－ 237 －－ 239 －－ 241 －ROLES OF REGULATORY SYSTEMS AND PHARMACISTS ON ENSURING PROPERACCESS TO QUALITY ASSURED MEDICINES (JFY 2017)
LORALYN P. PASCUAPHILIPPINES
UNIVERSITY OF THE PHILIPPINES-PHILIPPINE GENERAL HOSPITAL
1. ORGANIZATIONAL CHART
National Pharmaceutical Administration (organizational chart on page 3)
Food and Drug Administration
To ensure the safety, efficacy health products, which includes drugs, the Philippine Bureau of Foodand Drugs (BFAD) was established under Republic Act No. 3720, series of 1963 and amended by
Executive Order 175, series of 1987, otherwise known as the “Food, Drugs and Devices, andCosmetics Act”. This regulatory agency is under the Department of Health. Bureau of Food andDrugs (BFAD) was later changed to Food and Drug Administration (FDA) by Republic Act No. 9711
otherwise known as “The Food and Drug Administration Act of 2009”.
Following the strengthening of the agency, health products under the watch of Philippine Food andDrug Administration included not only food and drugs, but also cosmetics, devices, radio-emitting
devices or equipments, and household/urban hazardous substances, pesticides, and toys or otherconsumer products that may have effect on the health of people.
Relative to the regulation of pharmaceuticals, FDA assumes the following functions:• Sets standards for efficacy and quality of drugs• Conducts research to address the drug needs of the country• Responsible for the collection of samples of drugs, analysis and inspection of drugs• Establishes analytical data to serve as basis for the preparation of drugs• Ensures compliance with technical requirements of manufacturers, importers, exporters,
distributors, wholesalers, drug outlets, and other establishments and facilities of drugs• Requires all manufacturers, traders, distributors, importers, exporters, wholesalers, retailers,
consumers, and non-consumer users of drugs to report to the FDA any adverse events
encountered with the use of drugs• Orders the ban, recall, and/or withdrawal of drug, after due process, found to have caused
serious adverse drug reaction• Strengthens the post market surveillance system in monitoring of drugs• Recommends standards, guidelines, and regulations with respect to information,
advertisements and other marketing instruments and promotion, sponsorship, and othermarketing activities about drugs
The FDA is headed by the Director-General (DG), who is appointed by the President of the Philippines.
The Office of the Director General is directly in charge of the Public Assistance Information, andInformation and Communication Management, as well as the 4 centers of FDA namely Center for Drug

－ 243 －

Regulation and Research, Center for Food Regulation and Research, Cosmetics Regulation and Research,and Center for Device Regulation, Radiation Health and Research.
Assisting the Director General are the Deputy Director General for Internal Management and the Deputy
Director General for Field Regulatory Operations Office.
The Deputy Director General for Internal Management is involved in the 1) Policy and Planning Services
which includes policy formulation, monitoring and evaluation of the activities of the agency, training andpolicy dissemination, 2) Legal Services which includes investigation, litigation and enforcement services
3) Administrative and Finance Service which includes human resource management, budgeting, andaccounting services
The Deputy Director General for Field Regulatory Operations is in charge of the Regulatory Enforcement
Units as well as the operations in regional field offices in North Luzon, South Luzon, Visayas, MindanaoWest, and Mindanao East.
FDA collaborates with pharmacists to ensure that regulations with drugs are properly implemented. The
umbrella association of pharmacists is called the “Philippine Pharmacists Association” in which theassociation disseminates administrative orders/ advisories from Food and Drug Administration to its
about 18, 000 members who are registered pharmacists in the Philippines.

HOSPITAL PHARMACY
Majority of the hospital pharmacists in the Philippines are mainly responsible for the inventory, filling ofprescriptions and dispensing of medications to patients.
There are only a few major hospitals with clinical pharmacists whose roles in the medical institutions are
to identify drug therapy problems, resolve actual medication problems, and prevent medication
problems through prompt clinical pharmacist’s interventions which are communicated to the patient orother healthcare professionals directly involved with the care of the patient.
These clinical pharmacists go to clinical wards and read patient medical charts, assess for any drug
therapy problems of patients that are not being addressed such as drugs without indication, existing
medical conditions of patients warranting the use of drugs, drug orders with incomplete dosage form or
dosage strength or route of administration or frequency of administration or duration of therapy or
combination of any, actual or potential drug interactions, suspected adverse drug reactions, wrong
route of administration to name a few. Drug therapy plan will be prepared by the clinical pharmacists
and this will be communicated to the physician-in-charge of the patient.
There are also a few hospitals that have drug information pharmacists who are in charge of provision of
information about drugs and drug therapy. Likewise, only a few institutions have pharmacists whocounsel their patients about the proper use of medications to optimize the use of drugs for
improvement of patients’ health condition.

－ 244 －

－ 245 －2. LEGISLATION ON PHARMACEUTICAL ADMINISTRATION
National Level:•

Republic Act No. 3720, series of 1963 "Food, Drug, and Cosmetic Act”
- creation of Food and Drug Administration- administered by the Office of the President•

Executive Order 175, series of 1987 “An Act to Ensure the Safety and Purity ofFoods, Drugs, and Cosmetics Being Made Available to the Public by Creating theFood and Drug Administration Which Shall Administer and Enforce the Laws
Pertaining thereto, and for Other Purposes”•-

amending Republic Act No. 3720-

administered by the Office of the President

Republic Act No. 9711 “ Food and Drug Administration Act of 2009”- an act strengthening and rationalizing the regulatory capacity of the Bureauof Food and Drugs by establishing adequate laboratory centers and field
offices, upgrading its equipment, augmenting its human resourcecomplement, giving authority to retain its income, renaming it the Food andDrug Administration (FDA) , amending Certain Sections of Republic Act No.
3720, and appropriating funds- administered by the Office of the President

Local level: none
PIC/S member: NO
3. REGULATORY SERVICES•

Pharmaceutical Manufacturing
The Philippine Food and Drug Administration is in charge of regulating drug
manufacturers in the country. The first Good Manufacturing Guidelines for local
manufacturers is outlined in Administrative Order No. 43 series 1999 and was issued tothe public for dissemination to all concerned last September 1999. This Administrative
order was signed by the Secretary of Health (the secretary from which FDA is directly
reporting to).
The said administrative order covered the basic GMP guidelines consisting of the
responsibilities of personnel, functions, and the trainings that they should haveundergone, standard premise conditions, equipment used in manufacturing drugs andtheir maintenance, sanitation and hygiene processes, storage of starting and packaging
materials intermediates, bulk products and finished products, production and packaging
procedures, finished product quarantine and delivery process, quality control,
documentation, self-inspection, and handling of product returns, complaints and recalls.

－ 246 －•Drug Import/Export
Since the mandate of FDA is for all drugs that will be registered with the agency should
be manufactured using methods, facilities and control procedures adequate to preserve
their identity, strength, quality and purity, all drug importers are held responsible for
ensuring that all drugs that are brought to the Philippines are manufactured inaccordance to GMP.
If the importer imports raw material or finished products for use in the manufacture of
drug products, the importer must submit a certification from the country of origin thatthe manufacturer is registered in the country of origin (to be authenticated by thePhilippine Consulate), and evidence that the manufacturer complies with GMP
standards. If inspection by FDA is warranted, the applying drug importer will born thecost of inspection.
This procedure is outlined in the Administrative Order No. 2013- 0022 entitled“Guidelines for Current Good Manufacturing Practice (cGMP) Clearance and Inspectionof Foreign Drug Manufacture” issued by Food and Drug Administration (FDA).

•

Marketing Authorization
The Department of Health came up with Administrative Order 2014-0034 entitled“Rules and Regulations on the Licensing of Establishments Engaged in the Manufacture,
Conduct of Clinical Trial, Distribution, Importation, Exportation, and Retailing of Drug
Products, and Issuance of Other Related Authorizations” to regulate such activities. The
Administrative Order clearly defined the classifications of drug establishments and thepertinent requirements for registration and licensing, process of filing, evaluation andinspection of the drug establishment.
The Philippine FDA is strengthening their power in ensuring the safety and efficacy ofpharmaceutical products available in the Philippines. They have expanded the list of
products that require Bioequivalence Studies as part of the requirement for theapplication of product registration through FDA Circular 2016-019 entitled “Revised
Guidelines on the Submission of Equivalence Evidence for Registration of
Pharmaceutical Products”.

•

Drug distribution
Food and Drug Administration has issued Administrative Order 2014-026 “Guidelines on
Implementation of New Rules and Regulations on the Licensing of Drug Distributors”.
This administrative order was issued to update and streamline the approaches inlicensing of drug importers. The requirements include completely filled up application
forms, proof of business name registration, credentials of pharmacists and otherqualified personnel, risk management plan, and location plan.
From those registered drug distributors can any institution procure their drugs.
Majority of the hospitals, community pharmacies, and other drug outlets procure theirdrugs based on the historical drug consumption of their consumers. However,
government hospitals and institutions are mandated by Executive Order No. 49 whichstates that all government institutions can only procure medicines that are listed in the－ 247 －

current Philippine National Formulary which was published by the Formulary Executive
Council of the Philippines which is under the Department of Health. With this list of
medicines, government institutions rely on the bidding process wherein the major
qualification to determine from which drug distributor will the government institution
get their drugs from is the cost. The company with the lowest bid price for that specificdrug with the specific dosage form and strength will supply the government institution
with the specific drug.
With regards to the sale of drugs, drug outlets are required to follow the Maximum Drug
Retail Price which was enacted through Executive Order 821 series of 2009.
•

Medicine Safety (post-marketing)To supplement Administrative Order No. 67 series of 1989 “Revised Rules andRegulations on Registration of Pharmaceutical Products”, Food and Drug Administration(FDA) issued Administrative Order 2006-0021. This administrative order mandated that
all new drugs are required Post Marketing Surveillance (PMS) to complete clinicalstudies and to pass through 3-year initial registration under monitored release before amarket authorization can be granted. However, one of the reasons that FDA has
observed that extensions for monitored release status of drugs were requested was thefailure to achieve the required 3,000 patients to be included in clinical trials. Likewise,based on reports, the PMS conducted through monitored release were observationaland non-experimental studies.
With this, FDA came up with Circular No. 2013-004 entitled “Post Marketing Surveillanceof Authorized Drug Products” which extended the Monitored-release status of drugs
from 3 years to 5 years strictly without exemption. Likewise FDA has employed other
different PMS approaches such as sampling drug products in the market, inspecting drug
establishments and drug outlets, testing drug samples, and investigating spontaneousadverse drug reactions (ADRs) and adverse drug events (ADEs).

•

Relief System for Adverse Drug Reactions
Unfortunately, there exist no relief system for adverse drugs reactions encountered bypatients in the Philippines. As most of adverse drug reactions are not known to patients/
patients’ families, they usually do not ask for compensation for adverse drug reactions.

4. DRUG PRICING
In an attempt to increase the use of generic medicines and reduce medicine prices,
President Aquino approved in 1988 Republic Act 6675 known as the Generic Drug Act of1988. Its goal is to increase the use of generic medicine names throughout the supply chain
from importation/manufacture through prescription and dispensing, to increase theavailability of low-priced generic medicines, and to encourage use of generic medicines
together with advantages in health service training and operation.

－ 248 －

According to the Generics Act, drugs should be procured by generic names by all public entities.
However, originator brand or other medicines “identified by brand names” may be procured“where price and availability constraints make it necessary”. This is intended forcircumstances in which the branded medicines are the only products available or offeredat more advantageous prices than purely generic medicines.
To make drugs affordable and accessible to Filipinos, the Maximum Drug Retail Price wasenacted through Executive Order 821 series of 2009. MDRP is required on drugs that reduce theincidence of morbidity and mortality.
The imposition of MDRP considers the following factors: 1) the retail price in the Philippines andother countries 2) Supply availability 3) Costs including exchange rate, amortization costs ofmachinery for production, labor costs, and transport costs.
However, not all drugs were regulated by MDRP. To determine drugs covered by the MDRP, thefollowing criteria were used: 1) Conditions that address public health priorities especially thosethat account for the leading causes of mortality and morbidity 2) Drugs that have high pricedifferentials or arbitrage compared to international prices. 3) Drugs that have limitedcompetition in terms of lack of generic counterparts or lack of market access to these products4) Drugs where the innovator products is the most expensive yet most prescribed or mostdispensed in the market.
MDRP is imposed on all retail outlets, public or private, including drugstores, hospitals andhospital pharmacies, health maintenance organizations, convenience stores, supermarkets, andother sources whether public or private.
During the early stages of the policy implementation, it was the Secretary of Health who led
surprise inspection trips of drug stores. A few weeks and months after the policy was
implemented, 80-90% compliance rate among 40,000 drugstores and hospital pharmacies had
been reported by the media (Pazzibugan and Cabreza, 2009; Esplanada, 2010).
5. STATISTIC DATA
Number of pharmacists: approximately 40,000 (based on the number of pharmacists who
renewed their license to practice pharmacy within 3-year period from 2014- 2016)
Number of GMP inspector (National and Local): No data exist
Number of pharmaceutical manufacturers/ manufacturing sites: 284 (as of December 2009,
based on Philippine Institute for Development Studies “A Profile of the Philippine
Pharmaceutical Sector” by Reyes et al, published on May 2011)
Number of traditional medicine manufacturers/ manufacturing sites: No data exist
Number of pharmaceutical importers: 634 (as of December 2009, based on Philippine Institutefor Development Studies “A Profile of the Philippine Pharmaceutical Sector” by Reyes et al,
published on May 2011)－ 249 －

Number of pharmaceutical wholesalers: 3,956 (as of December 2009, based on Philippine
Institute for Development Studies “A Profile of the Philippine Pharmaceutical Sector” by Reyes
et al, published on May 2011)
6. INFORMATION ON YOUR HOSPITAL PHARMACY
Philippine General Hospital caters to about 1, 500 patients. There are 9 Pharmacy dispensing
areas in the hospital catering to the different needs of patients namely: 1) Charity in-patient
Pharmacy 2) Pay In-patient Pharmacy 3) Outpatient Pharmacy 4) Main Pharmacy 5)
Ophthalmology Pharmacy 6) Obstetrics and Gynecology Pharmacy 7) Operating Room Pharmacy8) Cancer Institute Pharmacy 9) Central Intensive Care Unit Pharmacy

Organization Chart of the Pharmacy Department
Chief
Pharmacist

Division Head

Training, Research andClinical Services

SeniorPharmacist

SeniorPharmacist

Division Head

Division Head

Drug Dispensing

Drug Supply andManagement

SeniorPharmacist

Pharmacist

Pharmacists

Pharmacy
Assistants

SeniorPharmacist

Pharmacist

Pharmacy
Assistants

SeniorPharmacist

Pharmacist

Pharmacy
Assistants

ClerksPharmacy
Assistants

1. Number of section chief: 1 (Chief Pharmacist)
Number of deputy chiefs: 3 (division heads)
1) Training, Research, and Clinical Services2) Drug Supply and Management Services－ 250 －

Supply Officer

3) Drug Dispensing Services
Number of managers: 5 senior pharmacists
2. Number of staff (as of June 6, 2017)a. Number of pharmacists: 75
b. Number of clinical pharmacists: 5
c. Number of technicians: 96
3. Number of the kinds of drugs managed in your pharmacy or hospitala. Oral medicine: 284
b. Injections: 227
c. Medicines for external use: 21
4. Number of prescriptions dealt in your pharmacy per day (as per average daily prescriptions
received on April 2017)
a. For inpatients: 22,108
b. For outpatients: 261
5.

Equipment of the pharmacy in your hospitala. Does your hospital have a dispensary room? YES. We have 9 dispensary rooms.
The dispensary rooms vary from as large as 126 square meters to as little as 50
square meters. We also have 2 warehouses for medications measuring
approximately 242 square meters and 122 square meters. We have anotherwarehouse solely for intravenous fluids measuring approximately 90 square meters.
b. Does the pharmacy have a clean room or laminar flow hood? YES
We have 2 cleanrooms in the Pharmacy. One is located at the Laboratory Section of
the Pharmacy Department wherein 2 laminar flowhoods are housed to cater to theparenteral nutrition needs of the inpatients in the hospital. The other clean room islocated at the Oncology Pharmacy with also 2 laminar flow hoods and these laminarflow hoods are utilized to prepare oncologic medications both for inpatients andoutpatients.
c. Does the pharmacy have computers? YES
Computers in the pharmacy are mainly used for inventory management,
identification of patients, and for the charging of medications to patients. However,in the Training, Research and Clinical Services Division of the Pharmacy Department,
computers are mainly used to aid in the provision of information about drugs anddrug therapy to patients and other healthcare professionals.
d. Do you implement Therapeutic Drug Monitoring (TDM) in your hospital? NO
e. Do you prepare Total Parenteral Nutrition (TPN)? YES－ 251 －

f. Can you use internet in the Pharmacy? YESInternet is used primarily in the Pharmacy to check patient data and for charging ofcosts of medications to patients. Internet connection is also used by pharmacists foranswering drug information inquiries.
7. EDUCATION AND LICENSE OF PHARMACISTS IN YOUR COUNTRY
1.

Number of years in primary, secondary and high school education
Primary: 6 years
Secondary: 4 years
High School: 2 years

2.

Number of years/weeks in the following categories during university or college
University/college: 5 years
Professional education: NA
Practical Training: NA
Duration of Training by each facility: NA
Hospital pharmacy: 200 hours
Community pharmacy: 200 hours
Pharmaceutical company: 200 hours
Others: 360 hours major internship at either hospital pharmacy, community pharmacy
or pharmaceutical company
Age at graduation: approximately 23 years old

3.

Are there national examinations for pharmacists in your country? YES
Academic Exams: 2 days
Clinical Exams: NA

4.

Which of the following must you fulfill to obtain a pharmacist’s license?
Practical training: NA

5.

Number of pharmaceutical university or college graduates: 2,7840 people (based on
number of Pharmacy Licensure examinees last June 2016)
Alumni placement rate: Data based on “Issues and Concerns on Utilization of Pharmacy
Workforce in the Philippines” by Loquias and Robles published in 2012
Hospital: 15%
Community Pharmacy: 77%
Government Organizations: less than 1%
Enterprise: 7%
Others: less than 1%

8. SIDE EFFECT REPORTThe national agency involved in the side effect reporting system is the Food and Drug
Administration. All healthcare professionals as well as consumers are enjoined to report adverse－ 252 －

drug events to the agency. Few years ago, FDA has an ADR form that is downloadable from theirwebsite which any healthcare professional can accomplish and submit the form to the office of
the agency. However, just a few years ago, the FDA has designed a user-friendly application in
their website to report adverse drug reactions which even the consumers of medications caneasily accomplish.
The FDA then collates all adverse drug reaction reports and submits them to World HealthOrganization (WHO).
However, in some hospitals like in our institution, we have the Medication Safety Subcommittee
which is under the Drug and Therapeutics Committee which is in charge of monitoring andreporting adverse drug reactions encountered by our patients. The nurses who are responsible
for the direct care of the patients are the ones who will report the adverse drug reactions to theresident-in-charge of the patient and collects the medical supplies used in the administration ofdrugs. The resident-in-charge of the patient then accomplishes ADR form after stabilizing thepatient. The Accomplished ADR form together with the medical supplies used to administer the
drug will be turned over to the Pharmacy. All ADR forms will be submitted to the Medication
Safety Subcommittee to discuss appropriate actions and recommend policies which will
emanate from the discussions of the committee. Any policy regarding the concerned drug will
be elevated to the hospital administration to communicate with the national authority which is
the FDA.

11－ 253 －

PHILIPPINESPHILIPPINE GENERALHOSPITAL L

Philippine General Hospital (PGH)－ 254 －

Pharmacy Department• Consists of 9 Pharmacy dispensing
areas and 2 major warehouses, and1 special service division• Training, Research and Clinical
Services Division

All about me• Started working in PGH on Sept 2005
– Liaison officer drugs not locally available throughcoordination with FDA– Member of the subcommittee that evaluates of drugs priorto admission in the Pharmacy– Secretariat of Drug and Therapeutics Committee– Senior pharmacist of the Unit Dose Drug Distribution
System (UDDDS)– Drug Information provider– Patient Medication counselor－ 255 －

Roles and Position of
Pharmacists in the Philippines• Mainly responsible for theinventory, filling of prescriptions
and dispensing of medications topatients• Clinical pharmacists involved in theprovision of pharmaceutical care topatients

Good Practice• Collaboration with the University of thePhilippines College of Pharmacy to train
students on– ward clinical pharmacy– patient medication counseling– drug information provision• Continuing Education Provider• Antimicrobial stewardship system• Screening of drugs prior to admission in the
Pharmacy－ 256 －

Difficulties/ Lessons Learned
from the Past
• Out-of-stock drugs- unpredicted increase in consumption of certain
drugs, undelivered drugs from distributors due to payment
issues, unavailability in the local market• Inadequate hospital funding- charity patients decked in the wards are only
allocated with P1,000 worth of drugs• Emerging antibiotic resistance- no regulatory measure for antibiotics

Difficulties/ Lessons Learned
from the Past
• Lack of manpower– Cannot provide clinical pharmacists in the wards• Difference in priorities between
administration and the department– Pharmacists are to serve patients by dispensing drugs
as per administration’s point of view while thedepartment wants pharmacists in the wards
functioning as clinical pharmacists－ 257 －

Interests• To see the differences in the system of
distribution of drugs in different countries
and identify which among the systems
are applicable in the Philippine setting• To be able to identify best practices inprocurement of drugs withoutcompromising the quality and efficacy ofdrugsInterests• Collaboration with other pharmacists
from different countries to be
updated with the current trends in
the Pharmacy procurement anddistribution systems－ 258 －

－ 259 －Roles of Regulatory Systems andPharmacists on Ensuring Proper Accessto Quality Assured Medicines (JFY 2017)
Course title and number: J1704206
Country: Mongolia
Organization: Mongolian National University of Medical
Sciences, Mongolia- Japan Teaching Hospital

Organizational chart
Government of Mongolia

Human Drug
Council
Ministry of Health a
HealthDevelopment
CentreRegulatory Agency(General Agency forSpecialized
Inspection)

Regulatory Agency(Centre forStandardization
Metrology)

Ministry of Human
Development andSocial Welfare

Division for
Health Inspection

Standard andtechnical regulation
officeSocial Insurance
General OfficeSpecial Permission
Committee
Department ofPharmaceuticals,
Manufacturing andTechnology

Drug Regulatory
Unit

Division of
Pharmaceuticals,
Medical Devices
and Manufacturing－ 261 －

Department of
Health InsuranceLegislation on pharmaceuticaladministration• National level: yes• Local level: yes• PIC/S: no (as of 06/2017)

Regulatory services: NMPM
2010

2012

2014

NATIONAL
STRATEGY TO FIGHT
AGAINTS
COUNTERFEIT AND
SUBSTANDARD
MEDICINES

STRATEGY ON
PREVENTION OF
ANTIBIOTICRESISTANCESTRATEGY ON
IMPROVING MEDICINESSAFETY MONITORINGSYSTEM/
PHARMACOVIGILANCE//2010-2015//2013-2017//2014-2018/－ 262 －

National standards
Manufacture

GMPpharmaceuticals
MNS 5524:2014
GMP –bio-preparations
MNS 5524:2014-1

SupplyPharmacy“GSP/ GDP ”
MNS 5530:2014

GPP, MNS
5260:2015

Prescription

Good prescribing
practice
MNS 5376:2014

Drug Pricing
•

•

•

•

The price of medicines has not been regulated by the Government since1997 and a 10% value-added- tax (VAT) was introduced in 1999. Taxes,
duties and other government charges applied to medicines include 5%
customs duty for imported medicines.
Registration fees do not differ between originator brands and genericequivalents. However, registration fees are lower for locally produced thanfor imported medicines; hence the government encourages local
production.
There are no public pharmacies, except those located in public hospitals
whose service is limited to inpatients. Furthermore, the government
controls dispensing fees for reimbursed essential medicines and somedata are available to support the insurers view on the dispensing fee.
Until 2014, there were no price control mechanisms specific to genericdrugs, however the latest revision of the NDPM indicates that the
maximum price of essential medicines shall be regulated by theGovernment.(Dorj et al, Drug pricing and reimbursement decision making
systems in Mongolia, JPPP, 2017)－ 263 －

Statistic data
1. Number of pharmacists: 1575 (2016)
2. Number of GMP inspectors (National & local): 8
3. Number of pharmaceutical manufacturers/
manufacturing sites: 33
4. Number of traditional medicine manufacturers/
manufacturing sites: 6
5. Number of pharmaceutical importers: 210
6. Number of pharmaceutical wholesalers: 210
Health indicators of Mongolia, HDC, MOH, 2016

MNUMS, Mongolia-Japan Teaching
Hospital Pharmacy(1) Organization:(4) Number of prescriptionsa.
Inpatients: 104 beds (2018)a. Number of section chiefs : 3
b. Number of deputy chiefs: 2b.
Outpatients: 10-15 per days (2018)c. Number of managers: 4(5) Equipment(2) Number of staff:a.
Dispensary: 12 m2
b.
Clean room or laminar flow: Aseptic
a. Number of pharmacists: 12
room / laminar flow*
b. Number of clinical pharmacists: 7c.
Computers: 5
c. Number of technicians: 2d.
TDM: in planning(3) Number of drugs: 1673
e.
TPN: no (as of 2018)a.
Oral medicine: (689, 41.2%)
f.
Internet: yesb.
Injections: (490, 29.3)
c.
Medicines for external use: (494, 29.5%)－ 264 －

Education and License of Pharmacists(1) Number of years in primary,secondary and high school
education: 1-5 year, 6-9 year, 10-12(3) National examinations:
Academic Exams: 2-3 days
Clinical Exams: 1 day
year(2) Number of years/ weeks during (4) Pharmacists license: Exam
(5) Number of pharmaceuticaluniversity or college:
University graduates: 252 pharmacist/
University: 5 years
124 technicians (2016)
Professional education: 6 months
Alumni placement rate (%)(postgraduate training)a. Hospital: 20%
Practical training: 2 credits
Duration of training by each faculty: b. Community pharmacy: 41%
Hospital &Community pharmacy: 2 c. Government organization: 7%
credits (64 hours)
d. Enterprise: 25%
Pharmaceutical company: 2 credits (64 hours) e. Others: 7%
Others (Pharmacognosy): 3 credits (88 hours)
Age at graduation: 22 years old

Side effect report

HM order #79,
HDC

MOH,
DPMDM

“Drug
regulatoryunit”

 HM order #415, “Registration
and report of drug safety andside effects” (2013.11.07)
 “Amendment to the regulation”
order # 89 (2015.03.10)－ 265 －

Registration and reporting of drug
safety and side effects
Pharmacology Sub-committee

Human Drug Council

Assessment and validation ofside effects

Decision making:implementation actions

HDC, DRU

Introduction to the Pharmacological subcommittee, collection of data, database, regulatory
activities

HospitalCommunity,
Patients

Reportthe SE

Registration andassessment• De-registration from the
National Drug List
• Removal from the market• Inform the manufacturers• Inform Internationalorganizations

Drug
Therapeutic
Committee－ 266 －

Country:
Mongolia
Organization:
Mongolian National University of
Medical Sciences, Mongolia – Japan
Teaching Hospital

Introduction of work
• Mongolian National University of Medical
Sciences, Mongolia- Japan Teaching Hospital• Pharmacy manager－ 267 －

Good Practice• Implementation of the Antimicrobial
stewardship programme at selected hospitalsof Mongolia• GMP, GLP implementation in Mongolia

Difficulties• Resources• Education• Lack of political stability－ 268 －

My interests• Drug regulation in Japan and other countries• Hospital pharmacy in Japan and othercountries• Health Technology Assessment, assurance ofquality, safe and cost-effective medicines－ 269 －

Roles of Regulatory Systems and Pharmacists
on Ensuring Proper Access to Quality Assured Medicines (JFY 2017)
Name:

Tsetsensanaa Gungaajav

Country:

Mongolia

Organization/Department/Division: Pharmaceutical and Medical Device Division, Center for
Health Development, Ministry of Health of Mongolia① Organizational chart

Governmentof Mongolia
Human
Drug
Council

MOH

Center for Health
Development
Drug
Regulation
Division -8

Pharmaceuticals
and Medical
devices Division5

DeputyPrime
Minister

GASI
Quality
Control
Laboratory

Division of
HealthInspection

Inspectors - 35

② Legislation on pharmaceutical administration
 National Level
 State Policy on Health (2017)

Parliament National Medicines Policy (revised in 2014, integrated into newly adopted－ 270 －

National Health Policy in 2017)

Parliament Law on Medicine and medical devices (revised 2010 and currently underrevision)

Parliament Law on HealthParliament Health ministerial orders

Government

 Local Level
 Decree and orders of Governor and Head of the local Health Departments(within the implementation of national level legislation)③ Regulatory services Pharmaceutical Manufacturing Licensing of pharmaceutical manufacturers is administered by the Ministryof Health according to Law on Licensing of Private Enterprises /2001/, Law
on Medicine and Medical Devices /2010/, Law on Health /2011/,
Regulation on Licensing of health activities /#145-2013/. There are 38
pharmaceutical manufacturers /2 of them complied with GMP/ as of 2016.
GMP certificate is also issued by the Ministry of Health based on GMP
inspector’s conclusion.
“General requirements on pharmaceutical manufacturing” MNS
5524:2014

 “General requirements on primary packaging materials for pharmaceuticals”
MNS 6622:2016
 Drug import/export Wholesalers and importers who are permitted by the Ministry of Health areallowed to conduct import and export of pharmaceuticals and medical－ 271 －

devices. Center for Health Development issue import and export license for
medicines and medical devices according to the “Regulation on import andexport licensing” of 2011.
Resolution of the Government of Mongolia №73 of 2011 states that allpharmaceuticals and medical devices should be imported through 4 border
points - Buyant-Ukhaa, Sukhbaatar, Altanbulag and Zamiin-Uud.
 Marketing Authorization
 Mongolia started to register medicine to be marketed in 1994 in order toprovide population and healthcare organizations with quality, safe andeffective medicine. Medicine registration is regulated by the “Law on
Medicine and Medical devices” /2010 and currently under revision/ and“Regulation on registration of pharmaceuticals and biologically active
products” approved by the ministerial order №13 of 2015.
 Drug Distribution
 Distribution of medicine conducted by manufacturers, wholesalers,
pharmacies /community and hospital/.
 Licensing of Medicine wholesalers /importers is administered by the
Ministry of Health according to Law on Licensing of Private Enterprises/2001/, Law on Medicine and Medical Devices /2010/, Law on Health/2011/, Regulation on Licensing of health activities /#145-2013/. Private
pharmacies act as community pharmacies, whereas hospital pharmacies arerun by Government from the state budget. Licensing of private pharmacies
conducted by the Local Health Departments.

－ 272 －

 “General requirements on storage and distribution of medicine and medical
devices” MNS 5530:2014
 “General requirements for pharmacy” MNS 5260:2015
“General requirements on drug prescription and prescribing” MNS
5376:2014

 ADB project on “Improving access of affordable medicines in public
hospital” is being implemented aiming to conduct centralized procurementin public hospitals, to establish outpatient pharmacy system in public
hospital, to strengthen the regulatory activities
 Medicine Safety
 Strategy for strengthening the medicine safety monitoring and assessment
system (Pharmacovigilance) /2014-2018/
 Regulation on registration and reporting of medicine adverse effects andsafety issues /Ministerial order #415 of 2014/
 Regulation on Post Marketing Surveillance /Ministerial order #33 of 2014/
 Implementation of the Medicine safety information e-system is included in
the Government Action Plan (2016-2019) which consists of four
components, Registration and Import, Distribution and Logistics, Eprescription, Adverse Drug Reactions
 Relief System for Adverse Drug Reactions
 Medicine Regulatory Agency /Center for Health Development/, Human
Drug Council-Pharmacology sub Council, Drug and Therapeutic
Committees of hospitals, Suppliers /wholesalers, pharmacies/－ 273 －

 Strategy for strengthening the medicine safety monitoring and assessment
system (Pharmacovigilance) /2014-2018/; Regulation on registration andreporting of medicine adverse effects and safety issues /Ministerial order#415 of 2014/
 To create database for drug adverse events, to detect serious adverse signal,
to take appropriate regulatory action, to send signals to Vigiflow databaseof UMC, to provide healthcare organizations with information, to conduct
trainings④ Drug Pricing
 50-90 percent of medicine included in the List of Discounted medicine arecovered by Health Insurance Fund.
 Weak price regulation for Essential Medicine /price of drugs tends to growdepending on currency rate raises/ 7th Essential Medicine List /8th is under revision/ There is no formulated policy that regulates medicine’s price⑤ Statistic Data /year of 2016/
1. Number of pharmacists

1586

2. Number of pharmacy technicians

1790

3. Number of GMP inspector (National and Local)

10

4. Number of pharmaceutical manufacturers/manufacturing sites

38－ 274 －

5. Number of traditional medicine manufacturers/manufacturing sites

7

6. Number of pharmaceutical importers/wholesalers

210⑦ Education and License of Pharmacists in your country
Mongolia already has its own education system for under- and postgraduate training inpharmaceutical field. Approximately, 8,4 percent of graduates of medical schools are pharmacists.
As of 2016, there were total 1586 pharmacists 1790 pharmacy technicians who were working inpublic and private healthcare sectors.
(1) Number of years in primary, secondary and high school education• Primary education

5 years• Secondary education 9 years• High school education 12 years(2) Number of years/weeks in the following categories during university or college
a. College education /pharmacy-technician/:

3 yearsb. University education /pharmacist/:

5 yearsc. Professional education /postgraduate/:

6 months− Clinical pharmacy− Pharmaceutical analysis− Pharmaceutical technology− Pharmaceutical administration− Pharmacist of Traditional medicine(3) Are there any national examinations for pharmacists in your country?
Yes
Academic exams: All pharmacists should obtain a license in order to conduct pharmaceutical－ 275 －

activities. License is issued or extended every 5 years.
Clinical exams /to obtain professional grade/:− Senior

after 8 years− Leaderafter 5 years of senior grade− Advisor

after 5 years of leader grade(4) Which of the followings must you fulfill to obtain a pharmacist’s license?
Pharmacists should be involved in continuous training in order to collect 6 credits each year,
totally 30 credits per 5 years to extend the license within the valid period of license. Otherwise,
he/she is required to take license exam to obtain the license.
There is no mandatory subject of continuous training required to extend the license.
(5) Number of pharmaceutical university or college graduates:
There are 8 universities that have pharmaceutical faculty of which 1 is public university. Students
can get college/diploma degree of pharmacy-technician in those universities completing 3 yearsof study.
On average, approximately 250 pharmacists and 300 pharmacy-technicians graduate
pharmaceutical universities per year.
According to statistics of 2011-2015, the alumni’s placement rate (%)
a. University or college

2b. Research institute

2.4

c. Government organizations, including government hospitals

9.8

d. Enterprise, including wholesale companies and community pharmacies

59.2

e. Representatives of foreign companies

1.6－ 276 －

f. Not in pharmaceutical sector

5.7

g. Continuously studying

6.5

h. Indefinite or unemployed

12.65－ 277 －

－ 279 －Roles of Regulatory Systems and Pharmacists
on Ensuring Proper Access to Quality Assured Medicines （JFY 2017）
Name: Doreen Dalle
Country:

Papua New Guinea

Organization/Department/Division:

National Department of Health, Pharmaceutical Services Standard Branch① 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.
Organizational Chart: The National Department of Health

The National Department of Health (NDoH) is the National Drug Regulatory Authority in Papua New Guinea. The
Pharmaceutical Services Standard Branch within NDoH is responsible for regulatory functions in relation topharmaceuticals and medical devices regulation. The Pharmaceutical Services Standard Branch executes thesefunctions:i.

Product Registration- marketing authorization of pharmaceuticals, medical devices, cosmetics.

ii.

Compliance, Licensing and Inspection-inspection of pharmaceutical facilities to ensure compliance to－ 281 －

regulation and standards. Process and inspects application for new establishments and renewals.
Ensure compliance to the Medicines and Cosmetic Act, 1999 and post marketing monitoring.
iii.

Pharmaceutical Care-responsible for pharmacovigilance and drug advertisement and promotion. The
unit is also responsible for coordinating training of pharmacists and provides secretariat to Pharmacy
Board of Papua New Guinea.

iv.

Medicines Laboratory Unit-responsible for quality control testing of medicines. The National
Department of Health is establishing a National Quality Control Laboratory and should be completed
by the end of this year (2017).

Organizational Chart: The Pharmaceutical Services Standard Branch

NB: The Officers marked with dotted lines are contracted through health support grants that is WHO and DFAT grants.
This is to support human resources in the regulatory branch.
※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.

－ 282 －

② Legislation on pharmaceutical administration−Please briefly bulletined major laws/acts◆National Level
・ Medicine & Cosmetic Act, 1999 administered by National Department of Health・ Dangerous Drug Act, 1952 administered by Narcotics Control Bureau◆Local Level
・

Medicine & Cosmetic Act, 1999 administered by National Department of Healthadministered by

・◆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.
◆Pharmaceutical Manufacturing
・Systems, Regulations, etc.
Papua New Guinea imports 100% of all pharmaceuticals and medical devices used in the country. However,
the National Department of Health is implementing GMP clearance process to ensure manufacturers ofpharmaceutical products coming in comply with GMP standards. The Department received technical assistancefrom Indonesia to assist in developing the Guideline and setting up the process.
・

Medicines & Cosmetic Regulation, 2001 administered by National Department of Healthadministered by・※Example: Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice◆Drug Import/Export
・Systems, Regulations, etc.
・Good Distribution Practice administered by National Department of Health・Good Pharmacy Practice administered by National Department of HealthGood Storage Practice administered by National Department of Health◆Marketing Authorization
・Systems, Regulations, etc.
The National Department of Health is implementing marketing authorization process this year. Registration
Guideline and Roadmap has been developed to guide the implementation process of this regulatory function.
・Good Review Practice administered by National Department of Health (just this year conducting training).
・Good Submission Practice administered by National Department of Health (conducting training for theapplicants.
※Example: Good Quality Practice◆Drug Distribution (including drug selection, procurement, sale)－ 283 －

・Systems, Regulations, etc.
・ Drug Procurement, Selection and Sale for the government facilities administered by National Department
of Health, by Medical Supplies Procurement and Distribution Branch.
・Public Finance and Management Act, 1995administered by Department of Finance and Treasury.
Medicines & Cosmetic Act, 1999 administered by National Department of Health.
◆Medicine Safety (post-marketing)・Systems, Regulations, etc.
The National Department of Health (NDoH) is slowly implementing this process. Currently, NDoH isadvocating for all government hospitals to set up Medicines Therapeutic Committees (MTCs) within hospitals.
The MTCs will consist of pharmacists of the hospitals pharmacies as well as other members within the hospitaland the terms of reference include reporting of ADRs.
・ The National Department of Health is yet to develop Guidelines on this process.
administered by・※Example: Good Pharmacovigilance Practice◆Relief System for Adverse Drug Reactions
・Systems, Regulations, etc.
・administered by・administered by④ Drug Pricing−Please describe about price control and drug price mechanism at public sector in your country.
Drug pricing is not regulated in Papua New Guinea. The price of other commodities is regulated by anothergovernment agency; Independent Consumer and Competition Commission (ICCC).
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

218 (2017)2.

Number of GMP inspector (National & Local)

1 (2017)3.

Number of pharmaceutical manufacturers / manufacturing sites

0 (2017)

4.

Number of traditional medicine manufacturers / manufacturing sites

0 (2017)

5.

Number of pharmaceutical importers

51 (2017)

6.

Number of pharmaceutical wholesalers

56 (2017)※Hospital pharmacy only

⑥ 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:－ 284 －

（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

f.

/

/ 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－ 285 －

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

8 years

Secondary

2 years

High school

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

4 years

Professional education:

4 years

Practical training:

1 yearDuration of training by each facility:

years

Hospital pharmacy:

16 weeks

Community pharmacy:

9 weeks

Pharmaceutical company:

Not Applicable weeks

Others:9

weeks Government Warehouse or

Pharmaceutical Wholesaler’s Warehouse and 8 weeks at Regulatory Services National Department of
Health.
Age at graduation:

20 to 25 years old（３）Are there any national examinations for pharmacists in your country?
Yes
Academic Exams

days

Clinical Exams

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 is mandatory to obtain a pharmacist’s license.
The training period is one (1) year. Practical training consists of the training at the designated sites bywhich supervisors will sign 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.
In addition, the intern pharmacist is required to do a research paper project on a subject topic in thearea of pharmaceutical and submit the project to the Pharmacy Board of Papua New Guinea forassessment and approval of license.
* If practical training is optional, give the reasons.
(i.e. Training is necessary to prepare for the national examination)
There is national exam for training pharmacist and registered pharmacist (on-job pharmacists).
（５）Number of pharmaceutical university or college graduates:
More than 20 people (varies annually)
per year.
The alumni's placement rate (%)
a. Hospital:

25 % estimated－ 286 －/

b. Community Pharmacy:

50 % estimatedc. Government Organization:

10 % estimatedd. Enterprise:

10 % estimatede. Others:

5 % (NGOs) estimated⑧ 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 National Department of Health is implementing this process slowly. However, the current practice iswhereby; upon the complain of a patient or medical officer or specialist due to a particular product issue, thepharmacist fills out the ADR Reporting Form and sends it to the National Department of Health immediately.
The National Department of Health verifies this information by requesting a stop on the use of this product andinvestigates to see whether similar cases are experienced in other hospitals. Samples of this product are also
requested for quality control testing to verify the content of the product. Upon confirmation of results by
Quality Control Laboratory Unit, the particular batch of product may be recalled back to the Warehouses for
disposal. The pharmaceutical importer and distributor that imported and distributed this product are also
informed of this ADR report. Depending on the nature of the ADR penalties can be applied to the importer anddistributor.

－ 287 －

－ 288 －Country: Papua New Guinea
Organisation: National Department of Health

National Department of Health is the National Drug Regulatory Authority in Papua New Guinea.

Worked for National Department of Health in the Pharmaceutical Services Standard Branch.







i.
ii.
iii.
iv.




The Pharmaceutical Services Standard Branch performs or executes the regulatory functions of
National Department of Health.
The Pharmaceutical Services Standard Branch has 27 staffs of which 22 are pharmacists
working in this section.
The Pharmaceutical Services Standard Branch has 4 units:

Product Registration
Compliance, Inspection & Licensing
Pharmaceutical Care
Medicine Laboratory

My Job Tenure:

Worked with Product Registration Unit as a Medicine Evaluator.
Assessment of product registration dossiers mostly generics medicines submitted to National
Department of Health for product registration (marketing authorization).

－ 289 －

Roles and Position of Pharmacists in Papua New Guinea
General duties of a pharmacist (Medicines & Cosmetic Regulation 2001)
1. A pharmacist who carries on a business as such or who is in charge of dispensary shall:(a). Ensure that the premises in which the business is carried on or dispensary, is adequately
locked and otherwise secured at all times, when the business or dispensary is not normally open
to the public; and(b). Maintain the business or dispensary in a clean, hygienic and orderly condition; and(c.) Provide and maintain in good order and condition such equipment, necessary for full andproper conduct of the business or the dispensary; and(d) Provide and maintain adequate stocks of all medicinal products as are reasonably required forfull and proper practice of the profession and as maybe prescribed by the medical practitioner,
veterinary surgeon or a dentist; and(e) Keep prominently displayed at all times at the premises so as to be readily visible to the
public, a notice a notice setting out the normal trading hours of the business or dispensary; and(f) Have legibly printed or written, and continually so maintained in a conspicuous place on thefront of the business premises; Name, Professional qualification and “Pharmacist in charge” and(e) Provide advice on rational drug use to the public and medical profession(F) Maintain professional knowledge in order to provide quality pharmaceutical care and services;and(g)At all times have regard to laws and regulations applying to medicinal products andpharmaceutical practices and maintain a high standard of professional conduct.

Roles and Position of Pharmacists in Papua New Guinea
 Pharmacist profession is still young in the country.
 Generally pharmacists are now working in these areas:i. Public and private Hospitals dispensary
ii. Retail shops outlets and pharmaceutical establishments
iii. Warehouses
iv. Regulatory at the national level
v. Procurement of pharmaceuticals at the national levelvi. Non-government organizations (Churches and humanitarian organizations) Generally most pharmacist practicing in the dispensary are involved indispensing practices.
 Workload is often high and often pharmacists are so busy that proper drugcounselling is often lacking.
 Pharmacist to Patient Ratio on average is 1:250.
 NDoH has captured in its Strategic Implementation Plan for hospitals to create
more positions for pharmacists with improved employment conditions.
 Continuous training for registered pharmacist is also lacking as employers
often don’t support their staff as it is deem unnecessary. Pharmacist are often
advised to resign if they want to pursue training.
 Although most pharmacists maintain a high standard in their practice andcode of conduct, there is still some pharmacists who have less value in theirprofession.

－ 290 －

Good Practices
 Good Practices in relation to product registration.
 Developing guidelines and Standard Operating Procedures (SOPs) has
prove to be a good practice in this process as it guides NDoH as wellas those involved (pharmaceutical companies) on this process.
 Developing a roadmap is very helpful-how the process will be
implemented phase by phase.
 Continuous meeting with applicants helps them to understand thisprocess and also assist NDoH to understand their challenges and how
both parties can worked together to implement this process.
 Keeping the higher management of NDoH inform of the process thepharmaceutical Services Standard Branch is carrying out is important
for their support in terms of funding and training of the staffs.
 Strategic Planning in relation to process, resources and tools is vitalfor a successful outcome for Papua New Guinea.

Difficulties & Lesson Learnt from Past
Experiences Setting up a database system for Product Registration as well asother regulatory functions is still a challenge for National
Department of Health.
 Limited resources is a big challenge.
 Making a good review or sound scientific judgement on the dossierof generic medicine that has not been registered by anotherregulatory authority is still a challenge for the Product Registration
Unit.
 Implementing a effective and efficient regulatory system is still amajor challenge for Papua New Guinea.

－ 291 －

My interest and what I hope to learn: Marketing authorisation of generic medicines and Japanese system ofdrug approval.
 GMP process and clearance of manufacturers .
 Good Distribution Practices of Japan Clinical trial clearance process and systems of Japan.
 Post marketing measures of drugs on the market.

With limited resources and capacity, what can be done and how best it
can be done to ensure access to quality assured medicines for Papua
New Guineans .

－ 292 －

－ 293 －Roles of Regulatory Systems and Pharmacists
on Ensuring Proper Access to Quality Assured Medicines （JFY 2017）
Country:

Republic of the Union of Myanmar

Organization/Department/Division: Ministry of Health and Sports/ Department of Food and Drug
Administration/Drug Control Division
Ministry of Health and Sports (MOHS)
Ministry of Health and Sports is the main organization which is taking responsibility forproviding comprehensive health care services covering activities for promoting health, preventing
diseases, providing effective treatment and rehabilitation to raise the health status of the people. The headof the Ministry is the Union Minister. There are altogether seven departments under Ministry of Healthand Sports and each department is headed by Director General. They are1.

Department of Medical Services

2.

Department of Public Health3.

Department of Medical Research4.

Department of Health Professional Resources Development and Management

5.

Department of Traditional Medicine

6.

Department of Food and Drug Administration

7.

Department of Sports and Physical Education
The objectives of the Ministry of Health and Sports are

1. To enable every citizen to attain full life expectancy and enjoy longevity of life
2. To ensure that every citizen is free from diseases.
To realize these objectives, all health activities are implemented in conformity with the following
strategies:
1. Widespread disseminations of health information and education to reach the rural areas.
2. Enhancing disease prevention activities
3. Providing effective treatment of prevailing diseases.

－ 295 －

Department of Food and Drug Administration (FDA)
The Food and Drug Administration was established in 1995 as one of the divisions under the
Department of Health, Ministry of Health. The Food and Drug Administration was upgraded to a separate
department in August 2013 as Department of Food and Drug Administration. It was extended to States/
Regional levels and border areas such as Muse, Tachileik, Tamu, Myawaddy etc. It is further extended to
district levels in 2017. The head office is situated in Nay Pyi Taw, the capital city of Myanmar.
The aim of the department is to ensure the safety and quality of Food, Drugs, Medical Devices andCosmetics in the country. The department is headed by Director General and constitutes six divisions asfollows;
1. Administrative Division
2. Planning and Auditing Division
3. Drug Control Division
4. Food Control Division
5. Medical Devices and Cosmetic Control Division
6. Laboratory Division
Organizational Chart
The organization chart of the Department of Food and Drug Administration is attached in
Annex-1.
Pharmaceutical Administration in Myanmar
Pharmaceutical administration in Myanmar is mainly done by Drug Control Division of FDA. It
controls both pre market and post market activities. The main functions are;
♦ Marketing authorization for new products, renewal registration and variation of existing products♦ Good Manufacturing Practice inspection and licensing of drug manufacturers♦ Good Storage and Distribution Practice inspection of importers and distributers♦ Random sampling and testing♦ Adverse Drug Reaction Monitoring♦ Training and Health Education－ 296 －

There are about 15000 drugs are registered in Myanmar. About 95% of them are imported
drugs.The documentations required for product registration are according to ASEAN Common TechnicalDossier (ACTD) format which is harmonized among ASEAN member countries. The quality control tests
for registration samples are done at Laboratory Division of FDA. The three main laboratories of FDA are
situated in Nay Pyi Taw, Yangon and Mandalay. The Pharmaceutical Chemistry Laboratory in Nay Pyi
Taw has achieved ISO/IEC 17025: 2005 Accreditation Certificate in December, 2016. The approval or
rejection of product registration is decided by Drug Advisory Committee (DAC).
FDA issues Drug RegistrationCertificate (DRC) for product registration, Drug Manufacturing
Licence for local drug manufacturers and Drug Importation Approval Certificate (DIAC) for drug
importers.The Post Market Surveillance (PMS) activities are regularly done by not only in head office(Central) but also in States/ Regional levels and District levels. FDA controls and takes the action on
illegal drug importers, manufacturers, distributors and drug sellers. FDA also notifies the counterfeit,
substandard, falsified and unregistered drugs to the public and health care professionals through the media
and FDA website (http://www.fdamyanmar.gov.mm).
The States/ Regional levels and District levels of FDA inspect the pharmacies in their respective
areas to comply with Good Pharmacy Practice. They also do the regular PMS activities according to theiraction plans and health advocacy to the public. The States/ Regional FDA and border FDA perform thescreening test for some medicines with mini laboratory facilities in order to detect the substandard andcounterfeit drugs. The suspected drugs are sent to the head office for confirmatory test. Mini laboratory
facilities have also been set up at FDA offices in 12 States/Regions and border areas. Mini laboratories
can perform identification and screening test for about 60 items of drugs including anti‐malaria, anti‐
tuberculosis, anti‐microbial and some analgesics.
The border FDA checks the drugs at border areas coming from neighboring countries incoordination with Custom Department.
FDA also closely collaborates and cooperates with other relevant agencies such as Department ofTrade, Myanmar Police Force, Custom Department and City Development Committee to ensure thequality, efficacy and safety of drugs which could be consumed in confidence by the public.

－ 297 －

Legislation on pharmaceutical administration◆National Level
・ National Drug Law (1992), updated in 2014 administered by Ministry of Health andSports◆Local Level
・◆PIC/S
Yes

OR

administered by

No

Regulatory Services◆Pharmaceutical Manufacturing
Pharmaceutical Manufacturing is regulated by Ministry of Health’s Notification 4/93. The
inspection team including officials from Central and States/ Regional FDA and members of respective
Food and Drug Supervisory Committee inspect the manufacturing sites of local pharmaceuticalmanufacturers in order to comply with Good Manufacturing Practice (GMP). For oversea inspection,
FDA only does for special cases such as anti-malarial drug manufacturers and only for the caserequested by manufacturers. FDA issues Drug Manufacturing Licence for local pharmaceuticalmanufacturers that conform to GMP with the validity of three years.
◆Drug Import/Export
Drug importation is regulated by Ministry of Health’s Notification 5/93. When the drug importer
applies the importation for registered drugs in Myanmar, FDA inspects this importer’s warehouse tocomply with Good Storage Practice (GSP) and Good Distribution Practice (GDP) and issues Drug
Importation Approval Certificate (DIAC) with the validity of three years.
◆Marketing Authorization
The product registration is regulated by Ministry of Health’s Notification 3/93. The applicant has
to submit the pharmaceutical dossiers in line with ASEAN Common Technical Dossier (ACTD)
format and samples. After the decision of Drug Advisory Committee (DAC) with the complete set of－ 298 －

documentation and good quality control test result, FDA issues Drug Registration Certificate (DRC)
for approved product with the validity of five years.
◆Drug Distribution (including drug selection, procurement, sale)
The distributors must get the authorized letter from marketing authorization holder and apply thewholesale licence for distribution that concern for private. For public sector, the distribution system isconcerned with Department of Medical Services.
◆Medicine Safety (Post-marketing)
Post Marketing Surveillance activities are regularly done by Central, States/ Regional andDistrict FDA.
◆Relief System for Adverse Drug Reactions
Adverse Drug Reaction (ADR) Reporting form is uploaded on FDA web page.There is an ADR
reviewing committee in Department of Medical Services. The Department of Food and Drug
Administration is one of the members of this committee.
Drug Pricing
The drug pricing is not controlled by Ministry of Health and Sports. The Ministry of Commerce
checks the difference of price between import drug price and drug price in market for both wholesales
and retails.
Statistic Data
1. Number of pharmacists

3810(Ph.D– 2, M. Pharm – 148, B. Pharm –3660 )2. Number of GMP inspector (National & Local)

15(2016)

3. Number of pharmaceutical manufacturers / manufacturing sites

9(2016)

4. Number of traditional medicine manufacturers / manufacturing sites-

5. Number of pharmaceutical importers214

6. Number of pharmaceutical wholesalers> 600

Education and License of Pharmacists in your country（１）Number of years in primary, secondary and high school education－ 299 －

(2016)(2016)(2017)

Primary
SecondaryHigh school

5

years
years
years

4
2

（２）Number of years / weeks in the following categories during university or college
University / college:
4 years
Professional education:
Practical training:
Duration of training by each facility:

years
years
years

Hospital pharmacy:
Community pharmacy:
Pharmaceutical company:

weeks
weeks
weeks

Others:weeks
Age at graduation:

about

22

years old（３）Are there any national examinations for pharmacists in your country?
Yes
Academic Exams
days
Clinical Exams
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.
NA* 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:
about 250/ per year
The alumni's placement rate (%)
a. Hospital:
10%b. Community Pharmacy:
5%c. Government Organization:
30%
d. Enterprise:40%
e. Others:
15%
Side effect report
Adverse Drug Reaction (ADR) form is uploaded on FDA webpage. The serious cases can be directly
reported to Director General of FDA by filling in ADR form by any health care professionals.

－ 300 －

Deputy Director General(Central)Director(Drug)

Director(Lab)

Director(Admin)Director(Planning&
Auditing)

Director General

Department of Food and Drug Administration - Organization Chart

Director(Food)

Director(Medical
devicesandcosmetic)

Director(YangonBranch)Deputy Director General(States/ Region)

Director(Mandalay
Branch)States/Regions

District
FDA

Border
FDA－ 301 －

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

Pharmaceutical
Administration

Ministry of Health and Sports (MOHS) Main organization responsible for the health of the people,
headed by Union Minister and constitutes seven departments Department of Medical Services
 Department of Public Health Department of Medical Research Department of Health Professional Resources Development andManagement
 Department of Traditional Medicine
 Department of Food and Drug Administration
 Department of Sports and Physical Education－ 302 －

2

FDA, Myanmar• Established Food and Drug Administration (FDA) in January, 1995
under Department of Health, Ministry of Health• Became a separate department in August, 2013 as Department ofFood and Drug Administration• Extended to States/ Regional levels and then border areas in 2014
• Further extended to District levels in 2017
 Aim - To ensure the safety and quality of Food, Drugs, Medical
Devices and Cosmetics in the country

3

Control of Pharmaceuticals
 Marketing authorization for new products, renewal registration andvariation of existing products
 Good Manufacturing Practice inspection and licensing of drug
manufacturers
 Good Storage and Distribution Practice inspection of importers anddistributers Random sampling and testing Adverse Drug Reaction MonitoringTraining and Health Education
4－ 303 －

5

Laws and Regulations in Myanmar
To protect the public from unsafe drugs• 1972

- Public Health Law• 1992 October- National Drug Law , Amendment of NDL(April, 2014)• 1993 August- Notifications for Registration, Manufacturing,
Importation, Sales and distribution, Labelingand advertisement• 2003 March- Order Relating to Control of Narcotic Drugs
and Psychotropic substances

6－ 304 －

Roles of Pharmacists in Myanmar
 Regulatory
 Quality Control and Quality Assurance Research Industry
 Hospital Academic
 Pharmaceutical companies
7

Good Practices and Achievements
 Good Manufacturing Practice (GMP), Good Storage Practice (GSP),
Good Distribution Practice (GDP) support quality assurance system
 Regulation of supply chain helps to access quality assured
medicines By coordination and collaboration with Custom Department,
Department of Trade, Consumer Protection Association and Stakes
holders to eliminate illegal drugs
 By coordination with Interpol and Myanmar Police Force to combat
the illegal pharmaceuticals trade through border areas8－ 305 －

Ongoing projects and Need to be strengthened
 Plan to organize the National workshop for counterfeit medicines
 To update pharmacovigilance guideline Need to upgrade local manufacturers to comply with GMP
 Need to control online selling such as food supplements etc. and toeducate the public Try to improve pharmacies in hard to reach areas and non peaceareas
9

My interest Pharmaceutical regulatory system in Japan Countermeasures against counterfeit medicines Site visit to the whole pharmaceutical supply chain

10－ 306 －

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

Republic of Indonesia
Japan, June
2017

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.

－ 309 －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 and Department
Directorate of Distribution Control of Therapeutic Products,
NADFC, consists of 3 Sub Directorates:
1. Surveillance and Risk Analysis of Therapeutic Products
2. Promotion and Labelling Control of Therapeutic Products
3. Inspection and Certification of Distribution Facilities- Conducting audit and investigation in Distribution and Health Facillities,- Evaluating inspection’s result and taking a follow up action of it- Evaluating CAPA submitted by the Facillities-Evaluating inspection’s result conducted by NADFC Province via online
reporting system- Providing Quarter report of Distribution and Health Facilities Control- Conducting Surveillance Audit for Certificate Drug Wholeseller- Making tools or guidance of Good Distribution Product－ 310 －

Job Tenure
Joined with NADFC since 2013
Placed in Directorate of Distribution Controlof Therapeutic Products
General Staff at Directorate of Distribution
Control of Therapeutic Products (2013-2014)
Inspection Staff of Distribution Control of
Therapeutic Products
Drug and food inspector-first level (2015now)

Roles and Position of Pharmacists
1. Ensuring and maintaining the implementation of Quality Management
System
2. Focusing on all activities of their duty and within their authority
3. Supervising the training program for personnel related with distribution
activities
4. Supervising the product’s recall and the product’s complaint
5. Doing the qualification of customer and suppliers
6. Having a role in Contract Cooperation
7. Conducting self inspection－ 311 －

The Implementation of Good Distribution
Practices
The low ofawareness andknowledge
about GDP ofdrugwholesaler

PROBLEM
The low of
Pharmacist
Role inwholesaler
management

ACTION•Providing a guidance of Good Distribution
Product• Doing Mapping Wholesaler- Getting a picture of the real conditions of the
GDP implementation in wholesalers inIndonesia- Obtaining the data about the classification ofwholesaler (risk-based approach)• Giving assistance and workshop of GDP

IMPLEMENTATIONON GOING PROJECT• Routine inspection to Wholesaler• GDP Certification (Mandatory Planning)- Ensuring the consistency of GDP implementation- Ensuring the consistency of medicines quality according to approved specifications.
• Conducting Surveillance Audit• Conducting GDP Technical Meeting for NADFC Province• Providing Guidance of Follow up Action• Conducting Desk CAPA Evaluation
ACHIEVEMENT- Improvement wholesaler’s awareness and knowledge in GDP- The increase of role and responsibility of Pharmacists- The increase of drug safety- Ensuring drug quality distributed in society- The increase of GDP compliance by wholesaler－ 312 －

Current Issue and Challenge
Current Issue
The low of role and lack of competency of Pharmacists
in health Facilities
The increase of the counterfeit drug distributed in oursociety
The lack of coordination among NADFC and otherrelated sectors, primarily in giving authorization andrevoking the licence
Challenge- The breaking out of Drug selling via online- The low of punishment given to businessmen- The low of authority to follow up the drug inspection
resultInterest and Expectationa. Acquiring information about:•The regulatory management in Japan for access to quality medicines
including the inspection system•The actual operations both in govermental and medical institutions
for ensuring quality of medicines•Lectures on countermeasures against counterfeit medicines
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 and Pharmacists
in Ensuring Proper Access to Quality Assured Medicines.
-Handle and take countermeasures against counterfeit medicines－ 313 －

Republic of Indonesia
National Agency of Drug and Food Control

INTRODUCTION OF THE WORKORGANIZATION
National Agency of Drug and Food Control in Surabaya
DEPARTMENT
Certification and Customer Information Service
JOB TENURE
2,5 years in current position; 13,5 years overall
1－ 314 －REGULATORY SERVICES• Drafting drug and food control plans and programs.
• Implementing laboratory examination, testing andassessing quality of therapeutic products, narcotics,
psychotropic, addictive substances, traditional medicines,
cosmetics, complementary products, food and hazardous
substances.
• Implementing laboratory examination, testing andassessment of the microbiological quality of the product.
• Implementing local inspection, sampling and inspecting
production facilities and distribution.
2

REGULATORY SERVICES (continued)• Investigating crime cases in the field of Drug and Foodcontrol.
• Implementing certification of products, production
and distribution facilities imposed by the Head of
NADFC• Implementing consumer information services.
• Evaluating and drafting Drug and Food testing report.
• Implementing administrative affairs.
• Implementing other duties in the respective field, set
by the Head of NADFC.
3－ 315 －

ROLES OF PHARMACIST IN INDONESIA• Management of Pharmaceutical Supplies (Supervisor,
Manager, Director)• Pharmaceutical Services (Pharmacist in Charge)• Development of Drug, Drug substance and Traditional
Medicine (Analyst, Supervisor, Manager, Director)

4

GOOD PRACTICES
Almost no noticeable achievement in drug
monitoring5－ 316 －

DIFFICULTIES/LESSONS LEARNED FROM PAST
EXPERIENCE• The challenges from the health programme (neglected tropicaldiseases, contraceptive drugs), new technology medication(NCE, biosimilar, blood product, stem cell) or drugs on uncommunicable diseases (cancer, diabetes mellitus, hipertension)• Drugs appear to be safe and well-tolerated, but the safety in the‘real world’ is unclear (the fact about chronically/repeatedly useof drugs, and drug interaction)

6

DIFFICULTIES/LESSONS LEARNED FROM PAST
EXPERIENCE (CONTINUED)• Drug safety in vulnerable groups is unknown (pregnant
women, breastfeeding mother, elderly and young children)• Patient genotype, phenotype, social and economic conditions
are markedly distinct, so we can’t extrapolate data fromdeveloped countries• Numbers of counterfeit drugs

7－ 317 －

INTERESTS
1. Detecting drug counterfeits
2. Pharmacovigilance reporting
3. Pharmaceutical care8

－ 318 －

－ 319 －Roles of Regulatory Systems and Pharmacists
on Ensuring Proper Access to Quality Assured Medicines (JFY 2017)

Country: Sri Lanka
Organization: National Medicines Regulatory Authority

1.

Overview of country and organization

Sri Lanka is a beautiful island around 65,000 sq. km in the Indian Ocean, also famous as ‘Isle of
Serendipity’ and ‘Ceylon’ in all over the world in the Past. It lies between northern latitudes
50 55’ and 90 50’ and eastern longitudes 790 42’ and 810 52’.Travellers from deferent countries
attracted to my mother land due to the natural beauty of the country given by sea beaches, nature
reserves, wild life and variety in climate, landscape and rich cultural heritage. As such Sri Lanka
introduce as a ‘Pearl of the Indian Ocean”.
Democratic Socialist Republic of Sri Lanka has a parliamentary democratic system ofgovernment in which, legislative powers are vested in parliament. The executive authority is
exercised by a Cabinet of Ministers, presided over by an Executive President. The President andMembers of the Parliament are elected directly by the people.
Sri Lanka’s population is about 21 million and population growth is about 1.2% per year
according to the government estimation.
Sri Lanka is Multinational and Multicultural country. The largest ethnic groups in Sri Lanka are
the Sinhalese that around for 72% and others included Hindus, Muslims, Christians & otherminor communities. As such three languages are used mainly Sinhala, Tamil and English.
Buddhism is the dominant creed of the largest ethnic group. Other religions like Hindu, Islam &Christians also available. Although all Sri Lankans are live peacefully in the country.

－ 321 －

Agricultural side is highly developed in Sri Lanka. The chief crop is rice with which the country
is almost self-sufficient. Tea, rubber and coconut are also important agricultural crops, with tea
being a major foreign exchange earner well known as “Ceylon tea”. In addition, other crops ofimportance are cocoa and spices such as cinnamon, cardamom, nutmeg, pepper and cloves. Fruitand vegetables, native to both tropical and temperate regions, grow well in Sri Lanka.
The last three decades have seen tourism emerge as an important industry. There has also been arapid growth in manufacturing industries, which offer a wide range of export goods such as
petroleum products, leather goods, ready-made garments and electronic equipment in minor
level.
Health Care System
Sri Lanka is a country known to the world for providing cost effective healthcare free of direct
cost to the patient. As such Gross national income per capita (PPP international $, 2014) was
10270. Total expenditure on health per capita (Intl $, 2014) was 308 and the total expenditure on
health as percentage of gross Domestic product (GDP) (2014) around 3.
The maternal mortality ratio, neonatal mortality rate, life expectancy at birth and many more
health indicators are comparable with those of the developed world. As per the Annual healthbulletin 2014, life expectancy among male and female 72.0 and 78.6 years respectively,
According to 2014 statistics from registrar general department, the midyear population the crude
birth rate was 16.9/1000 population and crude death rate was 6.2/1000 population (5). Based on
2014 data, maternal mortality ratio per 100,000 live births was 19.3.
As per the, update data there were 1085 medical institutions with inpatient facilities. There were
included 20 teaching Hospitals 21 DHPs 487 Primary Health Care Unit and 337 Medical Officer
of Health (MOH) areas in Sri Lanka. The number of beds in the hospitals increased to 76,781 in2014 and the hospital beds per 1,000 populations is 3.7.

－ 322 －

The total number of medical officers was 15,910 in 2012. Accordingly, medical officers per
100,000 populations were 78. The total numbers of nurses were 36,486 in 2012. This was 180
nurses per 100,000 populations. A shortage of qualified paramedical staff, such as pharmacists,
medical laboratory technicians, radiographers, physiotherapists and electrocardiogram (ECG)
technicians still exists.
Total pharmacists employed at public hospitals by 2012 was around 1200, that is 6.7 pharmacists
per 100, 000 population . Almost all of them were with diploma in Pharmacy qualification.
Although these Sri Lankan indicators are the best in the region, much has to be done to ensure
quality and safety in the delivery of healthcare, especially in hospitals
2.

Organizational chart of Ministry of Health, Nutrition and Indigenous Medicine

Ministry of Health Nutrition and Indigenous Medicine appointed by the President and govern by
the Health Minister who is responsible for the vital heath care system of the country.
Organization chat is complex attached with Annexure 01.
In order to ensure proper drug management system of the state sector an organizational frame
work exists within the Ministry of Health. However Organization system related to thepharmaceutical administration can be summarized as follows:
Minister of Health
Secretory/ Health

Chairman/ NMRANMRA/NMQAL

Director General of HealthServices
D/MSD, D/RMSD,
D/TH, PDGH etc

Chairman/ SPC &SPMC
SPC/ SPMC

Figure 1: Organizational chart of Pharmaceutical administration－ 323 －

 Minister of Health- responsible Policy making, such as introducing necessary
amendments to the act and making regulations appointed by the President.
 Secretory /Health- Responsible for all administration and support to the Minister.


SPMC- Procurement of Pharmaceuticals to the Public sector SPM- Drug manufacturing by state sector
 NMRA; Regulation of Pharmaceuticals
 NMQAL: Quality Assurance of Pharmaceuticals
 DGHS,D/MSD, D/RMSD- Distribution of Pharmaceutical locally through state
Hospitals.

Figure 2: Procurement & distribution of Pharmaceuticals at state sector－ 324 －

2.
I.

Legislation Govern the Pharmaceutical Administration in Sri Lanka.
NMRA Act

National Medicines Regulatory Authority Act no.5 of 2015 and regulations made under theprovisions of this act is responsible for the regulation and control of registration, licensing,
manufacture importation and all other aspects pertaining to medicines, medical devices, andborderline products and conducting of clinical trials in a manner compatible with national
medicines policy. This act was come into operation from 19th March 2015.
The Act controls:
Registration, Manufacture, Importation, Transportation, Sale (Retail and Wholesale) &Distributions, Labeling & Advertising, Testing, Disposal of outdated or spoilt drugs Medicines,
Devices, Borderline Products, Clinical Trial regulations, Pharmacovigilance, Research and
Education on Pharmaceuticals etc.
Under the above the act establishment of new NMRA was done in 2015 including following
structure.

Figure 3: Organizational structure of NMRA

－ 325 －

(ii) Poisons, Opium and Dangerous Drugs (Amended) Act.
Poisons, opium and dangerous drugs ordinance (Chapter 218) as amended by Act No 13 of 1984
regulates,
 Importation
 Storage
 Distribution and Use of Poisons, opium and dangerous drugs
III.

Other Act : Pesticides Act, Consumer Affairs Act, Food Act
3.

Regulatory Service

NMRA provide following regulatory services
 Regulation of Medicines, Medical Devices and Borderline Products used in Sri Lanka
through a market authorization scheme and a post marketing surveillance system.
 Inspection of manufacturing premises for compliance of Good Manufacturing Practices(GMP).
 Inspection and licensing of retail and wholesale establishments of pharmaceuticals andvehicles used to transport pharmaceuticals.
 Monitoring of suspected adverse drug reactions.
 Recalling of Medicines, Medical Devices and Borderline Products from the market on
safety grounds.
 Control of advertisement on medicinal drugs.
 Control of Narcotics, Psychotropic substances, and Precursors used as medicines,
industrial chemicals or used for other scientific purposes.
 Regulation of clinical trials.
 Development of guidelines and manuals on medicines and related practices.
 Training of healthcare professionals and their students with related to Cosmetics,
 Devices and Drugs Act and its regulations. Awareness programs for the general public.

－ 326 －

Pharmaceutical Manufacturing
The Sri Lankan pharmaceutical industry comprises 15% of the local market as there are few
pharmaceutical manufactures in Sri Lanka. Some of the local pharmaceutical manufacturers
include State Pharmaceutical Manufacturing Corporation (SPMC), Astron Ltd, Interpharm (Pvt)
Ltd, J. L. Morison Son and Jones (Ceylon) PLC, GlaxoSmithKline Pharmaceuticals Ltd,
Ceylinco Pharmaceuticals Ltd, Gamma Pharmaceuticals (Pvt) Ltd and Unical (Ceylon) (Pvt) Ltd.
All of these are members of Sri Lanka Pharmaceutical Manufacturers Association which was
founded in 1963 with the mission of collectively lobbying with its stakeholders for the benefit oflocal manufacturers of pharmaceuticals in making their ventures successful.
Though more than 200 pharmaceutical products are being locally manufactured all most all ofthem are belong to oral liquid or solid dosage forms or topical dosage forms. The State
Pharmaceutical Manufacturing Corporation (SPMC), which was established in 1987 based on a
grant aid received from the Japanese government through JICA (Japan International
Cooperation Agency), is the largest oral solid dosage form (tablets and capsules) manufacturer in
Sri Lanka .
SPMC is the only state owned pharmaceutical manufacturer in the country. It actively produced
40 drugs during the year 2012 out of its total of 63 products. Every section of the SPMC
conforms to the current GMP (cGMP) requirements under the guidelines of the WHO . SPMC
maintains British (BP) and United State (USP) Pharmacopeial quality standards. Some of othermanufacturing industries are maintaining Indian Pharmacopeial quality standards as well.
Importation
Imports of Pharmaceuticals are done by both Public and Private Sector. SPC is the whole local
agent for State sector. All the drug imports to Sri Lanka should be registered under Medicines
Regulatory Division (MR Division) established under NMRA.

－ 327 －

•

Marketing Authorization

Marketing authorization is either taken by the manufacturer to market the products manufactured
or by importers. All these functions are monitored and authorized by the Regulatory Divisions
under NMRA.
•Drug Distribution

For the public sector, drug distribution is mainly controlled and monitored by the Medical
Supplies Division (MSD). This is a centrally located government organization under Ministry of
Health, and there are provisional supplies divisions to supply medicines to other regional
hospitals. MSD is responsible for procuring medicines, surgical items and devices forgovernment sector hospitals, for procuring private sector hospitals and pharmacies there is nosuch distribution channel operating at the moment. (Figure: 2)
Private hospitals can procure their requirements directly from available drug manufacturers or
suppliers. Apart from this there is government owned pharmacies known as “Osusalas” managed
by the State Pharmaceuticals Corporation (SPC). SPC is responsible in supplying medicines andother additional pharmaceutical products for all the pharmacies (“Osusala”) located island wide.
All these functions are monitored and authorized by the NMRA.
 Medicines Safety
National Medicines Quality Assurance Laboratory (NMQAL) is responsible to conduct post
marketing surveillance program and check the quality of all the drugs in the market Sri Lanka,
Quality testing done for Registration and Complain Samples as well. Samples collected by thefood and drug inspectors also tested at NMQAL. Most of the test done as per the BP and USP
specifications, and in case by case basis in-house methods also has been followed. Maintenanceof GLP is highly considered within the laboratory and focusing of ISO Accreditation is the main
target in 2017.
 Relief System of Adverse Drug reaction
In an event of an adverse drug reaction a doctor or the patient can submit the details of adverse
drug reactions to the Pharmacovigilance unit located at the Department of Pharmacology,
Faculty of Medicine, University of Colombo, Where details of serious adverse drug reactions are－ 328 －

collected from government hospitals and government medical institutions, private medical
institutions and from the patients and provided investigation reports. Meanwhile Safety of drugs
and risk evaluation Sub-Committee (SAFRESC) under NMRA investigate and makerecommendations on adverse drug reactions reported. As per the decisions taken by thecommittee the drugs are subject to withhold, withdraw. (Decisions based on quality testing by
the NMQAL as well).
4. Drug Pricing
Drugs for public sector in Sri Lanka are free of charge. They procure drugs, according togovernment tender procedures. Therefore, those who bid for the tenders will govern the prices.
However, apart from that the government also procures drugs directly from the State
Pharmaceuticals Manufacturing Corporation. Prices for these drugs are negotiated between thetwo government organizations. In the case of the private sector, there are now fixed prize drugs
are available in different prices in the market. However as per the new act NMRA introduced
price regulation system for pharmaceuticals in 2016.
4.

Statistical Data
Categorya) Number of government
pharmacistsb) Number of GMP inspectors(Pharmacists do inspections)c) Number of pharmaceutical
Manufacturers (Medicines,
Borderline Products)d) Number of pharmaceutical
Manufacturers (Devices)e) Number of traditional
medicine manufacturersf) Number of pharmaceuticalimportersg) Number of pharmaceuticalwhole sellers

Data

Year

1386

2015

26

2016

38
(Small scale-28 andlarge scale 10)

2016

57

2016

Statistical data not available
1500

2016

299

2016

Table 1: Statistical Data on Pharmacy Practice－ 329 －

6) Education and License of Pharmacists
Pharmacy training was first introduced in Sri Lanka in the early 1950’s. By 1957, a full time
pharmacy certificate course was introduced (16). Since then, three types of pharmacy certificateshave been developed: A certificate of proficiency in pharmacy, a certificate of efficiency inpharmacy and a diploma of pharmacy.
A Bachelor of Science (Special in Pharmacy) degree course commenced at the University ofColombo in 1999. The Bachelor of Pharmacy (B. Pharm) program was introduced in 2006 at the
University of Peradeniya (UP) in Central part of Sri Lanka and University of SriJayewardenepura (USJ) in Colombo and University of Jaffna (UJ). Followed by, University of
Ruhuna (2010) in Galle Southern province, Open University of Sri Lanka (2013) and Kotelawala
Defense University (2014) in Colombo have also started B. Pharm degree programs at theirrespective universities.
So far no local university is providing postgraduate programs in pharmacy.
Currently approximately around 100 graduate Pharmacists are produced from local public
universities. Some students after their Advanced Level examination get some scholarship andstudy B. Pharm or Pharm.D in overseas specifically in South Asian Countries.

Four years
Three years
One yearDuration
DiplomaPharmacist(Hospital)
Three years
Two years
One year

DiplomaPharmacist(Community)
Three years
Two years
Two years

24- 26 years old

23 years old

Depends age started

Graduate
Pharmacist

Category
University/ college
Professional training
Duration of training by each facility
Hospital pharmacy
Community pharmacy
Pharmaceutical company
Other (Regulatory Authority)
Age of graduation

Table 2: Statistical Data on Pharmacy Education－ 330 －

National Examinations for Pharmacists
The Sri Lanka Medical council (SLMC)conducts the National Examination for Diploma
pharmacists and it has one day Academic Exam and one day Clinical Exam.
Pharmacist’s license
SLMC is registered qualified Pharmacist on who completed any of the above three category of
Pharmacy education successfully and provided Pharmacist License.
To obtain a pharmacist license practical training is mandatory for both of graduate or diploma
pharmacists. The overall knowledge on following areas is mandatory in practical training.
Forensic Pharmacy- Study the laws applicable to running any kind of pharmacy (retail/wholesale), business laws applicable to the pharmacy and study the role of authorized officers.
Prescription based learning- Read and understand prescriptions,enter the details of theprescriptions in prescription book,dispense prescriptions with proper patient advice－ 331 －

Packaging and labeling requirements- check the labels and packagings whether they comply
with regulations.
Management and Storage- Arrangement of stocks in the pharmacy,study inventory control
systems in pharmacy and how to handle expiry and quality failed drugs.
Dosage forms- Classify dosage forms in pharmacy, prepare and dispensing of immediate
preparations.
Quality assurance- Organoleptic detection of deterioration of dosage forms, detection ofparticles and microbial spoilage in small and large volume parental preparations.

8) Challenges in the pharmacy practiceIn Sri Lanka, practice of pharmacy is one of the neglected areas of health services and medical
practice.
In many government sectors including Ministry of Health, government hospitals and NMRA,
there are only few or no graduate pharmacists are employed.
At present, in Sri Lanka the clinical pharmacy service is minimal or almost neglected; this isperhaps due to professional isolation, lack of qualified clinical pharmacists and lack ofrecognition of the role of clinical pharmacists within the healthcare system.
Students had limited exposure to clinical placements during their undergraduate years, this ismay be due to lack inter medical professional understanding towards the goal of healthprofession.
Sri Lankan academics were concerned about gaps in clinical pharmacy expertise and so
approached Australian pharmacist academics to collaborate to develop and teach the clinicalpharmacy subject.
Migration of pharmacy professionals also remains high, adding further strain on the industry.

－ 332 －

On a separate note, intensifying competitive pressures over the medium to longer term could
Challenge the existing players.
Community pharmacy practice should be improved in Sri Lanka, law enforcement regarding
dispensing prescription and controlled drugs should be strengthened. In the current practice,almost everyone can get any drug from most of the private community pharmacies in Sri Lanka.
Pharmacy institutions in the country are facing problem with lack equipment’s and laboratory
facilities to conduct pharmacy related practical’s during their undergraduate pharmacy training.
There are no different categories of qualified pharmacist’s registration process among external
Apprentice pharmacists, diploma pharmacists and graduate pharmacists.
There is no separate carder for graduate pharmacists in government sector. Both diploma
and graduate pharmacists are recruited in the same salary scale.
And also there are less in service training available to update Pharmacist knowledge intheir professional field,

References:
1. Annual Health Bulletin, Sri Lanka ,2014
2. National Medicines Regulatory Act, 2015
3. Manual of Drug Management System, 2008
4. Book Chapter: Pharmacy practice in Sri Lanka; Shukry Zawahir, Dhakshila
Niyangoda,Nadeesha Lakmali.

－ 333 －

－ 334 －“CEYLON”/ SRI LANKA－ 335 －Government expenditure as per
GMP

3%

Number of Hospitals

622

Number of Hospitals beds per
1000

3.9

Medical officer per 100000

84.8

Nurses per 100000

185.1

Pharmacist per 100000

6.7Life expectancy Male

72

Life expectancy Female

78.6－ 336 －

Pharmacy PracticeCategory
Number of government
pharmacists
Number of GMP inspectors(Pharmacists do inspections)
Number of pharmaceutical
Manufacturers (Medicines,
Borderline Products)
Number of pharmaceutical
Manufacturers (Devices)
Number of traditional medicine
manufacturers
Number of pharmaceuticalimporters
Number of pharmaceuticalwhole sellers－ 337 －

Data

Year

1386

2015

26

2016

38
(Small scale-28 andlarge scale 10)

2016

57

2016

Statistical data not available
1500

2016

299

2016

Pharmacy Education

Category

Graduate
Pharmacist

Duration
DiplomaPharmacist(Hospital)
Three years
Two years
One year

Four years
University/ college
Three years
Professional training
Duration of training by each facility One year
Hospital pharmacy
Community pharmacy
Pharmaceutical company
Other (Regulatory Authority)24- 26 years old 23 years old
Age of graduation

NMRA－ 338 －

DiplomaPharmacist(Community)
Three years
Two years
Two years

Depends age started

Vision, Mission, Objective and Strategies of NMRAVISIONTo achieve a healthier nation by
ensuring the provisions of safe, quality
and efficacious medicinal products.

To

regulate

MISSIONand control the

manufacture,

Importation, sale, storage and distribution
medicines,

medicinalofdevices,

includingnutraceuticals and borderline devices

efficiently

and effectively while ensuring rational usage.






OBJECTIVE
To ensure that all the Medicines, medicinal devices and borderline products
available in Sri Lanka are of safe, efficacious and acceptable quality.
Strategy
To ensure uninterrupted availabilityof cosmetics, devices and drugs
To ensure rational usage.
STRATEGIES

Ensureorganisation Strengthen
al efficiency enforceme
andnt activity
effectivenessAttain aStrengthen
Ensure continuous
Upgrademutualdedicatedresearch
Visionpersonnel
understanding andand fully
activities
cooperation
potentialcommitte
andbetween regulatory
andbodies and private
d workupgradeexpertise
sectorforce
facilities
7/31/2017 NMRA-HVNL

Create aconducive
workingenvironment
9National Medicines Regulatory Authority
Act no.5 of 2015
Registration
Licensing

Education

Advertising &Promotion

Surveillance
7/31/2017

Pharmacovigilence
NMRA-HVNL－ 339 －

10

Patients• Expect treatment using new medical innovations• Timely access to new drugs• Accountability• TrustPrescribers• Expect drugs to be reviewed and approved in a
judicious manner• Expect drugs to be of quality, efficacious, safe
• Timely access• Flexibility• Responsiveness• Confidence

Industry• Reduction in bureaucratic procedures• Harmonization of standards and technicalrequirements
NMRA-HVNL• Predictability

7/31/2017

7/31/2017

NMRA-HVNL－ 340 －

11

12

Achievements• Establishment of new Act• CDDRANMRA• Implementation of Price regulation for
Medicines

7/31/2017

NMRA-HVNL

13

7/31/2017

NMRA-HVNL

14－ 341 －

Solutions for past problems
GMP inspection of manufacturing facilities.
Regulation of API manufacturers.
Registration of Similar Bio therapeutic
products
accordingtotheformatrecommended by the WHO.
Making bioequivalence studies mandatory forregistration
Implementation of novel recall procedure.
Prequalification of supplier7/31/2017

NMRA-HVNL

15

Ongoing projects to deal withcurrent problems
NDQAL / MT&S
NMQAL/ NMRA
Implementation
Regulatory act

7/31/2017ofnew

NMRA-HVNL－ 342 －

Clinical

Trial

16

Difficulties / Lessons leaned
from Past experienceHuman Resources• Qualified Pharmacist (Limited number ofstaff)• In-service training Enhancement of Laboratory Facilities
Building and other facilities

7/31/2017

NMRA-HVNL

17

SWOT

7/31/2017

NMRA-HVNL－ 343 －

18

Interest in KCCP/JICA
Local and international recognition
Harmonizing the regulation processes withother countries.
Understanding Health care & regulatory
system in Japan

7/31/2017

NMRA-HVNLState Pharmaceuticals Manufacturing
Corporation

19

 SPMC- 1987 By JICA
 Manufacture quality, effective and safe medicinal drugs.
 First proposed in the Bibile - Wickramasinghe Reportpublished in March 1971.
 Only state owned pharmaceutical manufacturer in Sri
Lanka.
 Total products 70.
 Active products 58 drugs(2016)－ 344 －

HumanResource
Division

Finance
Division

Formulation
Development
Division

Vision.....

Production
DivisionState
Pharmaceuticals
Manufacturing
Corporation(SPMC)

Marketing
Division
Engineering
Division

Quality
Control andQuality
Assurance
Division

Planning andProcurement
DivisionTobeaninternationallyrecognized,
model manufacturing andmarketing organization forpharmaceuticals and healthcare products in South Asia.

Mission.....

To manufacture
safe, effective and affordable
medicinal drugs of goodquality up to international
standards to the local andinternational markets.

Formulation, Research andDevelopment Department
I have been working in this department since April,2015.
As a chemist,• Involve in formulation development• Conducting analysis of developed formulas according
to the official monographs• Manufacturing and quality assurance ofpharmaceutical solid oral dosage forms－ 345 －

The regulatory services which I engaged,
Prepare documentation on formulation
approval and drug registration.
Designing labeling and packaging
according to the regulations.
Handling stability testing anddetermining the shelf life of genericproducts

Good Practice• Reduced the products cost by implementing new
manufacturing process, such as alcohol coating
method replaced by aqueous coating method.
• Established a regulatory committee which
represent each department to smoothly flow ofdrug registration and regulatory activity on
timely.
• Join collaboration with professional bodies tocarry out clinical trials of the pharmaceuticalproducts which we manufacturing.

－ 346 －

Difficulties/ Lessons Learned from Past
Experience• The major issue is finding good quality raw
materials at reasonable prices.
• During the recent past trend was seen thatfrequent drug shortages occur due to quality
failures of the imported products.
• How to do SPMC expansions withoutcompromising GMP standards.
• Job fluctuations and lack of trained persons.

Interests• Current trends in drug manufacturing andregulatory affairs in Japan.
• Current Good Manufacturing Practice(CGMP)• To get understand about pharmaceuticalinspection system－ 347 －

References Annual Health Bulletin, Sri Lanka 2014
 Manual on management of drugs 2nd revision 2008 by
Ministry of healthcare and nutrition.
 NMRA act.
 Chapter 5 : Pharmacy practice in developing countries.
(Shukry Zawahir,Dhakshila Niyangoda, Nadeesha Lakmali)－ 348 －

Roles of Regulatory Systems and Pharmacists
on Ensuring Proper Access to Quality Assured Medicines (JFY 2017)

Country: Sri Lanka
Organization : State Pharmaceutical Manufacturing
Corporation of Sri Lanka

1. Overview of country and organization
Sri Lanka is a South Asia country with a Population about 21 million and 65610 Km2 land.
Politically, it is a country governs by parliament Democracy and headed by the Executive President.
In Sri Lanka, both public and private sectors provide health care. The public sector provides
free Healthcare System which is providing Healthcare to people irrespective of their wealth,
income or social status. Ninety five percent of inpatient care is provided by the public sector. The
private sector provides mainly curative care of the outpatient and is largely concentrated in the urban
and suburban areas.
Western, Ayurvedic, Unani, Siddha and Homoeopathy systems of medicine are practiced in Sri
Lanka. Of these, western medicine is the main sector catering to the needs of a vast majority of thepeople. The public sector comprises Western and Ayurvedic systems, while the private sector
consists of practitioners in all types of medicine.
As per the Annual health bulletin 2014, life expectancy among male and female 72.0 and 78.6
years respectively, According to 2014 statistics from registrar general department, the midyear
population the crude birth rate was 16.9/1000 population and crude death rate was 6.2/1000
population. Based on 2014 data, maternal mortality ratio per 100,000 live births was 19.3
As per the, update data there were 1085 medical institutions with inpatient facilities. There
were included 20 teaching Hospitals 21 DHPs 487 Primary Health Care Unit and 337 Medical
Officer of Health (MOH) areas in Sri Lanka. The number of beds in the hospitals increased to 76,781
in 2014 and the hospital beds per 1,000 populations is 3.7

Organizational chart of Ministry of Health, Nutrition and Indigenous Medicine－ 349 －

 Minister of Health- Policy making, such as introducing necessary amendments to theregulatory act and making regulations.
 Secretory /Health- Responsible for all administration and support to the Minister.
 Director General of Health Services- DGHS is the “Drug Authority” of the country
responsible for forming Drug Therapeutic Committees. Functions of the committee would be
to monitor supply, distribution and consumption of drugs at national, provincial, andinstitutional levels. Similarly, there are Drug therapeutic Committees for both provincial levels
and regional levels.
 Director/Medical Supplies Division (MSD)-The MSD of the Ministry of Health Nutrition &Indigenous Medicine is responsible for the consolidation of annual requirements of drugs forthe institutions under the Central Ministry and the Provincial Councils. Director, MSD and his
staff periodically visit and monitor the activities in relation to drug management in therespective provinces / institutions.
 Director/Regional Medical Supplies Divisions (RMSD) - MSD functions as the sole supplierof all the medicinal items to the public sector and these items are distributed via the RMSD’S
located in 26 Divisions Island wide.
 National Medicines Regulatory Authority (NMRA) - Regulation body of pharmaceuticals.
 National Medicines Quality Assurance Laboratory (NMQAL)-The primary function of the
NMQAL is to conduct laboratory tests necessary for determining compliance with productsafety and quality requirements. Quality testing of drug products is carried out on samples
collected on a random basis at different points of the distribution; namely at pre-marketing andpost marketingstages,andissuereports/recommendations
based
on
the
analyses/evaluations.
 State Pharmaceuticals Corporation (SPC) - The SPC has been designated as thesole procurement agency for pharmaceuticals and surgical consumable items required by
the government health institutions. These items are imported or locally purchased and supplied
to the MSD of the Department of Health Services from where they are distributed togovernment healthcare institutions.
 State Pharmaceuticals Manufacturing Corporation (SPMC) - The State Pharmaceutical
Manufacturing Corporation (SPMC), which was established in 1987 based on a grant aid
received from the Japanese government through JICA (Japan International Cooperation
Agency), is the largest oral solid dosage form (tablets and capsules) manufacturer in Sri Lanka .
SPMC is the only state owned pharmaceutical manufacturer in the country. It
actively produced 58 drugs during the year 2016 out of its total of 70 products. Every section of
the SPMC conforms to the current GMP (cGMP) requirements under the guidelines of the
WHO . SPMC maintains British (BP) and the United State (USP) Pharmacopeial quality
standards. Some of other manufacturing industries are maintaining Indian Pharmacopeialquality standards as well.
－ 350 －

2. Legislation Govern the Pharmaceutical Administration in Sri Lanka.
National Medicines Regulatory Authority Act no.5 of 2015 and regulations made under theprovisions of this act is responsible for the regulation and control of registration, licensing,
manufacturing, importation and all other aspects pertaining to medicines, medical devices, borderline
products and conducting of clinical trials in a manner compatible with national medicines policy.
This act was come into operation from 19th March 2015.
National Medicines Regulatory Authority (NMRA) was the body corporate established under thisact and has following objectives.
(a). Ensure the availability of efficacious, safe and good quality medicines, medical
devices and borderline products to the general public at affordable prices(b). Function as the central regulator for all matters connected with the registration,
licensing, cancellation of registration or licensing, pricing, manufacture,importation, storage, transport, distribution, sale, advertising and disposal of
medicines, medical devices and borderline products.
(c). Ensure that all activities related to registration, licensing and importation of
medicines, medical devices, borderline products and investigational medicinal
products are carried out in a transparent, sustainable and equitable manner.
(d). Encourage the manufacturing of good quality medicines in Sri Lanka with a view
to assuring the availability of essential medicines at affordable prices.
(e). Promote the safe and rational use of medicines, medical devices and borderline
products by healthcare professionals and consumers.
(f). Recommend appropriate amendments to relevant laws pertaining to medicines,
medical devices and borderline products.
(g). Educate the general public, health care professionals and all stakeholders on
medicines, medical devices and borderline products.
(h). Regulate the promotion and marketing of medicines, medical devices andborderline products.
(i). Regulate the availability of the medicines, medical devices and borderline
products.
(j). Conduct post marketing surveillance on quality, safety and adverse reaction of the
medicines, medical devices and borderline products.
(k). Regulate all matters pertaining to the conduct of clinical trials in Sri Lanka.

－ 351 －

Institutions established under NMRA act

3. Regulatory Service

 Pharmaceutical Manufacturing
Both public and private sectors are involved in pharmaceutical manufacturing in Sri Lanka. Any
manufacturer must obtain prior approval (Formulation Approval) to carry out trials to obtain astable formula from Medicines Regulatory Division (MR Division). The items to be manufactured
commercially, should have to obtain separate license for such manufacturing from the Medicines
Regulatory Division (MR Division). This license can be provisional which is valid for one year,
and can be upgraded to a full registration with time and necessary documentation. Good
Manufacturing Practices for manufacturing processes are monitored and given by the Medicines
Regulatory Division (MR Division).

 Drug import

Drug import to Sri Lanka can be divided into two categories such as imports to public sector andprivate sector. For the public sector drugs are imported mainly through the State Pharmaceuticals
Corporation (SPC). They procure all the essential drugs, devices, surgical items for the Medical
Supplies Division, which lies as the main unit responsible in distributing drugs and related items
to government sector hospitals. All the drug imports to Sri Lanka should be registered under
Medicines Regulatory Division (MR Division) established under NMRA.

 Marketing Authorization

Marketing authorization is either taken by the manufacturer to market the products manufactured
or by importers. All these functions are monitored and authorized by the Medicines Regulatory
Division (MR Division) under NMRA act no 5 in 2015.
－ 352 －

 Drug Distribution

For the public sector, drug distribution is mainly controlled and monitored by the Medical
Supplies Division (MSD). This is a centrally located government organization under Ministry of

Health, and there are provisional supplies divisions to supply medicines to other regional
hospitals. MSD is responsible for procuring medicines, surgical items and devices for government
sector hospitals, for procuring private sector hospitals and pharmacies there is no such distribution
channel operating at the moment. Private hospitals can procure their requirements directly fromavailable drug manufacturers or suppliers. Apart from this there are government owned
pharmacies known as “Osusalas” managed by the State Pharmaceuticals Corporation (SPC). SPC
is responsible in supplying medicines and other additional pharmaceutical products for all thepharmacies (“Osusala”) located island wide. All these functions are monitored and authorized by
the National Medicines Regulatory Authority act no 5 in 2015.

 Medicine Safety (Post - Marketing)
In Sri Lanka there is no such organized system for post marketing surveillance. But we have an
independent laboratory to check the quality of all the drugs manufactured in Sri Lanka and all the
drugs imported to Sri Lanka termed National Medicines Quality Assurance Laboratory(NMQAL). They monitor the safety and efficacy of the drugs, prevails within the island.

 Relief system for adverse drug reactions
In an event of an adverse drug reaction a doctor or the patient can submit the details of adverse
drug reactions to the Pharmacovigilance unit located at the Department of Pharmacology, Facultyof Medicine, University of Colombo, Where details of serious adverse drug reactions are collectedfrom government hospitals and government medical institutions, private medical institutions andfrom the patients. As per the decisions taken by the committee the drugs are subject to withhold,withdraw or quality testing by the NMQAL.
4. Drug Pricing
Drugs for public sector in Sri Lanka are free of charge. They procure drugs, according togovernment tender procedures. Therefore, those who bid for the tenders, will govern the prices.
However, apart from that the government also procures drugs directly from the State
Pharmaceuticals Manufacturing Corporation. Prices for these drugs are negotiated between thetwo government organizations. In the case of the private sector, there are now fixed price drugs
are available in different prices in the market. However, as per the new act NMRA introduced aprice regulation system for pharmaceuticals in 2016.
－ 353 －

5. Statistical Data
Categorya) Number of government
pharmacistsb) Number of GMP inspectors(Pharmacists do inspections)c) Number of pharmaceutical
Manufacturers (Medicines)d) Number of pharmaceutical
Manufacturers (Devices)e) Number of traditional
medicine manufacturersf) Number of pharmaceuticalimportersg) Number of pharmaceuticalwhole sellers

Data

Year

1386

2015

26

2016

38
(Small scale-28 andlarge scale 10)

2016

57

2016

Statistical data not available
1500

2016

299

2016

6. Education and License of Pharmacists(1) Primary, Secondary and high school education
In our education system of primary, secondary and high school is not specialized as
pharmacists. Those stages, students get the only overall idea about health sciences.
(2) University and College education
Pharmacy training was first introduced in Sri Lanka in the early 1950’s. By 1957, a full time
pharmacy certificate course was introduced (16). Since then, three types of pharmacy
certificates have been developed: A certificate of proficiency in pharmacy, a certificate ofefficiency in pharmacy and a diploma of pharmacy.
A Bachelor of Science (Special in Pharmacy) degree course commenced at the University ofColombo in 1999. The Bachelor of Pharmacy (B. Pharm) program was introduced in 2006 at the
University of Peradeniya (UP) in Central part of Sri Lanka and University of SriJayewardenepura (USJ) in Colombo and University of Jaffna (UJ). Followed by, University of
Ruhuna (2010) in Galle Southern province, Open University of Sri Lanka (2013) andKotelawala Defense University (2014) in Colombo have also started B. Pharm degree programs
at their respective universities.

－ 354 －

Statistical Data on Pharmacy Education

Category
University/ college
Professional training
Duration of training by each facility
Hospital pharmacy
Community pharmacy
Pharmaceutical company
Other (Regulatory Authority)
Age of graduation

Graduate
Pharmacist
Four years
Three years

Duration
DiplomaPharmacist(Hospital)
Three years
Two years

One year

One year

24 years old

23 years old

DiplomaPharmacist(Community)
Three years
Two years

Two years

Depends age started(3) National Examinations for Pharmacists
The Sri Lanka Medical council conducts the National Examination for Diploma pharmacists andit has one day Academic Exam and one day Clinical Exam.

－ 355 －

(4) To obtain a pharmacist’s license
To obtain a pharmacist license practical training is mandatory for both of graduate or diploma
pharmacists. The overall summary of subjects in practical training.

 Forensic Pharmacy- Study the laws applicable to running any kind of pharmacy (retail/wholesale), business laws applicable to the pharmacy and study the role of authorized
officers.

 Prescription based learning- Read and understand prescriptions,enter the details of theprescriptions in prescription book,dispense prescriptions with proper patient advice

 Packaging and labeling requirements- check the labels and packagings whether they
comply with regulations.

 Management and Storage-

Arrangement of stocks in the pharmacy,study inventory
control systems in pharmacy and how to handle expiry and quality failed drugs.

 Dosage forms- Classify dosage forms in pharmacy, prepare and dispensing of immediate
preparations.

 Quality assurance- Organoleptic detection of deterioration of dosage forms, detection ofparticles and microbial spoilage in small and large volume parental preparations.

(5) Number of Pharmaceutical University or college graduates
Graduate Pharmacists 100 people per years
Diploma Pharmacists 250 people per years
There are no data available on the alumni’s placement rate for the industry.

7. Side effect or adverse drug reaction report
In an event of a severe Side effect case a doctor or the patient can submit the details of adverse drug
reactions to the Pharmacovigilance unit located at the Department of Pharmacology, Faculty of
Medicine, University of Colombo, Where details of serious adverse drug reactions are collectedfrom government hospitals and government medical institutions, private medical institutions andfrom the patients. As per the decisions taken by the committee the drugs are subject to withhold,withdraw or quality testing by the NMQAL.

References:
1. Annual Health Bulletin, Sri Lanka ,2014
2. National Medicines Regulatory Act, 2015
3. Manual of Drug Management System, 2008
4. Book Chapter: Pharmacy practice in Sri Lanka; Shukry Zawahir, Dhakshila Niyangoda,Nadeesha
Lakmali.

－ 356 －

Country: Sri Lanka
Organization : State Pharmaceutical Manufacturing
Corporation

Over view of Sri Lanka• Democratic Socialist
Republic of Sri Lanka• South Asian country• Multi national andmulti religious country－ 357 －

Over view of Sri Lanka• Population around 21
million• Ethics groups
Sinhalese - 75%
Tamils – 15.3%
Muslims – 9.2%
Others – 0.5%
• Major religion
Buddhism others are
Hindu, Islam andChristian

Organizational chart of Ministry of Health,Nutrition and Indigenous Medicine－ 358 －

Health Care System
 Sri Lanka is a country known to the world for providing costeffective healthcare free of direct cost to the patient.
 life expectancy among male and female 72.0 and 78.6 years crude birth rate was 16.9/1000 population and crude death rate
was 6.2/1000 population.
 maternal mortality ratio per 100,000 live births was 19.3
 Medical institutions with inpatient facilities - 1085.
 Teaching Hospitals- 21
 District/Base Hospitals - 577
 Primary Health Care Unit- 487
 Medical Officer of Health (MOH) - 337 areas in Sri Lanka.
 The number of beds in the hospitals increased to 76,781 in 2014
and the hospital beds per 1,000 populations is 3.7

Legislation Govern the Pharmaceutical
Administration in Sri Lanka
 National Medicines Regulatory Authority Act no.5 of2015 National Medicines Regulatory Authority (NMRA) was
the body corporate established under this act
 There are eleven objectives of this authority such as
control of registration, licensing, manufacturing,
importation and all other aspects pertaining to medicines,
medical devices, borderline products and conducting ofclinical trials in a manner compatible with national
medicines policy－ 359 －

Regulatory Services of Sri Lanka
 Pharmaceutical Manufacturing
Both public and private sectors are involved in pharmaceutical manufacturing in Sri
Lanka.
 Drug import
Drug import to Sri Lanka can be divided into two categories such as imports topublic sector and private sector. For the public sector drugs are imported mainly
through the State Pharmaceuticals Corporation (SPC).
 Marketing Authorization
monitored and authorized by the Medicines Regulatory Division (MR Division)under NMRA act no 5 in 2015.
 Drug Distribution
For the public sector, drug distribution is mainly controlled and monitored by the
Medical Supplies Division (MSD) to government hospitals. The government owned
pharmacies known as “Osusalas” managed by the State Pharmaceuticals
Corporation (SPC).
 Medicine Safety (Post - Marketing) Relief system for adverse drug reactions
In an event of an adverse drug reaction a doctor or the patient can submit the detailsof adverse drug reactions to the Pharmacovigilance unit

Statistical Data
Category

Data

Year

a) Number of government pharmacists

1386

2015

a) Number of GMP inspectors(Pharmacists do inspections)

26

2016

38
(Small scale-28 andlarge scale 10)

2016

57

2016

a) Number of pharmaceutical
Manufacturers (Medicines)a) Number of pharmaceutical
Manufacturers (Devices)a) Number of traditional medicine
manufacturers

Statistical data not availablea) Number of pharmaceutical importers

1500

2016

a) Number of pharmaceutical wholesellers299

2016－ 360 －

Education and License of Pharmacists
Category

Graduate
Pharmacist

University/ college
Four years
Professional training
Three years
Duration of training by
each facility
Hospital pharmacy
Community pharmacy
One year
Pharmaceutical company
Other(Regulatory
Authority)
Age of graduation
24 years old

Duration
DiplomaPharmacist(Hospital)
Three years
Two years

DiplomaPharmacist(Community)
Three years
Two years

One year

Two years

23 years old

Depends age
startedEducation and License of Pharmacists
cont….
 The Sri Lanka Medical council conducts the National

Examination for Diploma pharmacists and it has one day
Academic Exam and one day Clinical Exam.
 To obtain a pharmacist license practical training is
mandatory for both of graduate or diploma pharmacists.
 The area covered by practical training.
 Forensic Pharmacy
 Prescription based learning Packaging and labeling requirements
 Management and Storage
 Dosage forms
 Quality assurance－ 361 －

Roles of Regulatory Systems and Pharmacists on
Ensuring Proper Access to Quality Assured Medicines

State Pharmaceuticals
Manufacturing Corporation
Sri Lanka

01 Introduction of the work
The State Pharmaceutical Manufacturing
Corporation (SPMC) was established in the year 1987
based on a grant aid received from the Japanese
government
through
JICA(JapanInternational
Cooperation Agency) with a commitment to manufacture
quality, effective and safe medicinal drugs. This far-sighted
decision was first proposed in the Bibile - Wickramasinghe
Report published in March 1971.
SPMC is the only state owned pharmaceuticalmanufacturer in the country. It actively produced 58
drugs during the year 2016 out of its total of 70 products.

－ 362 －

Vision.....

To
be
an
internationallyrecognized,
model manufacturing andmarketing organization forpharmaceuticals and healthcare products in South Asia.

Mission.....

To manufacture
safe, effective and affordable
medicinal drugs of goodquality up to international
standards to the local andinternational markets.

Formulation, Research andDevelopment Department
I have been working in this department since April,2015.
As a chemist,• Involve in formulation development• Conducting analysis of developed formulas according
to the official monographs• Manufacturing and quality assurance ofpharmaceutical solid oral dosage forms－ 363 －

Roles and position of pharmacists in
Sri Lanka• Pharmacists are in charged with dispensing andcompounding medicines as prescribed by the doctors.
• Patient counseling with regards their medications toensure compliance and prevent drug misuse.
• Pharmacist are also highly engaged in the regulatory
sector where they ensure companies manufacturing
medicines both internationally and locally, which
compliance with current GMP while adhering to a setof guidelines and regulations as provided by the
National Medicinal Regulatory Authority(NMRA) of
Sri Lanka.

The regulatory services which I engaged,
Prepare documentation on formulation
approval and drug registration.
Designing labeling and packaging
according to the regulations.
Handling stability testing anddetermining the shelf life of genericproducts－ 364 －

02 Good Practice• Reduced the products cost by implementing new
manufacturing process, such as alcohol coating
method replaced by aqueous coating method.
• Established a regulatory committee which
represent each department to smoothly flow ofdrug registration and regulatory activity on
timely.
• Join collaboration with professional bodies tocarry out clinical trials of the pharmaceuticalproducts which we manufacturing.

03 Difficulties/ Lessons Learned from
Past Experience• The major issue is finding good quality raw
materials at reasonable prices.
• During the recent past trend was seen thatfrequent drug shortages occur due to quality
failures of the imported products.
• How to do SPMC expansions withoutcompromising GMP standards.
• Job fluctuations and lack of trained persons.

－ 365 －

04 Interests• Current trends in drug regulatory affairs
in Japan.
• Current Good Manufacturing Practice(CGMP)• To get understand about pharmaceuticalinspection system－ 366 －

－ 367 －－ 381 －Roles of Regulatory Systems and Pharmacists
on Ensuring Proper Access to Quality Assured Medicines（JFY 2017）

Country: Republic of Moldova
Organization/Department/Division: Ministry of Health, Medicines and medical devices dept.
1

Organizational Chart

Pharmaceutic system in Republic of Moldova:
Regulatory authorities:
Ministry of Health – bears responsibility to elaborate policy in the area of medicines and pharmaceuticalactivities.
Medicines and Medical Devices Agency – bears responsibility of the following procedures management:-

drugs authorization,-

pharmacovigilance system,-

announces and monitors clinical trials,-

register manufacturer’s price of medicines and manages national Register of prices,-

authorization of drugs import,-

quality control of autohtonous and imported drugs (by means of Laboratory of quality control ),-control and monitoring of pharmaceutical activities of pharmaceutical units and institutions; control of
implementation and adherence to GMP and GDP.

Locally:
Pharmaceutical units and institutions are:-drug manufacturers-

importers/distributors-

pharmacies:a) public/community pharmcyb) closed-type pharmcy (hospital pharmcy)

2

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

Law on Pharmaceutical Activity no 1456-XII dated 25.05.1993;-

Law on Drugs no 1409-XIII dated 17.12.1997;◆Local Level- Government decrees- Laws of the Ministry of Health－ 383 －

◆PIC/SNo① Regulatory Services◆Pharmaceutical Manufacturing

Medicines and Medical Devices Agency by means of Inspectorate GMP and GDP bears responsibility for:•management and execution of GMP inspections of manufacturers which produce drugs for human use and control ofdrug manufacturing activities, according, suspension and revoking certificates for manufacturing of drugs / medicinalcompounds as well as GMP certificates, offering conciliation and management of eventual defects in quality .
Legal framework:
Activities in the area of manufacturing drugs for human use
Order of the Ministry of Health nr. 309 of 26.03.2013 regarding approval of GMP guidelines for drugs for human use
Order of theMMDA nr. 24 of 04.04. 2013 regarding approval of GMP guidelines for drugs for human use
Order of the Ministry of Health nr. 1024 of 25.09.2013 regarding authorization of manufacturing of medicines forhuman use in Republic of Moldova

Before implementation of GMP guidelines there were 26 drug manufaturers in Moldova.
Implementation of GMP guidelines startedin 2013, 6 manufacturers have been certfied.
Information is available on Drug Agency site:
http://amed.md/sites/default/files/attach/201504_List.fabr_.certif.GMP_.pdf◆Drug Import/Export
Import authorization by Medicines and Medical Devices Agency is a permission issued by the state for an
economical agent in order to perform external commercial activity (import) for a definite period, on a scale as specified
in the authorization.
MMDA Order nr. 1 of 16.01.2006 "Regarding authorization of import – export of medicines, otherpharmaceutical and parapharmaceutical products"- Import authorization for imported medicines- Permission for import of medicinal products and other pharmaceutical products for preclinical studies,
bioequivalence trials and clinical trials.
- Permission for import of medicines and other pharmaceutical products for advertisement and promotion during an
exhibition, congress, conference, symposium etc.
It is settled by law that in state of emergency (natural disaster, catastrophe, epidemics, epizootics, mass poisoning
other cases of health-threatening situations; absence of analogs or substituents on pharmacy market), Medicines andMedical Devices Agency is authorized to grant permission for import, distribution and medical use of medicines, otherpharmaceutical and medical devices and medicinal raw material which are not authorized in the Republic of Moldova,
but being authorized in the country of origin.
The procedure is defined by Order of the Ministry of Health nr. 820 of 15 October 2015 “Guidelines regarding
import authorization of medicines, other pharmaceutical and parapharmaceutical products and medicinal raw－ 384 －

material which are not authorized in the Republic of Moldova,◆Marketing Authorization
 Medicines for human use may be commercialized in the Republic of Moldova only after Medicines and Medical
Devices Agency issued certificate of registration of a medicine.
Medicines and Medical Devices Agency uses all reasonable efforts in order a certificate ofregistration of a medicine to be issued within at most 210 days.
Medicines and Medical Devices Agency performs expertise of a medical product and accompanying

documentation, makes reports based on its results and takes decision during drug committee sessions.
On the base of positive reply of drug committee Medicines and Medical Devices Agency elaborates

draft of order for authorization of medical products which will be subsequently approved by the Ministry of
Health.
Medicinal products, listed in the MoH order are considered to be included in State Registry of

medicinal products, authorized in the Republic of Moldova, starting with the effective date of respective order.
Legal framework:
Order of the Ministry of Health no. 739 of 23.07.2012 "Regarding regulation of authorization of medicinal
products for human use and introduction post-authorization changes"
Order of the Medicines and Medical Devices Agency no. 309 of 28.12.2015 "On the approval of the necessary
Guidance for authorization of medicinal products for human use and introduction post-authorization changes"◆Drug Distribution (including drug selection, procurement, sale)
Regulatory Authority: Medicines and Medical Devices Agency
Coordinating and conducting inspections of Best Practice for the Distribution
Legal framework:
Order of the Minister of Health no. 1400 of 09.12.2014 on the testing of the Good Practice of Distribution of
Medicines (GDP) for human use.
List of certified GDP distributors:
http://amed.md/sites/default/files/inspectorat/Lista%20distribuitorilor%20din%20Moldova%20certificati%20GDP%20G
DP.pdf
The procurement of medicines.
Regulatory Authority: Center for Centralized Public Procurement in Health
Legal framework:
Law on Public Procurement no. 131 of 03.07.2015
Government Decision No.1128 of 10.10.2016 on Center for Centralized Public Procurement in HealthMissions of the Center for Centralized Public Procurement in Health- Planning of procurement procedures for medicines, other medical products and medical devices;- Carrying out procurement procedures for medicines, other medical products and medical devices;- Coordination of public procurement processes for the needs of the health system;- Supervising and monitoring the execution of public procurement contracts for the procurement of medicines, othermedical products, medical devices.

－ 385 －

Task: Tendering or price negotiation of medicines. Pharmacotherapeutic Committees of public health facilities andmedical institutions determine the need for medicines for the planned period (the next year), taking into account theInstitutional Pharmacotherapeutics Formulary, dosage, pharmaceutical form of medicines, clinical protocols approved by
MoH, the amount needed to treat one patient, stocks of drugs in institutions, and provide this information to Center.
MoH determine the necessary amount of medicines for National vertical and special Programs. Criteria: Requirements
for each batch of medicines are evaluated separately. The tender prices are benchmarked against the registered price in
the National Catalogue.
Beneficiaries: 371 medical institutions at republican, municipal, rayon level.
Institutional Pharmacotherapeutic Committees:
Task: Decision on introduction of medicines in the needed for procurement list of medicines Criteria: eligibility for
diseases, efficiency, safety, cost criteria. VEN and ABC analysis.
The hospitals purchase the medicines from the winning bidder. The cost of medicines is included in the DRG price. Highcost medicines are reimbursed separately by the National Health Insurance Company (surfactant, chemotherapeutics).
At the same time, the Ministry of Health procures vaccines from the National Immunization Program through UNICEF
and through UNDP procures medicines and medical devices for some national and special health programs.
Pricing in the in-patient sector◆Medicine Safety (post-marketing)
The system of pharmacovigilance - the state system created for the storage, scientific evaluation and control of
information about adverse reactions of drugs and other pharmaceuticals, for the purpose of undertaking appropriate
measures at the stage of clinical trials and at the stage of their use in medical practice.
In the Republic of Moldova, responsible for collecting data on adverse drug reactions, is the Pharmacovigilance
Department of the Agency for Medicines and Medical Products.
Legal framework:
Order of the Minister of Health no. 358 of 12.05.2017 Concerning the approval of the Regulation on performing
pharmacovigilance activities◆Relief System for Adverse Drug Reactions
Process description of managing of Adverse Drug Reactions
1. Receiving the Adverse Drug Reaction/Ineffectiveness Reporting Form, reported by healthcare
professionals and patients
Adverse Drug Reaction/Ineffectiveness Reporting Form for healthcare specialists and for patients are transmitting toPharmacovigilance Department by phone, fax, paper support, e-mail or E-Reporting.
Reports of suspected cases of ADR on medicinal products can be completed by doctors and other healthcare
professionals (pharmacists, nurses, etc.) within the healthcare institutions, manufacturers / manufacturer authorization
holders (MAH) or their official representatives and patients.
Reports of suspected cases of ADR are received by responsible person from Pharmacovigilance Department andrecorded in Register, maintained electronically.
2. Validation of Adverse Drug Reaction’s Reports (ADR Report)
The ADR reports are validated on the basis of the validation criteria. Reports that do not contain the description of theadverse reaction or the name of the medicine are not validated.

－ 386 －

Invalid reports are recorded in the database. The report classified as invalid will be validated only after the insufficient
data will be filled in, further requested from the rapporteur.
The reports are identified by a reference number generated in the VigiFlow program.
3. Primary assesment of Adverse Drug Reaction’s Reports
After validation, reports of unexpected or serious adverse drug reactions are being followed with caution in order toobtain additional information from the original rapporteur or other available sources
4. Specialized assesment of Adverse Drug Reaction’s Reports
On this stage, the ADR is classified by different criteria.
The type of ADR is established taking into account several unique or combined criteria as follows:- frequency;- severity;- latency and duration;- the mechanism underlying their appearance;- predictability; Dose, time, susceptibility (DoTS classification).
After establishing and identifying the type of ADR, according to the above-mentioned criteria, the WHO-ART
classification, ADR reports are evaluated for severity, predictability to assess the causality.
Data of ADR or drug ineffectiveness are recorded in the national database (Vigi Flow), maintained onelectronic support and in the ADR register. Subsequently, they are transmitted (electronically) to UMC, the Uppsala
Monitoring Centre, Sweden.
In dependence of case, the response will be sent to the rapporteur.
② Drug Pricing
Pharmaceutical pricing and reimbursement policies in the in- and out-patient sector
PRICING at ex -factory price level:
All type of medicines (Rx and OTC) authorised and included in the State Medicines Nomenclature.
Regulatory Authority: Bureau of Price, from Medicines and Medical Devices Agency.
Task: Calculation of average price of the lowest three prices of the reference countries: Romania, Greece, Bulgaria,
Serbia, Croatia, Czech Republic, Slovakia, Lithuania and Hungary; generic medicine price does not exceed 75% of
the original medicine; medicines price that cannot be found in the reference countries must be equal to the averageof InternationalNon-proprietaryName (INN) recorded in the Register.
Criteria: External reference pricing.
The manufacturer price of medicines is approved for a period of one year, calculated from the date of issuing
the Agency order. The price is declared by the applicant in the national currency (Moldavian lei) and foreign
currency. If there is no price information in the reference countries, the manufacturer price for medicines iscompared with:a) the price in the country of origin, with a copy of the Catalogue of the prices of medicines on thepharmaceutical market of the country of origin of the medicine;b) the manufacturer's price, recorded in the National Prices Catalogue of Producer's for similar medicines
according to the ATC code (anatomicaltherapeutic-chemical);c) the average import price for the previous years for the given pharmaceutical product, if it was imported.
PRICING at wholesale and pharmacy price level:－ 387 －

Pricing in the out-patient sector:
Medicines distributed via wholesale and pharmacy, regressive mark-up.
Purchase
Final
Wholesale
Pharmacy
price (MDL)
marginark-upmark-up

0-30,00
≤40%
≤15%
≤25%
30,01-60,00
0 ≤32%≤12%≤20%
60,01- 120,00
≤26%
≤10%
≤16%
120,01- 240,00
≤21%
≤8%
≤13%
>240,01
≤16%
≤5%
≤11%
Annotation: The average exchange rate in May 2017: 1 EUR = 20.6037 MDL

Forreimbursed
medicines
Pharmacy markup
≤15%
≤15%
≤15%
≤13%
≤11%

VAT for all types of medicines: 8 %Reimbursement:
Reimbursement in the out-patient sector
Council of reimbursed medicines from compulsory health insurance funds
Task: Decision on reimbursement status and rate of International Non-proprietary Name.
Criteria: eligibility for priority diseases, efficiency, safety, pharmacoeconomic criteria.
List of medicines for sustained (long-term) treatment in ambulatory care
• Reimbursed rate:➢100% (full price);➢50% and 70% from median retail price (from 50 community pharmacies).
87 INN for:✓Cardiovascular diseases; Digestive diseases; Endocrine diseases (inclusive Diabetes mellitus (100%); Bronchialasthma; Anaemias in pregnant women (100%); Some diseases of children up to 18 years (100%); Epilepsy (100%);
Parkinson diseases (100%); Psychical diseases (100%); Some autoimmune diseases (100%); Some rare diseases(100%) etc.
List of medicines for episodic treatment in the day hospital/day care room, procedures room and at home treatment,of diseases commonly found in the practice of family physician
Reimbursed rate:➢100% (full price) for children up to 18 years;➢70% from median retail price (from 50 community pharmacies).
• 47 INN for:✓ Respiratory system diseases: Pneumonia; Chronic bronchitis; COPD, Bronchial asthma; Digestive systemdiseases: Chronic hepatitis; Fibrosis and liver cirrhosis; Chronic pancreatitis, Ulcerative disease; Mental diseases:
Multiple sclerosis; Myelopathy; Cerebrovascular disease; Encephalopathy; Osteoarticular diseases: Rheumatoid
arthritis; Reactive arthritis; Psoriatic arthritis; Gout; Back pain; Endocrine diseases: Diabetes mellitus + diabetic
neuropathy; Diabetes + angiopathies; Diabetic Nephropathy; Infection diseases: Acute Respiratory Viral Infection(on children③ Statistic Data
−Please answer the following questions (if the number is not applicable, please give an answer to the best of yourknowledge).

－ 388 －

−Put the year of the presented data as well if it's available.
1.

Number of pharmacists(year)

2.

Number of GMP inspector (National & Local)

3.

Number of pharmaceutical manufacturers / manufacturing sites

4.

Number of traditional medicine manufacturers / manufacturing sites

5.

Number of pharmaceutical importers/ Number of pharmaceutical wholesalers 7 GDP certified and 15 GDP-

2 (2017)
6 (2017)-(year)

free, if by 2017 they will not have GDP in 2018 they will not be active (2017)④ Education and License of Pharmacists in your country（１） Number of years in primary, secondary and high school education
Primary

4

years

Secondary

5 years

High school

3 years（２） Number of years / weeks in the following categories during university or college
Pharmaceutical frames:
University - 5 years, pharmacists
Postuniversity - 2 years, (mangement, pharmacists - clinicians, technologists)
College - three years, lab farmaişti
（３）Are there any national examinations for pharmacists in your country?
Yes
Pharmacists graduating from a university hold a state examination, composed of practical and theory. If they failto take the exam, they do not get the activity license（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.

3 %Hospital:b. Community Pharmacy:
c.

70 %

Government Organization:

3 %d. Enterprise:

20 %

e.

4 %

Others:⑤ Side effect report
5. Management of a serious adverse drug reaction
Ifanadversedrug

reactionisassessedasserious,－ 389 －

thefollowing

actionswillbetaken:

- contacting the reporter by phone and / or the specialists from pharmacovigilance department are moving at the scene totake samples of drug, collect the patient's history, analyze the patient's observation sheet (if applicable), get to know thepatient's dynamics;- samples of drug are taking by Inspectors / Pharmacists from Laboratory for Quality Control/ Pharmacovigilance
specialists from Medicines and Medical Devices Agency, according to the sampling procedure, with their transmission toLaboratory for Quality Control;- After receiving and evaluating the laboratory results, it is preparing the report including the description of the data(anamnestic, clinical, laboratory, etc.);-The report - Report of serious adverse drug reaction evaluation is submitted to the Medicine’s Committee- Medicine’s Committee takes a decision, and on the basis of this decision, are taken necessary actions.
Examples of decisions: withdrawal of medicine from market/suspension, including variations in SmPC (Summary
Product Characteristics)－ 390 －

PartⅡ Presentation format

REPUBLIC of MOLDOVA‿※⁀※⁅⁆⁄⁋‒⁁‸‒›‷″‾⁆›‒Maria Lapteanu

Organizational Chart
Minister
Deputy Ministers
State Secretary
The Cabinet of the Minister
Department:- Primary, Emergency and Community Care
- Hospital care
- Medical Personnel Management‿⁗⁖⁛⁕⁛⁠⁗⁥‒⁓⁠⁖‒‿⁗⁖⁛⁕⁓⁞‒‶⁗⁨⁛⁕⁗⁥‒- Budget, finance and insurance- Legal- External Relations and European Integration- Accounting and heritage
Policy Analysis and Monitoring Section
E-transformation and e-health service
Human resources service
The information and communication service with the media
Internal audit service, petitions, audience and secretariat service
1－ 391 －

1. Organizational Chart2

1. Introduction of the work
Currently Republic of Moldova is in theprocess of joining EU, and all the areas of workanddevelopment
are
under
continuous
improvement. The medicines and medical devices
field is one the field is under transformation, inorder to develop and implement the best practices.

3－ 392 －

1. Introduction of the work
• ⁂⁞⁓⁠⁥‒⁓⁠⁖‒⁕⁓⁤⁤⁛⁗⁥‒⁡⁧⁦‒⁤⁗⁘⁡⁤ ⁥‒⁡⁘‒⁦⁚⁗‒⁚⁗⁓⁞⁦⁚‒⁥⁗⁕⁦⁡⁤‒⁦⁡‒⁗⁠⁥⁧⁤⁗‒⁦⁚⁗‒⁚⁛⁙⁚⁗⁥⁦‒⁞⁗⁨⁗⁞‒⁡⁘‒⁕⁡ ⁢⁞⁛⁓⁠⁕⁗‒⁡⁘‒⁦⁚⁗‒⁚⁗⁓⁞⁦⁚‒⁥⁫⁥⁦⁗ ‒⁦⁡‒⁦⁚⁗‒⁠⁗⁗⁖⁥„‒⁢⁤⁗⁘⁗⁤⁗⁠⁕⁗⁥‒⁓⁠⁖‒⁗⁪⁢⁗⁕⁦⁓⁦⁛⁡⁠⁥‒⁡⁘‒⁓⁢⁢⁤⁡⁢⁤⁛⁓⁦⁗‒⁢⁡⁢⁧⁞⁓⁦⁛⁡⁠„‒⁗⁥⁢⁗⁕⁛⁓⁞⁞⁫‒⁡⁘‒⁥⁡⁕⁛⁓⁞⁞⁫‒⁨⁧⁞⁠⁗⁤⁓⁔⁞⁗‒⁙⁤⁡⁧⁢⁥„‒⁤⁗⁕⁡⁙⁠⁛⁬⁛⁠⁙‒⁓⁠⁖‒⁤⁗⁥⁢⁗⁕⁦⁛⁠⁙‒⁦⁚⁗‒⁤⁛⁙⁚⁦⁥‒⁓⁠⁖‒⁤⁗⁥⁢⁡⁠⁥⁛⁔⁛⁞⁛⁦⁛⁗⁥‒⁩⁛⁦⁚‒⁤⁗⁙⁓⁤⁖‒⁦⁡‒⁚⁗⁓⁞⁦⁚†

4

1. Introduction of the work
Working with:
State authority:‟ ‿⁗⁖⁛⁕⁛⁠⁗⁥‒⁓⁠⁖‒‿⁗⁖⁛⁕⁓⁞‒‶⁗⁨⁛⁕⁗⁥‒″⁙⁗⁠⁕⁫‒‟ ‵⁗⁠⁦⁗⁤‒⁘⁡⁤‒‵⁗⁠⁦⁤⁓⁞⁛⁬⁗⁖‒⁂⁧⁔⁞⁛⁕‒⁂⁤⁡⁕⁧⁤⁗ ⁗⁠⁦‒⁛⁠‒›⁗⁓⁞⁦⁚

5－ 393 －

1. Introduction of the work⁂⁚⁓⁤ ⁓⁕⁗⁧⁦⁛⁕⁓⁞‒⁧⁠⁛⁦⁥‒⁓⁠⁖‒⁛⁠⁥⁦⁛⁦⁧⁦⁛⁡⁠⁥‒⁓⁤⁗‬• ⁖⁤⁧⁙‒ ⁓⁠⁧⁘⁓⁕⁦⁧⁤⁗⁤⁥• ⁛ ⁢⁡⁤⁦⁗⁤⁥‡⁖⁛⁥⁦⁤⁛⁔⁧⁦⁡⁤⁥• ⁢⁚⁓⁤ ⁓⁕⁛⁗⁥‬‟ ⁢⁧⁔⁞⁛⁕‡⁕⁡⁧⁠⁛⁦⁫‒⁢⁚⁓⁤ ⁕⁫‟ ⁕⁞⁡⁥⁗⁖‟⁦⁫⁢⁗‒⁢⁚⁓⁤ ⁕⁫ ‚⁚⁡⁥⁢⁛⁦⁓⁞‒⁢⁚⁓⁤ ⁕⁫‛‒‒

6

1. Introduction of the work
Pharmacist is a Qualified Person who deals with the preparation, control
and distribution or sale of medicines.

The profession of pharmacist is exercised through the following activities:- preparation of pharmaceutical forms of medicinal products;- manufacture and control of medicines;- drug control in a drug control laboratory;- storage, preservation and distribution of wholesale medicines;- preparing, controlling, storing and distributing drugs in pharmacies
open to the public;- preparing, controlling, storing and dispensing medications from
hospital pharmacies;- providing information and advice on medicines.

7－ 394 －

1. Introduction of the work
The pharmacist, in accordance with his / her university education, iscompetent to practice other professional activities such as:- collaboration with the doctor for the establishment and follow-up of thepatient's therapy;- pharmacovigilance;- manufacture, control, storage, preservation and distribution of herbal
products, nutritional supplements, hygienic-cosmetic products, medical
devices, veterinary medicines, active and auxiliary pharmaceuticalsubstances;
analyzes in biochemistry, toxicology and hygiene laboratories of theenvironment and foodstuffs;- marketing and pharmaceutical management;- didactic activities or sanitary administration.

8

1. Introduction of the work
(1) Organization and department that you belong to(2) Job tenure(3) Regulatory services that you are engaged in(4) roles and position of pharmacists in yourcountry1) Organizația și departamentul căruia îiaparțineți
(2) Loc de muncă
(3) Serviciile de reglementare în care sunteți angajat(4) rolurile și poziția farmacistului din țara dvs.
9

－ 395 －

2. Good PracticeGood Manufacturing Practice:
Before implementation of GMP guidelines there were 26
drug manufaturers in Moldova.
Implementation of GMP guidelines startedin 2013, 6
manufacturers have been certfied.
Good Distribution Practice:

Number of pharmaceutical wholesalers - 7 GDP
certified and 15 GDP-free, if by 2017 they will not have
GDP in 2018 they will not be active.
10

3. Difficulties/Lessons Learned from Past Experience⁆⁚⁗‒⁢⁤⁡⁕⁧⁤⁗ ⁗⁠⁦‒⁡⁘‒ ⁗⁖⁛⁕⁛⁠⁗⁥†
Procurement of insulin analogues in the context
of centralized ⁢⁤⁡⁕⁧⁤⁗ ⁗⁠⁦‒⁠⁓⁦⁛⁡⁠⁓⁞‡⁇⁀‶⁂

11－ 396 －

－ 397 －－ 399 －－ 400 －－ 401 －－ 402 －－ 403 －Malawi
Ministry of HealthCharles Chimenya
From the warm Hear t of Africa

1. Introduction of the work Ministry of Health, Directorate of Health Technical Support
Services responsible for Pharmaceutical Services.
 Three departments-Pharmaceuticals, Physical Assets
Management and Diagnostics(Laboratory and Radiology)
 Full time Position –risen through the ranks of theprofession and works directly under the Deputy Director
 Mission HTSS-P: To contribute to the improvement of the health ofMalawians through equitable access to and rational use of good quality,
safe and efficacious medicines and medical supplies at an affordable cost,with particular attention to vulnerable sections of the populations: Children,
women and the poor through well trained , motivated and dedicatedpersonnel

1－ 404 －

Regulatory services-MOH• Provides Policy direction for the Pharmaceutical sector
both public and private.
• Provides oversight function in the registration of medicinal
products, Pharmacy professionals, establishments dealing
in pharmaceutical products.
• Selection of medicinal products for use in public healthfacilities.
• Regulates the training of Pharmacy professionals in the
country.
2

Roles and position of pharmacists• Pharmacists in public service are either trained locallyor abroad• Primarily they are responsible for managing drug
supply in hospitals and even at National level –supply
chain management• Regulatory services – Registration and inspection ofpharmaceutical services in public and private sector• Training institutions• Private sector-Community/retail/wholesaling
Pharmacies, manufacturing plants

3－ 405 －

2. Good Practice
Until 2006, when Malawi started training its own Pharmacists at College ofMedicine, the industry had critical shortage of Pharmacists-only
From 2009, Pharmaceutical sector has seen improvements in the numbersof Pharmacists.
Challenges still remain:-locally trained Pharmacists are opting to work in theprivate sector (poor remuneration in civil service)-lack of specialized training for limited pharmacists to workin public sector.
- Storage space for health commodities
Improving HR Pharmaceutical department – GOM increasing no. of
training institutions for lower level Pharmacy Assistants for health centres
Logistics management information system(LMIS) – Data visibility forlogistics data expected to improve with introduction of a (web based Open
LMIS).
4

2. Good Practice• Achievements: establishment of school of pharmacy• Solutions for past problems: continue with trainings for
all Pharmacy cadres to improve on staffing levels andservice delivery at HCs-access to quality medicines• On-going projects to deal with current problems• -Training of Pharmacy Assistants for H/Cs
• - Installation of web based system for improving data
visibility.
- Infrastructure improvement(SIAB) at lowest level ofcare
5－ 406 －

Infrastructure
improvement at Healthcentre : SIAB Unit

6

3. Difficulties
Challenges struggling to solve-MOH
 Theft and pilferage of medicines and medical supplies inpublic hospitals.
 Expired medicines –Donations and inventory control
management challenges
 Visibility of end user data-accountability of medicines issued
out of the pharmacy.
 Infrastructure improvement at lowest level of care7

－ 407 －

4. My interests(1) Learn from counterparts from participating
countries on how they are handling issues ofaccountability for medicines in hospitals(Primary, Secondary and Tertiary).
(2) Technology being used in Japan to track
products up to patient level8－ 408 －

－ 409 －THE UNITED REPUBLIC OF TANZANIAMINISTRY OF HEALTH, COMMUNITY DEVELOPMENT, GENDER, ELDERLY & CHILDRENINCEPTION REPORT

Roles of Regulatory Systems and Pharmacists
on Ensuring Proper Access to Quality Assured Medicines （JFY 2017 - 04206）－ 411 －

Contents
1. Organisational Chart (Pharmaceutical Administration Only)....................................2
2. Roles and Responsibilities....................................................................................2
3. Legislation on Pharmaceutical Administration........................................................3
National level............................................................................................................3
4. Regulatory Services.............................................................................................4
5. Drug Pricing .......................................................................................................5
6. Statistic Data ......................................................................................................5
7. Education and License of Pharmacists in your country...........................................5
8. Side effect report ................................................................................................7－ 412 －

Roles of Regulatory Systems and Pharmacists
on Ensuring Proper Access to Quality Assured Medicines （JFY 2017 - 04206）
Name:
Country:

Ambwene R Mwakalobo
Tanzania

Organization:

Ministry of Health, Community Development, Gender, Elderly andChildren /Pharmaceutical Services Unit

1. Organisational Chart (Pharmaceutical Administration Only)
Minister for
HealthPermanent
Secretary

Director TFDA

Director MSD

Chief Medical
Officer
Registrar
Pharmacy
Council

Chief Pharmacist

2. Roles and Responsibilities
Minister for Health is the Minister responsible for Health－ 413 －

The Permanent Secretary is the Chief Executive Officer for the Ministry of Health,Community Development, Gender, Elderly and Children
TFDA is a regulatory body for the products regulated under TFDA act, 2003
Medical stores Department (MSD) is responsible for procurement, storage anddistribution of health commodities for the public sector, it is non-profit seeking
organisations which is financially self-sustaining
Chief Medical Officer (CMO) is a technical advisor to the Permanent Secretary and all
Professional Councils (Nurses, Doctors, Pharmacists etc.) Registrars report to CMO,
Directors from all Directorates also reports to the CMO
The Chief Pharmacist / Director of Pharmaceutical Services is responsible for the
Pharmaceutical Sector in the Country, it is the technical unit that advises the Ministry
regarding all matters related to Pharmaceuticals and Medical supplies as per policy
guidelines, Strategic plans, health policies, budgets, supply chain of medicines, regulatory
in collaboration with the TFDA, Practice of Pharmaceutical personnel in collaboration with
the Pharmacy council, etc.

3. Legislation on Pharmaceutical Administration

National level
Tanzania Food, Drugs and Cosmetics Act, 2003 administered by Tanzania Food andDrugs Authority (TFDA)
The Pharmacy Act No 7 of 2002 administered by The Pharmacy Council
Other related acts for specific items
Local level
At the local level same laws are administered by the above entities in collaboration with
the Local Government Authorities.

－ 414 －

Tanzania is NOT a PIC/S member

4. Regulatory Services
Pharmaceutical manufacturing systems, regulations etc
Good Manufacturing Practice (GMP) administered by TFDA
Good Laboratory Practice (Private) administered by Private Health Laboratory Board(PHLB)
Good Pharmacy Practice administered by The Pharmacy Council
Good Clinical Practice administered by professional councils’ e.g. The Pharmacy Councilof Tanzania
Drug Import/Export
Import is administered by the TFDA/TBS/TPRI/TAEC
Marketing Authorization systems, regulations etc
Marketing authorization is administered by TFDA
Drug distribution (including drug selection and procurement) systems, regulations etc
Drug procurement, storage and distribution for public health facilities is administered by
The Medical Stores Department
Drug procurement, storage and distribution for private health facilities is administered by
Private companies, Non-governmental organisations etc
Drug selection for public health facilities is done centrally at the Ministry of Health,Community Development, Gender, Elderly and Children. The list of National Essential
Medicines is created and is normally aligned to the Standard Treatment Guidelines
Medicines safety (Post-marketing) systems, regulations
Pharmacovigilance is administered by the TFDA
Relief System for Adverse Drug Reactions systems and regulations－ 415 －

The current system to capture ADRs is a passive one, where by healthcare workers aresupposed to report them through filling pre-paid post forms and patient normally gettreated at the respective facilities

5. Drug Pricing
Procurement of health commodities is done centrally through the Medical Stores
Department (MSD). That is a semi-autonomous entity established by act no 13 of 1993.
Its role is to procure, store and distribute all health commodities to all public healthfacilities in Tanzania. Thus bulky procurement reduces the transactions costs, they sell
these products at a small profit margin. Patient buy drugs from public facilities at a
reduced cost as per MoHCDGEC cost sharing guidelines. Normally pricing surveys are
conducted to monitor what is happening on the ground. However currently there is nocomprehensive drug pricing policy guidelines.

6. Statistic Data
Put the year of the presented data as well if it's available.
1. Number of pharmacists

around 1300

2. Number of GMP inspector (National & Local)(2015)(year)

3. Number of pharmaceutical manufacturers / manufacturing sites
4. Number of traditional medicine manufacturers / manufacturing sites(year)
5. Number of pharmaceutical importers(year)

6. Number of pharmaceutical wholesalers(year)

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

7 years－ 416 －

(year)

Secondary

4

years

High school

2

years

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

4

years

Professional education:

years

Practical training:1

Duration of training by each facility:

years

4

years

Hospital pharmacy:

52 weeks

Community pharmacy:

26 weeks

Pharmaceutical company:

weeks

Others:weeks

Age at graduation:variesyears old（３）Are there any national examinations for pharmacists in your country?
Yes
Academic Exams
Clinical Exams

1
nil

days
days

No
（４）Which of the followings must you fulfill to obtain a pharmacist's license?
Finish a 4-year University degree, Internship for at least 12 months, Pass a written examadministered by the Pharmacy Council* If practical training is mandatory, give the subjects and training period.
All subjects that relate to pharmaceutical services are covered depending on thefield of interest. But mostly it is in a hospital setting.
* If practical training is optional, give the reasons. NOT optional(i.e. Training is necessary to prepare for the national examination)－ 417 －

（５）Number of pharmaceutical university or college graduates: on averagepeople / per year
The alumni's placement rate (%)
a. Hospital:%b. Community Pharmacy:%c. Government Organization:%d. Enterprise:%e. Others:%

8. Side effect report
Currently reporting system for side effects is a passive one, that is once health care
notices or is informed by the patients of the side effects, they are supposed to fill in prepaid yellow forms all the details of the patients and the details of all the medications thatthe patient is taking. Including the trade names, batch numbers, dosage formulation etc.
then the forms needs to be posted to Tanzania Food and Drug Authority. There the forms
are entered in a database. In case TFDA find that product unfit for human consumption,
it will be banned immediately and reverse logistics applies to recall and destroy the
product. At the same time its importation is banned.

－ 418 －

Tanzania
Ministry of Health, Community
Development, Gender, Elderly and Children

Ambwene R Mwakalobo

1. Introduction of the work
- Ministry of Health, Community
Development, Gender, Elderly and Children- Pharmaceutical Services Unit (PSU)- PSU in collaboration with the TFDA, and IPs
and the Pharmacy Council conduct regularinspections, pharmacovigilance andsupportive supervisions to both private andpublic sector
1－ 419 －

- Roles of pharmacists includes to ensure
availability of safe and efficacious drugs
and medical supplies to all needy patientsin Tanzania- Also to ensure rational use of medicines‟ ⁆⁡‒⁕⁡⁠⁖⁧⁕⁦‒⁢⁡⁥⁦‒ ⁓⁤⁝⁗⁦⁛⁠⁙‒⁥⁧⁤⁨⁗⁛⁞⁞⁓⁠⁕⁗‒⁡⁘‒⁦⁚⁗‒⁓⁧⁦⁚⁡⁤⁛⁥⁗⁖‒⁢⁤⁡⁖⁧⁕⁦⁥‒⁛⁠‒⁦⁚⁗‒ ⁓⁤⁝⁗⁦
2

2. Good Practice

Implementation of the pull system of supply chain for
health commodities
Engaging all stakeholders on regulatory matters
especially the donors and the local Government
Authorities
Improvement of management of health commodities
through 5S-KAIZEN-TQM (ongoing)3－ 420 －

3. Difficulties/Lessons Learned from Past Experience

Ad-hoc imports that come as donations thatsometimes do not comply the regulations
Donation policy guidelines is an important tool that cancounter ad-hoc and unplanned donations
Off budget clearing and forwarding costs as well as
distribution costs

4

High valued products that can be bought by CMS
at a much lower cost
Passive reporting of ADRs must be combined withactive reporting to improve reporting
Pile-up of expired commodities awaiting
appropriate disposal

5－ 421 －

Emerging problems includes the counterfeit
products, these products are sometimes difficult tocontrol given the porous borders and the capacityof TFDA to monitor all ports of entry
Shortage of Human resources to implement
properly various strategies in the pharmaceuticalsector6

4. Interests and Expectations
Improve Pharmaceutical services in Tanzania(Pharmaceutical Personnel)
Learn best practices from other participating
countries
Strengthen Tanzania pharmaceutical regulatory
system in line with EAC harmonisation

7－ 422 －

－ 423 －ZAMBIA
Ministry of HealthPrincipal Pharmacist
Southern Province

MAP OF ZAMBIAZambia harbors a population of about 14,000,000 while the Southern Province a population of
1,778,540.

Victoria Falls in Zambia－ 425 －

INTRODUCTION I work in the Ministry of Health – Southern Province Health

Office

 I have been working at PHO for over 12 years now (First atCentral hospital) The Pharmaceutical Services operate under the department ofClinical Care and Diagnostic Services at the SPHO with otherunits like -Laboratory services, Nursing standards, dental andmedical equipment

-Objectives of the pharmaceutical unit
Logistics Management-To ensure the availability ofadequate quality, safe, efficacious and affordable
essential medicines and medical supplies to all the
284 health facilities in the Province (Adapted from
National objective that takes into consideration
procurement and cooperation with Pharmaceuticalcompanies)
1.

2. RMU- Accessibility and promotion of the rationaluse of these life saving commodities i.e. essential
medicines and medical supplies.
3. Management of Stocks- to constantly monitor stocklevels of essential & medical supplies at all the 84
levels of supply chain in the province－ 426 －

Regulatory services
Work in collaboration with the office of Zambia
Medicines Regulatory Authority (ZAMRA) as aninspector, Drug and Enforcement Office (DEC) andthe Customs Office. Also with the HealthProfessions Council of Zambia an independent
department for the three mentioned above.
Services include:Inspections of medicines and medical supplies atborder entry points (Southern province has 3border entry points i.e. Zimbabwe, Botswana andNamibia including 1 international airport).

Regulatory services Cont’d

Checking for conformity with what has been
allowed by ZAMR
-Checking to see if there is any expired, near to
expire or damaged items-checking to see if there are any narcotics notallowed by ZAMRAInspections of premises handlingpharmaceuticals and medical supplies forconformity with ZAMRA regulations forsuitability-－ 427 －

Regulatory services Cont’d
Providing technical support in thedisposal of expired drugs and medical
supplies in the province
Inspection of health facilities both private
and public concerning suitability offacilities to deal with pharmaceuticals
and also other parameters concernedwith standards for a health facility likeavailability of valid licenses of premises
and individual valid staff practising
licenses

SPECIFIC PROVINCIAL ROLES
1.

2.

3.
4.

Coordinate pharmaceutical services and toprovide supervision and technical support tolower levels (Hospitals and Districts – 284
facilities)
To ensure the availability of essential medicinesand medical supplies in the province to be
maintained within and above 85%
To strengthen existing operational systems
through effective and efficient (MTC) functioning
To Halt and Reverse the value of medicines andmedical supplies expiring－ 428 －

Positions of Pharmacist in Zambia
Pharmacist positions are:
- Chief pharmacist- Principal pharmacists (National, Regional)- Hospital Pharmacy in-charges (Senior,Pharmacist)- Ward pharmacist (clinical and stock mgt)
- District pharmacist (oversees the district)- Mobile hospital pharmacist (in-charge ofmobile Hospital pharmacy….)

Roles of pharmacists• 1. Coordinates and undertakes effectively, the preparationsof action plans in order to facilitate effective delivery ofhealth services• 2. Orders timely, essential drugs and other pharmaceuticals
in order to ensure effective and efficient delivery ofservices• 3. Undertakes effectively, the preparations of the budget inorder to facilitate the acquisition of financial resources• 4. Coordinates timely, the undertaking of quality control
measures in order to ensure adherence to set standards－ 429 －

Roles of pharmacists• 5. Monitors and evaluates regularly, activities
in the delivery of Pharmaceutical Services inorder to implement appropriate interventions• 6. Undertakes timely delivery andimplementation of capacity building
interventions in order to impart knowledge
and skills• 7. Undertakes effectively development of
individual and unit work plans in order tomonitor and evaluate performance

Roles of pharmacists• 8. Undertakes regularly, research on
pharmaceutical services and programmes inorder to generate information• 9. Undertakes regularly, updating of thedatabase in order to ensure storage andretrieval of information (though very little
done)－ 430 －

GOOD PRACTICES ACHIEVEMENTS

1.

2.
3.
4.

5.
6.

Since 2006, only two times imported drugs wereconfiscated by me
Good cooperation from organisations involved inimportation of medicines in the province
Support from the Provincial Health office
Established improved storage capacities andconditions for health commodities with support
from partners in 4 out of 13 districts
Increase in medicines availability >85% until recent
few months
Implemented Vaccine logistics information system
LOGISTIMO for the management of vaccines

Failed Countermeasures to deal with• To have a full time officer at all border posts• Lack of funds to conduct pharmaceuticalbusiness as it should be• Lack of funds to train all pharmaceutical staff
in Good Pharmaceutical Practices (GMP, GPP)
• Transport to conduct pharmaceutical services
uninterruptedly like monitoring GPP in
facilities, TSS and OJTFailure to undertake studies and surveys on
the rational use of medicines and medical
supplies.
－ 431 －

Failed Counter measures
Improving
inactive
Medicines&
Therapeutic Committees at all levels of
health care system.
Inactive Pharmacovigilance activities (lowreporting rates)
Inadequate pharmaceutically trained staff toprovide quality pharmaceutical services
Unscheduled distribution by MSL due to lackof fleets and sometimes availability of
medicines (creating stock outs)

Failed Countermeasures
Failure to undertake studies and surveys on therational use of medicines and medical supplies.
Lobbying for a dedicated transport forpharmaceuticalservicesinlogistics
management, pharmacy mentorship and M&E
activities.
Improving the inactive Pharmacovigilance
activities
Increasing pharmaceutically trained staff toprovide quality pharmaceutical services
Acquiring adequate funds for Pharmaceuticalprogrammes(Rationale medicine use trainings,
MTC training workshops, OJT in facilities)－ 432 －

Difficulties/Lessons learnt
1.
2.

3.
4.
5.
6.
7.

Lack of dedicated transport
Weak medicines/supplies logistics
management especially in Healthcenter.
Inadequate pharmacy personnel
Inadequate storage spaces & conditions
Irrational medicine use
Weak internal controls
Weak drug utilization studies
EMERGING/RE-EMERGING CHALLENGES

1.

2.
3.
4.
5.
6.
7.

Weak medicines/supplies logistics
management especially in Health center (NoPharmaceutical personnel)
Inadequate pharmacy personnel ?
Inadequate storage spaces & conditions
Irrational medicine use
Weak internal controls
Weak drug utilization studies
Inadequate inclusion in training for pharmacy
personnel
18－ 433 －

Expected outcomes from training

1. Acquire knowledge - Capacity
building in my roles ofregulatory authority participation
2. Adopt some Japanese and other participating countries
practices in regulatory roles practices
3. Acquire support financially in conducting regulatory
activities improvement back home (e.g. building capacity inother pharmaceutical staff and other healthcare workers,
and providing mentorship, provision of DEDICATED
transport, and conducting scheduled regulatory active
inspections of shops-illegal sale of medicines)
4. Support for improvement of storage facilities to meet GPP

THE

END

Arigato gozaimasu
Anne desu
Shigotowa yakuzaishi desu
Kuni wa Zambia desu

－ 434 －

REPUBLIC OF ZAMBIAMINISTRY OF HEALTHROLES OF REGULATORY SYSTEMS AND PHARMACISTS ON ENSURING
PROPER ACCESS TO QUALITY ASSURED MEDICINESINCEPTION REPORTJICA TOKYO INTERNATIONAL CENTRE
28TH JUNE TO 2ND AUGUST 2017

－ 435 －

1.0

Introduction

The Government of the Republic of Zambia recognizes health as one of the priority
sectors that contribute to the well-being of the nation and, therefore, remains committed
to providing quality health services to all its citizens. The Government will remaincommitted to ensuring continued investment in the health sector, in order to ensuresustainability of the nation’s human capital base, required for sustainable economic
growth.
The Ministry of Health has been on a drive to improve access to Essential Medicines
and Medical Supplies (EMMS) to the population of Zambia. In recent years there havebeen a number of interventions by Government and cooperating partners to improveand ensure availability, accessibility and accountability of adequate quality, safe andefficacious EMMS which are affordable and rationally used at every level of health care.
Appropriate legislation for medicines regulation was enacted through the establishmentof Zambia Medicines Regulatory Authority (ZAMRA) with the basic infrastructure andactivities necessary to operate efficiently and effectively.
Medical Stores Limited (MSL) as a government owned institution is mandated to storeand distribute pharmaceuticals and medical supplies to public health institutions in the
country. Significant investments have been made in upgrading the MSL infrastructureand drugs logistics systems.
The National Supply Chain Strategy 2013-2016 has been developed and presents asignificant change in the way the supply chain of EMMS is managed. This placesemphasis on having a single lead entity managing and coordinating all elements of the
public health supply chain cycle which include quantification, procurement anddistribution up to the last mile. The National Supply Chain Strategy was developed
within the context of the overall public health sector agenda, and forms an integral partof the National Health Strategic Plan 2013-2016 which is linked to multi-sector strategic
frameworks, with relevance to the public health in Zambia.
2.0

Situation Analysis

2.1

National Supply Chain Strategy

VisionAn effective, efficient and sustainable national supply chain whichenables a healthy and productive people

MissionTo provide equitable access to affordable quality essential medicinesand medical supplies to support the Zambian public health system.

Overall
Goal

To improve the health status of people in Zambia in order tocontribute to socio-economic development－ 436 －

Principles

•
•
•
•
•
•
•
•

2.2

Efficiency, transparency, accountability and cost-effectiveness in the
procurement, supply and distribution of drugs and medical supplies
Decentralisation and equity of access of medical supplies acrossZambiaPrivate sector participation
A coordinated approach to resource utilisation and programme
implementation
Clarity of roles of supply chain members
People centred
Environmentally aware
Operate within the country’s legal frameworks

National Drug Policy

A number of significant interventions have been attempted to improve the availability ofhealth commodities and enhance the performance of the supply chain within the
Ministry of Health. Another example was the development and adoption of the National
Drug Policy (NDP) in 1996 to provide, among other things, policy direction to the
management of EMMS. The NDP reflects government’s commitment to addressing theissues affecting the Pharmaceutical Sector in a comprehensive manner. The NDP iscurrently under review, to respond to emerging issues and challenges in the
Pharmaceutical Sector.
2.3

Zambia Medicines Regulatory Authority

The Zambia Medicines Regulatory Authority (ZAMRA) is the Statutory National
Medicines Regulatory Body for Zambia established under an Act of Parliament, theMedicines and Allied Substances Act No. 3 of 2013 of the Laws of Zambia to regulate
and control the manufacture, importation, storage, distribution, supply, sale and use of
medicines and allied substances.
2.3.1 Objective
The main objective of the Authority is to ensure that all medicines and allied substances
being made available to the Zambian people consistently meet the set standards ofquality, safety and efficacy.
2.3.2 Mission Statement
To effectively regulate and control Medicines and Allied Substances made available tothe Zambian population to ensure their conformity to set standards thereby
safeguarding public health.

－ 437 －

2.3.3 Functions
The functions of the Authority are stipulated by the Medicines and Allied substances Act(No. 3) of 2013 to:
1. Grant pharmaceuticals license and marketing authorization.
2. Inspect any premises used for the purpose of manufacturing, distribution, sale,
importation or exportation of medicines or allied substances
3. Regulate and control the manufacture, importation or exportation, distribution,
sale of medicines and allied substances
4. Regulate and control the advertisement and promotion of medicines and allied
substances
5. Register and regulate pharmacies and ago-veterinary shops.
6. In consultation with relevant professional bodies, establish, maintain anddevelop standards for the operations of pharmacies and agro-veterinary shops.
7. Serve and protect the public interest in all matters relating to the sale ofmedicines and allied substances.
8. Regulate and monitor the conduct of clinical trials
9. Establish, maintain and enforce standards relating to the manufacture,importation, exportation, distribution and sale of medicines and allied substances
10.Conduct post-market surveillance
11.Establish, maintain and enforce standards for drug quality control laboratories
12.Advise the Minister of Health on policies relating to the regulation and control of
medicines and allied substances
13.Collaborate with corresponding medicines regulatory authorities in othercountries
14. In consultation with the relevant research institutions, determine national
priorities
inpharmaceuticals
research
2.4

Quality Assurance:

The Government through the Minister of Health laid a foundation stone in June 2017 forthe construction of the National Drug Quality Control Laboratory. This infrastructure will
also accommodate ZAMRA offices once fully functional. This development will enhancemonitoring of quality and safety of products circulating on the Zambian market which
poses a serious risk to public health from substandard or counterfeit medicines andrelated products. In addition, post-marketing surveillance at all levels needs to bestrengthened.

－ 438 －

Reference
1. Zambia National Health Strategy Plan 2011 - 2015
2. Zambia Medicines Regulatory Authority website
3. Zambia National Supply Chain Strategy for Essential Medicines and Medical
Supplies 2013-2016－ 439 －

REPUBLIC OF ZAMBIAMINISTRY OF HEALTH
LUSAKA PROVINCIAL HEALTH OFFICEROLES OF REGULATORY SYSTEMS & PHARMACISTS ON ENSURING
PROPER ACCESS TO QUALITY ASSURED MEDICINESJICA TOKYO INT’L CENTRE
28TH JUNE TO 2ND AUGUST 2017

National Hierarchy-Pharmaceutical Services
Ministry of HealthDirector-Clinical Care and Diagnostic Services
Chief Pharmacist
Principal Pharmacist-RUM & Logistics (MOH)
Provincial Principal Pharmacist
District Pharmacist－ 440 －

Provincial Principal Pharmacist
ObjectiveTo
ensureavailability,
accountability of EMMS.

accessibility

andRoles & responsibilities
Coordinates pharmaceutical services in order toensure effective & efficient service delivery in theProvince.
(eight districts, one 2nd level & three specialized
hospitals)

Zambia Medicines Regulatory Authority
ZAMRA is the Statutory National Medicines
Regulatory Body for Zambia established underan Act of Parliament, the Medicines and Allied
Substances Act No. 3 of 2013 of the Laws ofZambia to regulate and control the manufacture,importation, storage, distribution, supply, saleand use of medicines and allied substances－ 441 －ZAMRA Hierarchy
Director General

Director

Director

Assistant Director

Assistant Director

Objective of ZAMRA
The main objective of the Authority is to ensure that all
medicines and allied substances being made available to the
Zambian people consistently meet the set standards of quality,
safety and efficacy.
Useful links• Ministry of Health• MSL• HPCZ• Zambia Bureau of Standards• Patents & Companies Registration Office－ 442 －

Functions of ZAMRAThe functions of the Authority are stipulated by the
Medicines and Allied substances Act (No. 3) of 2013 to:• Grant pharmaceuticals license and marketing
authorization.
• Inspect any premises used for the purpose of
manufacturing, distribution, sale, importation orexportation of medicines or allied substances• Regulate and control the manufacture, importation orexportation, distribution, sale of medicines andallied substances• Regulate and control the advertisement andpromotion of medicines and allied substances

Functions of ZAMRA cont’d• Register and regulate pharmacies and ago-veterinary
shops.
• In consultation with relevant professional bodies,
establish, maintain and develop standards for theoperations of pharmacies and agro-veterinary shops.
• Serve and protect the public interest in all mattersrelating to the sale of medicines and allied substances.
• Regulate and monitor the conduct of clinical trials• Establish, maintain and enforce standards relating tothemanufacture,importation,
exportation,
distribution and sale of medicines and allied
substances－ 443 －

Functions of ZAMRA cont’d• Conduct post-market surveillance• Establish, maintain and enforce standards for drug
quality control laboratories• Advise the Minister of Health on policies relating to
the regulation and control of medicines and allied
substances• Collaborate with corresponding medicines regulatory
authorities in other countries• In consultation with the relevant research institutions,determine national priorities in pharmaceuticals
research

Successes• Increased drug availability and reduced expiries due
to improved drug management (M&E, Audit trails).
• Improved data visibility to enable timely reporting
andimpactful
supplychain
decisions(eLMIS/logistimo).
• Improved storage facilities and conditions (SIBs)
resulting in reduction in running costs.
• Secured land to erect the National Drug Quality
Control Laboratory• Established regional offices across the country• Created awareness in pharmacovigilance across thecountry－ 444 －

Challenges
SN

Challenges

Best practices

1

Inadequate storage facilities

Provide space by constructing

2

Lack of dedicated transport
for logistics management

Lobby for transport/integrate activities

3

Inability to attain zero stockout rate of EMMS

Revise EDL & RHC Kits &redistribution

4

Weak post-marketingsurveillanceStrengthen post-marketing surveillanceat all levels

5

Lack of a full-fledged
Establish a fully functional National
National Drug Quality Control Drug Quality Control Laboratory
Laboratory

6

Illegal retail pharmacy outlets

Strengthen & enforce inspections

Expectations from JICA training• Share good practices & experiences• Share new updates regarding roles
regulatory systems & pharmacists• Capacity building－ 445 －of－ 447 －"Roles of Regulatory Systems and Pharmacists on Ensuring Proper Access to Quality Assured
Medicines (J17-04206)"
Inception ReportCountry: BRAZIL
Organization/Department/Division:(Anvisa)①

BRAZILIAN

HEALTHREGULATORYAGENCY

Organizational Chart− Please attach the organizational chart at national/state & local levels aboutpharmaceutical administration in your country.

Created in 1999 by Law 9.782, the Brazilian Health Regulatory Agency (Anvisa) is anadministrative 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 the health of Brazilian population. The ANVISA competence covers the health products
regulation as well as the economic regulation of the market.
The agency’s institutional mission is “to protect and promote public health, by exercising
health surveillance over products and services, including processes, ingredients and technologies thatpose any health risks.”. The scope of regulatory authority action includes food, cosmetics, sanitizers,
tobacco, pesticides, health services, medicines, medical devices, official laboratories, blood, tissues
and organs, pharmacovigilance, advertisement, ports, airports and borders, international affairs and－ 449 －

National Health Surveillance System coordination. (www.portal.anvisa.gov.br)Anvisa is structured in five board of directors: 1. Institutional Management (DIGES), 2. HealthRegulation (DIREG), 3. Coordination and Articulation of the National Health Surveillance System(DSNVS), 4. Authorization and Registration (DIARE), and 5. Control and Health Monitoring(DIMON).
The participants selected by JICA work in the office of safety and efficacy assessment of new
synthetic drugs (GESEF) and in the office of pharmaceutical technology assessment of synthetic
drugs(GRMED), both subordinated to the Drugs and Biological Products General-Office. We areresponsible for the review of clinical and non-clinical reports, and chemical manufacturing andcontrols documentation sent by the pharmaceutical companies, with the purpose of granting amarketing authorization.
− Please briefly describe each role and responsibility on pharmaceutical administration.
(hospital pharmacy only): Not applicable.
− Please briefly describe the role of pharmacist in medical care system in your country.
If possible to focus on the position of the pharmacist in medical institutions.

Brazil has almost 200,000 licensed pharmacists who work mainly in hospitals, industries,
pharmacies, drugstores, and public health services.
The duties of a hospital pharmacist include manipulation and dispensation of medicines,
participation in multidisciplinary assistance teams, health surveillance activities, and management
activities (selection, planning, and acquisition of medicines, medical devices, sanitizers…).
Pharmacists who works in industries are responsible for the enforcement of healthsurveillance regulations, and for the implementation of quality system, among others.
The role of the pharmacist in Brazilian public medical care system is divided between careand management actions. The management activities are mainly focused on the logistics of medicines.
This logistic encompass plan, execute, and supervise local acquisition of medicines, assure adequate
storage and efficient distribution. On the other hand, the care activities are focused on the patient, andincludes all activities that have the purpose of correct use of medication and effectiveness of treatment.
Among those activities are community health education, and orientation regarding the correct use ofprescribed medicines.
Recently, the approval of Resolution No. 585/2013, which regulates the clinical pharmacist’s
attributions, along with Resolution No. 586/2013, which regulates pharmaceutical prescription in
Brazil, introduced a change in Brazilian pharmaceutical field. Although not fully applied in practice,those regulations allow the pharmacist to participate in the planning and evaluation ofpharmacotherapy, provide pharmaceutical consultation, request laboratory tests, proceed a patients’
pharmacotherapeutic follow-up, and to perform prescription of medicines and other products fortherapeutic purposes, which dispensing does not require medical prescription, for example. Those
measures are part of a fought for social recognition of the pharmacists as a healthcare professional,
not only as medicine-based experts.
②

Legislation on pharmaceutical administration− Please briefly bulletined major laws/acts－ 450 －◆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,and give 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
Resolution RDC 60/2014 – provides the criteria required to grant a new marketing authorization forsynthetic and semi synthetic drugs.
◆Local Level
According to the decentralized principle of the Unified Health System in Brazil, the Statesand Municipalities should follow the national legislation and may establish supplementary andcomplementary legislations.
◆PIC/S
Yes ＯＲ No

If yes, joined whenAnvisa is not a PIC/S member yet, but in 2010 Brazil formalized the intention to become amember and it is expected in 2018/2019 an assessment by the PIC/S delegation in order to determine
whether Anvisa can become a member.
Anvisa participated in the PIC/S between the years 2015-2016 and exchanged experience withEngland and Austria in Good Clinical Practice.
③

Regulatory Services− Please describe pharmaceutical regulatory services of your country in response to eachissues 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.
◆

Drug Import/Export

・

Systems, Regulations, etc.

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 Generaloffice of ports, airports and borders (GGPAF). The other departments are responsible for reviewing－ 451 －

petitions to import products within it scope. For example, the Office of blood, tissues, cells, andorgans (GSTCO), decides over the importation of blood.
As defined by Law 6.360/1976, imported drug products must be approved at its country oforigin and must be registered by Anvisa before being made available for sale. The regulatory
requirements for approval of 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 thecommitments made with another regulatory 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, areforbidden.Concerning drug export there is specific regulation, RDC 62/2016, only for narcotics, andpsychotropic drugs export, which require an export authorization. Besides that, Anvisa issues export
certificates to companies that require this document for its products registered in Brazil.
◆

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 anddrug products for human use must require an operation permit (autorização de funcionamento - AFE),
issued by Anvisa. This permit is granted upon proof of compliance to technical and administrativerequirements listed in the resolution.
Another document issued by Anvisa for drug product’s manufacturers is the good
manufacturing practices (GMP) certificate (certificado de boas práticas de fabricação - CBPF). The
minimum regulatory requirements for manufacture of drug products are described in Resolution RDC
nº 17/2010, which also guides the inspections to verify compliance with the principles of GMP. The
GMP inspection team is generally composed for two inspectors who evaluate 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 Inspection and Health Fiscalization(GGIMP), subordinated to the board of Control and Health Monitoring (DIMON), is responsible for
granting ou 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 locatedoutside 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-officeof Drugs and Biological Products (GGMED).
Good Clinical Practice
The major regulation in Good Clinical Practice in Brazil is the resolution RDC nº09/2015,
which regulates the conduction of clinical trials with drugs in Brazil. Nowadays, this resolution is the
only one among our resolutions that incorporates an ICH guideline, the E6 (Good Clinical Practice).
The GCP’s inspections made by Anvisa analyses the clinical research centers’ systems, the ethicaldocuments, the case report forms. The inspections are done in some centers based on risk factors－ 452 －

(such as population involved and disease studied) and on the number of patients recruited (centerswith a greater number of patients recruited are preferred). An inspection may also be conducted after
a complaint.
Good Laboratory Practices
The Office of Health Public Laboratories (GELAS) is responsible for coordinating the
National Network of Sanitary Surveillance Laboratories (RNLVISA) and the Brazilian Network ofAnalytical Laboratories for Health (REBLAS). Actions should be coordinated with sanitary
authorities of the states and municipalities. Among other responsibilities, GELAS/ Anvisa is
responsible for participate in the development of public polices and national directives for RNLVISA,
in partnership with the Ministry of Health policies and for the development of technical normatives
for the laboratories which analyses products and services under sanitary surveillance.
RNLVISA is composed by 27 Central Public Health Laboratories, one for each state andfor the Federal District, the National Institute of Quality Control in Health (INCQS) and fivemunicipal laboratories.
REBLAS is composed of analytical laboratories, public or private, enabled by Anvisa andcapable to offer services of sanitary interest with quality, confidence, safety and traceability.
For being part of REBLAS, the laboratories must have a license issued by the sanitary
authority and must be have its conformance status certified or recognized by the National Institute ofMetrology, Normatization and Industrial Quality (INMETRO). The habilitation is valid for a 2 years
period and is specific for a certain scope of activities.
The qualification of laboratories is conducted following ABNT resolutions, the principles
of Good Laboratory Practice, complementary documents of the Organization for Cooperation andEconomic Development (OCDE) and other applicable legislations and directives.
A list of REBLAS laboratories and of RNLVISA laboratories and its analytical capabilities
is available at Anvisa website.
※Example: Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice◆Marketing Authorization

For granting a product register, the marketing authorization 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 andapproval of clinical trials design for trials conducted in Brazil), during the assessment of theapplication (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 andorigin, and for each category there is specific legislation and requirements. Currently, medicines are
categorized as new synthetic medicines, generic medicines, brand generic medicines, herbal
medicines, biologic medicines, radiopharmaceuticals, homeopathic and dynamized medicines andspecific 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－ 453 －

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 an electronic 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-clinical and clinical trials reports and also for ensuring product information
compliance with critical non-clinical and clinical findings. . The reviewer conduct its individual
assessment of the dossier and write a detailed and conclusive report about new register, renewal andpost-marketing applications of synthetic medicines. Depending on data complexity, an ad hoc expert
assessement may be requested. Anvisa counts with the support of three council of experts in different
therapeutical areas that work as consulters for the regulatory decision making process.
The labelling coordination (CBREM) evaluates the regulatory content of package andleaflets, focusing in compliance with standard format and mandatory statements according to specificlegislations (RDC 71/2009 for labels and RDC 47/2009 for leaflet).
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 theactive pharmaceutical ingredient (API) used, the drug product production report, the quality control
report, analytical method validation, stability studies, and for generic or branded generic,pharmaceutical equivalence studies. The requirements for analytical method validation are provided
by resolution RE nº 899/2003; the resolution RE nº 1/2005, approved the Guideline for conducting
stability studies of drug products; and the pharmaceutical equivalence studies are regulated byresolution RDC nº 31/2010. GRMED is responsible for suggesting the approval or rejection of thepetition, based on its own review of quality documentation and on GESEF’s reports about safety andefficacy.
Before marketing authorization, it is also required a pharmacovigilance plan, which isanalyzed by Pharmacovigilance Office (GFARM). When it is identified a notable risk for the newdrug, 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 thequestions, otherwise the new drug application will be rejected.
・Systems, Regulations, etc※Example: Good Quality Practice◆Drug Distribution (including drug selection, procurement, sale)

Systems, Regulations, etc
In Brazil everybody must 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
the Constitution. This is a decentralized system, in which the municipal and state governments havethe responsibility for the management and financing of the health care. There is a budget shared by
the federal, state and municipal governments.
Medicines acquisition is not part of Anvisa legal responsibilities. Once the medicine isapproved and marketed, the drug selection, procurement and distribution to population through publichealth service is a attribution of the Ministry of Health (MoH).
CONITEC (National Comission of Health Technology Assessment for the Unified Health
System) is a collegiate 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

・－ 454 －

adopted by SUS. CONITEC should follow some directives such as adopting rational criteria andefficacy, efficiency and effectiveness parameters adequate for the health necessities and incorporate
health technologies relevant for the citizens and the health system, based on a cost effectivenesspositive relationship. CONITEC should also review the National Relation of Essential Medicines(RENAME).
CONITEC is composed of a plenary that takes technical decisions and an executivesecretariat 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 publichealth 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 or procedure under assessment, that where considered by the authority responsible
for their register or authorization;- 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 therelevance of 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 andactive pharmaceutical ingredients companies in Brazil.
※Example: Good Distribution Practice◆Medicine Safety (post-marketing)・

Systems, Regulations, etc.

The main national regulations in pharmacovigilance are RDC 04/2009, which regulates how
the pharmacovigilance should be done by the marketing authorization holders and RDC nº36/2013,
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 websiteforbothpractitioners(http://portal.anvisa.gov.br/como-notificar-)(http://www8.anvisa.gov.br/notivisa/frmlogin.asp)andpatients(http://www16.anvisa.gov.br/notivisaServicos/cidadao/notificacao/evento-adverso). The adverse
events’ reports are also collected by the ombudsman service.
The health surveillance reporting system is called Notivisa Notivisa is an electronic systemdeveloped by Anvisa to receive notifications of incidents, adverse events and technical complaints
related to products and services under sanitary surveillance.
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 andadverse 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 and pharmaceutical 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 or－ 455 －

unpleasant product effects;
Improve the knowledge about product effects and, as appropriate, change therecommendations of use;
- 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 andmunicipalities. 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 technical complaint.
Different sanitary actions may be adopted depending on this analyses, such as, poolingnotifications 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 PracticeRelief 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 thehealth practitioners. This letter is sent to medical associations, to hospitals and institutions that are
member of a sentinel 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.
◆

・

Systems, Regulations, etc.

④

Drug Pricing− Please describe about price control and drug price mechanism at public sector in yourcountry.
In Brazil drug product manufacturers must obey the requirements stablished by law
10.742/2003 to set and adjust their products’ prices. This law created the Drug Market Regulation
Chamber (Câmara de Regulação 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 an index. 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 thebydrugstores
andpharmacies
consumer(http://portal.anvisa.gov.br/documents/374947/2829072/LISTA+CONFORMIDADE_2017-0522.pdf/21e1fb07-ea45-4bc6-933e-dc2e1b5af0c1).
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 to promote resource optimization.

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⑤

Statistic Data

− Please answer the following questions (if the number is not applicable, please give ananswer to the best of your knowledge).
− Put the year of the presented data as well if it's available
1:
Number of pharmacists:
195.022
pharmacistsinBrazil(Source:
http://www.cff.org.br/pagina.php?id=801&menu=801&titulo=Dados+2015+, Federal council ofpharmacy, data from 2015).
2:
Number of GMP inspector (National & Local):National: 28 (Source: Anvisa, June,2016). We don’t have the number of local inspectors (municipal and state government inspectors).
3:
Number of pharmaceutical manufacturers / manufacturing sites: 914 national pharmaceuticalmanufacturers (Source: Anvisa, May/2016) .
4:

Number of traditional medicine manufacturers / manufacturing sites:(YEAR)
We don’t have this data, only the total number of pharmaceutical manufacturers.

5:

Number of pharmaceutical importers:(YEAR)
11.498 importers, distributors and transporters (Source: Anvisa, May/2016).

6:

Number of pharmaceutical wholesalers:(YEAR)We have only the total number of importers, distributors and transporters.

⑥⑦

Not applicable ※hospital pharmacy only
Not applicable ※hospital pharmacy only

⑧Side effect report

Please describe the flow of reporting (from a medical institution to an administrative agency), whena severe side effect case is occurred in a medical institution. Describe specifically the rule andresponsibility of each organization (an administrative agency/a medical institution), and its
collaborations.
The marketing authorization holder receives the AEs reporting from healthcare providers,patients and the 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 of death 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 ofdeath, 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 searchfor other AEs occurred in the Sentinel Network Hospitals.
About 50% of the AE’s reporting is from the Sentinel Network, a group of hospitals－ 457 －

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.

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Agência Nacional de Vigilância Sanitária - Anvisa

Brazilian HealthRegulatory Agency
Overview

GESEF and GRMED/ GGMED/ ANVISATokyo, July 2017

REGULATORY AGENCYAgência Nacional de Vigilância Sanitária - Anvisa

 Set up by Law 9.872/1999: 18 years
 Regulatory governmental agency
 Administrative independent and financially autonomic
 Connected to the Ministry of Health Management contract: indicators and goals
 Stable board of 5 directors
 Designated by the President for a 3 years mandate,renewable for more 3 years－ 459 －SCOPE OF REGULATORY ACTIVITYAgência Nacional de Vigilância Sanitária - Anvisa

FOODS

HEALTH SERVICESCOSMETICS

MEDICINES

PHARMACOVIGILANCE ADVERTISEMENTTABACCOPESTICIDESMEDICAL DEVICES

Laboratórios
OFFICIAL
LABORATORIESBLOOD, TISSUESAND ORGANSPORTS, AIRPORTS
AND BORDERS

INTERNACIONALAFFAIRSSNVS COORDINATIONSANITIZERSREGULATORY AGENCYAgência Nacional de Vigilância Sanitária - Anvisa－ 460 －

ROLES AND RESPONSIBILITIESAgência Nacional de Vigilância Sanitária - Anvisa• Pharmacist – public medical care system- Management:
Acquisition of medicines
Adequate storage
Efficient distribution- Care:Orientation
Community health education
Monitoring of effectiveness of treatment• News- Clinical attributions: pharmaceutical consultation, requisition of laboratory tests,
development of pharmaceutical care plan.
- Pharmaceutical prescription: non medical prescription medicines.

ROLES AND RESPONSIBILITIESAgência Nacional de Vigilância Sanitária - Anvisa

 Office of Assessment of Pharmaceutical Technology of Synthetic Drugs(GRMED):
Review chemistry, manufacturing, and controls documentation of generic, branded
generic, and new drug applications to market of synthetic medicines → technicalopinion on whether the product´s application should be approved, consideringother offices reports.
Harmonize technical and operational procedures.
Provide regulatory guidance → citizens and regulated industries (Anvisa’s contact
channels).
Assist GMP inspections pertaining synthetic drugs.

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ROLES AND RESPONSIBILITIESAgência Nacional de Vigilância Sanitária - Anvisa

 Office of Drugs Safety and Efficacy
Evaluation (GESEF):
Analyze and report a detailed conclusive
opinion about new register, renewal andpost-marketing applications of synthetic
medicines.

IDEAL
TREATMENTUNACEPTABLE
TREATMENT

Harmonize technical and operational
procedures.
Express, in thorough manner, the positionsof the agency about questions related todrugs safety and efficacy.

BENEFIT-RISK ASSESSMENT

Participate in inspections related to efficacy
and safety studies of drugs under its
jurisdiction.

PERSONAL EXPERIENCES
Agência Nacional de Vigilância Sanitária - Anvisa-

Luiza Novaes Borges – Industrial pharmacy degree and PPCR specialization

Experience with regulatory affairs and clinical trials assessment in multinational
pharmaceutical company.
Work as Specialist in Regulation and Health Surveillance at ANVISA in the Office ofDrugs Safety and Efficacy Evaluation.
Has been working as spokesperson in national and international meetings about
benefit-risk assessment and risk based strategies for prioritization of analysis.
-

Letícia Sousa – bachelor in pharmacy and master of pharmaceutical sciences

Experience with local public health services, community health edducation, medicines
distribution and dispensation.
Work as Specialist in Regulation and Health Surveillance at ANVISA in the Office ofAssessment of Pharmaceutical Technology of Synthetic Drugs.
Part of technical regulatory committees which oversees partnerships between public
pharmaceutical industries and private companies for the purpose of transfer technology
related to drug products provided by the Brazilian public health system (SUS).

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CHALLENGES AND DIFICULTIESAgência Nacional de Vigilância Sanitária - Anvisa

 Office of Assessment of Pharmaceutical Technology of Synthetic
Drugs (GRMED):
 Improve efficiency and reduce review time Increase transparency about the minimmun technical requirements for
CMC documentation approval
 Establish the directives for abbreviated review of low risk products Office of Drugs Safety and Efficacy Evaluation (GESEF):
 Accelerated register (Phase II): for medicines used for serious life
threatening diseases without therapeutical alternatives
 Establish the directives for follow up medicines registered based on phase
II trials
 Definition of aceptable clinical endpoints
 Increase transparency about the specific requirements for safety andefficacy studies by therapeutical classes

EXPECTATIONSAgência Nacional de Vigilância Sanitária - Anvisa

Have a broad knowledge and practical experience about the structure ofhealth regulation system in Japan.
Assist improvement of medicine’s authorization process andharmonization of technical requirements for registration with otherregulatory authorities.
Reach a higher standard of regulatory practices adopted in Brazil ensuring
access of quality, safety and efficacy assured medicines to Brazilian
population.
Benchmarking activity is aligned with first project defined in the Strategic
Program Plan of the Agency for the 2016-2019 period:
Betterment of procedures to register products in Brazil in alignment withthe best regulatory international practices－ 463 －

THANK YOU!

Agência Nacional de Vigilância Sanitária - Anvisa

ContactsAgência Nacional de Vigilância Sanitária - Anvisa
SIA Trecho 5 - Área especial 57 - Lote 200
CEP: 71205-050
Brasília - DF
Phone: + 55 61 3462 6000
www.anvisa.gov.br
www.twitter.com/anvisa_oficial
Anvisa Atende: 0800-642-9782
ouvidoria@anvisa.gov.br－ 464 －