, Psychotropics,
and Precursors

Section of Pharmacovigilance
Implementation Control of Drugs,
Narcotics, Psychotropics, andPrecursors

Section of Operational and
Administration－ 278 －NATIONAL AGENCY FOR DRUG AND FOOD CONTROL (NADFC)REPUBLIC OF INDONESIABADAN PENGAWAS OBAT DAN MAKANAN (BADAN POM)
REPUBLIK INDONESIAANGGI TIARANIJICA Training Course : Regulatory Systems on Ensuring Access to Quality Medicines(J1804225)
Tokyo, July 2018

1

VisionMission

Safe Food and Medicine to Improve Public
Health and National Competitiveness.

 Intensifying Risk-based Drug and Food Control
System to protect public health Encouraging Self Reliance of Business Actors
in ensuring Drug and Food Safety andstrengthening partnership with stakeholders
 Enhancing NADFC institutional capacity.

2－ 279 －

PRE-MARKETCONTROL
GMP CERTIFICATIONPRODUCTSREGISTRATION

DISTRIBUTION

MARKETING
AUTHORIZATIONDRUG AND FOOD
INDUSTRIES

RnD

Trial

POST-MARKETCONTROL
IMPORT-EXPORTCERTIFICATIONPRODUCT SAMPLING AND
LABORATORIUM TESTINGLAW ENFORCEMENTCONSUMERSADVERTISEMENT
AND LABELMONITORING
MANUFACTURING AND
DISTRIBUTION SITE
INSPECTIONSURVEILLANCE AND
PHARMACOVIGILANCE

3(as Head of NADFC Regulation No 26/2017)
NADFC Chairperson

Principal Inspector
Inspector I

Permanent Secretariat

Inspector II

Bureau ofPlanning and
Finance

Bureau ofLegal and
Organization

Bureau of
Cooperation

Bureau of General
Affairs and Human
Resources

Deputy of Drug, Narcotic,
Psychotropic, Precursor, andAddictive Substance Control

Deputy of Traditional Medicine,
Health Supplement, andCosmetic Control

Deputy of Processed
Food Control

Directorate of Drug, Narcotic,
Psychotropic, Precursor, andAddictive SubstanceStandardization

Directorate of Traditional
Medicine, Health Supplement
and Cosmetic Standardization

Directorate of Processed FoodStandardization

Directorate of Pacification

Directorate of Drug Registration

Directorate of Traditional
Medicine, Health Supplement
and Cosmetic Registration

Directorate of Processed Food
Registration

Directorate of Drug and FoodIntelligence

Directorate of Drug, Narcotic,
Psychotropic, and Precursor
Production Control

Directorate of Traditional
Medicine, and HealthSupplement Control

Directorate of Low andMedium Risk Processed FoodControl

Directorate of Drug and Food
Investigation

Directorate of Drug, Narcotic,
Psychotropic, and Precursor
Distribution Control

Directorate of Cosmetic Control

Directorate of High Risk and
New Technology of Processed
Food Control

Directorate of Safety, Quality, andExport-Import Control of Drug,
Narcotic, Psychotropic, Precursor,
and Addictive SubstanceCentre of Drug and Food
Information

Directorate ofCommunity and Industries
Empowerment

Centre of Human Resources
Development

Centre of National Quality
Control Development of Drugand Food－ 280 －

Bureau of Public
Relation andStrategic Support

Deputy of Law
Enforcement

Provincial Offices(33 technical units)

Centre of Drug and Food
Research and Studies

4Directorate of Drug
Registration
Sub Directorate of
New Drug and Biological
Product Registration

New Drug
Registration
SectionRenewal andVariation of New
Drug Registration
SectionBiological ProductRegistration
SectionSub Directorate ofGeneric Drug
New Generic Drug
Registration
SectionSub Directorate of
Evaluation on Clinical Trial
and Product Therapeutic forSpecial Purpose

Renewal and Variationof Generic Drug
Registration Section

Bioequivalence
Evaluation Section

Clinical Trial
Evaluation Section
Therapeutic Productfor Special Access
Scheme Section
Administration andOperational Section

Joined with NADFC since 2005

Placed in Directorate of Drug and Biological Product Evaluation
General Staff at Directorate of Drug and Biological ProductEvaluation as variation of generic drug evaluator (2005-2013)
Senior Staff at Directorate of Drug and Biological ProductEvaluation as variation of generic drug evaluator (2013-2018)
Senior Staff at Directorate of Drug Registration as variation ofgeneric drug evaluator (2018-now)

5

6－ 281 －

The low awarenessand knowledge
about drug
registration andguidance

PROBLEMLong
timeline andcomplexprocedure of
drugregistration

ACTION
Providing a guidance of drug
registration
Giving assistance and workshop on
drug registration
Development and implementation ofelectronic
applicationofdrug
registration

7

ON GOING PROJECT• Random inspection prior to marketing authorization• Electronic application of drug registration (new AeRO)• Conducting coaching clinic on drug registration• Conducting desk consultation of drug registration
ACHIEVEMENT- Improvement pharmaceutical industry’s awareness and knowledge indrug registration- Simplification on drug registration by electronic application andderegulation of drug registration- Ensuring drug quality, safety, and efficacy distributed in society

8－ 282 －

Current Issue
The lack of equal understanding on
registration between NADFC officer
pharmaceutical industry

drug
and

The long timeline and complex procedure of drug
registration
The lack of coordination among NADFC and otherrelated sectors
Challenge
Limited human resources to achieve timeline goal
The competency of the evaluator to conform to the
updated drug regulation
Implementation of electronic application of drug
registration
9

Acquiring information about:• The regulatory management in Japan for access to quality medicines
including regulatory system, inspection system, as well as trends ofinternational collaboration among regulatory authorities• The actual operations both in govermental and medical institutions for
ensuring quality of medicines• Lectures on countermeasures against counterfeit medicines and the
problems related which may lead to public health issue.
Doing observation at pharmaceutical company and pharmacy
Through this programme, I hope to be able to:- improve my knowledge in roles of Regulatory System on Ensuring
Access to Quality Medicines.
- observe and identify process that can be improved in drug regulatory
system.

10－ 283 －

Regulatory Systems on Ensuring Access to Quality Medicines (JFY 2018）
Inception ReportName: Anggi TiaraniCountry: Indonesia

Organization/Division: National Agency of Drugand Food Control (NADFC) / Directorate ofDrug Registration

National Agency of Drug and Food Control Republic of Indonesia (NADFC) is assigned andfunctioned as national regulatory authority on pharmaceutical administration in Indonesia.
Vision of NADFC: Safe Food and Medicine to Improve Public Health and National Competitiveness.
Mission:
1. Intensifying Risk-based Drug and Food Control System to protect public health
2. Encouraging Self Reliance of Business Actors in ensuring Drug and Food Safety andstrengthening partnership with stakeholders
3. Enhancing NADFC institutional capacity.
Organizational Chart
The organizational chart of NADFC at national & provincial offices (Attachment 1).
Organization of Directorate Of Drug Registration (Attachment 2).
Legislation on Pharmaceutical administration
In national level, legislation on pharmaceutical administration is conducted by Indonesia NADFC,
under The Deputy of Drug, Narcotic, Psychotropic, Precursor, and Addictive Substance Control. The
technical implementation of drug control locally is conducted by NADFC regional offices in 33
provincesIndonesia has become a PIC/S member No.41, effective since 1st July 2012.
Regulatory services
Regulatory services for pharmaceutical product are conducted by NADFC, under the Deputy of Drug,
Narcotic, Psychotropic, Precursor, and Addictive Substance Control, which responsible for theadministration of:Pharmaceutical manufacturing
Administered by : Directorate of Drug, Narcotic, Psychotropic, and Precursor Production Control
Standard: Indonesia GMP Code 2012 Edition－ 284 －

Drug import/export system
Administered by : Directorate of Safety, Quality, and Export-Import Control of Drug, Narcotic,
Psychotropic, Precursor and Addictive Substance (Sub-Directorate of ExportImport Control of Drug, Narcotic, Psychotropic, and Precursor)
Standard: Regulation of the Minister of Health and Head of NADFC Regulation on Export
and Import of Narcotic, Psychotropic, and Pharmaceutical Precursor
Merketing authorization
Administered by : Directorate of Drug Registration
Standard: Regulation of the Minister of Health on Drug Registration, Head of NADFC
Regulation on Criteria and Procedure of Drug Registration
Drug distribution
Administered by : Directorate of Drug, Narcotic, Psychotropic, and Precursor Distribution Control
Standard: Indonesia GDP Code 2012 Edition, Head of NADFC Regulation on theProcedure of GDP licensing
Medicine safety (post-marketing)
Administered by : Directorate of Safety, Quality, and Export-Import Control of Drug, Narcotic,
Psychotropic, Precursor, and Addictive Substance (Sub-Directorate of Safety
Control of Drug, Narcotic, Psychotropic, and Precursor)
Standard: Regulation of the Minister of Health on Pharmaceutical Industries, Head of
NADFC Regulation on the Implementation of Pharmacovigilance for
Pharmaceutical Industry
Relief System for Adverse Drug Reactions
None

Drug Pricing
Drug pricing policy is regulated and controlled by Minister of Health

Statistic Data
1. Number of pharmacists: ± 70000 (2018)
2. Number of GMP inspector (National & Local): 111 personal (2018)
3. Number of pharmaceutical manufacturers / manufacturing sites: 210 (2017)
4. Number of traditional medicine manufacturers / manufacturing sites: ± 80 (2017)
5. Number of pharmaceutical importers: ± 185 (2017)
6. Number of pharmaceutical wholesalers: ± 2200 (2018)
Education and License of Pharmacists in your country
1. Number of years in primary, secondary and high school education
Primary : 6 years
Secondary : 3 years
High school : 3 years
2. Number of years / weeks in the following categories during university or college
University / college: 3.5 -4 years－ 285 －

Professional education: 1 year (including practical training in national regulatory agency,
hospital pharmacy, community pharmacy, and pharmaceutical company)
Age at graduation: 23-24 years old
3.

Are there any national examinations for pharmacists in your country?
Yes, consist of academic exam (1 day) and practical exam (1 day)

4.

Which of the followings must you fulfil to obtain a pharmacist's license?
Practical training is necessary to prepare for the national examination

Side Effect Report
The monitoring system of side effect report conducted by NADFC consists of :1. Spontaneous reporting from health care professionals using Yellow Form (post mail to NADFC),
email to pv-center@pom.go.id or online reporting (http://e-meso.pom.go.id)
2. Report from pharmaceutical industries in the form of:- spontaneous reporting/CIOMS Form (using post mail to NADFC, email to pvcenter@pom.go.id or online reporting (http://e-meso.pom.go.id),- PSUR/PBRER , scientific publication and study reports (RMP), regulatory action in othercountry, and Marketing Authorization Holder action in other country (using post mail to
NADFC or email to pv-center@pom.go.id).
The rule and responsibility for side effect report as follows:
1. Regulatory and pharmaceutical industy are collaborating in managing risk in term of risk-benefit
ratio for population
2. Healthcare professionals and healthcare facilities manage risk in term of risk-benefit ratio forpatients
3. Patients manage risk in term of personal values－ 286 －

Attachment 1
The organizational chart of NADFC at national & provincial offices－ 287 －

Attachment 2

Organization of Directorate Of Drug Registration

Directorate of Drug
Registration
Sub Directorate of
New Drug and Biological
Product Registration
New Drug Registration
SectionRenewal and Variation of
New Drug Registration
SectionBiological ProductRegistration Section

Sub Directorate ofGeneric Drug

New Generic Drug
Registration Section
Renewal and Variationof Generic Drug
Registration Section
Bioequivalence
Evaluation Section

Sub Directorate of
Evaluation on Clinical Trial and
Product Therapeutic for Special
PurposeClinical Trial Evaluation
Section

Therapeutic Productfor Special Access
Scheme Section

Administration andOperational Section－ 288 －

Regulatory Systems
on Ensuring Access to Quality Medicines

IRAQ－ 289 －

Republic of Iraq
Ministry of Health
The state company for marketing drugs andmedical appliances ( Kimadia )Pharmacist : Wijdan Hussain Sabeh Al-Allaq( Senior Chief Pharmacist )The state company for marketing drugs andmedical appliances( Kimadia )－ 291 －

The State Company for Marketing Drugs and Medical Supplies(KIMADIA)- The State Company for Marketing Drugs and Medical Supplies was established in1964 Governed by public companies Law no. 22 in 1997 and its internal system no. 1
in 1999 and its entirely owned by the state and linked to the ministry of health , itis the only authorized company in the Ministry of Health to import, store anddistribute medicines, supplies, medical equipment, vaccines and chemicals to all
health institutions in Baghdad and the rest of the provinces of Iraq, and distributethem to all hospitals, health centers and Popular clinics.

Vision: Providing medicines and medical supplies of high quality with lowest costto all citizen over the year.

Mission:Providing medicines and medical supplies for all beneficiaries by importingthem from Arab and foreign countries in addition to national governmental andprivate factories through the optimal use of available resources.

Organization Chart of Kimadia
Director
General andChairman of
the Board
The assistantdirector general for
administrative,
financial, and legal
affairs

The assistantdirector generalfor storage anddistribution

Legal
department

Financialdepartment

Departmentof medical
supplies
distribution

Customs
department
Department ofstorage anddistribution of
medicines

Information
technology
department

Drug
information andpublic relation
department

thecommittees
for thestudy andanalysis ofoffersCoordinationand follow-up
division

Department ofadministrative
affairs

Kimadia
warehouse* The main departments－ 292 －

The
assistantdirector
generalfor importaffairs

ImportDepartments

Institute ofserums andvaccines

Mechanism drug
information
divisionInternal
control
department

The laws in which the company operates
1- Federal Budget Law .
2-Iraqi Civil law No. 40 in 1951 .
3- Public companies Law no. 22 in 1997.
4- Law No. 60 in 1998 for the scientific Bureaus and the instructions No. 4 in1998.
5- The law of practicing the profession No. 40 in 1970.
6- Public Health Law No. 89 in 1981.
7- The Government Debt Collection Law No. 56 in 1977.
8- The Law of Governmental Contracts No. 87 in 2004 and Instructions for
executing government contracts No. 2 in 2014.
The Ministry is currently working on the preparation of special instructions andcontrols for the purchase of medicines, medical devices and supplies, taking inconsideration the privacy of these materials and currently under considerationand study with the higher authorities in order to shortening many formal
procedures that do not conflict with the objective and scientific aspect of theprovision of these materials and thus contribute to the provision of medical
service in accordance with the objectives and mission of our ministry.

The Mechanism of Purchase in Kimadia• The contracting process takes about one year from the arrival of the annual
needs of medicines ( represent health institution needs for the next year )until the signing of contracts and arrival of the medicines and distribution
to the health institutions ,this process goes through the following stages:• Announcement Invitation: General Tenders , Direct invitations or invitationof one bid to the monopolistic companies , also invitations for directpurchase from the national ( governmental and private ) manufacturing
factories.
* All companies must introduce their offers according to the Standard Bidding
Documents attached with the invitation conditions.
• Study Offers by the committees for the study and analysis of the offers andmaking recommendations.
• Preparing and organizing Contracts by Import departments.
• Insurance of financial allocations.
• Open documentary Credit.
• Arrival of medicines to Kimadia Warehouse.
• Send Samples to the national center for drug control and research (NCDCR)
for analysis.
• Release and distribution of medicines from warehouses of Kimadia to thehealth institution after its success in the analysis.
* The Above processes done by Special instruction & laws.
－ 293 －

The Future Vision of KIMADIA
1- Developing cooperation in the scientific field with the research
institutions for medicine and exchange of experiences between ourcompany and the other side who wish to cooperate.
2. Entry of Kimadia as a shareholder with the national and foreigncompanies producing the medicine and appliances under an agreement
between two sides .

Office of assistant of director general affairs
Responsible for follow up of:- The study and analysis of the offers from the producing companies in the
study committees.
- All contracts of the import departments.
- The arrived items to the stores and their success in laboratory tests andevaluation.
- Coordinate the work between the departments of the company.
All the above mentioned duties to ensure the distribution of high quality
medicine to our health institutions continuously.

－ 294 －

Good Practice- Training in hospitals ( consultant clinic pharmacy)- Training at Samarra governmental pharmaceutical factory- Medicine import department ( contracts ).
- Laboratory import department( contracts after study the offers )- Kimadia warehouse especially for chemotherapy and immunosuppressant.
- committee for the study and analysis of drugs offers for many of producing
companies and for the national factories ( governmental and private ).
- Medical appliances import department .
- Training course at ST.Jude Brussels Medical Advanced Technology Center andthe program field is(ST.Jude combined vascular & cardiac surgery training.
- Office Of Assistance Director General For Import Affairs.
- ICD-10 training course at the directorate of planning and resource
development.
- Visiting many of manufacturing company at many countries.

Difficulties/Lessons Learned from Past Experience- Some of medicines doesn't success in analysis at the National Center for Drug
Control and Research (NCDCR) or not possible to do some tests because of lack ofequipment in the center or lack of experiences to do these tests especially forthe unconstitutional medicines.
- Inaccurate estimation of the annual requirements from health institutions.

- Selection of registered medicines of high quality and effective with lowest priceat the committee for the study and analysis of drugs offers.
- Do not receive offers for some medicines like ( medicines for rare diseases andantidote ) and difficulties to get offers for these items even after doing direct
invitation to the producing company.

－ 295 －

Interests-To increase the experience after viewing the latest system that applied in anadvanced country such as the state of Japan to supply safe medicines of highquality and to provide the best health services for the Iraqi citizens.
-To know what the bases that we depend on to select the safe and highly
effected medicine and to prevent trading of counterfeit medicines in order tocreate healthy environment and raise the level of pharmaceutical services in
the country.
- Gaining the experiences from the participating countries in this program.

To Contact With Us
Visit our website
www.kimada.iq
You can contact us via our E- mails below
dg@kimadia.iq
dg1@kimadia.iq
dg2@kimadia.iq
gen.relat@kimadia.iq－ 296 －

Duration course 8th,July - 8th, August, 2018
Pharmacist: Wijdan Hussain Sabeh Al-Allaq
Country: Republic of Iraq
Ministry of Health/The state company for marketing
drugs and medical appliances/ Office of assistancedirector general for import affairs

Republic of Iraq
Ministry of Health－ 297 －

Demographic data
Total population: 37,139,519 million in 2017 (7,916,847 million in Baghdad. ).
Population growth rate 2.2
Urban population is about 69.8% , rural population is about 30.2% of the total.
40,5% of the population is under 15 years of age and 5,0% is over 60 years.
Life expectancy at birth estimated 70.3 (68.3 for males and 72.3 for females).

Vital events indicator
Crude birth rate per (1000) of the population is (28.05)
Percentage of births inside health institutions is 83.5%
Percentage of births less than 2.5 Kg. is 6.6%
Percentage of caesarean section deliveries is 35.2%• This information from annual statistical report 2017/Republic of Iraq/ Ministry of Health

Ministry of Health
VisionComprehensive efficient and applicable Health Information System.

Mission
The Ministry of Health works to provide the infrastructure and logistic
supplies to build a statistical information base and an integrated, sustainable
Health Information System to insure access to health information by decision
makers, policy makers and researchers in the field of health to improve thecomprehensive coverage, quality and efficiency of health care with highest
quality.

－ 298 －

Organization Chart of Ministry of Health*
Minister of
HealthAgents of the
Minister of HealthInspector
general officeand Inspection
department

Directorate oftechnical
affairs

Kimadia

KimadiastoresImportdepartments

Pharmacy
department

Registration
department

The national
center for
drug control
and researchNeedestimation
department

Directorateof public
healthCommittee
ofmedicines
selection

Directorate ofplanning andresource
development
Drug
information
bureauAdvisory
Committees
SectionIraqi
pharmacovigilance
centerCommittee of
herbal medicinesand food
supplement
selection* The main departments

Health services and Medicines regulation departments in the Iraq Ministry of Health:All departments in the ministry play important role to regulate and control all health services and medicines
regulation in cooperation between them for the safety of the Iraqi citizens , listed below the main tasks of themain departments briefly:- Directorate of planning and resource development : concerned with affairs of health staff and the planningof health policy and record all the data base of the ministry and responsible for training developing of healthpersonnel by doing training courses like ( ICD-10 ) and training courses for clinical pharmacists andworkshops.
-Directorate of public health: health promotion and planning for health education for citizen and preparing for
epidemics .
- Kimadia: the only authorized for import and distribution of medicines, medical appliance, laboratory
reagents& equipment , medical equipment.
- Directorate of technical affairs: the most important department to control the health system and theimportant departments:
1- Committee of medicines selection: responsible for endorsement and selection of the medicines andarrange them in the essential list with their specification to be imported by Kimadia , Committee of herbal
medicines and food supplement selection related to this committee .
2-Need estimation department : collect the annual estimation of the medicines, medical appliance, laboratory
reagents& equipment , medical equipment for all health institution.
3- Registration department: responsible for registration of medicines and the manufacturing company withspecial conditions to guarantee the high quality of the medicines
4-The national center for drug control and research ( NCDCR): responsible for the analysis and evaluate all
the imported items for governmental and private sector.
5-Pharmacy department : responsible for organization and control trading process of medicines and medical
appliances and follow up the pharmaceutical issues for governmental and private sector , also responsible
for organization of import licenses to the scientific bureaus, ,and Iraqi pharmacovigilance center is one of
the important part in this department.
- Inspector general office and Inspection department: a supervisory authority cooperate with all departments.

－ 299 －

Legislation on Pharmaceutical Administration
The laws in which the ministry operates
There are many laws that arrange the work in the ministry like :- Federal Budget Law .
- Iraqi civil law No.40 in 1951.
- Law of the ministry of health No.10 in 1983.
- The law of practicing the profession No. 40 in 1970.
- Public Health Law No. 89 in 1981.
- Law of cancer council No.63 in 1985.
- Law of narcotics No.68 in 1965.
- Law of psychological health No.1 in 2005.
- Public companies Law no. 22 in 1997.
- Law No. 60 in 1998 for the scientific Bureaus and the instructions No. 4 in 1998.
- The Government Debt Collection Law No. 56 in 1977.
- The Law of Governmental Contracts No. 87 in 2004 and Instructions for executing
government contracts No. 2 in 2014.
The Ministry is currently working on the preparation of special instructions and controls forthe purchase of medicines, medical devices and supplies, taking in consideration theprivacy of these materials and currently under consideration and study with the higher
authorities in order to shortening many formal procedures that do not conflict with theobjective and scientific aspect of the provision of these materials and thus contribute to
the provision of medical service in accordance with the objectives and mission of our
ministry.
PIC/S : NO

Regulatory Services Pharmaceutical Manufacturing:-The ministry of health has taken several measures aimed at supporting thenational pharmaceutical industry while supporting investment in thepharmaceutical production sector in order to secure a number of varieties
domestically .
-National production currently covers only 20% of the country need .
-All the national factories products must be registered at the registration
department .

- The number of the national pharmaceutical factories is (26).
- Samarra pharmaceutical factory is one of the largest factory specialized in thepharmaceutical industry in the country which was founded in 1959, and thegraduated pharmacists train during the first year after graduation in its
manufacturing department & in the evaluation and quality control department.

－ 300 －

Regulatory Services

 Drug Import/Export :-The state company for marketing drugs and medical appliances ( Kimadia) is
the only authorized company in the Ministry of Health to import, store anddistribute medicines, supplies, medical equipment, vaccines and chemicals
to all health institutions in Baghdad and the rest of the provinces of Iraq , incooperation with other departments of ministry of the health.
-The scientific bureaus are responsible for import the medicines and medical
appliances for the private sector.

Regulatory Services Marketing Authorization, Drug Distribution :-Departments of storage and distribution of medicines and medical
appliances in Kimadia are responsible for the distribution of medicines to all
the health institution after successful in the analysis in the national centerfor drug control and research(NCDCR).

-

In the private sector the scientific bureaus are responsible for distribution
the medicines and medical appliances to the private sector after successful
in the analysis in the national center for drug control and research.

-

The items that allowed to be imported are only the registered items in theessential lists which has been listed before by the national committee forselection of the medicines.

－ 301 －

Regulatory Services
 Medicine Safety ( post-marketing) & Relief system for adverse drug reaction:-

Iraqi pharmacovigilance center in the pharmacy department in the ministry of health is
responsible for follow up the adverse effects (ADR)of the medicines , herbal medicines
and appliances after marketing and after used by patients, and this center depend on :••The medical staff when they report any side effects or ( ADR) appears on the patients .
The community in documenting and registration the side effects that appears when they
use the medicines by communicate through the websites of the centers , so that thecenter can study and identify the cause do the scientific action to prevent or reducethem in the future , and the web site of Iraqi pharmacovigilance center is( iraqiphcv@moh.gov.iq ) .

•The pharmaceutical companies which make conducts field studies continuously to follow
up their products after marketing and to introduce their reports for drug safety andefficacy(as mentioned in the next page ) by introducing continues reports includes
therapeutic recommendations for proper use by the medical staff like the other countries
and to reduce the side effects and to follow up the percentage of risks against benefits ofmedicines to reach to the proper use of the medicines .

-Iraqi pharmacovigilance center send a copy of the reports to the Uppsala Monitoring

centre for international scientific research in Sweden which associated closely with WHO
to adopt them in the world drug control program.

Instructions of the pharmacovigilance- Instructions of the pharmacovigilance: All the pharmaceutical companies must :1- apply pharmacovigilance system to the company organizational structure andmust introduce official commitment to the registration department to depend
and maintained this system.
2- prepare pharmacovigilance system master file (PSMF) for all the medicinesand must be available when requested by the Iraqi pharmacovigilance center .
3-prepare updated periodic safety reports {periodic benefit risk evaluation
report, periodic safety (PSUR-PBRER)} including the detection of variables andfollow-up the efficacy of the medicines and introduce to Iraqi pharmacovigilance
center.
4-Select one of the medical staff as local safety responsible (LSR) to carry outtasks and responsibilities for pharmacovigilance.

* The Iraqi pharmacovigilance center do periodical visits to the scientific bureaus
that represent the pharmaceutical companies in Iraq to continue applying
pharmacovigilance system and decisions will be taken against them if notapplied.

－ 302 －

Drug pricing
Drug pricing is done through a specialized ministerial committee
called the pricing committee which includes members from thepharmacy & registration departments in the directorate oftechnical affairs with a member of the pharmacists syndicate.

Statistic Data of Ministry of Health 2017
Items

NumberTotal number of governmental hospitals & Specialized centers with
inpatients

273

Total number of private hospitals

127

Total number of governmental hospitals’ beds

44527

Number of human resources works in health Field

252723

Number of human resources works in Ministry of health216681

Total number of physicians

31451

Number of dentists

9524

Number of pharmacists

10939

Number of nursing staff

64297

Number of paramedical staff

59961

Number of medical collages

28

Number of collages of dentistry

43

Number of collages of pharmacy37－ 303 －

Education and license of pharmacists in the republic of Iraq
The study

The duration

Primary school

6 years

Secondary school

6 years

High school ( collage of pharmacy)

5 years

The pharmacist registered at the syndicate of pharmacy and can practice theprofession directly after graduation from the collage of pharmacy and take thelicense to open the own pharmacy after three years of graduation from thecollage of pharmacy according to the law of practicing the profession no. 40 in1970 , also there are many training courses organized by the ministry todevelop the pharmacists skills especially the clinical pharmacists.

Statistic Data of Syndicate of Iraqi Pharmacists 2018
Items

NumberNumber of pharmacies

12500

Number of the scientific Bureaus

400

Number of the whole store

680

Side effect reports
There are many reports arrived to Iraqi pharmacovigilance center about the medicines
in the pharmaceutical market and we take some examples of them:- There was a report of serious symptoms due to the use of (plavix 75mg tab.) thatused in the private sector and after analyze it in the laboratories of the manufacturing
company( SANOFI pharmaceutical company )they found it doesn't contain the active
ingredient and the necessary action was taken by Iraqi pharmacovigilance center andnotify the health institution not to use this product for the safety of the citizens.
-SANOFI pharmaceutical company has reported Iraqi pharmacovigilance center about
the existence of counterfeit (Daonil 5mg tab.) in the private sector and they doanalysis to the counterfeit batches at their company laboratories and found thesetablets doesn't contain any active ingredient and the necessary action was taken by
Iraqi pharmacovigilance center.
Novartis pharmaceutical company has reported Iraqi pharmacovigilance center about
the existence of counterfeit medicine { Exoforge(valsartan+amlodipine)5/160mg tab.}and they notice that because their original products contain Serial NO. and Barcode
and Iraqi pharmacovigilance center notify the health institution not to use this productfor the safety of the citizens.
* Iraqi pharmacovigilance center notified the inspection department in the ministry
and in the health institutions ( governmental and private) about the adverse effectreports to cooperate in controlling the situation for the safety of the citizens.

－ 304 －

Regulatory Systems
on Ensuring Access to Quality Medicines

MYANMAR－ 305 －

Republic of Union of Myanmar
Ministry of Health and Sports
Department of Food And Drug Administration

Dr Mg Mg Thi Ha Htwe

1. Introduction of the work
(1)

Organization and department- Ministry of Health and Sports- Department of Food and Drug Administration(2) Job tenure- Assistant Director, Kayin State FDA(3) Regulatory services that I am engaged in(a) Pre- market assessment- GMP inspection of food factories(b) Post market assessment- pharmacies inspection (GPP)- pharmaceutical warehouse inspection ( GSP)
- Inspection on food shops and stores relating to food andcosmetic safety- Testing samples of food, drug and cosmetic in mini-laboratory- Public awareness about food, drug and cosmetic safety1－ 307 －

(4) roles and position of pharmacists in country
1. Clinical Pharmacists (in hospitals)-Manage the supply chain of drug store
2. Pharmacists in Research-Carrying out in analytical research of drugs and clinical trial
3. QC managers and Production managers in pharmaceuticalfactories
4. Academic pharmacists (in universities of pharmacy)
5. Sale managers (in pharmaceutical companies)
6. In-charge in private pharmacies-Manage GPP and GSP of pharmacies
7. Regulators in food and drug administration
2

2. Good PracticeExperiences about Good Practices
Achievement
1. Most of pharmacies came to notice GPP and abide thenational drug law
 No selling of unregistered drugs, expired drugs and multicombined drugs packs
 Can differentiate and sell POM and OTC
 Obtain information about falsified drugs
 Proper storage condition of drugs (+)
2. More skillful inspectors
3. Quality Lab services in local
4. Increased public awareness3－ 308 －

2. Good Practice
Solutions for past problems
1. Strengthen GPP training
2. Enforce law and regulation
3. Public awareness programs
4. Increased sampling and quality Lab testing
5. Regular inspection on pharmacies
On-going projects to deal with current problems
1. Training on members of township food and drugsupervisory committees about GPP
2. Risk-based PMS activities
3. Detecting and taking action drugs selling shops without
license4

2. Good Practice
4. More participation of township food and drug supervisorycommittee
5. Similar penalties for same offences all over the country
Successful countermeasures against problems
1. Regular Inspection on pharmacies (GPP & GSP)
2. Quality Mini-laboratory services
3. Notify the public and pharmacies
4. Training the inspectors, wholesalers and retailers
5. Public awareness programs
5－ 309 －

3. Difficulties/Lessons Learned from Past Experience

1. Many armed forces and illegal border trade
2. Light penalty for violation of the law
3. Weakness of activities of Township food and drug supervisorycommittees
4. Limited resources (man power, facilities, finance, etc)
5. Different penalties in different states and regions

6

4. My interests(1) GMP inspection training(2) Proper supply chain system(3) Administrative management in pharmaceuticalregulatory system

7－ 310 －

Part I: INFORMATION SHEETRegulatory Systems on Ensuring Access to Quality Medicines （JFY 2018）
Name: Mr. Mg Mg Thi Ha Htwe
Country: Republic of Union of Myanmar
Organization/Department/Division: Department of Food and Drug Administration,
Ministry of Health and Sports
1. Organizational Chart- Attached (Annex-1)
2. Legislation on pharmaceutical administration◆National Level
・Public Health Law (1972)
administered by Myanmar Food and Drug Board of Authority
・National Drug Law (2014 Amendment)
administered by Myanmar Food and Drug Board of Authority
・Narcotic Drugs and Psychotropic Substances Law (1993)
administered by Myanmar Food and Drug Board of Authority
・Traditional Drug Law (1996)
administered by Myanmar Food and Drug Board of Authority◆Local Level
・Public Health Law (1972)
administered by State and Region Food and Drug Supervisory Committee
・National Drug Law (2014 Amendment)
administered by State and Region Food and Drug Supervisory Committee
・Narcotic Drugs and Psychotropic Substances Law (1993)
administered by State and Region Food and Drug Supervisory Committee
・Traditional Drug Law (1996)
administered by Department of Traditional Medicine◆PIC/S- No
3. Regulatory Services◆Pharmaceutical Manufacturing
・Good Manufacturing Practiceadministered by Myanmar Food and Drug Board of Authority◆Drug Import/Export
・Good Storage Practiceadministered by Myanmar Food and Drug Board of Authority
・Good Distribution Practiceadministered by Myanmar Food and Drug Board of Authority◆Marketing Authorization
・ASEAN Common Technical Dossier (ACTD)
administered by Myanmar Food and Drug Board of Authority－ 311 －

・Laboratory analysis and confirmatory clinical trials
administered by Myanmar Food and Drug Board of Authority◆Drug Distribution (including drug selection, procurement, sale)・Good Clinical Practiceadministered by Department of Health◆Medicine Safety (post-marketing)・Good Pharmacy Practiceadministered by Department of Food and Drug Administration and Township Food and Drug
Supervisory Committee
・Good Pharmacovigilance Practiceadministered by Department of Food and Drug Administration and Department of Health◆Relief System for Adverse Drug Reactions
・Adverse Drug Reactions Monitoring Systemadministered by Department of Food and Drug Administration and Department of Health
4. Drug Pricing
There are no price control and drug price mechanism at public sector in my country.
5. Statistic Data
1. Number of pharmacists
3300(year 2018)
2. Number of GMP inspector (National & Local)
10 (year 2018)
3. Number of pharmaceutical manufacturers / manufacturing sites 9/ Yangon, Pyin Oo
Lwin,Kyaut Sae, Sagaing Township
4. Number of traditional medicine manufacturers / manufacturing sites About 100
5. /capital cities (year 2018)
6. Number of pharmaceutical importers
210 (year 2018)
7. Number of pharmaceutical wholesalers> 700 (year 2018)
6. Education and License of Pharmacists in your country(1) Number of years in primary, secondary and high school education
Primary
5 years
Secondary
4 years
High school
2 years(2) Number of years / weeks in the following categories during university or college
University / college:
4 years
Professional education:
3 years
Practical training:
4 years
Duration of training by each facility:
3 years
Hospital pharmacy:
12 weeks
Community pharmacy:- weeks
Pharmaceutical company:- weeks
Others:
1weeks (Pharmaceutical factory)
Age at graduation:
22 years old－ 312 －

(3) Are there any national examinations for pharmacists in your country?
Yes
Academic Exams
2 daysClinical Exams- days(4) Number of pharmaceutical university or college graduates: 250 people/per year
The alumni's placement rate (%)
a. Hospital:
10 %b. Community Pharmacy:30 %c. Government Organization:
5 %d. Enterprise:
20 %e. Others:
35 %(5) Side effect report
When a severe side effect case is occurred in a medical institution, the head or
medical superintendent of that institution informed to the department of health. And then,members of that department and the department of food and drug administration make aninspection team where members of department of health inspect the signs and symptoms
of side effects, nature of underlying disease and medical staff ' use of medicine while
members of department of food and drug administration inspect the quality and safety of
medicine. According to their findings, conclude the cause of side effect and take action.

－ 313 －

Annex-I
1. Organizational Chart of pharmaceutical administration at national/state & local
levelsMyanmar food and drug board of authority

Food advisory committee

Drug advisory committee
Central food and drug supervisorycommittee

State and region food and drug supervisory committee

District food and drug supervisory committee

Township food and drug supervisory committee－ 314 －

Role and responsibility on pharmaceutical administration
Myanmar food and drug board of authority was formed according to the national druglaw amending in 2014. The union minister of health and sports is the chairman of Myanmar
food and drug board of authority. Director General of department of food and drug
administration is the secretary of that board of authority and also the chairman of Central
food and drug supervisory committee while Drug control director of department of food anddrug administration is the secretary of that committee. Heads of states/regions and districts
health department are chairmen while heads of department of food and drug administration instates/regions and districts are also secretaries of respective States/ regions and districts foodand drug supervisory committees. There is no office of department of food and drug
administration in township level where the head of health department is the chairman.
Drug advisory committee provides technical support relating to drugs.
Role and responsibility of Myanmar food and drug board of authority (National level)
1. Laying down the policy relating to registration of drugs
2. Laying down the policy relating to determination of an essential drugs
3. Laying down the policy relating to the utilization of drugs
4. Determining the qualifications of persons entitled to apply for license and the terms
and conditions thereof for the manufacture, storage, distribution and sale ofpharmaceutical raw material or registered drug
5. Stipulating terms and conditions for the manufacture, import, export, storage,
distribution and sale of pharmaceutical raw material or registered drug
6. Determining good practices for assurance of quality in respect of manufacture, clinicaltests and laboratory analyses of the pharmaceutical raw material or registered drug andall matters relating to drugs
7. Permitting, refusing, temporary revocation and cancelation of registration of drug
8. Granting, refusing, temporary revocation and cancelation of a license
9. Stipulating terms and conditions relating to labeling of drugs, and advertising
10. Determining and cancelling any type of substance as a drug
11. Forming committees in respect of matters relating to expertise and determining thefunctions and duties of such committees
12. Forming Food and Drug Supervisory Committees in the states, divisions, districts andtownships in order to supervise matters relating to food and drugs; determining thefunctions and duties of such committees
13. Prescribing primary laboratories and appellate laboratories
14. Stipulating terms and conditions relating to food
The Board of Authority may delegate any organization or any person to carry out its
functions and duties.
Role and responsibility of central food and drug supervisory committee (Central level)
The Board of Authority delegated the central food and drug supervisory committee tocarry out its functions and duties.

－ 315 －

Role and responsibility of state/region food and drug supervisory committee(State/Region level)
1. Supervising district and township food and drug supervisory committees relating topermitting of pharmacy license
2. Supervising the manufacture, storage, distribution and sale of pharmaceuticalenterprises and food manufacturing businesses within the state/region
3. Carrying out the duties and functions of district and township food and drugsupervisory committees by itself if necessary
4. Obeying the order and directive issued by the central food and drug supervisorycommittee
Role and responsibility of district food and drug supervisory committee (District level)
1. Confirmation, postponing and cancelation of the pharmacy license from township foodand drug supervisory committees
2. Supervising the manufacture, storage, distribution and sale of pharmaceuticalenterprises and food manufacturing businesses within the district
3. Carrying out the duties and functions of township food and drug supervisorycommittees by itself if necessary
4. Confirmation, postponing and cancelation and directing action taking of township foodand drug supervisory committees relating to food and drug
5. Obeying the order and directive issued by the superior food and drug supervisorycommittee
Role and responsibility of township food and drug supervisory committee (Townshiplevel)
1. Issuing, postponing and cancelation of pharmacy license
2. Supervising, inspection and taking action the offences relating to all matters of foodand drug
3. Obeying the order and directive issued by the superior food and drug supervisorycommittee－ 316 －

Regulatory Systems
on Ensuring Access to Quality Medicines

SAMOA－ 317 －

SAMOANATIONAL HEALTH SERVICES
PHARMACY DIVISIONLEOLASI TAFUA-RIVERS
Principal Pharmacist Outpatient

Regulatory Systems on Ensuring
Access to Quality Medicines

INTRODUCTION-SAMOA
Population: 195,125
Population Growth Rate:
0.703% Annually
Age Dependency Ratio:
73.375% Working-Age
Population
Infant Mortality Rate:
14.8/1000 live births
Life Expectancy:
75.013 years

•
•
•
•
•
•

globaledge.msu.edge (2016)

Healthcare Treatment
Private OR Public
PRIVATE
14 Private Medical Clinics(approx. 16 Full-time Dr’s)
8 Private Pharmacies
2 Dental Clinics
1 Physiotherapist
3 Alternative Therapy
Numerous Traditional
Healers
Samoa Healthcare Sector Plan 2007-15

1－ 319 －

PUBLIC HEALTHCARENATIONAL HEALTH SERVICE A. Two Main Hospitals(NHS)
I.
Tupua Tamasese Meaole‘To deliver an efficient,effective and affordable
service to Samoa’

National Hospital in Apia, Upolu
(TTM)
II.
Malietoa Tanumafili II in
Tuasivi, Savaii (MTII)NHS operates as a government
corporate entity.
Funding for this service is 100% B. Six District Hospitals
from government, a small % fromcost recoveries.
C. Two Community Health
Cost recovery is minimal withservices practically fully subsidised. Centers

NHS Annual Report 2013‐14

2Roles of a Pharmacist in Samoa
PUBLIC AND PRIVATE• DISPENSE RX’S
• COUNSEL PATIENT AND PROVIDE FREEHEALTHCARE ADVICE• SELF CARE SERVICE• MEDICINE USE REVIEW• SMOKING CESSATION

5－ 320 －ORGANISATIONALSTRUCTURE

3－ 321 －

INPATIENTPHARMACY

Dispensing
Rx's foradmittedpatients safely
and keeping
their records.

NHS PHARMACY DIVISIONOUTPATIENTPHARMACY

Procurement,
storage anddistribution of
medicines andmedicalsupplies to allservicedelivery points
in Samoa.

WAREHOUSE

To
manufacture
local
preparations
pursuant toorders from
Inpatient,
Outpatient,Community
and District
Hospitals

MANUFACTURING

To assist with
distribution,
dispensing
andprocessing of
Rx's torural/district
hospitals.

COMMUNITY
OUTREACH

PHARMACY

Dispensing of
Rx's fromprivate andpublichealthcare
clinics. Ensure
records are
kept safe andsecure.

4－ 322 －

GOOD PRACTICE• Standard Operating Procedures (SOP’s)developed• Established an Essentials Medicines List (EML)
updated every 3 years• Ensure adequately trained staff on hand to
implement good practice and maintainprofessional standards

6

GOOD PRACTICE

Projects: Developing ongoing guidelines tomanage and regulate not only the
procurement, but the prescribing anddispensing process.
Countermeasures: Standard operatingprocedures developed and reviewed bydepartments to help manage problems that
may arise and resources7－ 323 －

DIFFICULTIES/LESSONS LEARNED FROMPAST EXPERIENCE• Managing limited resources• Short Staffed• Inadequate Training• Drug shortages• Medicine quality compromised

8

ISSUES

1. Interested in Regulatory Systems Japan
employs
2. Challenge applying knowledge learned
given vast differences between countries
involved
3. Language barrier

9－ 324 －

THANK YOU
FAAFETAI LAVA

10

－ 325 －

Annex1

Regulatory Systems on Ensuring Access to Quality Medicines （JFY 2018）
Inception Report Guideline
As indicated in the General Information, all participants are requested to prepare an Inception Report (Part I andPart II), and send it to JICA TOKYO and JICWELS (E-mail: ticthdop@jica.go.jp; jigyo@jicwels.or.jp) by 25
June, 2018. Please include ‘course title’ and ‘course number (J1804225)’in the e-mail.
This report consists of two parts: Part I and Part II. The main purpose of this report is to collect information inregard to pharmaceutical regulatory services of your country and more to help each participant to understand andcompare other countries' situations. Your report given here will be shared among all participants to prepare foractive discussions throughout the program. In each part, "why, what, when and how" to be used is explained.
Please follow the directions in each part.
Part I:INFORMATION SHEET

Why? To clarify and share the basic information on each country and yourself among all participants.
What? Information that overviews pharmaceutical administration framework/pharmaceutical management,
services, relating laws and regulations in your country.
When? Prepare your own reports before coming to Japan, and we will share them with other participants after
arrival in Japan.
How? Collect necessary information in your country and prepare reports and presentation materials.
Deepen understanding by comparison with other countries.
Note)
For your reference, you can refer to the past participants’ Information Sheet of the following countries uploaded to thewebsite below (only from Monday 11 to Sunday 17, June). However you should be aware that making your own
report by yourself is required.
-

Mongolia, Philippines, PNG, Sri Lanka
Website: http://jica.gigapod.jp/gf02d4966c4c6c56037ce8b6d65dacf6e3ceecee0
Login ID: jica

Part II:

Password: Jicwels123

PRESENTATION

Why? To share the basic information on your country and yourself among all participants in the limited time.
What? Introduction of the work, Good Practice, Difficulties/Lessons learned from past experiences, Your
expectation to the program
When? Prepare your presentation before coming to Japan. Inception Report presentation is scheduled on 13th
July.
How? Each participant will get to know each other and different situation in other countries.
Note: 1) Please prepare presentation within 10 slides by using the attached format.
PARTⅠ INFORMATION SHEET2) Each presentation is allocated about 15min. including Q/A.

－ 326 －

Part I:INFORMATION SHEETRegulatory Systems on Ensuring Access to Quality Medicines （JFY 2018）
Name: Leolasi Tafua-Rivers
Country: Samoa
Organization/Department/Division: National Health Services/Pharmacy Division① Organizational Chart−Please attach the organizational chart of pharmaceutical administration at national/state & local levels aboutpharmaceutical administration in your country.
−Please briefly describe each role and responsibility on pharmaceutical administration.
※Hospital pharmacy only

−Please briefly describe the role of pharmacist in medical care system in your country. If possible, focus on theposition of the pharmacist in medical institutions.
Please view chart attached. (FLOW CHART 1)－ 327 －

② Legislation on pharmaceutical administration−Please briefly bulletined major laws/acts◆National Level
The Pharmacy Act 2007 administered by the Ministry of Health

The Drugs Act 1967 administered by the CEO of the Ministry of Health and/or Minister of Health

Food Act 2015 administered by the Ministry of Health

Health Ordinance 1959 administered by Minister of Health

Healthcare Professions Registration and Standards Act 2007 administered by Ministry of Health

Ministry of Health Act 2006 administered by Minister of Health

Narcotics Act 1967 administered by CEO Ministry of Health and/or Minister of Health

National Health Service Act 2014 administered by Ministry of Health

The Poisons Act 1968 administered by Minister of Health

Samoa National Medicines Policy administered by Ministry of Health◆Local LevelNational Health Service Guidelines administered by Ministry of Health◆PIC/SNo③ Regulatory Services−Please describe pharmaceutical regulatory services of your country in response to each topic described below.
−It is recommended to add supplemental information such as systems, regulations, responsible administrators,
since you are expected to explain them to other participants.
◆Pharmaceutical Manufacturing
Systems
There are standard operating procedures (SOP’s) for pharmaceutical manufacturing. These may vary slightly inprivate practice but the baseline principles remain the same. In NHS pharmacy we operate under the NHS
guidelines to manufacture extemporaneous compounds. We use an aseptic technique with BP and USP standard
ingredients to make sure the right preparation is prepared at the right dose for the right patient at the right time. The
guidelines encompass the receipt of prescription, compounding, calculations, record-keeping and presentation offinished product.
Regulations:
The Drugs Act 1967 allows for the manufacture of medicines for the treatment of a patient pursuant to aprescription issued by a medical practitioner. A medical practitioner meaning they are qualified and registered inaccordance with Medical Practitioners Act 2007 and the Healthcare Professions Registration and Standards Act
2007.

－ 328 －

The manufacture of the medicine will be in accordance with Samoa National Medicines Policy 2008 stipulatingthat the medicines reaching the patient meet approved specifications and standards.
Administrators: Ministry of Health
1. It is the direct authorization of the pharmacist that ensures medicines released satisfy all legal requirements.
2. The pharmacist will act under the Pharmacy Act of 2007 which is administered by the Ministry of Health.

◆Drug Import/Export
Systems:
Import of Drugs: NHS SOP for the receipt of imported drugs and the procedure, in which they are processed,
stocked and distributed.
Export of Drugs: Not applicable as we do not export medicines.
Regulations:
The Drugs Act 1967 and Food Act 2015 govern the importation of new drugs into Samoa.
The Poisons Act 1968 govern the license or authority to import poison, sale and packing of poisonous substances
The Narcotics Act 1967 govern the restrictions on the import and export of narcotics and controlled precursors.
Only medicines registered in Samoa will be permitted to be procured and distributed in the country as stipulated in
the Samoa National Medicines Policy 2008. Any new medicines to be introduced must satisfy the legal restrictions
listed above.
Administrators: Ministry of Health◆Marketing Authorization
Systems
There is no set system in place for controlling advertising and promotion of medicines.
However, there is legislation indicating that all advertising and promotion of medicines must conform to therequirements of the Pharmacy Act 2007, Poisons Act 1968, Drugs Act 1967 and the National Medicines Policy
2008. Children should not be used in advertising. Ensure advertising is ethical and conform to governing legislation.
Promotion of pharmacy-only and prescription-only will be restricted to professional medical, pharmaceutical,
dental, veterinary, or nursing publication.
New Drugs:
If a new drug is to be introduced into Samoa, they must first get approval from the CEO of the Ministry of Health.
This application must satisfy legal requirements prior to any authorization. If the drug is already marketed in
Samoa and there is a slight change to the formula to alter activity. Approval must be sought first as well. There arealso further legal restrictions for openly advertising the drug,
Regulations: This is in accordance with the Drugs Act of 1697, Poisons Act 1968, Food Act 2015 and Samoa
National Medicines Policy 2008.
Administrators:

The Minister and/of Minister of Health◆Drug Distribution (including drug selection, procurement, sale)
Systems: The NHS guidelines provide an SOP for drug selection, procurement and sale.

－ 329 －

Regulations: It must satisfy the legal requirements stipulated in the MOH Act 2006 (regulation), Drugs Act 1967
(importation and reports on side effects), Poisons Act 1968(importation, sale, custody of poisons), Narcotics Act
1967 (importation, license in dealing narcotics and delivery) and the Pharmacy Act 2007(fulfill professional
standards).
Administrator: Ministry of Health◆Medicine Safety (post-marketing)
Systems: There are currently no medicine safety systems in place to monitor and evaluate efficacy, safety andquality of medicines.
Regulations: However, as part of the Samoa National Medicines Policy 2008 and Plan of Action, performance of
medicines registered in the country will be monitored for safety, efficacy and quality. This has yet to be established.
Also in concordance with the Drugs Act 1967 a report of side-effect profiles of medicines registered before
importation unless this is a profile widely known and published in a medical and/or pharmaceutical journal.
Administrators: Ministry of Health◆Relief System for Adverse Drug Reactions
Systems: There are currently no medicine safety systems in place to monitor and evaluate adverse drug reactions.
Regulations: However, as part of the Samoa National Medicines Policy 2008 an Adverse Medicine Reaction
Monitoring System including suitable Adverse Medicine Reporting procedures was proposed however this has yet
to be established.
This is also in concordance with appropriate professional medical treatment standards, Pharmacy Act 2007.
Administrators: Ministry of Health④

Drug Pricing−Please describe about price control and drug price mechanism at public sector in your country.
Public Sector:
NHS Pharmacy currently uses a formula from NHS Finance to calculate the price for medicines for in theoutpatient area and distribution to private clinics and ministries. On average the mark-up for Outpatient medicines
is 20% and for distribution to private clinics and/or other ministries is 60%. This formula from finance incorporates
shipping, handling and other overhead costs.
Private: No price control in place.

－ 330 －

⑤ Statistic Data
−Please answer the following questions (if the number is not applicable, please give an answer to the best of
your knowledge).
−Put the year of the presented data as well if it's available.
1.

Number of pharmacists

0(year)

2.

Number of GMP inspector (National & Local)

0 (year)3.

Number of pharmaceutical manufacturers / manufacturing sites

0 (year)4.

Number of traditional medicine manufacturers / manufacturing sites0(year)5.

Number of pharmaceutical importers

5 (year)6.

Number of pharmaceutical wholesalers0(year)※Hospital pharmacy only⑥

Information on your hospital pharmacy（１） Organization chart of the pharmaceutical department or the pharmacy to which you belong
a. Number of section chiefs:
b. Number of deputy chiefs:
c. Number of managers: 1: Please see associated flow chart. (FLOW CHART 2)（２） Number of staff
a. Number of pharmacists: 6
b. Number of clinical pharmacists: 1
c. Number of technicians: 17（３） Number of the kinds of drugs managed in your pharmacy or hospitala. Oral medicine:211

b. Injections: 109
c. Medicines for external use: 62（４） Number of prescriptions dealt in your pharmacy per day
a. For inpatients:73
b. For outpatients:300（５） Equipment of the pharmacy in your hospitala.

Does your hospital have a dispensary room? Yes
If "Yes", how large is it?
Yesb.

38.30 ㎡

Does the pharmacy have a clean room or laminar flow hood?
Noc.

Does the pharmacy have computers?
Yes－ 331 －

If "Yes", what is the purpose of using them.
Purpose: Dispensing prescriptions, processing orders, receipt of orders, creating prescription
reports, staff administration workd.

Do you implement Therapeutic Drug Monitoring (TDM : Therapeutic Drug Monitoring) in yourHospital?
Noe.

Do you prepare TPN (Total Parental Nutrition)Nof.

Can you use Internet at the pharmacy?
If "Yes", what is the purpose of using it.
No※All participants. Please describe the following general information as much as you know.

⑦

Education and License of Pharmacists in your country（１） Number of years in primary, secondary and high school education
Primary

8

years

Secondary

5

years

High school (Otherwise called Secondary School)

N/A

years

（２） Number of years / weeks in the following categories during university or college
University / college:

4 years

Professional education:

N/A years

Practical training:

1 years

Duration of training by each facility:

N/A years

Hospital pharmacy:

N/A

weeks

Community pharmacy:

N/A

weeks

Pharmaceutical company:

N/A

weeks

Others:Age at graduation:

weeks
22

years old（３）Are there any national examinations for pharmacists in your country? No（４）Which of the followings must you fulfill to obtain a pharmacist's license?
* If practical training is mandatory, give the subjects and training period.
There is a practical training period of 1 year that I carried out in New Zealand under the PSNZ

－ 332 －

Internship program to register as a pharmacist in New Zealand and obtain a license to practice as apharmacist. If graduates return to practice in Samoa, they observe a grace period under observation ofa registered pharmacist in Samoa 1 year before they are issued a practice license in community or
hospital as approved by the Pharmacy Board. For Fijian graduates, they must satisfy three years
before a license to practice in Samoa is issued. I currently have a license to practice in Private
pharmacy and Hospital pharmacy.
* If practical training is optional, give the reasons.
(i.e. Training is necessary to prepare for the national examination)
N/A（５）Number of pharmaceutical university or college graduates:
0

people/ per year

The alumni's placement rate (%)
a. Hospital:

50%

b. Community Pharmacy:

40%c. Government Organization:

10 %d. Enterprise:%e. Others:%⑧ Side effect report
Please describe the flow of reporting system (from a medical institution to an administrative agency), when asevere side effect case is occurred in a medical institution. Describe specifically the rule and responsibility ofeach organization (an administrative agency / a medical institution), and their collaboration/cooperation.

Side Effect Report
Patient reports side-effect to Pharmacy
Pharmacy reviews patient information on file, assesses risk to patient
Leaves note on patient file (Inpatient-physical file) and Outpatient on system.
Calls patients regular Dr to report side effect and request course of action
Patient will either be admitted immediately or referred to their acting physician for further care
IF side-effect is a new occurrence for this medicine, pharmacist involved in procurement of medicine isnotified to inform drug manufacture and request their tests for safety, efficacy and side-effect profile.
The last call is if the Chief Pharmacist is unsatisfied with quality/safety/efficacy and any recurring side-effects
that outweigh benefits of medicine. The medicine can be removed, returned to manufacturer and lines for that
medicine discontinued.

－ 333 －

Annex2
Preparation for Attendance
for
JICA Knowledge Co-Creation Program“ Regulatory Systems on Ensuring Access to Quality Medicines”(JFY 2018)
Dear participants,
We are delighted to have you for the captioned JICA program!
This program is organized by JICA in cooperation with Japan International Corporation of
Welfare Services (JICWELS).
Every participant is advised to read the following instructions carefully and well prepare forthe program. Please kindly check the attached Annex2-1 Preparation Sheet and email itback to JICA TOKYO & JICWELS (E-mail: jigyo@jicwels.or.jp, ticthdop@jica.go.jp) by 25
June, 2018.
For your information, we are schedule to have a trip to Toyama prefecture from 22 to
26 July during the program. It is located around 450km northeast from Tokyo. In thisregards, it is recommended to prepare a travel bag and other necessary things forthis short trip so that you can leave your large baggage / suitcase at JICA Tokyo.

 Food restraint
Please kindly let us know your food restraint which you are not able to take due toreligion, allergy, or any other reasons.

 Prayer room
Please kindly let us know if you need a prayer room during the lunch time or the breaktime. The prayer room is available in JICA Tokyo, however, it would be difficult to find
one at other study visit sites. Therefore, we will try to arrange it in beforehand,according to your request.

 Laptop Computer
A PC equipped with “Word” and “Power point” is necessary for preparation of reports
and / or power point presentations from the beginning of the program. If there are somecompelling reasons for not bringing a PC, please let us know. We will arrange a rental
laptop-computer for your study during the program. Please note however, if you fail to
inform us by the above date, it will take at least one week after his/her arrival to lend
him/her a PC.

 Size for your white coat (uniform) and indoor shoes
We are scheduled to visit a pharmaceutical manufacture and pharmacy during the
program, and all participants are requested to change into an uniform and indoor shoes
based on the GMP regulation in Japan.

－ 334 －

Annex2-1: Preparation Sheet(Name:Leolasi
Country:Samoa

Tafua-Rivers)

 Food restraint
×OK□Not OK
×OK□Not OK
×OK□Not OK
×OK□Not OK
×OK□Not OK
×OK□Not OK
×OK□Not OK
×OK□Not OK
×OK□Not OK
×OK□Not OK
×OK□Not OK
×OK□Not OK
×OK□Not OK
×OK□Not OK
Special remarks (

Beef
Pork
Chicken
Egg
Fish (cooked)
Fish (raw)
Shrimp
Scallop (shell)
CheeseAlcohol
Milk
CoffeeTea
Green tea) Prayer room
Please check the box if you request an arrangement of prayer room, or not.
×
Yes
No

 Laptop Computer
Please check the box if you request an arrangement of PC, or not.
Yes
×
No

 Size for your white coat (uniform) and indoor shoes
Please check the box and write your size information in ( ) below.
Your height( 180cm
cm / ft and in)
Clothes size….Most likely an XL-XXL
S
□
M
□
L
□
LL
□
XL
□

－ 335 －

Shoe size ( 28.5cm)【For your reference】
MEN’s Shirts
Japan
U.S. & U.K.

S

M

M

L

L

LL,XL

LL,XL

LL,XL

14 1/215

15 1/215 3/416 1/416 1/217

17 1/2

37

38

39

40

41

42

43

44

EU
MEN’s Shoes
Japan（㎝）

25.5

26

26.5

27.5

28.5

29.5

30.5

7 1/2

8

8 1/2

9

10 1/2

11 1/2

12 1/2

U.K.

7

7½

8

8 1/2

10

11

12

EU

40

41

42

43

44

45

46 1/2

Inches10

10 8/1

10 1/4

10 2/1

10 3/411

11 1/4

U.S.

&

CanadaWOMEN’s Dress & Suits
Japan

7(S)

9(M)

11(L)

13(LL)

15(XL)

17

19

21

U.S.&

4

6

8

10

12

14

16

18

U.K.

6

8

10

12

14

16

18

20

EU

34

36

38

40

42

44

46

48

CanadaWOMEN’s Shoes
Japan（㎝）

23.5

24

24.5

25

25.5

26

U.S. & Canada

7 1/2

8

8 1/2

9

9 1/2

10

U.K.

5

5 1/2

6

6 1/2

7

7 1/2

EU

38

38 1/2

39

40

41

42

Inches

9 5/8

9 3/4

9 7/8

10

10 1/8

10 1/4－ 336 －

Regulatory Systems
on Ensuring Access to Quality Medicines

THAILAND－ 337 －

THAILAND
THAI Food and Drug Administration

Pairoj Osatapirat

1. Introduction of the work
Roles and position of pharmacists in Thailand
Hospital Pharmacy
Community Pharmacy
Consumer Protection(i.e. Thai FDA)Enterprise(i.e. Marketing)Industry(i.e. Production, QA,
QC, R&D)
Others(i.e. RA, CRA, PV)1－ 339 －

1. Introduction of the work2

1. Introduction of the work
Bureau of Drug Control
THAI FDA

Director

Administrative Office Sub-Division

Division of National Drug Policy andStrategies Development
Division of Herbal and Traditional Medicine

Division of System
Development

Division of Standards
and Regulations

IT Development

Foreign Affairs andQuality System

Division of Premarketing Control
Biological
Products

Legal
Development

Chemical
Drugs

Regulation
Development

Drug Distribution
Channel Control& PMQA

Reclassification

Research andDevelopment

Re-evaluation

Veterinary
Drugs
Investigational
New Drugs(IND)

Advertisement
Control3－ 340 －

Division of Postmarketing Control
Licensing Unit
Inspectorate
Unit
Evidence
Compiling Unit
Support andDevelopment
Unit1. Introduction of the work
Job tenure & Regulatory Services- To monitor and conduct surveillance of the quality of the
medicinal products available in the market in order to comply
with the approved standard and requirements- To monitor the use of marketed drugs for unexpected healthrisks, taking action if risks are detected by informing the public,
investigating the root cause, removing the drugs from themarket (following the recall & rapid alert system), and informing
the consumer soon
- To ensure that all local manufacturers of modern medicine andhigh-risk traditional medicine are in compliance with GMP
requirements for quality assurance of their drugs (adopted
PIC/S GMP Guide), and also the overseas manufacturers aremet GMP clearance standard which equivalent to GMP
requirements for domestic manufacturers

4

1. Introduction of the work5

－ 341 －

1. Introduction of the work
Thai FDA
Drug Quality
Sampling Program
Int’l Rapid Alert
Network- ASEAN Rapid Alert Channel- WHO GSMS
- PIC/S Rapid Alert Notification

Domestic report
Hospital,
Product owner,
Healthcare
professional,
Patient, etc.

Drug
Quality
DefectIdentify the risk class and propose theimmediate action in case of high risk

Analyze the riskof products inmarket andmanage to plan
the Sampling
Program

Evaluate the investigation report and identified
root cause including correction and CAPA fromMarket Authorization Holder
Regulatory Action
Recall/Rapid Alert
Suspension of Market Authorization
Re-evaluate product registration
Law Enforcement

MarketSurveillance

2. Good PracticeManagement of Drug Quality defectProblem:
Lack of comprehensive database that can beanalyzed and identify the risk of Drug Quality Defect.
Solution & Ongoing development:
Develop the database of Drug Quality Defect whichenable us to improve the tracking process. In addition,
The database is expected to be analyzed for futureplanning in order to prevent Drug Quality Defect.
7－ 342 －

2. Good Practice
Segregated databases of Drug Quality Defect
DB FDADB Provincial
hospital

DB NCLDB etc.

Integrated database
DB Provincial
DB FDAhospitalComprehensive
Database
DB etc.
DB NCL
Trend analysis &Risk assessment

Data cannot
be analyzed
Poor Risk-based planning onmarket surveillance

Well Planned and Risk-based
market surveillance

Waste of the limited resources ofsurveillance units

Maximize available resources
8

3. Difficulties/Lessons Learned from Past Experience
Number of registered drug: Over 20,000 items
Number of samples per year committed with NCL:
Pre-planned sampling program – 400 samples/year
Emerging risk sampling – 100 samples/year
Cost: 12M Baht/year
Key challenge to maximize available resources:• Sampling of medicines prioritized/risk-based• Limited to a small number of registered medicines• Activities occur at central level; little coordination with
provincial or other stakeholders
9－ 343 －

4. Your interests
Expectation from this program(1) The knowledge on the effective regulatory systems for detecting
the defective medicinal products in the pharmaceutical supply
chain.
(2) Experiences shared with other participants should be useful for ourfurther improvement on securing medicinal product quality throughthe supply chain in my country. The open discussion between
experts from different countries should also generate the new idea
for monitoring the pharmaceutical supply chain in quality
perspective.
(3) The best practice on Management of Drug Quality Defect including
the effective detection method such as sampling program orreporting system.

10－ 344 －

Regulatory Systems on Ensuring Access to Quality Medicines（JFY 2018）

Mr. Pairoj Osatapirat
ThailandThai Food and Drug Administration (Thai FDA)/ Bureau of drug control/ Post-Marketing control Division① Organizational Chart
The organizational chart of pharmaceutical administration at national level in Thailand

Thai FDA is responsible as National Regulatory Authority (NRA) of pharmaceutical products in Thailand. The FDA
is under the cluster of Public Health Service Support belonging to the Ministry of Public Health.
The Cluster of Public Health Service Support comprises of three departments: Thai FDA, Health Service Support
and Medical Sciences. This group of departments working on an integrated program to achieve greater efficiency
and effectiveness on public health services. The Department of Medical Science plays an important role as National
Control Laboratory (NCL).

－ 345 －

The organization chart of Thai FDA

Bureau of Drug Control plays the key role as National Regulatory Authority to administer the pharmaceuticalproducts in Thailand. The administrative function is including National Regulatory System, Registration andMarketing Authorization, Licensing Premises, Market Surveillance and Control, Regulatory inspections andRegulatory oversight of clinical trials.
② Legislation on pharmaceutical administration◆ National Level
Drug Act, B.E. 2510 (1967) and Amendment No.2 (1975), No.3 (1979), No. 4 (1985) and No. 5 (1987)
administered by Thai FDA
Narcotic Act, B.E. 2522 (1979) and Amendment No.2 (1985), No.3 (1987) and No. 4 (2000) administeredby Thai FDA
Psychotropic Substance Act B.E. 2559 (2016) administered by Thai FDA◆ Local Level
None◆ PIC/S
Yes, participated since 1 August 2016

－ 346 －

③ Regulatory Services◆ Pharmaceutical Manufacturing
Thai Food and Drug Administration (Thai FDA) oversees pharmaceutical manufacturers in Thailand. The
current GMP regulation is outlined in Ministerial Notification regarding the GMP requirement formodern drug manufacturing and traditional drug manufacturing B.E.2559, issued on 18 May 2016. The
said notification was signed by Minister of Public Health. It is mandatory and applicable to be
implemented to all manufacturers of medicinal products regardless of origin (domestic or foreign
manufacturers) by which the GMP Guidelines are equivalent to PIC/S GMP Guide PE 009-12.
◆ Drug Import/Export
The medicinal products importation activities are mandated under the Drug Act. A person or
establishment who wants to import medicinal products should apply for license and Thai FDA willconsider and grant the license respectively. Then the licensee is required to apply for product registrationfor each medicinal product that proposed to be imported into the country.
When the importation is planned to be taken, the licensee for importing of medicinal product should
follow the procedure for handling of importation including the guideline for License per invoice
submission that is available in the website of the Bureau of Import and Export Inspection of Thai FDA,
http://www.fda.moph.go.th/sites/logistics/SitePages/LicensePerInvoice.aspx. The licensee is required to fillout and record all relevant data for importation through the National Single Window (NSW) prior to the
medicinal products are delivered from origin to Thailand.
The domestic pharmaceutical manufacturer who wants to export their medicinal products to theoverseas countries should follow national laws regulations as required by those destination countries.

◆ Marketing Authorization
The Thai FDA has implemented ASEAN common technical dossier, ACTD by which ASEAN
application form shall be supplemented. However, the requirement of ACTD is a minimum requirement
for application of medicinal product whereas full package of ACTD or ICH CTD will be required for
New Chemical Entity (NCE), biotechnology product and vaccine. All requirements are publicly available
on Thai FDA website.
◆ Drug Distribution (including drug selection, procurement, sale)
For wholesale distribution of medicinal products (including APIs): Those who want to wholesale
distribute medicinal products including APIs must apply for a wholesale license, or a license to sell
medicines prior to undertaking the wholesale activity.
Regarding drug selection and procurement, all medical institutes in public sector must follows theregulation on Procurement Act, B.E 2560.
◆ Medicine Safety (post-marketing)Thai FDA establishes a center namely Health Product Vigilance Center, HPVC which work forvigilance activities of all healthcare products administered by Thai FDA.

－ 347 －

Day-to-day operations of the HPVC including:- Collection, collation and analysis of adverse reactions (ARs) and adverse events (AEs) dataassociated with use of drugs and medical devices.
- Assessment of AEs to identify patterns of the product safety problem.
- Detection of signals and assessment for causal association between the signals and suspected
health products.
- Provision of data related to safety of health products to Thai FDA and committees or sub
committees responsible for the products.
- Work with the Bureau of Epidemiology of the Disease Control Department of the Ministry of
Public Health on adverse events following immunization (AEFI).
- Conduct or management of research on ARs and AEs.
- Submission of ARs and AEs reports to WHO UMC.
- Coordination with various units within and outside the Ministry of Public Health to improveawareness, management and communication on safety of health products.
◆ Relief System for Adverse Drug Reactions
HPVC has a guideline for Market Authorization Holder for reporting Adverse Events and also vigilance
activities. Also, HPVC has planning about PV activities in every year for example; Signal detection andassessment working group meeting, monitor product safety news (everyday), Risk communication
among reporter and Thai HPVC and Healthcare Professionals. In addition, The information/reports fromother countries/international bodies such as UMC reports (Vigibase) are considered in the related ADR
committee. After that ADR committee will conclude cases for finding the regulatory actions that
may/may not be related to other countries’ regulatory action.
④ Drug Pricing
Prices of medicinal products are regulated when they are listed on the National List of Essential Drugs(NLED), a “maximum list” from which government hospitals are expected to select their individual
hospital formulary. The prices of the drugs on this list are subject to a median price policy. In addition,
the Ministry of Finance has implemented a notification setting prices for government hospitals. However,these prices only apply to persons under the Civil Servant Medical Benefit Scheme CSMBS. The
Ministry of Public Health has implemented a notification on how much government hospitals areallowed to charge patients. The Drug Act is currently being revised, and these revisions may wellinclude cost-effectiveness as a required element for drug registration.
⑤ Statistic Data
1.

Number of pharmacists

38,389(2017)

2.

Number of GMP inspector (National & Local)

20(2018)

3.

Number of pharmaceutical manufacturers / manufacturing sites

175(2018)

4.

Number of traditional medicine manufacturers / manufacturing sites

223(2018)

5.

Number of pharmaceutical importers

566(2018)－ 348 －

6.

Number of pharmaceutical wholesalers

58※Hospital pharmacy only

⑥ Information on your hospital pharmacy
Not applicable※All participants. Please describe the following general information as much as you know.

⑦ Education and License of Pharmacists in your country
1.

2.

3.

Number of years in primary, secondary and high school education
Primary

3 years

Secondary

3 years

High school

6 years

Number of years / weeks in the following categories during university or college
University / college:

6 years

Professional education:

2 years (included in the above 6 years)

Practical training:

1 yearDuration of training by each facility:

1 yearHospital pharmacy:

6 weeks

Community pharmacy:

6 weeks

Pharmaceutical company:

6 weeks

Others:

6 weeks

Age at graduation:

approximately 22-25 years old

Are there any national examinations for pharmacists in your country?
Yes,

4.

Academic Exams

2 daysClinical Exams

1 daysWhich of the followings must you fulfill to obtain a pharmacist's license?
The practical training is mandatory.

5.

-

General pharmacy administration and services (Hospital & Pharmacy) > 400 hours-

Professional training specified by major subject> 1,600 hours

Number of pharmaceutical university or college graduates:
1,820 pharmacist’s license obtained in 2017.
The alumni's placement rate (%)
a.

Hospital:

40.4 %b.

Community Pharmacy:

17.0 %c.

Government Organization:

5.7 %

d.

Enterprise:22.0 %－ 349 －

(2018)

e.
Reference:

14.9 %

Others:1. https://www.pharmacycouncil.org/index.php?option=content&menuid=33
2. Past...Present...Future of Pharmacy Education in Thailand (Part II), PECT, IJPS,
Vol.10 No.2 May-Aug 2014, page 120⑧ Side effect report
In case of serious ADR/dead occurred, Pharmacovigilance advisory sub-committee and Signal detection andassessment working group would assess drug products with consideration of vigilance data. HPVC consider
vigilance data with specific standard which we do case by case. For example: withdrawal of Phenylbutazone.
Because there were the evidences that shown significant risk of aplastic anemia whereas NSAIDs can be usedinstead of phenylbutazone. The specific standard that we provided for considering this case were severity of
ADRs, reversibility, frequency of ADRs, risk occurrence in dread disease, chances for ADR occurrence ingeneral population, any known risks, alternative medicine, chances of misuse and committee’s suggestion.
Diagram of ADR reporting process from medical institutes to HPVC

-End of report-－ 350 －

Regulatory Systems
on Ensuring Access to Quality MedicinesUGANDA－ 351 －UGANDA
NATIONAL MEDICAL STORESANTHONY KABONGE DDAMBA

1. Introduction
ESTABLISHMENT
NMS was incorporated by an Act of Parliament in 1993 to ensure the economic procurement,
storage and distribution of quality and efficacious essential medicines and health supplies
primarily to public health facilities in Uganda. NMS also has a statutory advisory responsibility
to the National Drug Authority (NDA), the Ministry of Finance, Planning and Economic
Development (MoFPED), the Ministry of Health (MoH) and the Ministry of Local Government(MoLG) on the estimation of drug needs and the distribution and use of medicines in the publichealth services.
VISION“A population with adequate and accessible quality medicines and medical supplies”
MISSION“To effectively and efficiently supply essential medicines and medical supplies to Public HealthFacilities in Uganda”

1－ 353 －

1. Introduction
KEY POINTS OF NMSDistributes Essential Medicines and Health Supplies [EMHS] to all 3,000+ Public HealthFacilities in Uganda

Total throughput per annum is roughly 250 million USD (approximately 27,502,375,000 yen)Total Client touch‐points/visits roughly 20,000 annually.

SUMMARY JOB RESPONSIBILITIES AND TENURE

39 years old UgandanRegistered in 2003 to practice Pharmacy in Uganda by the Pharmacy Council

Member of the Pharmaceutical Society of Uganda.



Practiced Pharmacy in the areas of Community Pharmacy, Manufacturing and Supply Chain
Management for the last 15 years



Head the Client Services Department where I provide managerial leadership and oversight to
the Client Services Team of 33 members.

2

1. Introduction
DEPARTMENT OF CLIENT SERVICES

NMS has a Headquarters in Entebbe and has 9 Regional Offices in Uganda.

The Department of Client Services has 33 employees who have the following responsibilities:
1. Ensuring timely delivery of all EMHS while ensuring adherence to set standards
2. Provide advisory services which include: Analysis of needs
 Procurement planning Ordering and delivery of EMHS Capacity building and assisting Health Facilities at all levels of care improve and maintain good storagepractices (GSP) and Rational Use of Medicines

3. Manage Complaints and Feedback
4. Monitoring and evaluation of programs and interventions to Health Facilities
5. Advising the Government of Uganda on: Estimation of drug needs
 Optimal distribution and use of medicines in the public health services
3－ 354 －

1. Introduction

Gulu

Mbale

KampalaMbararaPlaceholder

Kabarole

SorotiStorage

Hoima

Distribution

MorotoProcurement

Procurement

Arua

Each of the 9 Regional Offices ismanned by Customer Care Staff
who continuously monitor andevaluate the service offering of
NMS in the Regions

4

1. Introduction
REGULATORY SERVICES INVOLVED IN MY ROLE


Ensuring that distribution and use of medicines is in line with legal, professional and ethicalstandards of the practice of the Pharmacy in Uganda

ROLES AND POSITIONS OF PHARMACISTS IN UGANDAAs of 2018, there are 450 Registered Pharmacists in Uganda

Majority (about 60%) practice in Community Pharmacy

Other areas of practice include: Hospital Pharmacy (20%)
 Industrial Pharmacy (7%)
 Regulation (5%)
 Academia (2%)
 Ministry of Health (1%)
 Others (5%)
5－ 355 －

2. Good Practice
KEY ACHIEVEMENTS
1. Developed systems for better Supply Chain Needs Analysis, Planning and Inventory
Management to all 3,000‐plus Health Facilities through leading drives to: Introduce the Research and Monitoring & Evaluation Functions to NMS
 Introduce the 9 Regional Offices

2. Member of Steering Committee on Projects including Enterprise Resource Planning Systems
3. Led the Department in adopting the ISO 9001:2008 and ISO 9001:2015 Quality Management
Standards
4. Developed policy and procedure manuals
5. Managed the introduction of new products through all the regulatory requirements
6. Led the project of installing and validating two new manufacturing lines at the
manufacturing plant in line with Good Manufacturing Practice standards
6

3. Difficulties/Lessons Learned from Past Experience
CURRENT CHALLENGES (WHICH ARE IMPROVING)
1. Low number of pharmacists in the country
2. Very low concentration of pharmacists in the Rural Hospitals
3. Low capacity of Manufacturing Industries in Uganda
4. Low distribution of community pharmacies in rural or small towns
CURRENT CHALLENGES (WHICH ARE GETTING WORSE)
1. Increasing medicine counterfeits
2. Poor prescribing habits by Prescribers e.g., polypharmacy and excessive use of antibiotics
3. Self‐prescription
4. Drug abuse
LESSONS LEARNT
1. Value of setting up strong central warehouses
2. Value in having sufficient number of Pharmacists in Hospitals, especially in the areas ofClinical Pharmacy and Good Storage Practice7－ 356 －

4. My Interests
1.How to effectively manage the quality ofdrugs/medicines within the country when thenumber of professional pharmacists is low

8

THANK YOUANTHONY KABONGE DDAMBANATIONAL MEDICAL STORES－ 357 －

Part I:INFORMATION SHEETRegulatory Systems on Ensuring Access to Quality Medicines （JFY 2018）
Name: ANTHONY KABONGE DDAMBACountry: UGANDA
Organization/Department/Division: NATIONAL MEDICAL STORES① Organizational Chart−Please attach the organizational chart of pharmaceutical administration at national/state & local levels aboutpharmaceutical administration in your country.
NATIONAL ORGANIZATION OF THE MINISTRY OF HEALTH - UGANDA
Hon. Minister

Permanent
Secretary

Director Generalof HealthServices

MoH
Partners

Directors ofReferralHospitals

Under
Secretary

National
Medical Stores
National Drug
Authority

Directorate ofClinical andCommunity

Directorate ofPlanning andDevelopment−Please briefly describe each role and responsibility on pharmaceutical administration.
1. Cabinet – Overall Executive Management of the Government. Set the political agenda
2. Parliamentary Committee on Health – Set laws in place. Determine budget allocated to the Health Sector.
Carry out an oversight role to the Ministry of Health and Autonomous Institutions under it.
3. Ministry of Health – Policy formulation, oversight to the autonomous bodies
4. Autonomous Institutions that include:i.

National Drug Authority (NDA) – is mandated to ensure the availability, at all times, of essential,
efficacious and cost-effective drugs to the entire population of Uganda as a means of providing－ 358 －

satisfactory healthcare and safeguarding the appropriate use of drugs.
ii.

National Medical Stores (NMS) – has a statutory advisory responsibility to the National Drug Authority,
the Ministry responsible for Health, the Ministry responsible for Finance, Planning and Economic
Development and the Ministry responsible for Local Government either on request or at the Board’s own
initiative on essential issues relating to the state of the Corporation and its future development, as well as
to related matters, including the estimation of drug needs and the distribution and use of medicines in the
public health service.

iii.

National Chemotherapeutics Research Laboratory - undertakes the development of quality natural
products and services for improved health care delivery by applying both indigenous and modern
technologies.

iv.

Uganda Blood Transfusion Services – a centrally coordinated department in the Ministry of Health tooffer efficient central and decentralized services of safe blood collection, storage and distribution in
Uganda.

v.

Referral Hospitals Boards - provide the oversight role for the effective functioning of the hospital inorder to deliver quality services.

5. District Executive Committees - provide oversight for policy implementation, planning and resource
allocation and use for the health system at this level, in adherence to national laws.
6. Health Facility (General Hospital, HC IV, III & II) Management Committees which draw representation fromthe community members provide the oversight function for primary care facilities
7. Local Councils at Community level - ensure effective community participation in management of healthservices.
※Hospital pharmacy only

−Please briefly describe the role of pharmacist in medical care system in your country. If possible, focus on theposition of the pharmacist in medical institutions.

－ 359 －

② Legislation on pharmaceutical administration−Please briefly bulletined major laws/acts◆National Level

Narcotic Drugs and Psychotropic Substances (Control) Act 2016 administered by the Uganda PoliceNational Drug Policy and Authority Act 1993 cap 206 administered by National Drug AuthorityNational Medical Stores Act 1993 cap 207 administered by National Medical StoresPharmacy and Drugs Act 1971 cap 280 administered by the Pharmacy Board◆Local Level
administered by

・◆PIC/SYes

ORNo

If yes, joined when

－ 360 －

③ Regulatory Services−Please describe pharmaceutical regulatory services of your country in response to each topic described below.
−It is recommended to add supplemental information such as systems, regulations, responsible administrators,
since you are expected to explain them to other participants.
◆Pharmaceutical Manufacturing
・ Good Manufacturing Practice administered by National Drug Authority (NDA)・ Licensing and Registration administered by NDA and Uganda National Bureau of Registration◆Drug Import/Export
・ Registration of Drugs administered by National Drug Authority (NDA)
・ Drug Retention on the Drug Register administered by National Drug Authority (NDA)・ Importation, Export and Re-export of Drugs administered by National Drug Authority (NDA)・ Importation, Export and Re-export of Drugs administered by Uganda Revenue Authority (URA)◆Marketing Authorization
・ Certificate of Good Practice administered by National Drug Authority (NDA)・ Pharmacist Registration Certificate administered by Uganda Pharmacy Board
・ Pharmacist Annual License to Practice administered by Uganda Pharmaceutical Council◆Drug Distribution (including drug selection, procurement, sale)・ Registration of Drugs administered by National Drug Authority (NDA)
・ Drug Retention on the Drug Register administered by National Drug Authority (NDA)・ Distribution of Drugs to Public Health Facilities administered by National Medical Stores (NMS)・ Distribution of Vaccines to All Health Facilities administered by National Medical Stores (NMS)◆Medicine Safety (post-marketing)・Systems, Regulations, etc.
・ Good Pharmacovigilance Practice of Drugs administered by National Drug Authority (NDA)◆Relief System for Adverse Drug Reactions
・ Good Pharmacovigilance Practice of Drugs administered by National Drug Authority (NDA)－ 361 －

④ Drug Pricing−The drug pricing in public health facilities is calculated at 8% mark-up of Essential Medicines and HealthSupplies (EMHS) publicly procured by NMS under the Public Procurement and Disposal of Assets Act(PPDA)⑤ Statistic Data
−Please answer the following questions (if the number is not applicable, please give an answer to the best of
your knowledge).
−Put the year of the presented data as well if it's available.
1.

Number of pharmacists

456 year (2018)

2.

Number of GMP inspector (National & Local)

20+ year (2018)

3.

Number of pharmaceutical manufacturers / manufacturing sites

15 year (2018)

4.

Number of traditional medicine manufacturers / manufacturing sites

37 year (2018)

5.

Number of pharmaceutical importers

82 year (2018)

6.

Number of pharmaceutical wholesalers

462 year (2018)※Hospital pharmacy only⑥

Information on your hospital pharmacy（１） Organization chart of the pharmaceutical department or the pharmacy to which you belong
a. Number of section chiefs:
b. Number of deputy chiefs:
c. Number of managers:（２） Number of staff
a. Number of pharmacists:
b. Number of clinical pharmacists:
c. Number of technicians:（３） Number of the kinds of drugs managed in your pharmacy or hospitala. Oral medicine:b. Injections:c. Medicines for external use:
（４） Number of prescriptions dealt in your pharmacy per day
a. For inpatients:
b. For outpatients:（５） Equipment of the pharmacy in your hospitala.

Does your hospital have a dispensary room?
If "Yes", how large is it?
Yes

b.

㎡

No

Does the pharmacy have a clean room or laminar flow hood?
Yes

/

No

If "Yes", please describe it in detail
Detail:－ 362 －

c.

Does the pharmacy have computers?
Yes

/

No

If "Yes", what is the purpose of using them.
Purpose:d.

Do you implement Therapeutic Drug Monitoring (TDM : Therapeutic Drug Monitoring) in yourHospital?
Yes

e.

/

Do you prepare TPN (Total Parental Nutrition)
Yes

f.

No

/ No

Can you use Internet at the pharmacy?
If "Yes", what is the purpose of using it.
Yes

/

No

Purpose:－ 363 －

※All participants. Please describe the following general information as much as you know.

⑦

Education and License of Pharmacists in your country（１） Number of years in primary, secondary and high school education
Primary

8 years

Secondary

4 years

High school

2 years（２） Number of years / weeks in the following categories during university or college
University / college:

4 years

Professional education:

2 years

Practical training:

2 years

Duration of training by each facility:
Hospital pharmacy:

52 weeks

Community pharmacy:

26 weeks

Pharmaceutical company:

26 weeks

Others:N/A

Age at graduation:

22 years old（３）Are there any national examinations for pharmacists in your country?
Yes
Academic Exams

1 day

Clinical Exams

1 day

No
（４）Which of the followings must you fulfill to obtain a pharmacist's license?
* If practical training is mandatory, give the subjects and training period.
addamba_transcript.pdf* If practical training is optional, give the reasons.
(i.e. Training is necessary to prepare for the national examination)（５）Number of pharmaceutical university or college graduates:
25-30 People / per year
The alumni's placement rate (%)
a. Hospital:

20%

b. Community Pharmacy:

60%c. Government Organization:

10%d. Enterprise:5%e. Others:

5%⑧ Side effect report
Please describe the flow of reporting system (from a medical institution to an administrative agency), when a－ 364 －

severe side effect case is occurred in a medical institution. Describe specifically the rule and responsibility ofeach organization (an administrative agency / a medical institution), and their collaboration/cooperation.
UGANDA PHARMACOVIGILANCE REPORTING SYSTEM

Adverse Drug Reaction (ADR) communication channels in Uganda. Abbreviations: NPC= National Pharmacovigilance Centre; NDA=
National Drug Authority; PV= Pharmacovigilance; MoH = Uganda Ministry of Health.

－ 365 －

Regulatory Systems
on Ensuring Access to Quality Medicines

VENEZUELA－ 367 －

Venezuela
Central University of Venezuela
School of Pharmacy

Valentina De Freitas Assalone

1. Introduction of the work
I work at the Central University of Venezuelain the Pharmacy School as a professor of“Pharmaceutical
ServicesinRegional
Projects”
This subject is part of the curriculum of theSanitary-Health Care Mention, it is an option
in the fifth year of pharmacy studies.
1－ 369 －

1. Introduction of the work
The curriculum of the Health Care Mention
includes a subject called Health Surveillance,
where everything related to regulatory systems isstudied.
After the theory students spend five weeks
rotating through the National Hygiene Institute2

1. Introduction of the work
Ministry Popular Power for
HealthAutonomous Service
Sanitary Comptroller

Direction of Food andBeverage Safety

Direction of Drugs,
Medicines and Cosmetics

Direction of Regulation and Control ofMaterials, Equipment, Establishments and
Health Professionals

Direction of Customs

Sanitary Registration
Division

Import and Export Division

Health Establishments
Division

Buildings, Equipment andContainers DivisionInspections Division

Health Professionals Division

Vigilance and Control
Division

Cosmetic Products Division

Health Materials andEquipment Division

Psychotropics and Narcotics
Division

Natural and Homeopathic
Products Division

Tobacco Division3－ 370 －

State SanitaryComptrollerships

Group of Customs
Coordinators

Direction of Food andBeverage Safety

Direction of Drugs,
Medicines and Cosmetics

Direction of Regulation and Control of Materials,
Equipment, Establishments and HealthProfessionals

1. Introduction of the work

National Hygiene
Institute “Rafael
Rangel”‐Presidency‐

GeneralManagement

SectoralManagement ofRegistration andControl

Division of FoodControl

Division of Control of
Medicines andCosmetics

Division of National
Control of Biological
Products

Capture andInspection

Quality Assurance

Adviser Commission

CENAVIF(Pharmacovigilance)

4

2. Good Practice•My experience related to Good Practices istheoretical obtained through diploma courses
and in the rotation within the National Hygiene
Institute.

5－ 371 －

3. Difficulties/Lessons Learned from Past Experience

Difficulties
Currently in Venezuela the crisis in the matter of
medicines, has generated the entry into thecountry of products through illegal routes
without the revision and approval of theRegulatory Agency.

6

4. Your interests(1) Know the management of the regulatory
systems of other countries and their impact
on the drugs that patients finally receive inthe hospital and community pharmacies.
.
7－ 372 －

4. Your interests(2) Observe the procedures in different work
areas through the field visits must be anenriching experience, which will allow
consolidating theoretical knowledge.

8－ 373 －

Part I:INFORMATION SHEETRegulatory Systems on Ensuring Access to Quality Medicines （JFY 2018）
Name: Valentina De Freitas Assalone
Country: Bolivarian Republic of Venezuela
Organization/Department/Division: Central University of Venezuela / School of Pharmacy/Sanitary-Health Care.
① Organizational Chart

Ministry PopularPower for HealthNational Hygiene Institute “Rafael Rangel”

Autonomous Service
Sanitary Comptroller

Direction of Food andBeverage Safety

Direction of Drugs,
Medicines andCosmetics

Direction of Regulation andControl of Materials, Equipment,
Establishments and HealthProfessionals

Direction of Customs

State SanitaryComptrollerships

Group of Customs
Coordinators

Direction of Food andBeverage Safety

Sanitary Registration
Division

Import and Export
Division

Health Establishments
Division

Buildings, Equipment
and Containers
Division

Inspections Division

Health Professionals
Division

Direction of Drugs,
Medicines andCosmetics

Vigilance and Control
Division

Cosmetic Products
Division

Health Materials andEquipment Division

Direction of Regulation and Control ofMaterials, Equipment, Establishments
and Health Professionals

Psychotropics andNarcotics Division

Natural andHomeopathic Products
Division

Tobacco Division

The Ministry of Popular Power for Health through the Autonomous Sanitary Comptroller Service in the
Bolivarian Republic of Venezuela is in charge of all the subjects related to the registration and control ofproducts for human consumption: food, medicines, cosmetics, natural products, as of medical equipment andmaterials. It also controls the health professions and their establishments.
The National Hygiene Institute is a support agency for the Ministry of Popular Power for Health, exercisingsanitary control over products for human consumption. The products are initially evaluated in the Institute anddepending on their results the Ministry makes the final decision to give or not the sanitary registration.

Organization chart of the National Hygiene Institute (referent only to sanitary control)－ 374 －

National Hygiene
Institute “Rafael
Rangel”-Presidency-

General Management

Sectoral Managementof Registration andControl

Division of FoodControl

Division of Control of
Medicines andCosmetics

Division of National
Control of Biological
Products

Capture and Inspection

Quality Assurance

Adviser Commission

CENAVIF(Pharmacovigilance)

Pharmacists work in each of the divisions of the Institute and as Sanitary Comptroller, from evaluating
documentation, sample analysis to decision making in conjunction with doctors and other officials. Likewise,
they are responsible for the inspections to the pharmaceutical establishments to verify the compliance with theregulations and the collection of samples.
※Hospital pharmacy

The hospital pharmacist is in charge in conjunction with the purchasing department of guaranteeing the
medicines supply in health institutions, and participates in each of the stages of the supply system: selection,
programming, acquisition, storage and distribution. Also fulfills functions in other pharmaceutical services suchas pharmaceutical care, information and education about drugs and pharmacovigilance② Legislation on pharmaceutical administration◆At National and local level
・Pharmacy Exercise Law, administered by Ministry of Popular Power for Health through the Autonomous Serviceof Sanitary Comptroller
・Medicaments Law, administered by Ministry of Popular Power for Health through the Autonomous Service ofSanitary Comptroller◆PIC/SNo③ Regulatory Services◆Pharmaceutical Manufacturing
・Good Manufacturing Practice, administered by the National Hygiene Institute “Rafael Rangel”, and theMinistry of Popular Power for Health, through the Autonomous Service of Sanitary Comptroller.

－ 375 －

◆Drug Import/Export
・Standards of the Pharmaceutical Products Review Board , administered by the National Hygiene Institute“Rafael Rangel” and the Ministry of Popular Power for Health, through the Autonomous Service of SanitaryComptroller.
◆Marketing Authorization
・Standards of the Pharmaceutical Products Review Board

administered by the National Hygiene Institute“Rafael Rangel” and the Ministry of Popular Power for Health, through the Autonomous Service of SanitaryComptroller.
◆Drug Distribution (including drug selection, procurement, sale)・Standards of Good Practice for the Distribution of Medicines by the Ministry of Popular Power for Health,through the Autonomous Service of Sanitary Comptroller.
◆Medicine Safety (post-marketing)・Good Pharmacovigilance Practice administered by the National Hygiene Institute “Rafael Rangel”◆Relief System for Adverse Drug Reactions
・Good Pharmacovigilance Practice administered by the National Hygiene Institute “Rafael Rangel”④ Drug Pricing−

Medications in public hospitals are free; in addition, there is a list of medicines whose price is regulated by
the State.

⑤ Statistic Data (waiting for information)
1.

Number of pharmacists(year)

2.

Number of GMP inspector (National & Local)(year)

3.

Number of pharmaceutical manufacturers / manufacturing sites(year)

4.

Number of traditional medicine manufacturers / manufacturing sites(year)

5.

Number of pharmaceutical importers(year)

6.

Number of pharmaceutical wholesalers(year)※Hospital pharmacy only⑥

Information on your hospital pharmacy
Caracas University Hospital (Is within the Central University of Venezuela)（１） Organization chart of the pharmaceutical department or the pharmacy to which you belong
a. Number of section chiefs: 0
b. Number of deputy chiefs: 1－ 376 －

c. Number of managers: 1（２） Number of staff
a. Number of pharmacists: 24
b. Number of clinical pharmacists: 3
c. Number of technicians: 48（３） Number of the kinds of drugs managed in your pharmacy or hospitala. Oral medicine: (waiting for information)b. Injections: (waiting for information)c. Medicines for external use: (waiting for information)（４） Number of prescriptions dealt in your pharmacy per day
a. For inpatients: (waiting for information)
b. For outpatients: (waiting for information)（５） Equipment of the pharmacy in your hospitala.

Does your hospital have a dispensary room?
If "Yes", how large is it?
Yes

b.

㎡

Does the pharmacy have a clean room or laminar flow hood?
Yes
Detail: The hospital has five units of intravenous mixtures with laminar flow hoods: Intensive
Therapy, Anesthesiology, Pediatrics, Hematology and Parenteral Nutrition.

c.

Does the pharmacy have computers?
Yes
Purpose: Inventory control systemd.

Do you implement Therapeutic Drug Monitoring (TDM : Therapeutic Drug Monitoring) in yourHospital?
Noe.

Do you prepare TPN (Total Parental Nutrition)Yesf.

Can you use Internet at the pharmacy?
Yes
Purpose: Communication and research.

⑦

Education and License of Pharmacists in your country（１） Number of years in primary, secondary and high school education
Primary

6 years

Secondary

3 years－ 377 －

High school

2 years（２） Number of years / weeks in the following categories during university or college
University / college:

5 years

Professional education:

5 years

Practical training:

5 years

Duration of training by each facility:

6 months/1 year

Hospital pharmacy:

4 weeks

Community pharmacy:

4 weeks

Pharmaceutical company:

4 weeks

Others:weeks

Age at graduation:

24 years old（３）Are there any national examinations for pharmacists in your country?
Yes
Academic Exams

days

Clinical Exams

days

No X
（４）Which of the followings must you fulfill to obtain a pharmacist's license?
* If practical training is mandatory, give the subjects and training period.

* If practical training is optional, give the reasons.
(i.e. Training is necessary to prepare for the national examination)（５）Number of pharmaceutical university or college graduates:
120 people / per year
The alumni's placement rate (%)
a. Hospital:

37%

b. Community Pharmacy:

19%c. Government Organization:

13%d. Enterprise:

23%

e. Others:

8% (Academy)

Currently, pharmacists as well as other professionals emigrates when obtain their professional title emigrates,
therefore the statistics are affected by this fact
⑧ Side effect report－ 378 －

MPPS: Ministry of Popular Power of Heal by its initials in Spanish－ 379 －

Regulatory Systems
on Ensuring Access to Quality Medicines

ZAMBIA－ 381 －

Zambia

Zambia Medicines Regulatory
Authority

Mr. Nyambe Lyoko

1. Introduction of the work
(1) My organization and Department
I work for the Zambia Medicines Regulatory Authority (ZAMRA) under theMarketing Authorisation Section.

(2) Job tenure
I work as Assistant Director – Marketing Authorisation (ADMA), which ispermanent and pensionable job.

(3) The regulatory services that I am engaged:
I manage the following activities: a) registration of medicines and allied substances in order to achievecompliance to set standards of quality, safety and efficacy;b) inspection and authorisation of clinical trials; andc) pharmacovigilance - monitoring the quality and safety of medicines
and allied substances;1－ 383 －

1. Introduction of the work(4) Roles and position of pharmacists in my country
In Zambia, pharmacists occupy various positions and play diverseroles, in both public and private sectors, in assurance of access toquality, safe and efficacious medicines and allied products.
Pharmacists work in various decision making positions including:regulators, inspectors, registration officers, procurement officers,
managers of supply chain of medicines, quantification of country’s
medicines requirements, dispensing of medicines to patients, giving
input on policy issues regarding medicines and pharmacy practice,
managing private retail and wholesale pharmaceutical premises, andlecturing in colleges and universities.
In the above roles, pharmacists occupy various positions from officers
implementing programs to managers/ chief executives making policy
decisions.

2

2. Good Practice
I have a few experiences regarding Good Regulatory Practices.
Some of the examples include:
Achievements
1) Reduction of the backlog of product applications using the following
mechanisms:
a)

b)

c)

Triaging of pending product applications into: human medicines, allied substancesand veterinary medicines; and introducing abridged assessment procedure for low
risk products such as nutritional supplements. This led to reduced timelines toregistration for nutritional supplements from 18 to 24 months to below 9 months.
Retreat sessions for evaluation of applications for registration of medicines. Moreproducts were reviewed within the sessions. This shortened the timeline toregistration of medicines.
Engagement of external experts from academia to review some dossiers where
there was limited capacity within the Authority e.g. applications for registration of
biological or biosimilar products. This enabled the Authority to make regulatory
decisions on products, based on scientific opinion from experts.
3－ 384 －

2. Good Practice
Achievements ….cont’d2) Reduced number of poor quality dossiers for registration of medicines
The Authority introduced and implemented a screening procedure for applications forregistration of medicines. This has helped prevent receipt of poorly prepared dossiers by
the Authority.

3) Increased collaboration on registration of medicines
The Authority participates in WHO prequalification and SRA collaborative registration
procedure. In addition, the Authority is an integral member of the Zazibona regionalgrouping on collaborative registration procedure. Through these routes, the Authority hasregistered a number of medicines.
Further, the collaboration has opened new avenues for international collaboration andcooperation on various issues, including GMP inspections and monitoring of substandard.

4

2. Good Practice
Achievements ….cont’d4) Contribution to the global database on counterfeit medicines andadverse drug reactions
The Authority is part of the global network on the fight against counterfeit medicines.
Zambia has contributed a number of reports to the WHO Rapid Alert system and the
VIGIFLOW.

5) Participation in proficiency testing
The national drug quality control laboratory of the Authority participates in the USP and
WHO organized proficiency testing schemes, where they have been performing very well.

6) Development of a national antimicrobial resistance plan
Zambia developed and implemented a National Antimicrobial Resistance Plan. Which isa multisectorial strategy for tackling antimicrobial resistance. So far, a number ofsensitization programs have been conducted.

5－ 385 －

2. Good Practice
Achievements ….cont’d7) Increased number of technical staff in the Authority
Over the past two years the Authority has grown the number of its staff from slightly over
50 to over 100. Most of the filled positions are for technical officers working in theRegistration, Inspectorate and Laboratory Departments. This has contributed to theefficiency seen in terms of executing the Authority’s mandate.

8) Acquisition of support from the EU HSSPThe Authority is grateful to the EU which has granted financial and technical support to
the Authority for the following areas: Construction of the National Drug Quality Control Laboratory and ZAMRA offices; Short term technical support e.g. trainings in assessment of product applications,
quality management system, laboratory standards (ISO 9001) and internal auditors;
 Procurement of refrigerated vehicles for sampling medicines for use in post-marketingsurveillance; Building of QMS and other systems for the national laboratory with view to getting
WHO prequalification.
6

2. Good Practice
Achievements ….cont’d9) Acquisition of support from the Global Fund
The Authority is grateful to the Global Fund for the financial support to the Authority thatfacilitated putting up of a modern incinerator and procurement of laboratory equipment,
including an HPLC.

7－ 386 －

2. Good Practice
Solutions for past problems
 Long list of pending applications: Use of WHO/SRA collaborative
registration procedure the timeline to register essential medicines(ARVs, antimalarials, vaccines, TB) has reduced;
 Long list of pending applications: Conducting retreats for review ofdossiers has greatly reduced the backlog;
 Limited storage space: change of hard copy dossiers to electronic
version has helped create space for new dossiers;
On-going projects to deal with current problems: Limited capacity in biosimilar assessment: one officer will be attachedwith the HPRA, Ireland to learn how to assess biological medicines; Unregulated blood products: ZAMRA will collaborate with ZNBTS todevelop guidelines for regulation of blood and blood products;
Successful countermeasures against problems: Implementation of CTD guidelines has helped us collaborate better withother agencies as information is in the same format and easy to share.
8

3. Difficulties/Lessons Learned from Past ExperienceProblems that cannot be improved or solved Lack of reliable medicines registration database: This is an ICT
challenge where we need in order to effectively manage theregistration processes;

Failed countermeasures to deal with the problems
 ZAMRA invited a few suppliers to showcase the database systems
they have but none of these met the requirements for the Authority;



Emerging or Re-emerging Problems, if any
 Anti-microbial resistance is a problem that needs concerted efforts inorder to avoid emergence of highly resistant pathogens.

9－ 387 －

4. Your interests(1) ZAMRA regards Japan as an SRA. Therefore, I would
like to learn as much as possible the Japanese regulatory
system and identify what best practices can bedomesticated in Zambia. It would be nice to collaborate in
the areas of registration and GMP with the regulatory
authority in Japan;(2) To establish networks for continued collaboration withJapan and participating countries in sharing regulatory
information of mutual interest.
(3) To explore for solutions on acquisition of a database formanaging applications for registration of medicines.
10－ 388 －

INCEPTION REPORT: JICA KNOWLEDGE CO-CREATION PROGRAM

Regulatory Systems on Ensuring Access to Quality Medicines (JFY 2018)

Name: Nyambe Lyoko (Mr)Country: Zambia
Organisation/ Department/ Division:Zambia Medicines Regulatory Authority/
Department of Medicines Control/Marketing Authorisation Section

INTRODUCTION
In Zambia, the Ministry of Health (MOH) carries the overall responsibility of providing
healthcare to all Zambians. In order to effective carry-out its mandate, the Ministrycollaborates with various stakeholders including cooperating partners (i.e. donors andnon-governmental organisations) and the private sector; all of whom are contributing
to universal health coverage.
The Ministry of Health has various Directorates, Departments and Statutory Boards
with specific functions and responsibilities. For instance, the Department of Clinical
Care & Diagnostic Services is responsible for the provision of clinical and diagnostic
services for improved health outcomes. The Zambia Medicines Regulatory Authority(ZAMRA) is a Statutory Board that is responsible for regulating and controlling of
medicines and upholding of good practices regarding the manufacture, storage,
distribution and sale of medicines and allied substances in Zambia.
The mandate of ZAMRA to regulate medicines and pharmaceutical premises isderived from the Medicines and Allied Substances Act (No. 3) of 2013. The Act
continues the existence of the Pharmaceutical Regulatory Authority and re-names it
as the Zambia Medicines Regulatory Authority (ZAMRA); provides for the functions
and powers of the Authority; provides for the registration and regulation of pharmacies,
health shops and agro-veterinary shops; provides for the registration and regulation of
medicines and allied substances; provides for the regulation of the manufacture,importation, exportation, possession, storage, distribution, supply, promotion,
advertising, sale and use of medicines and allied substances; and provide for the
regulation and control of clinical trials.
The other important legislations and statutes include: the Dangerous Drugs Act,
Narcotic and Psychotropic Substances Act, Regulations on Pharmaceutical Licences,
Regulations on Wholesale Dealing, Regulations on Health Shops, Regulations on
Agrovet Shops, and Statutory Instrument (No. 38) on Fees.

－ 389 －

1. ORGANISATIONAL CHART

DHPESD

DNS

NMEC

DNMR

Minister

DPP

Statutory Bodies

GH

DME

DHRMA

DHRPD

DPIMT

*Internal Audit
*HCF
*PSU
*Accounts*ICT*LegalUnits

PS ‐ Administration

ORGANISATIONAL STRUCTURE – MINISTRY OF HEALTH

The organisational chart for pharmaceutical administration in Zambia is given below:

DPH

PS – Technical Services

DCCDS

PHDs
*CDL
*FDCL
*MCHATS*Dental TS*NCHATS－ 390 －

Assistant Director –Pharmaceutical Services (1)Director (1)National Coordinators (20)

DEPARTMENT OF CLINICAL CARE & DIAGNOSTIC SERVICES

Assistant Director (1)Clinical Care Specialist (1)Administrative Assistant (2)Secretary (2)－ 391 －

NUCLEAR MEDICINE & RESEARCH DEPARTMENT

Consultant ‐ Nuclear Medicine Research (1)Director (1)Consultant – Nuclear
Medicine Physician (1)Chief Medical
Physicist (1)Senior Registrar ‐ Nuclear Medicine Research(1)

Chief Radio
Pharmacist (1)Senior Registrar –Nuclear Medicine
Physician (1)Chief Radiographer (1)Principal

Senior Medical
Physicist (1)Principal Medical
Physicist (1)Senior Radio
Pharmacist (1)Medical Physicist (1)Principal Radio
Pharmacist (1)Senior Radiographer(4)Radiopharmacist (1)Radiographer –SPECT/CT, PET/CT,
PET/MIR, PET (4)Radiographer (8)Ancillary Staff (13)－ 392 －

Internal
Medicine

SurgicalServices

Anaesthesia& Critical
Care

Emergency
MedicalServices

Senior Medical Superintendent

Human
ResourceandAdministration

Head Clinical Care

Radiology

UNITS
Accounts
Audiology
Catering Services
Engineering & Maintenance
Environmental Health & Waste Management
Health Information
Information & Communications Technology
Internal Audit
Planning
Premium Medical Services
Prosthetics and Orthotics
Purchasing & Supplies
Public & Customer Relations
Social Welfare Services

NursingServices

Physiotherapy

UNIVERSITY TEACHING HOSPITAL – ADULT HOSPITAL

Laboratory& Blood
Transfusion
















Pharmacy

Biomedical
Engineering－ 393 －

Senior
Inspector ‐Investigations

Licensing
Officer ‐
GMP &
GDP

Inspector
GMP (2)

SeniorInspector ‐Licensi
ng,
GMP
& GDP

Principal
Inspector
Licensing &EnforcementSurveillance
Officer‐ PV

Internal Auditor

Personal Assistant

Chief
AnalystPhysicoChemicalPrincipal
AnalystMicrobiology

Chief Analyst
Microbiology& AnimalFacility

Quality
Unit

Laboratory
Quality
Officer

SeniorAnalyst‐AnalyticalTechniq
ues

Analytical
Techniques

SampleCustodian&
Registry

Laboratory
StoresControllerMetrology
OfficerLaboratory
Information
Officer

Safety &Environment
Officer

SupportServices

Quality Assurance Officer

Senior Quality Assurance Officer

DIRECTOR GENERAL
Assistant Internal Auditor
Legal Officer

Principal
AnalystPhysicoChemicalSeniorAnalystMicrobiology

Director Laboratory Services

Narcotics

SeniorAnalystPhysicoChemicalLaboratory
Technol
ogist

Senior
Licensing
Officer ‐Narcotics

Laboratory
Technologi
stLaboratory
Assistant

AnimalFacility
Officer

AnalystMicrobio
logy
Licensing
Officer‐
Narcotics

Assistant
Inspectors(3)

AnalystPhysicoChemica
l (5)

Ports
of
Entry

Public Relations Officer

Assistant
Inspector‐
LivingstoneSub
Offices

Principal
Regulatory
Officer:
LusakaRegionAssistant
Inspector‐ GDP &
Access (2)InspecInspec tor ‐tor
Investi
GDP & gation
Accesss

SeniorRegulatory
Officer

Assistant DIrector
Licensing, Surveillance &Enforcemnt

Assistant
Inspector‐
KabompoSub
Offices

Principal
Regulatory
Officer:
Copperbelt
RegionInspector ‐Investigations

SeniorRegulatory
Officer

Inspector
Surveillance GDP &Officer Access‐ PMS

SeniorSurveillance
Officer

Principal
Surveillan
ce Officer

Director Medicines Control

SeniorRegistration
Officer
AlliedSubstanc
es
Registration
Officer‐ Allied
Substances

Registration
Officer ‐Cosmetics &otherAlliedSubstances (2)

Assistant
Inspector ‐KasamaLaboratory
Assistant

Chief
Accountant

Senior
Accountant

Accounta
nt

Assistant
Account
ant (3)

Receptioni
stRecords
Officer(2)

Secretary

SeniorHuman
Resource &Administrati
on Officer

Driver(6)

Head
DriverAdministrative
Assistant (2)

Procurement
Officer

Procurement
Unit

Director Corporate Services

Head Human
Resource &Administration

OfficeAssistants(7)GeneralWorkers(3)

M&E
Officer

M&E
Unit

ORGANISATIONAL STRUCTURE – ZAMBIA MEDICINES REGULATORY AUTHORITY

Registrati
on Officer‐
Veterinary (2)SeniorRegistration Officer:
Veterinary
Medicines

Principal
Registrati
Principal
onRegistration
Officer:
Officer:
AlliedVeterinary
Substance
Productss

Assistant Director
MarketingAuthorisation
Principal
Registrati
on
Officer:
Medicines& Clinical
TrialsSeniorSeniorRegistraRegistrat
tion
ion
Officer
officer:
ClinicalMedicin
Trialses &Biotechnologies
Registration
Officer ‐Medicines (6)Registration
Officer
Biotechnologies

Registration
Officer ‐HerbalRegistration
Officer ‐Medical
Devices

Assistant
Inspector ‐GDP &Access(2)

AnimalAttenda
nt

ICT
Unit

ICT
Officer

Assistant
ICT
Officer－ 394 －

The roles and responsibilities for pharmacists working at the following levels in the Ministry of Health are summarised below:a) Ministry of Health:- provides policy direction, resources including medicines and other health technologies;- ensure access to quality healthcare services and commodities at all times;- lead the process of quantification and procurement of medicines and health commodities for the public sector;- storage and distribution of medicines and other health commodities (Medical Stores Limited, MSL);- MSL has central and regional warehouses for effective storage and distribution of medicines and other health commodities.
- identification of training needs for personnel.

b) Ministry of Health (Provincial and District levels)- implement policy and manage resources, including medicines and other health technologies;- ensure access to quality healthcare services and commodities at all times;- participate in the process of quantification of medicines and health commodities for the public sector;c) Hospital level- quantification of medicines requirements;- participate in ward rounds as part of clinical care team to develop pharmaceutical care plans;- undertaking monthly orders of medicines;- generating various monthly departmental reports, including stock-outs, needs assessments, trainings conducted andmedicines safety issues;
dispensing of medicines and counselling patients;
ordering medicines from main stores to dispensary;-d) Zambia Medicines Regulatory Authority- undertake registration of medicines;- undertake inspection and licensing of premises used for distribution, sale and manufacture of medicines;- undertake quality control testing of products on the Zambian market;- undertake authorisation of conduct of clinical trials;- undertake post-marketing surveillance and pharmacovigilance activities.

－ 395 －

2. LEGISLATION ON PHARMACEUTICAL ADMINISTRATION◆National Level
・Medicines and Allied Substances Act (No. 3) of 2013 administered by the Zambia
Medicines Regulatory Authority (ZAMRA)
・Dangerous Drugs Act administered by the Zambia Medicines Regulatory Authority(ZAMRA)・Narcotic and Psychotropic Substances Act administered by the Zambia Medicines
Regulatory Authority (ZAMRA) and the Drug Enforcement Commission (DEC)・Public Health Act administered by the Ministry of Health and Zambia Medicines
Regulatory Authority (ZAMRA)
・Food and Drug Act administered by the Ministry of Health and Food and Drug
Laboratory◆Local Level・above laws apply at all levels◆PIC/S
Yes

OR

No 

If yes, joined when
Zambia is not a member of PIC/s but would like to join in the near future.

3. REGULATORY SERVICES
The Medicines and Allied Substances Act (No. 3) of 2013 is the overarching lawthat provides for various regulatory services, including the following:◆Pharmaceutical Manufacturing
・Regulations on Pharmaceutical Licences (for manufacturers) administered by
ZAMRA・WHO Good Manufacturing Practice (GMP) guidelines administered by ZAMRA
・WHO Good Laboratory Practice (GLP) guidelines administered by ZAMRA
・WHO Good Clinical Practice (GCP) guidelines administered by ZAMRAMost of the guidelines used by the Authority are WHO guidelines.

－ 396 －

◆Drug Import/Export
・Statutory Instrument (No. 38) on Fees administered by ZAMRA
・Customs and Exercise Duty Act administered by Zambia Revenue Authority (ZRA)
・Dangerous Drugs Act (for Narcotics and Psychotropic Substances) administered by
ZAMRA. In addition, Zambia abides with the conventions under the International
Narcotics Convention Board (INCB) specifically for controlled substances◆Marketing Authorization
・Guidelines on preparation and submission of dossiers in CTD format administered by
ZAMRA
・Guidelines on grant of marketing authorisation for human medicines administered by
ZAMRA
・Guidelines on grant of marketing authorisation for veterinary medicines administered
by ZAMRA
・Guidelines on grant of marketing authorisation for biological products administered by
ZAMRA・WHO Guidelines on assessment of biosimilar products administered by ZAMRA
・Guidelines on grant of marketing authorisation for nutritional supplements
administered by ZAMRA
・Guidelines on grant of marketing authorisation for human medicines administered by
ZAMRA
・Guidelines on grant of marketing authorisation for herbal medicines administered by
ZAMRA
・Guidelines on bioavailability or bioequivalence administered by ZAMRA◆Drug Distribution (including drug selection, procurement, sale)・Guidelines on good distribution practices (GDP) administered by ZAMRA
・Regulations on Wholesale Dealing administered by ZAMRA◆Medicine Safety (post-marketing)・Regulations on Wholesale Dealing administered by ZAMRA
・Guidelines on pharmacovigilance administered by ZAMRA◆Relief System for Adverse Drug Reactions
・Guidelines on pharmacovigilance administered by ZAMRA－ 397 －

4. Drug Pricing◆Since 1991 when the Zambian government introduced liberalisation policy of the Economy,
there is no price control of pharmaceutical products or any other commodities. Thus, market
forces determine what prices businesses charge for their good and services.

5. Statistic dataa) Number of pharmacists: 630 (2017)b) Number of GMP inspectors: 6 (2018)c) Number of pharmaceutical manufacturers/ manufacturing sites: 7 (2018)d) Number of traditional medicine manufacturers/ manufacturing sites: unknown (notregulated)e) Number of pharmaceutical importers: 117 wholesalers (2017) (but other players
including Ministry of Health, cooperating partners, non-governmental organisations,private companies and donors also import medicines)f)Number of pharmaceutical importers: 117 (2017)※All participants. Please describe the following general information as much as you know.

① Education and License of Pharmacists in your country（１） Number of years in primary, secondary and high school education
Primary (Grade 1 to 7)
7 years
Secondary (Grade 8 to 9)
2 years
High school (Grade 10 to 12)
3 years（２） Number of years / weeks in the following categories during university or college
University / college:
5 years
Professional education:
2 years
Practical training:
2 years
Duration of training by each facility:
5 years
Hospital pharmacy:
52 weeks
Community pharmacy:
weeks (Not applicable)
Pharmaceutical company:
weeks (Not applicable)
Others:weeks (Not applicable)
Age at graduation:
24 years old (average)（３）Are there any national examinations for pharmacists in your country?
Yes
Academic Exams
Clinical Exams

5
1

days
days

No

－ 398 －

（４）Which of the following must you fulfil to obtain a pharmacist's license?
* If practical training is mandatory, give the subjects and training period.
Practical training in dispensing medicines at a public hospital and clinical pharmacy
practice, including participating in clinical care team on wards.
（５）Number of pharmaceutical university or college graduates:≈100 people / per year
The alumni's placement rate (%)
a.
b.
c.
d.
e.

Hospital:Community Pharmacy:
Government Organization:
Enterprise:
Others:

80
5
10
3
2

%
%
%
%
% (e.g. academia)② Side effect report
Please describe the flow of reporting system (from a medical institution to an administrative
agency), when a severe side effect case is occurred in a medical institution. Describe
specifically the rule and responsibility of each organization (an administrative agency / a
medical institution), and their collaboration/cooperation.
The Medicines and Allied Substances Act (No. 3) of 2013 gives mandate to ZAMRA toundertake pharmacovigilance activities. The reports on suspected adverse drug
reactions (ADRs) or suspected medicine quality defects (MQDs) are sent directly to the
Authority (ZAMRA) using any of the following mechanisms:
Electronic submission using ADRA* mobile application or directly on ZAMRA
website (www.zamra.co.zm);(*The ADRA app requires one time registration)
Completed hard copy of adverse drug reaction (ADR) report form (for health care
professionals, members of public) or adverse event following immunisation(AEFI) form;
Calling ZAMRA directly on +260211220429. Reports received by phone aretranscribed on the reporting form;

All received reports are forwarded to the National Pharmacovigilance Unit (NPVU),
within ZAMRA, which records the received reports, prepares summaries forconsideration by the Technical Committee on Pharmacovigilance and Clinical Trials,
and uploads the reports on VIGIFLOW when the committee establishes causalrelationship with the medicinal product.

－ 399 －

The chart below summarises the flow of reports and information from hospitals and theroles/functions of organisations involved in management of reports at this level:
Ministry of HealthTechnical
Committee on
Pharmacovigilance
and Clinical Trials
Roles/ responsibilities Conduct causality
assessment on
ADR reports
 Advise theAuthority on safetyof the medicinesand proposes how
to manage thepatient

Zambia Medicines
Regulatory Authority
NPVU

Roles/ responsibilities
 Provides policy direction
 Guides on all matters of public health recruits and trains staff for the Unit; providing ADR reporting forms/tools; develop manuals and guidelines for healthfacilities and laboratories;
 train health care workers in the use ofreport forms;
 collecting data; manage a coding and archive system fordata entry and retrieval; and provides feedback to reporters on the
ADRs.

Provincial Medical
Office (PMO) Collaborate/ cooperate with DMOs andtheir health facilities;
 providing administrative, technical andlogistical support to MDOs and hospitals;
 provide feedback to and from ZAMRA; distribute blank ADR forms;
 collect and forward completed forms; and verifies/ investigates ADRs, when needed.

District Medical
Office (DMO) supervise the collection of reports fromsites within their jurisdiction;
 distribute blank ADRs reporting forms;
 collect and forward completed forms;
 verify/ investigate ADR, if required; provide administrative, technical andlogistical support to health centres,
laboratories, and (in some cases)
hospitals; and provide feedback from PMO and ZAMRA.

Public/ Private
Hospital or HealthCentreKEY
Submit report/ information
Receive feedback－ 400 －

 record and report ADRs;
 forwarding completed forms directly to
ZAMRA and to the District Medical Office;and provide feedback to the patient.

Regulatory Systems
on Ensuring Access to Quality Medicines

LAOS－ 401 －

Regulatory System(Regulation of Drug Law to Medicine)

By: Ms. Vongviengsa SITHIDETH
Drug Control Division
Food and Drug Department, MoH
Lao PDR.

Vision & Mission
Vision: To ensure good quality, Safety and Efficacy of Drugs and Medical product aswell as their rational use for Lao people.

Mission:•Develop and implement strategy, Policy, Law and Regulation.

•Enforcement of law and regulation governing drug and medical devices.
•Pre-marketing and Post-marketing surveillance of drugs, medical devices and cosmetic
product.
•Strengthening of drugs and medical product quality assurance system including quality
control.
•Provide education and information on the use of drugs and medical products for bothpublic and private sector.
•Promote rational use of drugs.

－ 403 －

Food and Drug Organization Chart
Food and Drug Department
Administration Div.,

Drug Control Div.,
Drug Registration
Committee

Food Control Div.,
Public Pharmacy Div.,

Food andDrugCommittee

Essential Medicine
Committee

Narcotic-Chemise-Cosmetic Control
Div.,
IEC Div.,
Traditional Medicine Control Div.,
Bureau of Food and Drug Inspection(BFDI)
Food and Drug Quality Control Center
Medical Product Supply Center
Provincial Food and Drug Unit

Law and regulation•

Law on Drug and Medical Products No: 07/NA , date: 21 December 2011.

•

Regulation for Drug registration No. 1441, dated 13 Aug 2003.

•

Regulation for Pharmacy No. 2922, dated 21 Sep 2016.

•

Regulation Establish Factory and Company No.1820, date 25 Aug 2017.

•

Regulation for good manufacturing practice and quality control of drugs No. 1021,
dated 11 Aug 1999.

•

Regulation on Good Manufacturing Practice No.937/MoH dated 12/07/2004.

•

Regulation for disposal of medicines including vaccines No.1862, dated 05 Aug 2016.

•

Regulation of Donation of Drugs and Medical Product No.2579/MoH dated 12th Nov
2003.

•

Regulation on the banned drug in Lao No.1018/MoH in 2003.

－ 404 －

Good Practices
Administered pharmaceuticals and medical products such as:• The pharmaceutical business unit is growing as a pillar to supply
medicine and medical products to the public health sector across thecountry.
• Has Issued the License for the pharmaceutical professionals topharmaceutical and medical products.
• Has issued Certificate of medicines are now available to 1865 items.
• Has issued a Certificate of Good Manufacturing Practice (GMP) to four

factories: Factory No. 3, Codupha Factoty, CBF Factory, Tungmeng
Factory.

Good Practices (Con’t)• The value of domestic production has increased, generating an average of
US $ 11,799,756 per year, accounting for 50% of the total drug.
• Has developed and strengthened its ongoing Food and Drug Researchwork, which has provided ISO / IEC17025 ISO / IEC17025 Certificates ofVietnam VILAS in Vietnam in 2017.
• Establish a system of tracking the impact of drug use, monitoring theeffects of drug use, deepening monitoring, reporting on antiretroviral(AEFI) antiretroviral screening system, expanding 7 provinces and 5
central hospitals.

－ 405 －

Good Practices (Con’t)
Implementation of drug procurement:• Strengthening the procurement work together with the hospitals and centers, which
now a days together with 5 central hospitals and 3 Centers for special healthcare

services.
• Jointly organized for 4 provinces in southern Laos (Champasak, Saravane, Sekong
and Attapeu) and expanded to jointly operate in Khammouane, Savannakhet andHouaphanh Province.
• Implementing Joint Drug Management Operations of 05 central hospitals and 10
provinces, which can address the problem of drug quality and drug prices at state-run

facilities. In the two provinces, the procurement of pharmaceuticals was organized.

Good Practices(Con’t)
Follow-up of drug use:
•The hospital management work has been well-developed, especially in promoting
basic medicines, using rational drugs and tracking the consequences of drug use.

•Has established a system of tracking the impact of the World Health Organization's
drug treatment, which began with ARV treatment at 5 HIV treatment centers andexpanded to nine centers nationwide in collaboration with the Department of Health,

the Center for AIDS, Pathology and related provinces.
•As a result of this work, Lao PDR has become a Official member of the World HealthOrganization (WHO) on the consequences of drug use (WHO-UMC) as the 122th

country in 2015.

－ 406 －

Good Practices(Con’t)
Rational use of Medicine•Follow up and promote the implementation of the Central andDistrict Medical and Health Committee.

•Provide provincial and district training on rational use of drugs,
follow up, encourage central hospitals - provincial hospitals -district hospitals and health clinics based on 10 indicators for theuse of rational and 25 chronic diseases in accordance with the
National Uniform Handbook.

Difficulties/Lessons learned•

Management of supply, supply and distribution of drugs at all levels from central tolocal levels is not uniform.

•

Promoting the use of traditional medicine combined with traditional medicine, but theimplementation policy has not yet been formulated.

•

The use of medicine at the hospital at each level, especially at the central and provincial
levels, is also good, there is a need for over-the-counter medication, expensive drugs,
medicines, trade names and drugs that are not essential to basic medicines.

•

Promoting Domestic Production to Achieve Good Manufacturing Standards GMP has
not been actively implemented and there are no strictly planned and planned measures
to comply with the requirements of ASEAN and the WTO.

－ 407 －

The priority topic in this workshop
We were interested all topics from the course•We would like to learn from Japanese experience and otherparticipating countries how they manage the implementing ofpharmaceutical Law as well as related regulations.

•The lesson from the course, that we have learn it could be sharedfor better practice on health product management to increase

accessibility of drug in reasonable price and enhancing regulatory
system to reach the objective of Universal Health Coverage.

Challenges• Assessment experiences are limited among staffs• Insufficiency of English skills• Learning from the ASEAN region on ACTD/ACTR
implementation• Not enough experiences on New drug review practices.

－ 408 －

COUNTRY REPORTFORRegulatory Systems on Ensuring Access to Quality Medicine(JFY 2018)(July 8 – August 11, 2018)
Tokyo, JAPANMrs. Vongviengsa SITHIDETH
Technical officer

Ministry of Health – Lao P.D.R
Drug Control Division, Food and Drug Department
Tel: ( 856 ) 21 214014
Fax: ( 856 ) 21 213495
E-mail: s_vongviengsa@yahoo.com
Website: www.fdd.gov.la－ 409 －

1. Organizational Chart

The Ministry of Health is a central management authority, which collaborates with
the Food and Drug Department to regulate implementation of the inspection andremoval of drug from the market, the Food and Drug Administrative Committee,
according to the decree No. 49 of the Council of Ministers, has the role to assure
quality of Food and Drug, when problem on quality of food and Drug occurs, theFood and Drug administrative Committee should coordinate with the Ministers(Prime Minister’s Office).

－ 410 －

◆ Vision:-

To ensure good quality, safety and efficacy of drug and Food for Lao people◆ Mission:•Develop and implementing strategy and Policy•

Develop, implementing and enforcement of law and regulation governing Food,
Drug and Medical Product•Pre-marketing and Post marketing surveillances activities•

Strengthening of quality assurance system including quality control for Food,
Drug and Medical Product•Continue education for both public and private providers•

Promotion of rational use of drug amongst health worker as well as
communities

The Food and Drug has responsibility for consumer protection on food and drug basedon the Forth MoH’s action plan, In the Organizational structure of the food and drug
Department there are seven divisions in the organization chart and the Drug Control
Division is a one in Charge of the Pharmaceutical Regulatory Systems on Ensuring
Access to Quality Medicine.

2. Legislation on Pharmaceutical administration
The Legislation establishment is one of the thirteen elements (priorities) in the National－ 411 －

Policy to assure that the successful implantation of the Drug policy through using therelated, updates appropriate law and regulations. The first Law on Drug and Medical
Product endorsed and promulgated in the late year 2000, the law consist 8 sections and
45 articles, based on this law, many related regulations as listed below had beenformulated and revised in order to facilitate the control and management on the quality
safety and efficacy of medicine.
1. Revised National Drug Policies, dated on 13/8/2003
2. Revised Drug and Medical Product law issued in 21 December 2011
3. Regulation for Drug registration No. 1441, dated 13 Aug 2003
4. Regulation Establish Factory and Company No. 1820, dated 25 Aug 2017
5. Regulation for Pharmacy No. 2922, dated 21 Sep 2016
6. Regulation for good manufacturing practice and quality control of drugs No.
1021, dated 11 Aug 1999
7. Regulation on Good Manufacturing Practice No. 937/MOH, 12/07/2004
8. Regulation for disposal of medicines including vaccines No. 1862, dated 05
Aug 2016
9. Decision/Approval based on National medicine policy main goal and related
components
10. Regulation of Donation of Drugs and Medical Product No.2579/MoH dated 12th
Nov 2003 concerning Drug and Medical Equipment Donation.
11. Regulation on the banned drug in Lao No.1018/MOH in 2003
12. Regulation on specific controlled medicine and uncontrolled and OTC Drug
No.2580/MOH, on 25/11/2002
13. Regulation on concerning Food, Drug and Medical Equipment Advertisement
No. 2581/MOH in 2003

So far, based on the Scio-economic growth, and integrations to ASEAN harmonizationin pharmaceutical areas, the law on Drug and Medical Product has been revised,endorsed end of 2011, this revised law has been added new five articles regarding
Monitoring Quality of Drug and Medical Product (Post Marketing Surveillance);
Classification of Medical Device, Intellectual Property Right Protection; Clinical Trial
Test in the Laboratory and Etc….the revise law has 50 articles. The above existing
regulation needs to be revised.

－ 412 －

3. Regulatory Services
Drug Division in charge of the Pharmaceutical Regulatory Systems on Ensuring Accessto Quality Medicine respectively:◆ Pharmaceutical Manufacturing-

Licensing of manufacturing site:

Licensing and Registration is a pre-marketing authorization activity with belong to the
responsibility of business Control Division. Within this Division, the licensing for
manufacturing site and the qualification of the product activities are under to control of
the Licensing Unit-

Licensing pharmaceutical Company and pharmacy:

The Licensing for Pharmaceutical to operate pharmacy is belong to Drug BusinessControl Division responsible for evaluating the compliance with law and regulation
before issuing the license for the pharmacist for instance, we check pharmacist
qualification and appropriate room and location of pharmacy, According to the article
number 18 of law and Medical Product, The sale at retail of drugs and medical products
shall be conducted by authorized retail pharmacies only-

Drug Registration System:

According to the regulation No. 1441, on August 13, 2003 covering drug registration in
Lao PDR, every drug before marketing must be registered. The drug selection forregistration is mainly based on National Essential Drug List and needs of hospitals.
Now the drug products has registered about 1,865 items,

there are the importproduction 1562 items, the local production 303 items and traditional medicinesregistered 281 items, in registration system, after 3 years the companies have tosubmit application forms for renewal of registration. The procedure of registration isdivided into 2 steps:•

Step 1: Application for the permission to import or manufacture drug sample
intended to be registered.

•

Step 2: Application for the approval of granted credential certificate◆Drug Import/Export

The drug Import/Export must only be license Certificate of the pharmaceuticalcompanies and the product must be registered, for the process the pharmaceuticalcompanies must be submit the documentation of import to Food and drug Department,－ 413 －

the document that required are :- Letter from the company for importation request- Purchase order- Invoice- Packing list
The application form is approved by the Food and Drug Department after 3 days, an
import permit license will be issued by Director of FDD.
◆Drug Distribution( including drug selection, procurement, sale )The Food and Drug Administration is an integral part of the Ministry of Public Health's
Procurement and Supply Committee under the agreement of Ministry of Public HealthNo. 0150 / SAT on January 24, 2017 on the establishment of the Committee on
Procurement of Drugs, Chemicals, Medical Equipment, Vehicles, Drug Supply Centers
as a coordinating point with the Food and Drug Department and The Board of Directorsof the Board of Directors, the Board of Directors, is also the chief contractor of thebidding process. It is a year since printing, auctioning, auctioning, auctioning,
auctioning and technical research of each type of equipment in the procurement plan
provided to 5 central hospital and 3 centers for special health services.
Technical meeting is essentially the procurement of medicine and there are regulations
and steps of research starting from- Compile all requirements- Assess the qualifications of the factory and the company- Academic research with representatives from each region (5 Central hospitals and 3
centers for special health services.
- Assessment by technical team is based on specifications, registrations, pricing andso on. It will be selected from 1 to 2 to 3 in order to present a committee to be adecision-making alternative.
- Subsequent to the bidding and execution of the contract.

◆ Medicine Safety ( post-marketing )The Food and Drug Department monitors quality assurance program ofpharmaceutical products in the market by collaborative work with the Food and Drug
Quality Control Center.
The Bureau of Food and Drug Inspection have been taking drugs samples from the－ 414 －

markets. The drug import companies submit document for importation must be refer tothe list of drug which have been registered, and inspection activities should be done at
the port of entry as well. Beside this, the indicators for the pharmaceutical inspection
have been established to be guidance for inspectors on control and inspection ofpharmacies.
The 10 indicators are as follows:
1. Order in the Pharmacy
2. Banned drug
3. Availability of ED with INN + clear label
4. Quality of Drug + Expiry date
5. The correct bill
6. Drug dispensing
7. Knowledge of drugs sellers
8. Prescription for antibiotics drug
9. Essential equipment and documents
10. Presence of technical staff
One of the requirements for drug registration is that a sample of the productshould b e sent for analysis. Since the registration sample is selected by the company
applying for registration, it might not necessarily be representative of the quality of the
product that will be eventually marketed. Post-marketing surveillance, i.e. analysis ofsample taken from the distribution chain by the BFDI, essential to identify substandard
and counterfeit products.
◆ Relief System for Adverse Drug Reactions

In year 2000, we organized training course for ADR to the pharmacists and Drug
Therapeutic Committee of central and provincial levels whole country, and the ADR
Report forms were developed and distributed to all hospital, but the reporting was notvery actively. In the year 2012, the FDD is implementing the pilot project on PV focus
on retroviral medicines, PV report Form has been developed and safety reports arerequested to all cases. Laos became official Uppsala Monitoring Center as WHO
system of ADR report as 122 member countries in May 2015.

4. Drug Pricing
Price of drugs is decided in different stage if its distribution from local－ 415 －

manufacturers or importers to consumers. They depend also mainly of the competition
between those sellers in actual free market. In public sector for ensuring that, with thebudget provided by the government for drugs supply, how to obtain essential withadequate quality (efficacy and safety) but also quality more important too,manufactures are requested to produce drugs with less of sophistication for hospitalutilization.
In the present, we are preparing the survey for regulation Pharmaceutical Price Control
The price of drugs was indicated by increasing of 25% of the procurement price asmark up to be indicated; for the imported drugs have no price mechanism wasindicated.

5. Statistic Dataa/. Number of Pharmacists(Average number of Pharmacists by category (Data year 2016-2017)
Data

2684

Years

2017

b/. Number of GMP inspection
Data

13 (GPM Committee)

Years

2017

c/. Number of Pharmaceutical manufacturers/ manufacturing sites
Data

9

Years

2017

d/. Number of traditional medicine manufacturers/ manufacturing sites
Data

3

Years

2017

e/. Number of pharmaceutical importers
Data

66

Years

2017

f/. Number of pharmaceutical wholesalers－ 416 －

Data

2684

Years

2017

6. Information on your hospital pharmacy◆ Organization chart of the pharmaceutical department or the pharmacy towhich you belong
Remark: This is a presentation information of only one hospital-

Roles, responsibilities and missions

Drug division is a crucial and indispensable division which is responsible for seeking
the source of medicines, medical devices and other chemicals to become available fordemand of each division, sectors and relevant units who provide the healthcare ofpatients in the hospital.
Research, contact and collaboration with divisions, sectors, and health centers which
belong to ministry of health for discussion on medicines- medical devices-chemicals tofollow up on registered and unregistered medicines in Laos.

◆ Organizational structure of Mittaphab Hospital

Drug division comprises 1 Chief , 2 Deputy chiefs, 1 Sectoral chief, 1 Sectoral Deputy
Chief, 1 Head of unit and drug division comprises 3 main sectors, divided in 7 units :4 main sectors:- Accounting management and administration sector- Analytical chemistry - Medicine sector－ 417 －

- Medical device management sector- Dispensing sector
7 Units:-

In-Out accounting unit
Daily accounting unit
In-out medicine and medical device unit
Daily dispensing unit
Sectorial Medicine service unit
Analytical chemistry-medicine management unit
Medical device management unita/. Number of section chiefs:
Data

1

Years

2017

b/. Number of deputy chiefs
Data

2

Years

2017

c/. Number of managers:
Data

4

Years

2017

◆ Number of staff
a/. Number of pharmacists

Data

26 peoples, Female 22 peoples

Years 2017b/. Number of clinical pharmacists

Data

21 peoples

Years

2017

c/. Number of technicians:Data

15 peoples

Years

2017

－ 418 －

◆ Number of the kinds of drugs managed in your pharmacy or hospital

Item

NumberBag

28

Flacon61

Ampoule113

Tablet194

Sachet

14

Tube

20
Total:

430◆ Number of prescriptions dealt in your pharmacy per day

Item

Numberinpatients

547

outpatients

129

Equipment of the pharmacy in your hospitalAt the hospital have a dispensary room and the room area about 70 m2 , in side of theroom there are rules and facilities available such as cabinet for general medicine, cabinet
for psychotherapy medicine, cold storage for cold medicine, medication tray and soon..., there are also use excel sheet system for the control and recode of medicine
information.

7. Education and License of Pharmacists in your country( 1 ) Number of years in primary, secondary and high school education
Items

NumberPrimary

5 years

Secondary

4 years

High school

3 years( 2 ) Number of years / weeks in the following categories during university orcollege
Items

NumberUniversity / college:

5-6 years－ 419 －

Professional education:

2 years

Practical training:

42 years

Duration of training by each facility:

6 years

Hospital pharmacy:

4 weeks

Community pharmacy:

4 weeks

Pharmaceutical company:

4 weeks

Others:4 weeks

Age at graduation:

6 years old( 3 ) Are there any national examinations for pharmacists in your country?
Items
Academic Exams
Clinical Exams

Number
5 daysBased on a completion of thepractical training（４）Which of the followings must you fulfill to obtain a pharmacist's license?
1 To be a university or college graduate
2 Pass the national examination
3 Conclude practical training after graduation（５）Number of pharmaceutical university or college graduates:- Approximate 70-80 person per year
The alumni's placement rate (as of: 100 %)Hospital

30 %Community Pharmacy

15 %Government Organization

30 %Enterprise

20 %Others5%－ 420 －

References:-

Drug Control Division, Food and Drug Department (MoH)-

Medical Statistic Division, Budgeting and Planning Department (MOH).

-

Administration and Statistic Division of Mitaphab Hospital-

Administration Division, The Pharmaceutical Development Center (PDC)
Pharmaceutical Factory No: 3.

-

Administration and Statistic Division of University of Health Science.

－ 421 －

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