Regulatory Systems
on Ensuring Access to Quality
Medicines

Country Reports
FY2023

Japan International Corporation of Welfare Services (JICWELS)Table of Contents
1. BANGLADESH ................................................................................................................................... 1
2. BRAZIL ............................................................................................................................................... 12
3. EGYPT ................................................................................................................................................ 32
4. INDONESIA ....................................................................................................................................... 42
5. LAOS................................................................................................................................................... 51
6. TIMOR-LESTE ................................................................................................................................. 69

1. Bangladesh

Regulatory Systems on Ensuring Access to Quality Medicines （JFY 2023）

Name
Country::

Organization/Department/Division :Md. Aziulla
Bangladesh
Directorate General of Drug
Administration1

Organizational Chart
Historical Background of DGDA
• In 1940, the Drug Acts (1940) was enacted, which was implemented by the thenDirectorate of health services of undivided India.
• Since 1947 it had been regulated by Directorate of health services, East Pakistan, until
independence of Bangladesh in 1971.
• After liberation of Bangladesh, it was regulated by the Directorate of health services• Formation of Directorate of Drug Administration under Ministry of Health and Family
Welfare in 1974.
• In 10th January, 2010 it was upgraded to Directorate General of Drug Administration(DGDA).
Vision of DGDA
We strive to ensure quality and safe medicines for all
Mission of DGDA
To safeguard the health of humans and animals by ensuring safety, efficacy and quality of
medicines, alternative medicines and medical devices.
2. To ensure availability, accessibility and affordability of essential medicines.
3. To implement GMP compliance in production and quality control of health products to ensure
consumer safety as well as to facilitate export.

2

Management Infrastructure➢ Ministry of Health and Family Welfare approved new organogram of DGDA with thetotal manpower 720.
➢ DGDA have two Quality Assurance department, who directly report to DG.
➢ Quality Assurance – NRA (DGDA),➢ Quality Assurance – NCL (Laboratory)➢ In DGDA organogram there are 1 ADG, 10 Directors and 31 Deputy Directors including
Deputy Chief who are responsible for the below departments:➢ Admin & HRM: Admin, HRM, Law, Statistics department and IT Cell. There are another
Admin department for the laboratories.

Legislation on pharmaceutical administration
Legal Framework of DGDA
Legislation: The Drugs Act 1940
 The Drug Rules 1945
 The Bengal Drug Rules 1946 The Drug (Control) Ordinance 1982
 Proposed Drug and Cosmetic Act 2023
Gazette Notification:
 Bangladesh Gazette Notification dated 17 May, 2020, Mandating DGDA to issue EUA /NOC in public health emergency.
 Govt. Notification No. 45.00.0000.182.89.001.21.93, dated: 24 April, 2021, mandated
DGDA to consider Covid-19 vaccine for EUA considering EUA of country of origin andsatisfactory clinical study data.
 Bangladesh Gazette Notification dated 28 June 2021, Mandating DGDA to perform CT,
PV and Lot release function.
 Previously we were performing these functions according to guidelines for PV and CT
and Ministry Orders.
Regulations and mandate: The National Drug Policy 2016
 Guidelines
 Standard Operating Procedures (SOPs)
 A number of manuals, forms, checklists and other documents.

3Regulatory /Administrative Services
Directorate General of Drug Administration (DGDA) is the NRA of Bangladesh. It’s a governmentorganization under the Ministry of Health and Family Welfare, Bangladesh.Director General (DG)
is the Head of NRA and also the Licensing Authority for Drugs. Enforce all prevailing drug laws
and regulations and supervises all activities of DGDA. National Regulatory Authorities (NRA) aremandated to ensure Quality, Safety and Efficacy of the medical products to protect public health.
Regulates and monitors all activities of the pharmaceuticals, medical devices and traditional
medicines of the country. A number of Committees, composed of experts and representatives ofdifferent associations advise the Director General on matters related to his responsibilities.

4

Drug Pricing
Government of Bangladesh control the price of Primary Health Care Products (117 products). For
the rest of the product DGDA give the price certificate only to the manufacturers as per theirapplication for pay the VAT and Tax to the Government.

Statistic Data
Bangladesh is almost self-sufficient in manufacturing of different pharmaceuticals products.
Around 98% of the country’s needs met by domestic manufacturers and the rest of the 2% is importdependent. Current domestic pharmaceutical market is estimated 3 billion USD. At present, local
pharma companies of Bangladesh produce 31908 brands and about 1610 generics drugs(Allopathic) and there are 206 functional allopathic medicine manufacturers in Bangladesh. There
are around 248 Unani Medicine manufacturers, 162 Ayurvedic Medicines manufacturers, 50
Homeopathic Manufacturers and 34 Herbal Manufacturers in Bangladesh.
We are exporting finished pharmaceutical products to around 157 countries with a substantial
growth every year. In the year of 2020 total export value was around 500 million USD.
Bangladesh imports 95% of Active Pharmaceutical Ingredients (APIs, key raw materials for
Pharmaceutical Industries) and total value is approximately around $1 billion. Currently there are
20 API manufacturers in Bangladesh.
We import around 97% medical devices. Demand for medical equipment is being driven by thedevelopment of healthcare facilities.
The pharmaceutical sector has been among the highest priority sectors of Bangladesh’s export
policy since 2006. Highest priority sectors are entitled to income tax exemption for export
earnings, export credit at reduced rates, assistance in marketing in overseas markets throughparticipating in export fairs, andso on.
There are 161000 registered retail Pharmacy outlet in Bangladesh. Most of the cases manufacturers
distribute their medicines through their own distribution channel. In that case they need the wholesale drug license.
In Bangladesh there are 18921 registered A grade Pharmacists, 5731 registered diploma
pharmacists, 148202 registered Pharmacy Technician,5Information on hospital pharmacy
In the public hospital Government appointed the Diploma Pharmacists for the management of thehospital pharmacy. The pharmacy is regulated by the DGDA but the hospital is regulated by
DGHS. In the private hospital there is the hospital pharmacy run by the A grade
pharmacist/Diploma Pharmacist/Pharmacy Technicians. Besides the hospital pharmacy and retailpharmacy there are model pharmacy nationwide which are supervise by the A grade registeredpharmacists.

Education and License of Pharmacists
In Bangladesh there are 3 categories pharmacists like Category A, Category B and Category C.
Category A are Bachelor of Pharmacy (4 years Honors), Category B is 3 years diploma andCategory C (Pharmacy Technician) is 6 months short training course.
In Bangladesh Pharmacy Education is regulated by Pharmacy council of Bangladesh. In 13 public
universities and 30 private universities have the pharmacy education. For Diploma Pharmacist
there are 16 registered institute.
To get the registration from pharmacy council need to complete the degree from the
Universities/Institution and apply to the council. After checking all the documents, they provide
the registration for 5 years.

6

ADR (Adverse Drug Reaction) report
Pharmacovigilance (PV) is defined by the World Health Organization (WHO) as –“The science and activities relating to the detection, assessment, understanding, and preventionof adverse effects or any other drug-related problem”.
• PV ensures Rational and Safe use of Medicines & Vaccines
Minimum Information requirements for AE report• Identifiable Patient – Age and Gender with other information (weight, pregnancy, contact
number etc.)• Suspected Drugs- Indication, generic name, daily dose with other information (Brand
name, Dosage form etc.)• Adverse Events- Brief description of the event, seriousness, start date, steps taken after
event, outcome etc.
• Identifiable Reporter- Name, profession, address & contact.

Online Reporting by U POs , C Os/MMOs,
RPs/RMOs, Statisticians, O, A O,
SIMOs/ onal Officers, Civil Surgeons,
MA /Distributor, Superintendent/ ead of
Private ealth facilities,

Drugs and Other Vaccines

EPI Vaccines

COVID -19 Vaccines

District PV Committee
Online/Offline AE I Reporting from
National and Sub-national levels

Online / Offline ADE
Reporting

AE I

Investigation of Serious AE I by District/City
Corporation AE I Committee for COVID -19
Vaccines

District/City Corporation AE I
Investigation Committee

Adverse Drugs Reaction Monitoring(ADRM) Cell for preliminary assessment

Causality Assessment by Divisional AE I
Causality Assessment Committee for
COVID -19 Vaccines

AE I Expert Review Committee of
EPI for Causality Assessment

Technical Sub Committee for Causality
Assessment

National AE I Advisory Committee for
COVID -19 Vaccines

Adverse Drug Reaction Advisory Committee(ADRAC) for regulatory recommendation/decisionGoot e sta e olde s

Regulato

7

ctionsigi loDirectorate General of Drug Administration(DGDA)
Bangladesh
Presented By
Md. Aziulla
Assistant Director, DGDA

1. Introduction of the work
Directorate General of Drug Administration (DGDA) is
the NRA of Bangladesh. Director General (DG) is the
Head of NRA and also the Licensing Authority for Drugs.
Regulates and monitors all activities of thepharmaceuticals, vaccines, biotech industries medical
devices and traditional medicines of the country.
I work with the Directorate General of Drug
Administration since February 2013. Among the 9functions of DGDA, I work with the Marketing
Authorization Department.

8

Introduction of the work
As a member of Marketing Authorization Department I
engage with the following activities:
Dossier evaluation of Vaccines and Biological products for
new registration and Marketing Authorization (MA).
Document evaluation of Vaccines and Biological products
for renew registration and marketing authorization (MA).
Review and Evaluation of Variation Application for
Vaccines and Biological products
Inspect the manufacturer facilities regularly.
Any other activities instructed by the Head of theOrganization

Introduction of the work
Roles and Position of Pharmacists in Bangladesh
As per the Drug Acts and policy Appointment ofregistered Pharmacists is mandatory in the
Pharmaceutical manufacturing facility.
Registered Pharmacist works at the hospital
pharmacy/Model
Pharmacyasahospital
pharmacist/clinical pharmacist.
In the retail pharmacy registered A grade/B Grade/
Pharmacy Technician works
Registered Pharmacists works with the various
Development Partners/Health Related NGOs.

9

2. Good Practice
DGDA, Bangladesh is going to face the final audit of
WHO ML-3 assessment in terms of vaccines.
Dossier evaluated according to the CTD guideline
GMP Inspection to manufacturers according to the
WHO GMP.
Contribute to the SOP and Guideline Preparations
Risk Assessment, CAPA Management

3. Difficulties/Lessons Learned from Past
Experience
Issuance Deficiency letter to Manufacturers during
Dossier Evaluation
Implementation of Online Application system.
Implementation of online database
Emergency Use Authorization

104. My Interests

QMS aspects of regulatory systems
eCTD Dossier Evaluation
Emergency Use Authorization

11

2. Brazil

Regulatory Systems on Ensuring Access to Quality
Medicines(JFY 2023）(202208270J001)

Name: Lara Paro Dias
Country: Brazil
Organization/Department/Division:
Unicamp/

Hospitaldas

Clínicas/

Pharmacy Service① Organizational Chart
Health in Brazil is divided today into public and supplementary. Public health is structured within the
Unified Health System (SUS), while supplementary health refers to private healthcare. Data from2022 showed that 75% of Brazilians rely exclusively on SUS, while the remaining population utilizes
private healthcare.
The SUS is one of the largest and most complex public healthcare systems in the world,
encompassing everything from basic primary care to highly complex procedures like organtransplants. It ensures comprehensive, universal, and free access to healthcare for the entire
population of the country, without discrimination based on social class or culture. Comprehensive
healthcare, focusing on quality of life, prevention, and health promotion, has become a right for all
Brazilians from conception throughout their lives.
The management of healthcare actions and services should be collaborative and participatory
among the three levels of government: the federal government, states, and municipalities. The SUS
network is extensive and includes both healthcare actions and services. It encompasses primary,medium, and high-complexity care, emergency services, hospital care, epidemiological, sanitary andenvironmental surveillance actions and services, as well as pharmaceutical assistance.
According to the Federal Constitution of 1988, "Health is the right of all and the duty of the State."
Therefore, SUS consists of the Ministry of Health, states, and municipalities, as determined by theFederal Constitution. Each level of government has its own responsibilities:
1.
MINISTRY OF HEALTH (MS) - National Level
As the national manager of the SUS, the Ministry of Health formulates, regulates, supervises,monitors, and evaluates policies and actions in coordination with the National Health Council.
2.

STATE HEALTH SECRETARIAT (SES) - State Level

The State Health Secretariat participates in the formulation of health policies and actions, provides
support to municipalities in coordination with the state council, and participates in the Bipartite

12

Intermanagement Committee to approve and implement the state health plan. Each Brazilian state
has a Health Secretariat responsible for coordinating and implementing health policies at the statelevel. Within the State Health Secretariat, there may be a specific structure for pharmaceuticaladministration, such as the State Pharmaceutical Assistance Coordination, which is responsible
for coordinating and implementing pharmaceutical assistance policies in the state, including
medication distribution and management of related health programs.
3.

MUNICIPAL HEALTH SECRETARIAT (SMS) - Local Level

The Municipal Health Secretariat plans, organizes, controls, evaluates, and executes healthactions and services in coordination with the municipal council and the state level to approve andimplement the municipal health plan.
In each Brazilian municipality, there is a Health Secretariat responsible for implementing healthpolicies at the local level. Within the Municipal Health Secretariat, there may be a structure
dedicated to pharmaceutical administration, such as the Regional Health Department, which is
responsible for coordinating and implementing activities related to pharmaceutical assistance inthe municipality, including medication stock management, dispensing of medications, andsupervision of municipal pharmacies.
Therefore, each level mentioned above is involved in ensuring accessibility to medications for the
SUS population.
The National Commission for the Incorporation of Technologies in the Unified Health System(Conitec) was created by Law No. 12,401 on April 28, 2011, and it deals with therapeutic
assistance and the incorporation of health technologies within the SUS scope. Its objective is toadvise the Ministry of Health on matters related to the incorporation, exclusion, or alteration ofhealth technologies by the SUS, as well as the establishment or modification of clinical protocols
or therapeutic guidelines. Thus, the medications available free of charge to the population haveguidelines and protocols defined by Conitec/MS, with the action plan for accessibility being the
responsibility of the State Health Secretariats, and the distribution plan being the responsibility ofthe municipal health secretariats.

From a sanitary standpoint, the regulation of medications in Brazil is governed by the National
Health Surveillance Agency (ANVISA), which is responsible for:●Regulating and controlling the manufacturing, distribution, commercialization, and use of

medications;●

Approving the registration of medications, authorizing their commercialization in Brazil;●

Establishing norms and regulations related to the quality, safety, and efficacy ofpharmaceutical products;●

inspecting and monitoring pharmaceutical companies to ensure compliance with good

manufacturing practices.
The pharmaceutical professional not only plays a fundamental role in all the aforementioned

13

instances but is also essential in healthcare institutions. Their work encompasses various areas,
contributing to health promotion, disease prevention, and the safe and effective use of
medications. Here are some positions and roles performed by pharmacists in healthcare
establishments:
1.

Hospital Pharmacy●

Provides Pharmaceutical Care to inpatients and outpatients, aiming for the rational use of

medications;●

Works in pharmaceutical logistics, with medication being the most important input;●

Represents the pharmacy in hospital committees, serving as the decision-maker in all

matters related to medication;●

Acts as the legal responsible pharmacist for the medication flow within the hospital unit;●

Develops norms and controls that ensure the qualification of suppliers;●

Is responsible for medication dispensing through systems that allow for rational flows andminimize errors;●

Analyzes and compares costs and consequences of medication therapies for patients;●

Compounds magistral, officinal, and parenteral formulations according to the principles ofgood pharmacy manipulation practices;●

Is responsible for activities related to quality control of received inputs;●

Conducts pharmacovigilance actions within the hospital pharmacy;●

Actively participates in hospital committees such as the "Hospital Infection Control

Committee" and the "Pharmacy and Therapeutics Committee”.;●

Prepares procurement bids and technical specifications for medications and related

products.

2.

Clinical Pharmacy●

Provides patient-centered care;●

Participates in the planning and evaluation of pharmacotherapy;●

Performs pharmaceutical interventions and provides pharmaceutical opinions to othermembers of the healthcare team, aiming to assist in the selection, addition, substitution,
adjustment, or discontinuation of patient pharmacotherapy;●

Provides pharmaceutical consultations in a pharmaceutical office or other appropriate

14environment that guarantees the privacy of the consultation;●

Performs pharmaceutical progress notes and documents them in the patient's medical

record;●Participates in and promotes integrated clinical case discussions with other healthcare teammembers;●

Orders laboratory tests within their professional competence to monitor the results ofpharmacotherapy;●

Evaluates clinical and laboratory test results of the patient as a tool for individualizing

pharmacotherapy;●

Monitors therapeutic levels of medications through clinical pharmacokinetic data;●

Develops the patient's pharmaceutical care plan;3.

Community Pharmacy and Primary Care●In community pharmacies, pharmacists play an important role in providing guidance andcorrect dispensing of medications;●

They perform pharmacotherapeutic monitoring, identifying possible problems and druginteractions;●

They promote health education, guiding patients on the proper use of medications and theimportance of treatment adherence;●

They participate in health campaigns such as vaccination and disease prevention.

The practice of the pharmaceutical profession is regulated by the "Federal Council of Pharmacy"(CFF) and "Regional Councils of Pharmacy" (CRF), which are also responsible for overseeing
the practice of the pharmaceutical profession throughout the country:●

Monitor compliance with ethical and legal standards by pharmaceutical professionals;●

Promote educational and training initiatives for pharmacists;●

Contribute to the definition of policies related to pharmaceutical care.

15

② Legislation on pharmaceutical administration
The Health Surveillance agency is responsible for promoting, protecting, and controlling thehealth of the population, acting in the prevention of risks and damages to health arising from theuse of products and services. It contributes to pharmaceutical management through:●Licensing and Authorization: The Health Surveillance agency is responsible for licensing
and authorizing health establishments and services, such as pharmacies, hospitals, clinics,
laboratories, pharmaceutical industries, among others. It verifies if these places comply withhealth requirements and are in suitable conditions for operation;●
Quality Control: The Health Surveillance agency performs analysis and quality control of
health-related products and services. This includes the evaluation of laboratory tests, labeling
analysis, verification of good manufacturing practices, storage and distribution of medicines, food,and other products;●
Investigation of Health Risks: The Health Surveillance agency works in the identificationand investigation of disease outbreaks, food poisoning incidents, adverse events related to
medicines, and other public health issues. It collects information, conducts epidemiologicalanalyses, and takes measures to control and prevent the spread of diseases and health risks.
Here are some of the main legislations related to pharmaceutical services in healthcare
establishments and accessibility to medication in the unified health system:◆

National Level• Law No. 12,401/2011 - Provides for therapeutic assistance and the incorporation of healthtechnology within the scope of the Unified Health System (SUS).
• Law No. 13,021/2014 - Deals with the exercise and supervision of pharmaceutical activities.
• Portaria 344/98 (and updates) - Approves the Technical Regulation on substances andmedicines subject to special control.
• Portaria 3,916/1998 - Approves the National Drug Policy (PNM).
• Portaria 1,017/2002 - Establishes that Hospital Pharmacies and/or medication dispensaries in
hospitals that are part of the Unified Health System must operate under the Technical
Responsibility of a duly registered Pharmaceutical Professional in the respective Regional
Pharmacy Council.
• Resolution 338/2004 - Approves the National Pharmaceutical Assistance Policy (PNAF).
• Resolution CFF 577/2013 - Deals with the technical management or technical responsibility ofcompanies or establishments that dispense, sell, supply, and distribute pharmaceutical products,
cosmetics, and health products.
• Resolution CFF 585/2013 - Regulates the clinical attributions of the pharmacist and provides forother provisions.
• Resolution CFF 596/2014 - Deals with the Pharmaceutical Code of Ethics, the Ethical Process
Code, and establishes infractions and rules for the application of disciplinary sanctions.
• Resolution CFF 675/2019 - Regulates the attributions of the clinical pharmacist in intensive careunits and provides for other provisions.
• Resolution CFF 735/2022 - Deals with the attributions of the pharmacist in the Pharmacy andTherapeutics Committee.
• Resolution CFF 746/2023 - Defines, regulates, and establishes the attributions andcompetencies of the pharmacist in the manipulation of medicines and health products.
• RDC 45/2003 - Provides for the Technical Regulation on Good Practices for the Use of
Parenteral Solutions. • RDC 220/2004 - Provides for the operation of Antineoplastic Therapy
Services.
• RDC 67/2007 - Deals with the fractionation of medicines in pharmacies and drugstores.

16• RDC 38/2008 - Provides for the installation and operation of "in vivo" Nuclear Medicine Services.
• RDC 44/2009 (as it applies to Hospital Pharmacies) - Provides for Good Pharmaceutical
Practices for the sanitary control of the operation, dispensing, and commercialization of products
and the provision of pharmaceutical services.
• RDC 63/2011 - Good Functioning Practices for Healthcare Services.
• RDC 36/2013 - Establishes actions for patient safety in healthcare services and provides forother provisions.

◆

Local Level.

• Resolution SMS No. 01/2017 - Provides guidelines for the renewal of the Operating License fordomestic health establishments in the municipality of Campinas③ Regulatory /Administrative Services◆

Pharmaceutical Manufacturing

RDC No. 301, dated August 21, 2019 - Provides guidelines for Good Manufacturing Practices for
Medicines. It applies to all stages of medicine manufacturing, from the receipt of raw materials tothe storage and distribution of finished products:
1.
Quality system: Medicine manufacturers must implement a comprehensive quality systemthat includes appropriate procedures, controls, and documentation to ensure the quality of the
manufacturing process.
2.
Facilities and equipment: Requirements are established for the physical facilities,
equipment, and utensils used in medicine manufacturing, aiming to ensure proper cleanliness,safety, and prevention of contamination.
3.
Control of raw materials and packaging materials: Guidelines are defined for the control
and qualification of raw materials and packaging materials used in medicine manufacturing,
including requirements for identification, storage, traceability, and quality control.
4.
Process and production control: Guidelines are established for the control of medicine
manufacturing processes, including process validation, monitoring, quality control at all stages,
and proper record-keeping.
5.
Finished product quality control: Criteria and procedures are defined for the quality controlof finished products, including laboratory testing, sampling, analysis, and release of medicines tothe market.
6.
Documentation system: The resolution sets detailed requirements for documentation
related to medicine manufacturing, including standard operating procedures, manufacturing
records, change control, among others.
◆Drug Import/Export
RDC 81/2018 - Provides for the Technical Regulation of Imported Goods and Products for
Sanitary Surveillance. It applies to all imported products that are subject to sanitary surveillance,
including medicines, food, cosmetics, health products, personal hygiene products, among others:
1.

Importer's responsibility: The importer is responsible for ensuring that the imported products

17

comply with Brazil's legal and regulatory requirements, including registration or notification with
ANVISA, when applicable.
2.
Documentation and information: The importer must provide detailed information to ANVISA
regarding the imported product, such as technical data, composition, manufacturer information,
analysis certificates, among others.
3.
Inspection and laboratory analysis: ANVISA may conduct inspections and collect samplesof imported products for laboratory analysis to verify their compliance with sanitary requirements.
4.
Customs control: The resolution establishes customs control procedures for imported
products, including document verification and physical inspection of the products.
5.
Rejection and return of products: If any non-compliance or health risks are identified,
ANVISA may reject the importation of the product and determine its return or destruction, in
accordance with applicable legislation.

RDC 203/2017 - Provides for the criteria and procedures for the exceptional importation of
products subject to sanitary surveillance without registration with ANVISA.
1.

Definition of exceptional importation: The resolution establishes that exceptional

importation is a temporary measure that allows the importation of products without registration
with ANVISA when there is a specific situation of public interest, such as cases of shortage, publichealth emergencies, clinical trials, among others.
2.

Requirements and procedures: The interested party in importing a product exceptionallymust submit a request to ANVISA, providing detailed information about the product, its purpose,justification for importation without registration, among other details.
3.

ANVISA's analysis and decision: ANVISA will evaluate the request for exceptional

importation, taking into consideration aspects such as the quality, efficacy, and safety of the
product, the availability of registered alternatives, the evidence of the need for exceptional
importation, and other criteria.
4.

Conditions and responsibilities: If exceptional importation is authorized, the applicant mustcomply with the conditions established by ANVISA, including obtaining additional documents,
implementing control and monitoring measures, and assuming responsibility for any adverse
events related to the use of the imported product.

◆Marketing Authorization
Instruction Normative (IN) No. 9/2009 establishes rules and guidelines regarding the list of
products permitted for dispensing and commercialization in pharmacies and drugstores. This
normative defines which products can be sold in these establishments, taking into consideration
aspects related to safety, quality, and current legislation. IN No. 9/2009 aims to ensure that only
appropriate and authorized products are made available in pharmacies and drugstores, protecting
the health and well-being of consumers.

18

◆Drug Distribution (including drug selection, procurement, sale)
RDC No. 304, dated September 17, 2019, and its updates - establishes Good Distribution
Practices, Storage, and Transportation of Medicines.

1.

Scope: The resolution applies to all companies and professionals involved in the
distribution, storage, and transportation of medicines, including distributors, storages,
transporters, pharmacies, among others.
2.
Infrastructure and facilities: Requirements are established for physical facilities, equipment,
and resources necessary to ensure proper storage and distribution of medicines, including
temperature and humidity control, security, organization, cleanliness, and suitable conditions for
product preservation.
3.
Quality control: Guidelines are defined for quality control of medicines during distribution,
storage, and transportation, including temperature control, batch traceability, assurance of
packaging integrity, and prevention of contamination or adulteration.
4.
Documentation and records: The resolution establishes the need for adequate
documentation, including records of receipt, storage, transportation, and distribution of medicines.
These records must be maintained in compliance with regulatory requirements and be available
for inspection by ANVISA.
5.
Training and qualification: RDC 304/2019 mandates appropriate training for professionals
involved in the distribution, storage, and transportation of medicines, ensuring knowledge of goodpractices, procedures, and responsibilities.
6.
Traceability: The resolution emphasizes the importance of traceability of medicines
throughout the distribution chain, enabling precise identification of batches, their origin anddestination, facilitating recall or withdrawal actions when necessary.
◆Medicine Safety (post-marketing)
It is the responsibility of pharmacovigilance to identify, evaluate, and monitor the occurrence ofadverse events related to medications used in the population after their registration, with the aimof ensuring that the benefits associated with the use of these products outweigh the risks they
may pose. RDC No. 406/2020 establishes Good Pharmacovigilance Practices for Holders of
Human-use Drug Registrations and provides other provisions:1.
Definitions and responsibilities: The resolution establishes important definitions related topharmacovigilance and identifies key stakeholders involved, such as the registration holder, theresponsible person, and the pharmacovigilance team.
2.
Pharmacovigilance System: RDC 406/2020 defines the requirements for the establishment
and maintenance of a robust pharmacovigilance system, including the appointment of a
responsible person, the establishment of standard operating procedures, the maintenance ofrecords, and the implementation of a risk management strategy.
3.
Data collection and analysis: Requirements are set for the collection, analysis, andcontinuous evaluation of medication safety data, including reports of adverse events, which must
be recorded and reported according to established standards.
4.
Safety communication: The resolution provides guidelines for the communication of safety
information related to medications, including the preparation of periodic safety reports, thecommunication of regulatory safety measures, and interaction with competent authorities.
5.
Risk management: RDC 406/2020 emphasizes the importance of risk management for
medications, including the identification, assessment, minimization, and communication of risks
associated with product use.
6.
Audit and inspection: The resolution includes provisions for internal audits and inspections
by ANVISA to verify compliance with good pharmacovigilance practices and adherence toestablished standards

19◆Relief System for Adverse Drug Reactions
ORDINANCE No. 529, OF APRIL 1, 2013 - Establishes the National Patient Safety Program(PNSP).
One of the goals of this ordinance is "Safe Medication," and the contribution of the clinicalpharmacist is through the pharmaceutical evaluation of the medical prescription, where it ispossible to detect and prevent any potential adverse event related to drug therapy. The main
pharmaceutical interventions are related to drug interactions, dosage, route of administration,
dilution and infusion time, medication allergies, and medication reconciliation.
④ Drug Pricing
The Chamber of Regulation of the Pharmaceutical Market (CMED) is the interministerial body
responsible for the economic regulation of the pharmaceutical market in Brazil, and the Brazilian
Health Regulatory Agency (Anvisa) serves as the Executive Secretariat of the Chamber. In the
public sector of Brazil, price control and the pricing mechanism for medications are regulated toensure equitable access to essential medications for the population.
CMED establishes price limits for medications, adopts rules that promote competition in the sector,
monitors commercialization, and applies penalties when its rules are violated. It is also
responsible for setting and monitoring the mandatory minimum discount for public procurement.
In the public sector, the federal government, states, and municipalities carry out public
procurement of medications through bidding processes and contracts, with electronic auctions
being the most common modality. These processes aim to obtain more competitive prices,seeking the best cost-benefit ratio for the public administration. Purchases can be made directlyfrom manufacturers or through authorized distributors.

⑤ Statistic Data
−Please answer the following questions (if the number is not applicable, please give an answer tothe best of your knowledge).
−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)(year)

3.

Number of pharmaceutical manufacturers / manufacturing sites(year)

4.

Number of traditional medicine manufacturers / manufacturing sites(year)

5.

Number of pharmaceutical importers(year)

6.

Number of pharmaceutical wholesalers(year)

Data not available or not found.
※About the Hospital pharmacy only, if possible;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: 1
b. Number of deputy chiefs: 420

c. Number of managers: 0（２） Number of staff
a. Number of pharmacists: 22
b. Number of clinical pharmacists: 0 (non-exclusive activity)
c. Number of technicians: 60
d. pharmacy college interns: 6（３） Number of the kinds of drugs managed in your pharmacy or hospital (542)
a. Oral medicine: 270
b. Injections: 250
c. Medicines for external use: 22（４） Number of prescriptions dealt in your pharmacy per day
a. For inpatients: 483
b. For outpatients: 294 (22 working days/month)c. For Emergency: 116
d. Oncology outpatients: 55 (22 working days/month)（５） Equipment of the pharmacy in your hospitala.

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

~354

㎡

/ No

The pharmacy service of HC/Unicamp has independent physical spaces:
Central Pharmacy - 126 ㎡
Emergency Satellite - 22.80 m²
Surgery Satellite - 55 m²
Ambulatory - Chemotherapy - 32.20 m²
Ambulatory outpatients - 84.70 m²
Unit Dose - 32.95 m²
Note: The warehouse is outsourced, and therefore, they have their own space for thepharmaceutical supply chain logisticsb.

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

/

No

If "Yes", please describe it in detail
Detail:The chemotherapy pharmacy has a clean room where the Class II B2 biological safety21cabinet (vertical for antineoplastic drugs) is installed. The structure includes ananteroom for hand hygiene and gowning, a manipulation room with HEPA filters, anda waste room. These three spaces are designed to have a unidirectional flow of work,
preventing cross-contamination.

c.

Does

the

pharmacy

have

computers?
Yes /

No

If "Yes", what is the purpose of using them.
Purpose:Computers are used for both administrative tasks and the dispensation of medications
through the computerized electronic prescription system.
d.

Do you implement Therapeutic Drug Monitoring (TDM : Therapeutic Drug Monitoring) inyour Hospital?
Yes / No
Currently, the monitoring of vancomycin levels is typically performed by the prescribing
physician. Vancomycin is an antibiotic commonly used to treat serious bacterial
infections, particularly those caused by methicillin-resistant Staphylococcus aureus(MRSA) and other Gram-positive bacteriae.

Do you prepare TPN (Total Parental Nutrition)
Yes

/ No

The supply service of Total Parenteral Nutrition (TPN) is outsourced and carried out by aspecialized pharmacy that handles the compounding of parenteral nutrition solutions.

f.

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

No

Purpose:The internet is used to access the electronic medical prescription system and handle them throughthe pharmacy module, record medication dispensing (with barcode reader in the high-cost
pharmacy), place stock replenishment orders for the pharmacy, perform administrative tasks forthe department such as shift scheduling, development of institutional projects, instruction on
medication procurement processes through bidding, consultation of medications in databases suchas Micromedex, UpToDate, ANVISA, and others. They are also used to request parenteral nutrition
from the contracted third-party company, provide inventory information and request medications
from the responsible entities for free medication programs at the municipal and Ministry of Healthlevels.

22

※All participants. Please describe the following general information as much as you know.
⑦ Education and License of Pharmacists in your country（１） Number of years in primary, secondary and high school
education Primary

5

years

Secondary

4

years

High school

3

years

（２） Number of years / weeks in the following categories during university orcollege
The data pertains to the “Faculty of Pharmaceutical Sciences of theState University of Campinas” - FCF/Unicamp:
University / college:

5 years (full time)

Professional education:

-

years

Practical training: at Faculty of Pharmaceutical Sciences(FCF/UNICAMP) students are enrolled in 7 internships~ 850 hours
Duration of training by each facility:~ 60

hours Hospital pharmacy:

~90

hours
Community pharmacy:

~120

hours

Pharmaceutical company:

~450

hours

Others:

~130

hours

Age at graduation:

22

years old

In Brazil, there are 1024 undergraduate pharmacy courses recognized by the Ministry of
Education (MEC) that grant a bachelor's degree. These courses are offered by both public
and private institutions, and the standard workload for the degree is 4,000 hours, although
there may be variations among different higher education institutions.
The undergraduate pharmacy program, leading to a bachelor's degree, should be
structured into three training areas, encompassing theoretical and practical activities,
mandatory internships, a final course project, and complementary activities. The programaims to integrate academic education with professional practice in a contextualized andproblem-based approach.
The practical training or internships are distributed throughout the course, and the start andend periods may vary depending on the educational institution. It is important to note thateach institution has autonomy in structuring its curriculum for the pharmacy program. The
information provided in the table above represents the "Faculty of Pharmaceutical
Sciences" at UNICAMP.

23

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

-

days

Clinical Exams

-

days

No
In Brazil, there is no mandatory national examination for obtaining the pharmacist diploma after
completing higher education. However, there are examinations to obtain a specialist title in a
specific area of interest. For example, in the hospital pharmacy field, there are specialists in:●
Hospital Pharmacy - examination administered by the "Brazilian Society of Hospital
Pharmacy";●
Clinical Pharmacy - examination administered by the "Brazilian Society of Hospital
Pharmacy"; Radiopharmacy - examination administered by the "Brazilian Society of Hospital
Pharmacy";●
Oncology - examination administered by the "Brazilian Society of Pharmacists in
Oncology".
（ 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.

To obtain the diploma, it is necessary to complete all the theoretical and practical disciplines
specified in the undergraduate pharmacy program and achieve the minimum satisfactory grade
determined by the educational institution.
Internships must correspond to a minimum of 20% of the total workload of the undergraduate
pharmacy program and should be developed in the following areas:
I - Drugs, Cosmetics, Medicines, and Pharmaceutical Assistance: 60%;
II - Clinical, Genetic, and Toxicological Analysis and Food: 30%;
III - Institutional and Regional Specificities: 10%.
The mandatory internships mentioned above should include practice settings within the UnifiedHealth System (SUS) at different levels of complexity.
As mentioned earlier, the duration of practical training/internship may vary throughout the course,
depending on the autonomy of each educational institution.
（５）Number of pharmaceutical university or college graduates:

people / per year
The alumni's placement rate (%)
a. Hospital:%b. Community Pharmacy:%c. Government Organization:%d. Enterprise:%e. Others:%

24

These data are not publicly available. However, the Federal Pharmacy Council (CFF) is theregulatory body responsible for the registration of professionals, regulation of pharmacy practiceand duties, and oversight. It is recommended for pharmacists to be registered with the CFF in
order to work in healthcare establishments, and it is mandatory for Technical Managers andSubstitute Technical Managers. Therefore, the CFF has the data on the number of registeredprofessionals, and currently, there are 9960 registered pharmacists in the year 2023.

⑧ ADR(Adverse Drug Reaction) report
Cases of adverse drug reactions (ADR) are reported to ANVISA through a dedicated portal called
VigMed. VigMed is the system for reporting adverse events related to medications and vaccines. It
is available for healthcare professionals without institutional affiliation or from healthcare
establishments that are not yet registered in VigMed. It is also accessible for healthcare services(sentinel networks, hospitals, outpatient clinics, and vaccination clinics) and for drug registration
holders.
In the case of adverse events (adverse reactions, ineffectiveness, or medication errors), it isrecommended by the responsible agencies to report primarily severe reactions that result in death,risk of death, hospitalization, prolonged hospitalization, congenital anomalies, or persistent orpermanent disability. Additionally, reactions not described in the medication's package insert should
be reported.
Any healthcare professional can make a notification, but healthcare establishments often undergoa prior institutional registration, and the notifier becomes linked to that healthcare service.
With the publication of Ordinance No. 529/2013, the National Patient Safety Program (PNSP) wasestablished, and since then, healthcare services are required to have a Patient Safety Center. Thiscenter is a partner in developing patient safety policies in the hospital environment, and one of its
activities involves reporting adverse events related to medications. When a hospital submits a
notification to local or state authorities (ANVISA), an investigation group is formed. The patient's
history, information about the suspected medication/product such as batch, expiration date,manufacturer, and registration holder's data are gathered.

9 Referências Bibliográficas

Lei Nº 8.666, de 21 de junho de 1993 - institui normas para licitações e contratos da Administração
Pública e dá outras providências.
PORTARIA Nº 4.279, DE 30 DE DEZEMBRO DE 2010 - Estabelece diretrizes para a organização
da Rede de Atenção à Saúde no âmbito do Sistema Único de Saúde (SUS).
RESOLUÇÃO No 6, DE 19 DE OUTUBRO DE 2017 - Institui as Diretrizes Curriculares Nacionais
do Curso de Graduação em Farmácia e dá outras providências.
RDC N203, DE 26 DE DEZEMBRO DE 2017 - Dispõe sobre os critérios e procedimentos para
importação, em caráter de excepcionalidade, de produtos sujeitos à vigilância sanitária sem registro

25

na Anvisa.
RDC No 81, DE 5 DE NOVEMBRO DE 2008. Dispõe sobre o Regulamento Técnico de Bens e
Produtos Importados para fins de Vigilância Sanitária.
RDC No 301, DE 21 DE AGOSTO DE 2019 Dispõe sobre as Diretrizes Gerais de Boas Práticas deFabricação de Medicamentos.
RESOLUÇÃO No 730, DE 28 DE JULHO DE 2022 - Regulamenta o exercício profissional nas
farmácias das unidades de saúde em quaisquer níveis de atenção, seja, primária, secundária e
terciária, e em outros serviços de saúde de natureza pública ou privada.
https://www.gov.br/conitec/pt-br/assuntos/a-comissao/conheca-a-conitec
https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/cmedhttps://site.cff.org.br/estatistica
http://sbrafh.tecnologia.ws/titulo-de-especialista/
https://sobrafo.org.br/titulo-de-especialista/
https://emec.mec.gov.br/emec/nova
https://www.gov.br/saude/pt-br/assuntos/saude-de-a-a-z/s/sus
https://www.ibge.gov.br/estatisticas/sociais/saude.html

26

Lara
Pharmacist
Hospital of Clinics
University of Campinas

Brazil

1. Introduction of the work
(1) HC/Unicamp - Pharmacy Service(Coordinator)(2) 12 years (3.5y as a pharmaceutical manager)a) selection and technical analysis of drugsb) Pharmacovigilance27

position of pharmacists in Brazil

1. Health Unitsa. Hospital Pharmacist and Community Careb. Clinical Pharmacist
c. Radiopharmacy
1. Industry and Regulatoy System
1. Clinical Analysis and Toxicology
1. Teaching and Research
2. Good Practice

Achievements + On-going projects to deal
with current problems
Implementation of electronic prescription
system integrated with pharmacy
approximation between pharmacist andprescriber in drug safety28

2. Good PracticeSuccessful countermeasures againstproblems
Contingency plan for worldwide shortageof iodate contrast
fractionation of doses
importprotocol review

3. Difficulties/Lessons Learned from Past Experience

Failed countermeasures to deal with the
problems
The only manufacturer of Immuno BCG had
its factory interdicted by VISA - drug
shortagealternative: import
Problem With COA

29

3. Difficulties/Lessons Learned from Past Experience

Emerging or Re-emerging Problems
Twice Contaminated chlorhexidine(same manufacturer)(Burkholderia P. - oral solution)

4. Your interests(1) Learn about health systems and drug
regulation of other countries and exchange
experiences(2) Improve technical qualification in theselection of medicines in public
procurement, both domestic and imported
drugs

30

Thank you!

Morro dois Irmãos - Rio de Janeiro/Brasil31

3. Egypt

Part I:INFORMATION SHEETRegulatory Systems on Ensuring Access to Quality Medicines （JFY 2023）
Name: Mohamed Fadel Mohamed
Country:Egypt
Organization/Department/Division:

Centraladministrationaffairsforpharmaceutical(CAPA)Ⓒ 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.
※About the Hospital pharmacy only, if possible;−Please briefly describe the position and role of pharmacist in the medical institution and the medical caresystem in your country.
Under the provisions of the law 127 for the year 1955, practicing the profession of pharmacy is
considered to be the preparation, composition or retailing of any medicine, drug, medicinal plant or
pharmaceutical substance that is used internally, externally or by injection to prevent humans or animals
from diseases or treat them from them or is described as having these advantages.
132Medicines in Egypt are government-regulated and its price is controlled by law and ministerial decrees.
Patients have to pay out-of-pocket (OOP) for their medicines. The public health insurance covers only
58% of the population. Public hospitals adhere to a list of standard medicines that are publicly tenderedand procured centrally. Patients have to purchase their medicines if not on the list of the public tender
medicines. Private pharmacies are licensed by the MOH 3 and considered as the main legal outlet to sell
medicines (i.e.: medicines are not sold in groceries or any commercial store other than the pharmacy)Ⓒ Legislation on pharmaceutical administration−Please briefly bulletined major laws/acts◆ National Level

Law 127 for the year 1955
◆ International Level:

The involvement of multiple committees and application reviews prior to MA is granted. Egypt’s public
pharmaceuticals registration process on transparency score is 6.03 using the WHO methodology for measuringtransparency (WHO, 2015). According to the report, low scores are related to problems of transparency inregistration and pricingⒸ Regulatory /Administrative 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

・Administered by good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice233◆ Drug Import/Export

Article (65):
It is not allowed to enter private pharmaceutical preparations into Egypt, even if they are free medical samples, nor torelease them unless the following conditions are met and after the approval of the Technical Committee for Drug
Control:(1) To be registered in the books of the Ministry of Public Health in accordance with Article (59) of this law.
(2) To have the same name by which it is known in its country of origin.
(3) It shall be brought in hermetically sealed envelopes, and it shall not be brought loose or unpacked.
(4) To mention on their labels the data stipulated in Article (57), and it is not permissible in any case to import
the empty containers of these preparations or their packaging free of medicines or their labels, or to makeanything of that except after obtaining the approval of the Ministry of Public Health.
◆ Marketing Authorization
Regulated by ministerial decrees numbers 425
For the year 2015, 645/2016 and 180/2019◆ Medicine Safety (post-marketing)

The structures and the processes of pharmacovigilance in Egypt has to be implemented following the Good
Pharmacovigilance practice. They can be achieved by having well-functioning pharmacovigilance system and aquality system for the pharmacovigilance, which are described in details in EMA GVP module IPharmacovigilance systems and their quality systems “I.B. Structures and processes’’. This topic explains
multiple items that shall be considered in implementation, such as Quality cycles, overall quality objectives for
PV, principles for GVP, responsibilities for the quality system within an organization, training of personnel for
PV, facilities and equipment for pharmacovigilance, specific quality system procedures and processes, including
compliance managements by MAHs and EDA. In addition to record control, documentation of quality systems
by MAHs and EDA, monitoring of the performance and the effectiveness of the PV system and its quality
systems, and preparedness planning for PV in public health emergencies④ Drug Pricing−Please describe about price control and drug price mechanism at public sector in your country.
With inadequate insurance coverage and high out-of-pocket health expenditure, income level becomes a major
determinant of access to medication. Rural areas are at higher risk of facing inadequate access to healthcare due totheir higher percentage of poverty. Adult literacy rate is 61%; illiteracy is particularly high in rural areas (WHO,2005). Lack of health awareness, negligence and reluctance to seek medical advice indirectly influence access tohealthcare services and, accordingly, Pricing is controlled through decrees
Resolution (373 of 2009) regarding drug pricing, issued by the Minister of Health, distinguishes in the pricing
process between two types of drugs: the original drug, and the identical or generic drug. The original medicine is
the medicine that contains a new active substance, while the generic medicine is the medicine that matches theoriginal medicine in terms of effectiveness, but is cheaper.
According to the new decision, the original drug sale price will be determined on the basis of the lowest selling
price to the public in the countries in which it is traded, after deducting 10% from this price.
Attached to the decision is an indicative list of 36 countries that the Ministry of Health will contact to confirm theprice of the drug in them
The selling price of a similar drug is often determined on the basis of the original drug price after deducting fixed
percentages from it. The decision defines three classes of generics based on the quality approvals obtained by the
manufacturer. The first category of similar medicines is priced at 30% less than the price of the original medicine ifthat preparation is manufactured in one of the factories licensed by the Ministry of Health with the approval of thefactory from one of the foreign or international bodies that the decision considered as a quality standard. The
second category of similar medicines is priced at 40% less than the price of the original product for the rest of thefactories licensed by the Ministry of Health - bearing in mind that this category exists only until 2020, which is theend date of the period granted by the Ministry to factories to obtain quality approvals or face closure.
3
34

Finally, the third category of similar medicines is priced at 60% less than the price of the original product, forthe preparations of companies that do not own factories and manufacture with third parties.

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

310000(2023)

2.

Number of GMP inspector (National & Local)

2000(2022)

3.

Number of pharmaceutical manufacturers / manufacturing sites

180(2020)

4.

Number of traditional medicine manufacturers / manufacturing sites(year)

5.

Number of pharmaceutical importers(year)

6.

Number of pharmaceutical wholesalers(year)※About the Hospital pharmacy only, if possible;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:

435

（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:536

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

Ⓒ

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

5yearsSecondary

3yearsHigh school

3years（２） Number of years / weeks in the following categories during university or college
University / college:

6yearsProfessional education:

5yearsPractical training:

1yearsDuration of training by each facility:

years

Hospital pharmacy:

weeks

Community pharmacy:

1000 hours

Pharmaceutical company:

weeks

Others:weeks

Age at graduation:

23-24years old（３）Are there any national examinations for pharmacists in your country?
No（４）Which of the followings must you fulfill to obtain a pharmacist's license?
* If practical training is mandatory, give the subjects and training period* 1000 hours of retail experience（５）Number of pharmaceutical university or college graduates:
20000

people / per year

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

10%b. Community Pharmacy:

50%c. Government Organization:

20

%

6
37

d. Enterprise:

10%

e. Others:

10%⑧ ADR(Adverse Drug Reaction) report
Please describe the flow of reporting system (from a medical institution to an administrative agency), when asevere ADR is detected in a medical institution. Describe specifically the rule and responsibility of eachorganization (an administrative agency / a medical institution), and their collaboration/cooperation.
The Egyptian Pharmaceutical Vigilance Center (EPVC) has been established at the Central Administration for
Pharmaceutical Affairs (CAPA) - Ministry Of Health & Population in December 2009.
The center is responsible for the collection, evaluation and assessment of information about the safety of pharmaceuticalproducts and Medical Devices marketed in Egypt.
The center is divided to Pharmacovigilance Department, Medical Device Safety Department & Biocidal Vigilance
Department. Cosmetics & Veterinary Vigilance Departments are under construction.
Regional centers have been established in Alexandria, Cairo and Sohag.

38

39

40

41

4. Indonesia

Part I:INFORMATION SHEETRegulatory Systems on Ensuring Access to Quality Medicines(JFY 2023)
Name
Country
Organization
Departement/ Division

:
:
:
:

Fauziah Ridho
Indonesia
Indonesian Food and Drug Authority (Badan POM)
Directorate of Drugs, Narcotics, Psychotropics, Precursors, Addictive
Substances Standardization

1. Organization Chart

The Indonesian FDA (Badan POM) organizational chart at national & provincial/district levels

The Indonesian FDA is assigned and functions as a national regulatory authority on pharmaceuticaladministration in Indonesia. Indonesian FDA is a National Regulatory Authority (NRA) on Drugs andFood in Indonesia that administers government affairs in the sectors of a drug, traditional medicine,
health supplement, cosmetic, and processed food control, which is responsible directly to the President.
To address the current challenges in drug control, the President of the Republic of Indonesia released
the legal basis to strengthen medicine control, which has effectively empowered the Indonesian FDA,
particularly in law enforcement and improving drug and food control effectiveness.
There are 3 Deputies under the Indonesian FDA Chairperson responsible for specific products and 1
Deputy for Law Enforcement. Concerning Indonesia’s large territory, the Indonesian FDA has
extensive coverage; thus, we are supported by 34 regional offices at the provincial level and 39 district
offices in smaller cities. The total number of staff is approximately 5.000 across the country, and thenumber is increasing gradually with the commitment of the Indonesian Government to strengthen drug
and food control in Indonesia continuously.

Fauziah Ridho (The Indonesian FDA)
42

1

Vission:
Drugs and food are safe, quality, and competitive to realize a sovereign developed Indonesia independentand have a personality based on cooperation.
Mission:
1. Build excellent human resources related to drugs and food by developing partnerships with allcomponents of the nation to improve the quality of Indonesian people.
2. Facilitating the acceleration of the development of the drug and food business world by taking sides
with MSMEs to build a productive and competitive economic structure for the nation's independence.
3. Increase the effectiveness of drug and food control and law enforcement of drug and food crimes
through the synergy of the central and regional governments within the framework of the Unitary
State to protect the whole nation and provide a sense of security to all citizens.
4. Clean, effective, and reliable government management to provide excellent public services in drugs
and food.
2. Legislation on Pharmaceutical administration
At the national level, legislation on pharmaceutical administration is conducted by the Indonesian FDA
under the Deputy for Drug, Narcotic, Psychotropic, Precursor, and Addictive Substance Control. The
technical implementation of drug control locally is conducted by provincial/district offices in 34
provinces.
a. National Level− Presidential Decree No. 80/2017 regarding BPOM (INDONESIAN FDA) to strengthen
regulatory function on law enforcement administered by President− Presidential Instruction No. 3/2017 regarding the Drug and Food Control EffectivenessImprovement administered by President
b. Local Level− Regulation of The Indonesian FDA No. 21/2020 on Organization in the Indonesian FDA
administered by The Chairperson of The Indonesian FDA− Regulation of The Indonesian FDA No. 23/2021 on the amendment to Regulation of The
Indonesian FDA No. 22/2020 regarding the Organization Technical Unit In the Indonesian
FDA administered by The Chairperson of The Indonesian FDA
c. International Level:− PIC/s member No.41, on 1st July 2012
− ICH observer− ASEAN Consultative Committee on Standards and Quality ACCSQ-PPWG member− APEC-LSIF RHSC member since 2013
− South East Asia Regulatory Network (SEARN) member− International Pharmaceutical Regulators Programme (IPRP) member since May 2020
3. Regulatory/Administrative Services
Regulatory services for pharmaceutical product are conducted by the Indonesian FDA, under the
Deputy for Drug, Narcotic, Psychotropic, Precursor, Addictive Substance Control, which responsible
for the administration of:a. Pharmaceutical Manufacturing
Standard: Regulation of the Chairperson of The Indonesian FDA on Indonesian
GMP Guideline, 2018 edition
Administered by : Directorate of Drug, Narcotic, Psychotropic, Precursor Production Control

Fauziah Ridho (The Indonesian FDA)
43

2

b. Drug Import/Export
Standard: Regulation of the Minister of Health and Regulation of the Chairpersonof The Indonesian FDA on Export and Import of Drug, Narcotic,
Psychotropic, and Precursor
Administered by : Directorate of Safety, Quality, and Export-Import Control of Drug,
Narcotic, Psychotropic, Precursor, and Addictive Substancec. Marketing Authorization
Standard: Regulation of the Minister of Health on Drug Registration,
Regulation of the Chairperson of The Indonesian FDA on Criteria andProcedure of Drug Registration
Administered by : Directorate of Drug Registrationd. Drug Distribution
Standard:
Administered by:Regulation of the Chairperson of The Indonesian FDA on Indonesian
GDP Guideline, 2020 edition
Directorate of Drug, Narcotic, Psychotropic, Precursor Distribution andService Control

e. Medicine Safety (post-marketing)Standard: a. Regulation of the Minister of Health on Pharmaceutical Industries,
b. Regulation of the Minister of Health on Standard of
Pharmaceutical Service in Hospitals,c. Regulation of the Minister of Health on Standard of
Pharmaceutical Service in Public Health Centers,d. Regulation of the Minister of Health on Standard of
Pharmaceutical Service in Pharmacy,e. Regulation of the Chairperson of The Indonesian FDA on the
Implementation of Pharmacovigilance for PharmaceuticalIndustry.
Administered by : Directorate of Safety, Quality, and Export-Import Control of Drug,
Narcotic, Psychotropic, Precursor, and Addictive Substancef.

Relief System for Adverse Drug Reactions
Only for COVID-19 Vaccine and administered by the Ministry of Health and Social Security
Health Agency
Standard: Regulation of the Minister of Health on Implementation of Vaccinationin order to Countermeasures COVID-19 Pandemic

4. Drug Pricing
Drug pricing policy is regulated and controlled by Ministry of Health.
5. Statistic Data
1 Number of pharmacists
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

:
:
:
:
:

± 77.000 – 82.000
± 165
± 240
± 130
± 85

Fauziah Ridho (The Indonesian FDA)
44

3

6

Number of pharmaceutical wholesalers:± 2.200

6. Education and License of Pharmacist in your country
1 Number of years in primary, secondary and high school education
Primary: 6 years
Secondary: 3 years
High school: 3 years
2

Number of years / weeks in the following categories during university or college
University / college: 4 years
Professional education: 1 years (including practical training in national regulatory
authority, hospital pharmacy, community pharmacy, andpharmaceutical company)
Age at graduation: 23 -24 years old

3

Are there any national examinations for pharmacists in your country?
Yes, consist of academic exam (1 day, Indonesian Pharmaceutical Competency Exam) andpractical exam (1 day, Objective Structured Clinical Examination)

4

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

5

Number of pharmaceutical university or college graduates± 2.000 - 2.500 people/per year

7. ADR (Adverse Drug Reaction) Report
The monitoring system of ADR report conducted by The Indonesian FDA (Badan POM) consists of:a. Spontaneous reporting from health care professionals using Yellow Form (post mail to Badan
POM), email to pv-center@pom.go.id or online reporting (http://e-meso.pom.go.id).
b. Reporting from pharmaceutical industries, consists of:i. Spontaneous reporting, using post mail to Badan POM, email to pv-center@pom.go.id or
online reporting (http://e-meso.pom.go.id);
ii. Periodic safety update report;iii. Reporting of post marketing safety study;
iv. Reporting of scientific publications/literature;
v. Reporting of NRA regulatory action in other country;
vi. Reporting of Marketing Authorization Holder action in other country;vii. Reporting of the risk management plan.
Reporting for points (b) to (g), using post mail to Badan POM or email to:
pv-center@pom.go.id.
The rule and responsibility for ADR report as follows:a. Regulatory and pharmaceutical industy are collaborating in managing risk in term of riskbenefit ratio for population.
b. Healthcare professionals and healthcare facilities manage risk in term of risk-benefit ratio forpatients.
c. Patients manage risk in term of personal values.

Fauziah Ridho (The Indonesian FDA)
45

4

Inception ReportFauziah Ridho, S.Farm, M.Si.

The Indonesian FDA

Outline46

1. INTRODUCTION

The Indonesian FDA Profile

47

Directore of Drugs, Narcotics, Psychotropics,
Precursors, Addictive SubstancesStandardization

Team for Preparation and
Dissemination of Quality
Standardization of
Medicines, Drug Materials,
and NPPTeam for Preparation and
Dissemination ofStandardization of ONPP
Production, Distribution andMaterials and Information
on Tobacco ProductsTeam for Preparation and
Dissemination ofStandardization of Efficacy
and Safety of Drugs

Team for Compilation of
Quality of Drug Control
Policy and Strategic
Studies in the Drug Sectorof Narcotics

Roles and Position of Pharmacists inIndonesia48

2. GOOD PRACTICE: REGULATION MAKING

3. DIFFICULTIES/LESSONS LEARNEDFROM PAST EXPERIENCE

49

INTERESTTERIMA KASIHTHANK YOU50

5. LaosCOUNTRY REPORTFORRegulatory Systems on Ensuring Access to Quality Medicine(JFY 2023)(July 6 – August 11, 2023)
Tokyo, JAPANMrs. Soutthida VONGSAVATH
Technical officer

Ministry of Health – Lao P.D.R
Drug and Medical Device Control Division, Food and Drug Department
Tel: (+ 856 -21) 214014; (+856-21) 226079
Fax: (+ 856 -21) 213495
Website: www.fdd.gov.la51

1. Organizational Chart

Ministry of HealthCabinet of the Ministry
Organization and Personnel
Dept.,

Cabinet of the National
Health Insurance Bureau
Health Promotion andHygiene Dept.,

Health Care Dept.,

Food and Drug Dept.,

Planning and finance Dept.,

Public Health Inspection
Dept.,

Education and Scientific
Research Dept.,

Communicable Disease
Control Dept.,

52

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

Food and Drug Organization Chart

Food and Drug Department

Administration Div.,
Drug Registration
Committee

Drug And Medical Device Control
Div.,
Food Control Div.,

Essential Medicine
Committee
Food and Drug
Committee

Pharmacy Hospital Management Div.,
Narcotic-Chemise-Cosmetic Control Div.,
GMP
Committee

Traditional Medicine Control Div.,
Information Education and Communication Div.,

Bureau of Food and Drug Inspection (BFDI)
Food and Drug Quality Control Center
Medical Product Supply Center
Manufacture No.2 and No.3
18 Provincial Food and Drug Unit

◆ Vision:-

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

53

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

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

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

The Food and Drug has responsibility for consumer protection on food and drug based on
the Forth MoH’s action plan, In the Organizational structure of the food and drug
Department there are seven divisions in the organization chart, for the Drug Control
Division is a one in Charge of the Pharmaceutical Regulatory Systems on Ensuring Accessto Quality Medicine and for the Pharmacy Hospital Management Division Ensuring
access the Essential medicines, Rational use of medicines and Pharmacovigillance in
Health facility.

2. Legislation on Pharmaceutical administration
The Legislation establishment is one of the thirteen elements (priorities) in the National
Policy to assure that the successful implantation of the Drug policy through using therelated, updates appropriate law and regulations. The first Law on Drug and Medical
Product endorsed and promulgated in the late year 2000, the law consist 8 sections and 45
articles, based on this law, many related regulations as listed below had been formulated
and revised in order to facilitate the control and management on the quality safety andefficacy of medicine.
1. Revised National Drug Policies, dated on 13/8/2003
2. Revised Drug and Medical Product law issued in 21 December 2011
3. Degree for National Health Insurance No. 470/Gov., dated 17 Oct 2012
4. Degree for Traditional Medicine No. 155, dated 30 Sep 2003
5. Regulation for Drug registration No. 1441, dated 13 Aug 2003
6. Regulation Establish Factory and Company No. 1820, dated 25 Aug 2017
7. Regulation for Pharmacy No. 2922, dated 21 Sep 2016
8. Regulation for good manufacturing practice and quality control of drugs No.
1021, dated 11 Aug 1999
9. Regulation on Good Manufacturing Practice No. 937/MOH, 12/07/2004

5410. Regulation for disposal of medicines including vaccines No. 1862, dated 05 Aug
2016
11. Decision/Approval based on National medicine policy main goal and related
components
12. Regulation of Donation of Drugs and Medical Product No.2579/MoH dated 12th
Nov 2003 concerning Drug and Medical Equipment Donation.
13. Regulation on the banned drug in Lao No.1018/MOH in 2003
14. Regulation on specific controlled medicine and uncontrolled and OTC Drug
No.2580/MOH, on 25/11/2002
15. Regulation on concerning Food, Drug and Medical Equipment Advertisement
No. 2581/MOH in 2003
16. Revolving Drug Fund Guideline
17. Lao Pharmacovigillance Guideline
18. Good Manufacturing Practice Guideline
19. The ASEAN common technical dossier (ACTD) for the registration of thepharmaceuticals for the human use.
20. SOP for recall Drug and medical Product21. SOP for fast track registration
22. Quality Management System (QMS) Manual
23. Good Regulatory Practice (GRP) Guideline
24. Draft revised Drug regulation
25. Draft Medical device regulation

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

3. Regulatory Services

55

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

Licensing of manufacturing site:

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

Licensing pharmaceutical Company and pharmacy:

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

-

Drug Registration System:

According to the regulation No. 1441, on August 13, 2003 covering drug registration in
Lao PDR, every drug before marketing must be registered. The drug selection forregistration is mainly based on National Essential Medicine List and needs of hospitals.
Now the drug products has registered about 2 372 items (June,2023), there are the importproducts 1 935 items and the local production 437 items and traditional medicines and
Health supplement registered more 600 items.
In registration system, after 3 years the companies have to submit application forms forrenewal of registration. The procedure of registration is divided into 2 steps:•

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

•

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

The drug Import/Export must only be license Certificate of the pharmaceuticalcompanies and the product must be registered, for the process the pharmaceuticalcompanies must be submit the documentation of import to Food and drug Department asfollowing detail:56

- Letter from the company for importation request- Purchase order- Invoice- Packing list.
In current, There is no any pharmaceutical product exported since the capacity ofdomestic pharmaceutical manufacturer still not reach the ASEAN GMP requirement.
Remark: For Donation of Drugs and Medical Product from Health Program not to beregistered, the document that required are:
- Letter from the Health Program for importation request- Purchase order- Invoice- Packing list
- Certificate of Origin- Certificate of Analysis- GMP- For Vaccine there should have Certificate of lot release and Prequalified from WHO.
◆Marketing Authorization

The marketing authorization for import pharmaceutical products is as mentioned
above, the importer must has the license Certificate and the product must be registered,
for the domestic manufacturer must has the GMP certificated which is issued by Ministryof Health Lao PDR, and the pharmaceutical products must be sent to the Food and Drug
Quality Control Center for analysis, the registration of the products must be after getting
their Certificate of Analysis. The registration certificate is invalid in 3 years period,
therefore the domestic and import products must be re-registering in every 3 years.
◆Drug Distribution ( including drug selection, procurement, sale )The Ministry of Health established Procurement and Supply Committee for
Medicines and Medical Products No. 0150 / SAT in January 24, 2017. This Committee
has been revised o 22 March 2019, No. 0583.
This Committee consists of Food and Drug Department, Finance Department,
Cabinet, Department Health Care and Rehabilitation, Department of Health Education andresearch, Department of Planning and Cooperation, and other related Ministry. Under
Food and Drug Department, the Medical Product Supply Center is appointed as a57

coordination agency for facilitating procurement process of medicines and medical
products.
In the past, decentralized system was use for procurement of medicines and medical
products, but now the food and Drug department and the Medical Product Supply Centerstarted central tendering procurement for the 5 central hospital and 17 provinces.
◆ Medicine Safety ( post-marketing )The Food and Drug Department in cooperation with the Bureau of Food and Drug
Inspection and the Food and Drug Quality Control Center play a key role in monitoring
quality and safety of pharmaceutical products in the market.
For inspection in Public and private sector is conducted once year using the 10
indicators for monitoring as following:
1. Order in the Pharmacy
2. Banned drug
3. Availability of ED with INN + clear label
4. Quality of Drug + Expiry date
5. The correct bill
6. Drug dispensing
7. Knowledge of drugs sellers
8. Prescription for antibiotics drug
9. Essential equipment and documents
10. Presence of technical staff
One of the requirements for drug registration is that a sample of the productshould b e sent for analysis. Since the company applying for registration selects theregistration sample, it might not necessarily be representative of the quality of the productthat will be eventually marketed. Post-marketing surveillance, i.e. analysis of sample
taken from the distribution chain by the BFDI, essential to identify substandard andcounterfeit products.

4. Drug Pricing
There is no pricing control in private sector. In Public sector the guideline on drug
revolving fund has been use for pricing of medicines with 25% markup. However,currently the National Health Insurance Bureau has implemented health insurance
program using capitation and case based payment.

58

There has been an issue of high price of medicines in the country. Therefore the Food andDrug Department conducted a survey on Medicine price and availability in Lao PDR in 2013 using
WHO/HAI methodology. The results of this survey has highlighted several areas in need ofattention for further in-depth study and development of new policies/regulations to increaseaffordability and availability of essential medicines in the country as core element of good quality
health services. Also, increase procurement distribution efficiency and/or new medicine pricing
policies/regulation can result in higher availability and affordability of essential medicines andimproved access for all. Most importantly, access to affordable medicines can make further
progress towards Universal Health Coverage (UHC) as high prices of medicines can be a burden
to the patients for access to health care services particularly the poor to cover Lao populationa scoping exercise on medicine pricing control has been conducted and there has been somerecommendation for the next step in term of medicines pricing control.

5. Statistic Dataa/. Number of Pharmacists(Average number of Pharmacists)
Data

3812

Years

2023

b/. Number of GMP inspectionData

27 (only Drug Product Manufacturer Committee)

Years

2023

c/. Number of Pharmaceutical manufacturers/ manufacturing sites
Data

13

Years

2023

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

5

Years

2023

e/. Number of traditional medicine household
Data

35

Years

2023

59

f/.Number of pharmaceutical importers
Data

104

Years

2023

g/. Number of pharmaceutical wholesalers
Data

12

Years

2023

6. Information on your hospital pharmacy
N/A
7. Education and License of Pharmacists in your country( 1 ) Number of years in primary, secondary and high school education
Items

NumberPrimary

5 years

Secondary

4 years

High school

3 Years( 2 ) Number of years / weeks in the following categories during university or college
Sample for Pharmacist Education:
Items

NumberUniversity / college:

5 years

Professional education:

2 years

Practical training:

2 years

Duration of training by each facility:

0.3 year

Hospital pharmacy:

4 weeks

Community pharmacy:

4 weeks

Pharmaceutical company:

4 weeks

Others:4 weeks

Age at graduation:

25 years old60

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

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

15 %Community Pharmacy

40 %Government Organization

30 %Enterprise

15 %Others5%References:-

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

Pharmacy Hospital Management Division, Food and Drug Department (MoH)-

Traditional medicine and Health supplement Control Division, Food and Drug
Department (MoH)-

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

-

Administration and Statistic Division of Mahosod Hospital-

Administration and Statistic Division of University of Health Science.

61

LAO PDR
Food and Drug Department

Ministry of Health
Mrs Soutthida VONGSAVATH

OutlineI. MoH and FDD Organization chart
II. Regulatory services that engaged inIII. roles and position of pharmacists in my country
IV. Achievements
V. Difficulties/Lessons Learned from Past
Experience
VI. ChallengeVII. My interests

62

Organization Chart of MoH
Ministry of HealthCabinet of the Ministry
Cabinet of the National Health
Insurance Bureau

Organization and Personnel Dept.,

Health Promotion and Hygiene
Dept.,

Health Care Dept.,

Food and Drug Dept.,

Planning and finance Dept.,

Public Health Inspection Dept.,

Education and Scientific Research
Dept.,

Communicable Disease Control
Dept.,

Organization Chart of FDD

63

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

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

Policy, Law, Regulation, SOP and Guideline
National Drug Policies, dated on 13/8/2003
Law on Drug and Medical Products No: 07/NA , review on date: 21 December 2011.

Degree for National Health Insurance No. 470/Gov., dated 17 Oct 2012
Degree for Traditional Medicine No. 155, dated 30 Sep 2003
Regulation for Drug registration No. 1441, dated 13 Aug 2003.
Regulation for Pharmacy No. 2922, dated 21 Sep 2016.
Regulation Establish Factory and Company No.1820, date 25 Aug 2017.
Regulation for good manufacturing practice and quality control of drugs No. 1021, dated 11 Aug
1999.
Regulation on Good Manufacturing Practice No.937/MoH dated 12/07/2004.
Regulation for disposal of medicines including vaccines No.1862, dated 05 Aug 2016.

64

Policy, Law, Regulation, SOP and Guideline
Regulation on the banned drug in Lao No.1018/MoH in 2003.
Regulation of Donation of Drugs and Medical Product No.2579/MoH dated 12 th Nov
2003.
Regulation on specific controlled medicine and uncontrolled and OTC Drug
No.2580/MOH, on 25/11/2002
Regulation on concerning Food, Drug and Medical Equipment Advertisement
No. 2581/MOH in 2003
Revised Drug regulation 2023
Regulation on the medical device registration 2023
Regulation on Price control 2023

I Introduction of the work
Job tenure: 8 years
Engaged Regulatory services in:- Evaluation on Import Permit of Drug and medical
devices- Evaluation and Monitoring of Good Pharmacy
Practice of Private Pharmacy- Evaluation on Application of Drug destruction

65II. Roles and position of pharmacists in Laos

1.Pharmacists in hospitals- Validate prescription and drug dispensation.
- Manage the supply chain of drug store
2. Pharmacists in Research-Carrying out in analytical research of drugs and clinical trial
3. QA,QC and Production staff, pharmacist license holder inpharmaceutical factories
4. Academic pharmacists (Faculty of pharmacy, UHS)
5. Sale, pharmacist license holder in pharmaceutical companies
6. In-charge in private pharmacies-Manage GPP and GSP of pharmacies
7. Technical officer at Ministry of Health
8. GMP inspector

III. Good Practice

Achievements
Revised Drug regulation, 2023
Regulation on the medical device registration, 2023
Regulation on Price control, 2023
Revised indicator of GPP inspection
GPP training to 108 pharmacies in 5 provinces(VTE, Vientiane, LPB, CPS, SVK)
Completed monitoring GPP implementation after
training
66

IV. Difficulties/Lessons learned- Limited Knowledge of GPP- Insufficient budget to improve the premise for the Owner- GPP inspection- Unregister medicines circulated in both public and private sector- Drug Price in whole country is very different- Review of Biological products and New Drug
- Availability Essential Medicine in some health facility under 85%

V. Challenge
Limited resource
Insufficiency of English skills
Limited expertise on review biological product
Lack of experience to implement the price control
Preparedness to new Online registration of drug products

67VI. My interests- The implementation of Price control- Risk management plan
- Drug licensing and approval system- Countermeasure against Counterfeit

Thank you68

6. Timor-Leste
PowerPoint Material only

Ministry of Health Timor-Leste

Delfim Da C.X.Ferreira
National Director of Pharmacies and Medicines
Head of NRA (Regulatory System)

1.Introduction

1.364,242 habitants (2022)
Life expectancy at Birth (2022) was total
71.5 years (M) 70 (F) 72.4.
13 Municipalities
1
1 Autonomy region (RAEOA-Oecusse)

The National Health System and Organic law of
MoH Timor-Leste(8th Government Constitutional)

Guarantee the availability of the
medicines and others pharmaceuticals
products for the country needs.
Planning and controlling the use of
medicines (quality-safety-efficacy) andothers pharmaceuticals products for the2
country.

2.Good Practices and Ongoing Projects

TLEML ( Essential Medicines List)and STGs implemented
International collaborations (TGA
Australia, WHO and others SEARN
countries)
Pre-benchmarking Assessment of
WHO experts ( ML 1)
Timor-Leste Electronic Single
Window piloted
Attending International and regional
training workshop
Priority adoption of the NMP
appears crucial to improve theregulation of medical products inTimor-Leste.

3703. Difficulties/Lessons Learned from Past Experience

Cross-Cutting challenges

ExamplesCurrent legal framework outdated
Stock out of the medicines ( frequently)
Fragmented organization and duplication of work
Inefficient communication within and between the NRAs
Absence of Quality Management System
Inadequate facilities and IT infrastructure
Insufficient resources to effectively regulate

4

4. Your interests(1) To gain Good Understanding how todevelopsthe Registration and Marketing
Authorization systm(2) To have Understanding on how to Develops
procedures and guideline of maket surveylanceand control(3) Well Understanding on regulatory inspections
procedures

5

THANK YOU
OBRIGADO72

出典：2023 年度 JICA 課題別研修「適正な医薬品の供給・品質管理・使用に向けた薬事行政」
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