Regulatory Systems
on Ensuring Access to Quality
Medicines

Country Reports
FY2021

Japan International Corporation of Welfare Services (JICWELS)Contents
1. Indonesia ………………1
2. Lebanon ………………..21
3. Palestine ……………….31
4. South Africa……………47

5. Thailand………………..58
6. Timor-Leste……………79

7. Uganda…………………91

1. Indonesia

1Indonesia

The Indonesian Food and Drug
Authority(Badan POM)
Alsya Utami Rahayu
JICA Knowledge Co-Creation Program
Regulatory Systems on Ensuring Access to Quality Medicines
January 25th, 2022

The Indonesian FDA (Badan POM)
Structure
Chairperson

Principal Inspector

Inspector I

Deputy for Drug, Narcotic,
Psychotropic, Precursor,
Addictive Substance Control

Permanent Secretariat

Inspector II

Deputy for Traditional Medicine,
Health Supplement and Cosmetic
Control

Bureau ofPlanning
andFinance

Bureau ofLegal and
Organization

Deputy for Processed Food
Product Control

Bureau of
Cooperation
and Public
RelationshipBureau of
Human
Resources

Deputy for Law
Enforcement

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

Directorate of Traditional
Medicine, HealthSupplement and Cosmetic
Standardization

Directorate ofProcessed FoodStandardization

Directorate of ceaseand desist

Directorate of Drug Registration

Directorate of Traditional
Medicine, HealthSupplement and Cosmetic
Registration

Directorate ofProcessed Food
Registration

Directorate of Drugand Food Intelligence

Directorate of Drug, Narcotic,
Psychotropic, Precursor
Production Control

Directorate of Traditional
Medicine, and HealthSupplement Control

Directorate ofProcessed Food
Production Control

Directorate of Drugand Food Cyber

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

Directorate of Cosmetic
Control

Directorate ofProcessed FoodDistribution Control

Directorate of Drugand Food
Investigation

Directorate of Safety, Quality, andExport-Import of Drug, Narcotic,
Psychotropic, Precursor, andAddictive Substance Control

Directorate ofCommunity and Traditional
Medicine, Health Supplement
and Cosmetic Industries
Empowerment

Directorate ofCommunity and Food
Processed Industries
Empowerment

Center of Drug and Food
Information

Center of Human
Resources Development

Center of National Quality Control
Development of Drug and Food

2

Bureau ofGeneralAffairs and

34 Provincial Offices
39 District Offices

Center of Drug and Food
Research and Studies

Departement Structure
Directorate of Drug, Narcotic, Psychotropic, Precursor, Addictive Substance Standardization,
Consist of 3 (three) substance:

Standardization of Quality
Drugs, Drug Ingredients,
Narcotics, Psychotropics, andPrecursors

Standardization of Efficacy and
Safety of Generic Drugs andProduct Information of Addictive
Substances

2019 - Now

Standardization of Efficacy,
Safety, and Information on Drug
Products and Drug Ingredients

Standardization of Production
and Distribution of Drugs, Drug
Ingredients, Narcotics,
Psychotropics, Precursors, andAddictive SubstanceStandardization of Efficacy and
Safety of New Drugs, Biological
Products, and New
Development Drugs

Operational Procedure

Job Tenure and Regulatory Services

Preparation of materials and implementation of policies
Preparation of norms, standards, procedures, criteria
Implementation of technical guidance and supervision
Monitoring,evaluation,
andreportingof
implementation of Standardization of Efficacy and
Safety of Generic Drugs and Product Information of
Addictive Substances

Roles and Position of Pharmacists
in Indonesia
Undertaking pharmaceutical work in procurement of pharmaceuticalpreparations in production facility, distribution facility and pharmaceutical careensuring the safety, quality, benefits and efficacy of pharmaceuticalfacility
preparation
Undertaking pharmaceutical work in production of pharmaceuticalensuring compliance with the GMP (responsible person in
preparations
production, QC, and QA Departement)
Undertaking pharmaceutical work in distribution of pharmaceuticalpreparations ensuring compliance with the GDP (responsible person in drug
distribution facility)
Undertaking pharmaceutical work in pharmaceutical careensuring
compliance with the pharmaceutical care standard (responsible person in
Pharmacy, Hospital Pharmacy Installation, Community Health Center, Clinic,
Drug Store, Shared Physician Practice)In undertaking pharmaceutical work, pharmacist shall ensure
and maintain the implementation of Quality Management
3
System3

Good Practice: Regulation Making

Drafting

Identification of legislative needs,
prepare materials for regulation

Discussion

Discussion of regulatory content withinternal or related stakeholders

Publicconsultation

Public consultations are conducted tosolicit input from stakeholders on the draft
regulation that has been prepared

Harmonization

jdih.pom.go.id

To harmonize and not overlap
With other regulations

Socialization

standarobat.pom.go.id

Difficulties/Lessons Learned from Past Experience

Unavailable regulations
for health emergencies

Needs making regulations forhealth emergencies
Emergency Use Authorization(EUA)
Expanded Access Program(EAP)

Launching information system(SISOBAT)The lack of equal
understanding on drug
legislation
4

Publication anddissemination ofregulation

Interest
The regulatory management inJapan for access to quality medicines
including regulatory system, as wellas trends of international
collaboration among regulatory
authorities

improve my knowledge in roles ofRegulatory System on Ensuring
Access to Quality Medicines.

Observe and identify process thatcan be improved in drug regulatory
systemThank You
Terima Kasih

5Indonesia
Regulatory Systems on Ensuring Access to Quality Medicines （JFY 2021）
Name

: 1.

Farida Ami Asviah

2.

Alsya Utami Rahayu

Country: Indonesia

Organization/: Indonesian FDA (Badan POM)/

Departement/

1.

Division

Directorate of Safety, Quality, and Export-Import Control of Drug, Narcotic,
Psychotropic, Precursor, and Addictive Substance/Subgroup of Quality Control of Drug,
Narcotic, Psychotropic, and Precursor

2.

Directorate of Standardization of Drug, Narcotic, Psychotropic, Precursor, andAddictive Substance/ Subgroup of Standardization of Efficacy and Safety of Generic
Drugs and Product Information of Addictive Substances① Organizational Chart
The organizational chart of Indonesian FDA (Badan POM) at national & provincial/district levels (Attachment 1).
Indonesian Food and Drug Authority or Badan POM is assigned and functioned as national regulatory authority on
pharmaceutical administration in Indonesia. Indonesian FDA is a National Regulatory Authority (NRA) on Drugand Food in Indonesia that administers government affairs in the sectors of drug, traditional medicine, healthsupplement, cosmetic and processed food control, which responsible directly to the President.
To address the current challenges in drug control, the President of Republic of Indonesia had released the legal basis
to strengthen the medicine control which has effectively empowered the Indonesian FDA, particularly in the context
of law enforcement and improving the drug and food control effectiveness.
There are 3 Deputies under the Chairperson of Indonesian FDA which responsible on specific products, and also 1
Deputy for Law Enforcement. With regard to Indonesia’s large territory, Indonesian FDA has a large coverage thus
we are supported by 34 regional offices in provincial level and 39 district offices in smaller cities. The total numberof staff is approximately 5.000 across the country, and the number is increasing gradually with the commitment of
the Indonesian Government to continuously strengthen drug and food control in Indonesia.
Vission:Drugs and food are safe, quality, and competitive to realize a sovereign developed Indonesia, independent, and has
a personality based on cooperation.
Mission:1.

Build excellent human resources related to drug and food by developing partnerships with all components 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 independence of the nation.

3.

Increase the effectiveness of drug and food control and law enforcement of drug and food crimes through thesynergy of the central and regional governments within the framework of the Unitary State to protect the whole
nation and provide a sense of secure to all citizens.

4.

Clean, effective, and reliable government management to provide excellent public services in the field of drug
and food.

6Indonesia② Legislation on pharmaceutical administration
In national level, legislation on pharmaceutical administration is conducted by Indonesian FDA (Badan POM),
under the Deputy for Drug, Narcotic, Psychotropic, Precursor, Addictive Substance Control. The technicalimplementation of drug control locally is conducted by provincial/district offices in 34 provinces.
◆

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 Effectiveness Improvementadministered by President◆

Local Level
・ Regulation of The Indonesian FDA No. 21/2020 regarding Organization in Indonesian FDA administeredby The Chairperson of The Indonesian FDA
・ Regulation of The Indonesian FDA No. 23/2021 about amendment to Regulation of The Indonesian FDA
No. 22/2020 regarding Organization Techinal Unit In Indonesian FDA administered by The Chairpersonof The Indonesian FDA◆

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 Badan POM, under the Deputy for Drug, Narcotic,
Psychotropic, Precursor, Addictive Substance Control, which responsible for the administration of:◆Pharmaceutical Manufacturing
Standard: Regulation of the Head of Badan POM on Indonesian GMP Guideline, 2018 edition

Administered by : Directorate of Drug, Narcotic, Psychotropic, Precursor Production Control◆

Drug Import/Export
Standard: Regulation of the Minister of Health and Regulation of the Head of Badan POM
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 Substance (Subdirectorate of Export andImport Control of Drug, Narcotic, Psychotropic, and Precursor)◆

Marketing Authorization
Standard: Regulation of the Minister of Health on Drug Registration,
Regulation of the Head of Badan POM on Criteria and Procedure of Drug Registration

Administered by : Directorate of Drug Registration

7

Indonesia◆

Drug Distribution
Standard: Regulation of the Head of Badan POM on Indonesian GDP Guideline, 2020 edition

Administered by : Directorate of Drug, Narcotic, Psychotropic, Precursor Distribution and Service
Control◆ Medicine Safety (post-marketing)Standard: Regulation of the Minister of Health on Pharmaceutical Industries,
Regulation of the Minister of Health on Standard of Pharmaceutical Service in Hospitals,
Regulation of the Minister of Health on Standard of Pharmaceutical Service in Public
Health Centers,
Regulation of the Minister of Health on Standard of Pharmaceutical Service inPharmacy,
Regulation of the Head of Badan POM on the Implementation of Pharmacovigilance for
Pharmaceutical Industry.

Administered by : Directorate of Safety, Quality, and Export-Import Control of Drug, Narcotic,
Psychotropic, Precursor, and Addictive Substance (Subdirectorate of Safety Control ofDrug, Narcotic, Psychotropic, and Precursor)◆ 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 Vaccination in order toCountermeasures COVID-19 Pandemic④ Drug Pricing
Drug pricing policy is regulated and controlled by Ministry of Health.
⑤ Statistic Data
1.

Number of pharmacists:± 75.000 – 80.000 (2021)

2.

Number of GMP inspector (National & Local):± 153 (2021)

3.

Number of pharmaceutical manufacturers / manufacturing sites:± 228 (2021)

4.

Number of traditional medicine manufacturers / manufacturing sites:± 129 (2021)

5.

Number of pharmaceutical importers:± 81 (2021)

6.

Number of pharmaceutical wholesalers:± 2.146 (2021)⑥ Education and License of Pharmacists in your country（１） Number of years in primary, secondary and high school education
Primary:

6 years

Secondary:

3 years

High school:

3 years8

Indonesia（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) and practical 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 Indonesian FDA (Badan POM) consists of:
1. 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).
2. Reporting from pharmaceutical industries, consists of:a. Spontaneous reporting, using post mail to Badan POM, email to pv-center@pom.go.id or online reporting(http://e-meso.pom.go.id);b. Periodic safety update report;
c. Reporting of post marketing safety study;
d. Reporting of scientific publications/literature;e. Reporting of NRA regulatory action in other country;
f. Reporting of Marketing Authorization Holder action in other country;
g. 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:
1. Regulatory and pharmaceutical industy are collaborating in managing risk in term of risk-benefit ratio for
population.
2. Healthcare professionals and healthcare facilities manage risk in term of risk-benefit ratio for patients.
3. Patients manage risk in term of personal values.

9Indonesia
Attachment 1
The organizational chart of Indonesian FDA (Badan POM) at national & provincial/district levels

10Indonesia

Indonesia FDA (Badan POM)
Farida Ami Asviah
JICA Knowledge
g Co
Coo-Creation ProgramgRegulatory Systems on Ensuring
g Access to Quality Medicines
January 25th, 2022

Indonesian FDA (Badan POM) Structure
Chairperson

Principal Inspector

Inspector I

Deputy for Drug, Narcotic,
Psychotropic, Precursor,
Addictive Substance Control

Permanent Secretariat

Inspector II

Deputy for Traditional Medicine,
Health Supplement and Cosmetic
Control

Bureau ofPlanning
andFinance

Bureau ofLegal and
Organization

Deputy for Processed Food
Product Control

Bureau of
Cooperation
and Public
RelationshipBureau of
Human
Resources

Deputy for Law
Enforcement

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

Directorate of Traditional
Medicine, HealthSupplement and Cosmetic
Standardization

Directorate ofProcessed FoodStandardization

Directorate of ceaseand desist

Directorate of Drug Registration

Directorate of Traditional
Medicine, HealthSupplement and Cosmetic
Registration

Directorate ofProcessed Food
Registration

Directorate of Drugand Food Intelligence

Directorate of Drug, Narcotic,
Psychotropic, Precursor
Production Control

Directorate of Traditional
Medicine, and HealthSupplement Control

Directorate ofProcessed Food
Production Control

Directorate of Drugand Food Cyber

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

Directorate of Cosmetic
Control

Directorate ofProcessed FoodDistribution Control

Directorate of Drugand Food
Investigation

Directorate of Safety, Quality,
and Export-Import of Drug,
Narcotic, Psychotropic,
Precursor, and Addictive
Substance Control

Directorate ofCommunity and Traditional
Medicine, Health Supplement
and Cosmetic Industries
Empowerment

Directorate ofCommunity and Food
Processed Industries
Empowerment

Center of Drug and Food
Information

Center of Human
Resources Development

Center of National Quality Control
Development of Drug and Food

11

Bureau ofGeneralAffairs and

34 Provincial Offices
39 District Offices

Center of Drug and Food
Research and Studies

Departement Structure
Directorateteeo
off SaSafety,S
afetyy, QuaQuality,
Q
ality
y, a
and
nd
d Ex
ExportExporrrttt-Import
-Im
m o
mpo
orrrtt Contr
ControlC
ontrrool ofo Drug,g, Narcotic,c, Psychotropic,
Precursor,
r, andd Addictive
e Substance,e, consist
st ofo 4 group
up:
up
Safety Control ofDrug, Narcotic,
Psychotropic, andPrecursor

Export and Import
Control of Drug,
Narcotic,
Psychotropic, andPrecursor

Quality andProduct
Information
rmation Contro
Con
Controloloof Drug, Narcotic,,
Psychotropic,
ychotropic, andan
Precursor

Quality Control off
Drug, Narcotic,
Psychotropic,
ychotropic, andaPrecursor

Product Information
Control of Drug,
Narcotic,
Psychotropic, andPrecursor

Tobacco Product
Information Control

 Preparing materials for policy-making
and policy implementation in the field ofquality control of drug.
 Preparing norms, standards, procedures,
criteria, technical guidance andmaterials supervision in the field ofquality control of drug.
 Preparing guidance of post market
sampling of drug.
 Evaluating substandard drug reports andtaking regulatory actions.
 Evaluating CAPA of substandard drug
which submitted by pharmaceuticalindustry.
 Providing national report of quality
control of drug.

Job Tenure and Regulatory Services

March 2018 – present: Directorateof Safety, Quality, and ExportImport of Drug, Narcotic,
Psychotropic, Precursor, Addictive
Substance Control

2010 – February 2018: Directorateof Production Control of
Therapeutic Product and Household
Medical Supplies

Evaluator of post marketing quality
surveillance:

Evaluating substandard drug reports (fromprovincial/district offices, pharmaceuticalindustry, public, and other stakeholders).
Propose appropriate regulatory action
against substandard drug based on
evaluation results.
12Roles and Position of Pharmacists
in Indonesia
Undertaking pharmaceutical work in procurement of pharmaceuticalpreparations in production facility, distribution facility and pharmaceutical carefacility Æ ensuring the safety, quality, benefits and efficacy of pharmaceuticalpreparation
Undertaking pharmaceutical work in production of pharmaceuticalpreparations Æ ensuring compliance with the GMP (responsible person in
production, QC, and QA Departement)

Undertaking pharmaceutical work in distribution of pharmaceuticalpreparations Æ ensuring compliance with the GDP (responsible person in drug
distribution facility)
Undertaking pharmaceutical work in pharmaceutical care Æ ensuring
compliance with the pharmaceutical care standard (responsible person in
Pharmacy, Hospital Pharmacy Installation, Community Health Center, Clinic,
Drug Store, Shared Physician Practice)In undertaking pharmaceutical work, pharmacist shall ensure
and maintain the implementation of Quality Management
4
SystemGood Practice: Post Market Quality Surveillance• Combining
targeted (riskbased) anddrandomsampling
strategiess• Updating regulationonnon the withdrawal andannddisposal of
substandard drugss Æ
on going, carried out
together with related
ted
departments

Sampling
Policy andPlanning

Laboratory
Testing

Regulatory
action against
substandard
drugs

AAvailabilityofmonographs/
analyticalmethods

13• Regionalization
concept to
optimize
laboratory testingÆ on going,
handled by Centerof National Quality
Control
Development ofDrug and Food

• Coordinating
Coowith related
departments
for thedep
developmentof
dev
analyticalmethods andana
updatingof monographs
upd
on pharmacopoeia
andprelevant
regulations Ælon going

Difficulties/Lessons Learned from Past Experience

Follow-up of new• Needs to develop analytical
impurity compound
methods for testing impurities and
OOS report (previously studies to determine the impurity
thresholdunknown)• Needs adequate risk assessment todetermine appropriate follow-up

Quality control ofmarketed COVID-19
vaccine with limited
data/under research• Needs intensive communication
with the pharmaceutical industry(EUA holder) and related
department regarding vaccine
quality control

Interest
Regulatory system for post-marketing quality surveillance,
including:Regulation forpost-marketing
qualitycesurveillance

Quality testing of Regulatory action
drugs andagainstsubstandard drugs
vaccines14

Thank You
Terima Kasih
ⅱ↹ⅻ↗ⅵↃↅⅳ↭ↈ

15

Indonesia

Regulatory Systems on Ensuring Access to Quality Medicines （JFY 2021）
Name

: 1.

Farida Ami Asviah

2.

Alsya Utami Rahayu

Country: Indonesia

Organization/: Indonesian FDA (Badan POM)/

Departement/

1.

Division

Directorate of Safety, Quality, and Export-Import Control of Drug, Narcotic,
Psychotropic, Precursor, and Addictive Substance/Subgroup of Quality Control of Drug,
Narcotic, Psychotropic, and Precursor

2.

Directorate of Standardization of Drug, Narcotic, Psychotropic, Precursor, andAddictive Substance/ Subgroup of Standardization of Efficacy and Safety of Generic
Drugs and Product Information of Addictive Substances① Organizational Chart
The organizational chart of Indonesian FDA (Badan POM) at national & provincial/district levels (Attachment 1).
Indonesian Food and Drug Authority or Badan POM is assigned and functioned as national regulatory authority on
pharmaceutical administration in Indonesia. Indonesian FDA is a National Regulatory Authority (NRA) on Drugand Food in Indonesia that administers government affairs in the sectors of drug, traditional medicine, healthsupplement, cosmetic and processed food control, which responsible directly to the President.
To address the current challenges in drug control, the President of Republic of Indonesia had released the legal basis
to strengthen the medicine control which has effectively empowered the Indonesian FDA, particularly in the context
of law enforcement and improving the drug and food control effectiveness.
There are 3 Deputies under the Chairperson of Indonesian FDA which responsible on specific products, and also 1
Deputy for Law Enforcement. With regard to Indonesia’s large territory, Indonesian FDA has a large coverage thus
we are supported by 34 regional offices in provincial level and 39 district offices in smaller cities. The total numberof staff is approximately 5.000 across the country, and the number is increasing gradually with the commitment of
the Indonesian Government to continuously strengthen drug and food control in Indonesia.
Vission:Drugs and food are safe, quality, and competitive to realize a sovereign developed Indonesia, independent, and has
a personality based on cooperation.
Mission:1.

Build excellent human resources related to drug and food by developing partnerships with all components 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 independence of the nation.

3.

Increase the effectiveness of drug and food control and law enforcement of drug and food crimes through thesynergy of the central and regional governments within the framework of the Unitary State to protect the whole
nation and provide a sense of secure to all citizens.

4.

Clean, effective, and reliable government management to provide excellent public services in the field of drug
and food.

16

② Legislation on pharmaceutical administration
In national level, legislation on pharmaceutical administration is conducted by Indonesian FDA (Badan POM),
under the Deputy for Drug, Narcotic, Psychotropic, Precursor, Addictive Substance Control. The technicalimplementation of drug control locally is conducted by provincial/district offices in 34 provinces.
◆

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 Effectiveness Improvementadministered by President◆

Local Level
・ Regulation of The Indonesian FDA No. 21/2020 regarding Organization in Indonesian FDA administeredby The Chairperson of The Indonesian FDA
・ Regulation of The Indonesian FDA No. 23/2021 about amendment to Regulation of The Indonesian FDA
No. 22/2020 regarding Organization Techinal Unit In Indonesian FDA administered by The Chairpersonof The Indonesian FDA◆

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 Badan POM, under the Deputy for Drug, Narcotic,
Psychotropic, Precursor, Addictive Substance Control, which responsible for the administration of:◆Pharmaceutical Manufacturing
Standard: Regulation of the Head of Badan POM on Indonesian GMP Guideline, 2018 edition

Administered by : Directorate of Drug, Narcotic, Psychotropic, Precursor Production Control◆

Drug Import/Export
Standard: Regulation of the Minister of Health and Regulation of the Head of Badan POM
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 Substance (Subdirectorate of Export andImport Control of Drug, Narcotic, Psychotropic, and Precursor)◆

Marketing Authorization
Standard: Regulation of the Minister of Health on Drug Registration,
Regulation of the Head of Badan POM on Criteria and Procedure of Drug Registration

Administered by : Directorate of Drug Registration

17

◆

Drug Distribution
Standard: Regulation of the Head of Badan POM on Indonesian GDP Guideline, 2020 edition

Administered by : Directorate of Drug, Narcotic, Psychotropic, Precursor Distribution and Service
Control◆ Medicine Safety (post-marketing)Standard: Regulation of the Minister of Health on Pharmaceutical Industries,
Regulation of the Minister of Health on Standard of Pharmaceutical Service in Hospitals,
Regulation of the Minister of Health on Standard of Pharmaceutical Service in Public
Health Centers,
Regulation of the Minister of Health on Standard of Pharmaceutical Service inPharmacy,
Regulation of the Head of Badan POM on the Implementation of Pharmacovigilance for
Pharmaceutical Industry.

Administered by : Directorate of Safety, Quality, and Export-Import Control of Drug, Narcotic,
Psychotropic, Precursor, and Addictive Substance (Subdirectorate of Safety Control ofDrug, Narcotic, Psychotropic, and Precursor)◆ 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 Vaccination in order toCountermeasures COVID-19 Pandemic④ Drug Pricing
Drug pricing policy is regulated and controlled by Ministry of Health.
⑤ Statistic Data
1.

Number of pharmacists:± 75.000 – 80.000 (2021)

2.

Number of GMP inspector (National & Local):± 153 (2021)

3.

Number of pharmaceutical manufacturers / manufacturing sites:± 228 (2021)

4.

Number of traditional medicine manufacturers / manufacturing sites:± 129 (2021)

5.

Number of pharmaceutical importers:± 81 (2021)

6.

Number of pharmaceutical wholesalers:± 2.146 (2021)⑥ Education and License of Pharmacists in your country（１） Number of years in primary, secondary and high school education
Primary:

6 years

Secondary:

3 years

High school:

3 years18

（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) and practical 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 Indonesian FDA (Badan POM) consists of:
1. 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).
2. Reporting from pharmaceutical industries, consists of:a. Spontaneous reporting, using post mail to Badan POM, email to pv-center@pom.go.id or online reporting(http://e-meso.pom.go.id);b. Periodic safety update report;
c. Reporting of post marketing safety study;
d. Reporting of scientific publications/literature;e. Reporting of NRA regulatory action in other country;
f. Reporting of Marketing Authorization Holder action in other country;
g. 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:
1. Regulatory and pharmaceutical industy are collaborating in managing risk in term of risk-benefit ratio for
population.
2. Healthcare professionals and healthcare facilities manage risk in term of risk-benefit ratio for patients.
3. Patients manage risk in term of personal values.

19

Attachment 1
The organizational chart of Indonesian FDA (Badan POM) at national & provincial/district levels

202. Lebanon

21

22

23

24

LebanonRegulatory Systems on Ensuring Access to Quality Medicines （JFY 2021）
Name:

Randa S. Hamadeh/Myriam Watfa
Country: Lebanon

Organization/Department/Division: Ministry of Public Health/ Pharmacy Service+ Quality Assurance of Pharmaceutical Products Program① Organizational Chart−Please attach the organizational chart of pharmaceutical administration at national/state & local levels aboutpharmaceutical administration in your country.
You may find the organizational chart of the different affiliated departments/services within the Ministryof Public Health (MoPH) in this link https://www.moph.gov.lb/en/Pages/9/1024/the-ministry . This chart
includes the public pharmaceutical services however no organizational chart is available for private
pharmaceutical entities.
−Please briefly describe each role and responsibility on pharmaceutical administration.
The Pharmacy Service at MoPH is the national regulatory authority for pharmaceutical products. Under
this Service, lies three departments: The import-export department, inspection department and narcotics
department. There are other programs at MoPH which do not fall under the Pharmacy Service however
have roles in the pharmaceutical administration such as the Expanded Program on Immunization, Primary
Health Care (PHC) Department, Quality Assurance of Pharmaceutical Products Program (QAPP), and ehealth program.
The Lebanese Order of Pharmacists' (OPL) mission is to raise the level of the profession. It also enforces
the laws, defends the rights of pharmacists, and improves the level of practice and development of scientificcompetence. It is also aiming at providing the conditions for enhancing the patient's access to theappropriate medications and its safe use.

② Legislation on pharmaceutical administration−Please briefly bulletined major laws/acts◆National Level
・https://www.moph.gov.lb/en/laws administered by Pharmacy Service at Ministry of Public Health・https://www.opl.org.lb/# administered by the Bylaws of Order of Pharmacists of Lebanon◆Local Level
NA・administered by◆International Level:
・ PIC/S:

Yes

OR

No

If yes, joined when・ Others if any
by

25

NA

Lebanon③ 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
・Systems, Regulations, etc.
・Good Laboratory Practice: GLP Lebanon 2017, self-assessment & evaluation of GLP Implementation
forLaboratories

dated

2017

Director

GeneralLetter

dated

2016

(availableon

https://www.moph.gov.lb/en/Pages/4/6642/quality-assurance-of-pharmaceutical-products ) administeredby the QAPP at MoPH.
・Good Manufacturing Practice: GMP Lebanon 2009, Minister Decision No.422/1 dated 2009, WHO
Progress

Report2010,

Country

Case

Study

and

Best

Practice(availableon

https://www.moph.gov.lb/en/Pages/4/6642/quality-assurance-of-pharmaceuticalproducts#/en/view/6645/good-manufacturing-practice) administered by the Pharmacy Service at the
MoPH.
・ Good Clinical Practice: Minister Decree No.1159/1 Date 23/6/2014 Concerning Clinical Trial
Regulations , IRB regulations, IRB Evaluation Report and Lebanon Clinical Trial Registry (LBCTR)(availableon

https://www.moph.gov.lb/en/DynamicPages/index/3/4760/clinical-trial-regulations)

administered by the Quality Assurance of Pharmaceutical Products Program※Example: Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice◆Drug Import/Export
・Systems, Regulations, etc.
・Regulations and requirements available on
https://www.moph.gov.lb/en/AdministrativeServices/index/1 administered by Import/Export
Department at MoPH.
◆Marketing Authorization
・Systems, Regulations, etc.
・Regulations and requirements available under “Registration of Pharmaceutical & Other Products”
available on https://www.moph.gov.lb/en/AdministrativeServices/index/1 administered by Import/Export
Department at MoPH.
・

Guidelines

for

the

Drug

Technical

Submission

available

https://www.moph.gov.lb/en/Pages/4/6642/quality-assurance-of-pharmaceutical-productsonadministeredby the QAPP at MoPH.
※Example: Good Quality Practice◆Drug Distribution (including drug selection, procurement, sale)・Systems, Regulations, etc.
・ Good Storage and Distribution Practices for food supplement and pharmaceutical products availableon

https://www.moph.gov.lb/en/Pages/4/6642/quality-assurance-of-pharmaceutical-products

administered by Quality Assurance of Pharmaceutical Products Program26

Lebanon◆Medicine Safety (post-marketing)・Systems, Regulations, etc.
・Regulations: Ministerial Decree No.13370 (2004), Ministerial Resolution No. 1636 (2013), Collaborative
Agreement (2016), PV Strategic Plan and Operational Plan (2020-2025), Ministerial Resolution No.
1438/1 (2019), Ministerial Resolution No. 427/1 (2020), Ministerial Resolution No. 556/1 (2020), Minister's
Decision No.180/1 (2021), Minister's Decision No.181/1 (2021), Memorandum No.8 (2021) available on
https://www.moph.gov.lb/en/Pages/4/44742/pharmacovigilance-system-lebanon administered by the QAPPat the MoPH
・Adverse

Event

ReportingForms:

https://www.moph.gov.lb/en/Pages/4/44742/pharmacovigilance-system-lebanon

available
administered

on
by

the

Quality Assurance of Pharmaceutical Products Program※Example: Good Pharmacovigilance Practice◆Relief System for Adverse Drug Reactions
・Systems, Regulations, etc.
NA
④ Drug Pricing−Please describe about price control and drug price mechanism at public sector in your country.
Public price is determined by an External reference pricing (ERP). It is one of the pricing policies adopted
by Lebanon, with different baskets of reference countries. This pricing policy is used to price originatorbrands and thereafter for most of the newly launched on-patent medicines in the country. The basket ofcountries to which the prices in each country are benchmarked varies. In Lebanon, prices arebenchmarked against three sets of prices with the lowest price adopted: ex-factory and patient selling priceof medicines in the country of origin; basket 1 which is composed of seven European countries; and basket
2 comprised of neighboring Arab countries. Regardless of the landed price at registration and the pricing
strategy used to set a registration price for a pharmaceutical, mark-ups are applied with different schemes
along the pharmaceutical supply chain in both countries. A decree detailing all the different mark-up
schemes is available to the public in Lebanon. In Lebanon, the MoPH decision 306/1 of 2005 wascontinuously reviewed with the latest update being Ministerial Decision 119/1 in 2020, adopting the lowest
price out of any of the price comparisons considered for registration. The different CIF and free-on-board(FOB) tranches were lately updated as well in decisions. The mark-up in Lebanon is variable andregressive depending on the CIF or FOB price and whether the medicine is exempted from taxes or not.
Mark-up includes custom duties, distributors and pharmacists’ margin. The public price is the one soldwithin community pharmacies. As for Lebanon where the market for generics is active, the price of generic
medicines is at least 30% less than their comparative originator. If no originator brand is registered, theprice of generics is reviewed once three generics are available in the market and average price is adopted.
Generally, the price of generic brands is pegged to the originator; this results in price review for bothoriginator and generic brands every 5 years. Hence, any change in the OB price is translated in a changeof the generic brand at a rate that equals half that of the originator. The MOPH in Lebanon is also
promoting the use of generics by supporting the local packaging and manufacturing of pharmaceutical as
expressed by a higher profit margin (higher mark-up schemes) applied to local manufactured generics. All
27

Lebanonregulations related to pricing are available on https://www.moph.gov.lb/en/Laws/index/10#/Laws/view/75
under ‫تسعير اﻷدوية‬Purchase and prices of medicines that are bought by governmental institutions (MoPH, army etc.) fallunder other schemes and procedures.
−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

8855 (2019)2.

Number of GMP inspector (National & Local)

NA

3.

Number of pharmaceutical manufacturers / manufacturing sites

12 (2022)

4.

Number of traditional medicine manufacturers / manufacturing sites

NA

5.

Number of pharmaceutical importers

120 (2022)

6.

Number of pharmaceutical wholesalers

10 to 15 (2022)⑤ Education and License of Pharmacists in your country（１） Number of years in primary, secondary and high school education
Primary

9 years

Secondary

4 years

High school

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

5 to 6 years (depending on the university)

Professional education:
Practical training:

4 to 5 years (practical trainings start after the 1st yearof Pharmacy school during summers and academic years)
Duration of training by each facility:
Hospital pharmacy:

6 weeks

Community pharmacy:

6 months

Pharmaceutical company:

Not required

Others:Laboratory training (8 weeks)

Age at graduation:

22 to 23 years old（３）Are there any national examinations for pharmacists in your country?
Yes
Academic Exams

2 daysClinical Exams

NA

No

28

Lebanon（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)
Training is mandatory to graduate from university and also necessary to prepare for the national
examination（５）Number of pharmaceutical university or college graduates: 6 pharmaceutical universities
The alumni's placement rate (%)
a. Hospital: 5% (2019)b. Community Pharmacy: 63.4% (2019)c. Government Organization: 3.7% (2019)d. Enterprise: 24% (2019)e. Others: 3.9% (2019)⑥ 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 Pharmacovigilance (PV) System in Lebanon includes many stakeholders:-

The government is responsible for providing all the support needed for the national PV Systemthrough well-established national policy and action plan.

-

The QAPPP at the MoPH, that is responsible for the implementation of quality standards related
to the safety of pharmaceutical products, aimed at ensuring that medicines reach the patient in asafe, effective and acceptable manner. The QAPPP oversees the implementation of the PV System.

-

The

Lebanese National Pharmacovigilance Center ( LNPVC) at the Faculty of Pharmacy -Lebanese University : http://phcvg-lebanon.com/index.php/en/phcvg-n/-

The WHO-PIDM which is the forum where member states can collaborate in PV. The PIDM is
responsible for policy issues, while the other partner, the Uppsala Monitoring Center (UMC)
conducts operations.

-

Other parties (e.g., Marketing Authorization Holder, Health-Care Providers, Public Health
Programs, Expanded Program for Immunization (EPI) and Primary Health Care Centers andpatients/consumers) responsible for reporting AEs which collaborate as main stakeholder to the
PV System through submitting Individual Case Study Reports (ICSRs) to the LNPVC.

Each medical institution/administrative agency has a (PV) focal point. The role of the PV focal point
is to make sure reporting forms are available in the respective medical setting, collect and centralize
notifications, validate forms’ content, send completed Adverse Event/Adverse Event Following
Immunization (AE/AEFI) Reporting Forms to National PV Center; and promote PV trainings andeducation in respective medical setting. In all cases, AE/AEFIs reporting forms are available on the
MoPH’s Website. The means of reporting are the same for medicines and vaccines except for COVID29

Lebanon

19 vaccines which fall under other means of reporting.
For COVID-19 vaccines, vaccine recipients experiencing any AEFI or PV focal points/healthcare
professional reporting on behalf of vaccine recipients can report through one of the following means:
1214 Hotline Call Center, IMPACT Platform established by MoPH, Vaccination Sites/Hospital Sites
through “Kobo tool box: AEFIs Software for reporting” or by direct contact with the PV program,
Preventive Medicine, Epidemiology Surveillance Program, Health Education and other departmentsfrom the MoPH. A case report refers to a report received by the PV Program which pertains to one
individual vaccine recipient who reported at least one adverse event after receiving the COVID-19
vaccine (i.e., temporally associated with the vaccine). All case reports are screened and validated fordata completion at the level of the PV Program. Incomplete or inconsistent case reports are followedup directly with the initial reporter. The case reports are classified as serious or non-serious cases.
The non-serious case reports are entered directly into the national web-based report management
system, VigiFlow, while serious cases go through a follow–up/ investigation and causality assessment
process before they are entered into VigiFlow.
As for the rest of vaccines and all medicines, patients experiencing any AE/AEFI can report throughone of these means: National AE/AEFI reporting form to be sent by email, e-reporting, hotline, andXML file to be sent by email (only applicable to Marketing Authorization Holders). All case reports
are screened and validated for data completion at the level of the PV Program. Incomplete orinconsistent case reports are followed-up directly with the initial reporter. The case reports areclassified as serious or non-serious cases. The non-serious case reports are entered directly into
VigiFlow, while serious cases go through a follow–up and causality assessment (without investigation)
process before they are entered into VigiFlow.

30

3. Palestine

31

StateofPalestine
MinistryofHealth
Reem Hijaz

to ensure that efficient, safeand good quality medicinesareaffordable,

accessible

and rationally used.

32

Pharmaceutical Quality
Dept.

Lot release

Human

Receiving/ Evaluationof COA

Inspection on
manufacturers

ReceivingComplaints/ recalls

Veterinary

Evaluation

Investigation

Food
supplements

Follow up

Human
VeterinaryComplaints/ recall

Cosmetics/
antiseptics
Herbal andfood
supplement

Medical devices
and antiseptics

Regulatory services engaged in…………….
¾Preparing the structure, organogram and responsibilities, laws……of the Palestinian Food and Drug safety Agency (PFDA).
¾Writing the SOP’s related to Pharmaceutical Quality control
Department.
¾Follow up complaints and recalls.
¾Releasing the first three lots after registration.
¾Licencing and Conducting inspection on pharmaceuticalmanufacturers.
¾Evaluating

certificatesofanalysisforproducts and conducting investigation if needed.
33

pharmaceuticalRole of pharmacists in Palestine
Pharmacists
GDP

Primary Health
Cares
Pharmaceuticalmanufacturers and stores

Hospitals
Community
pharmacy

Academicscheme*NGOs, Insurance companies….

Good Practices
Achievements¾ A national framework for good governance for medicines(GGM), starting up stage III.
¾ GDP has adopted ISO 9001:2015¾ Established instructions for registration pharmaceuticals
and

for

research

licensing&laboratories,

pharmaceuticaldevelopment
generalcenters,

guidelines

manufacturers,
Pharmaceutical
and

law

bioequivalence studies.
¾ Launching pharmacovigilance program activities.
34

forSolutions for past problems¾ Developed SOPs for most activities in GDP.
¾ E- services.
On-going projects to deal with current problems¾ Working on establishing the PFDA.
¾ Updating Pharmacy Practice Ordinance and EDL.
¾ Updating most of work instruction and guidelines.
¾ Establishing a network that connect all inspectors.

Problems that cannot be improved or solved¾ Lack of control over the crossings through borders andlack of control over the purchases via international mail.
¾ Palestine has limited control on land and borders due tooccupation. Therefore, authorities in Palestine need more
efforts to ensure quality and safety of medicines.
¾ Lack of experts in pharmaceutical field due to theirimmigration to other countries in search for better living
conditions.
35

Challenges¾ Shortage of medicines.
¾ Lack of a national database.
¾ Lack of financial and technical support toperform most of regulatory functions required.
¾ Lack of Laws to rely on.
¾ No post marketing surveillance.

Palestinian interests¾ Identifying gaps in Palestinian regulations.
¾ Establishing a regulatory information exchange,
collaboration and harmonization networks between
members of this training.
¾ Identifying areas in need for external technicalsupport.

36

37

Palestine

Regulatory Systems on Ensuring Access to Quality Medicines （JFY 2021）
Name: Reem N.M. Hijaz.
Country: Palestine.
Organization: Ministry of HealthGeneral Directorate of pharmacy

Pharmaceutical Quality Department Quality control division.
① Organizational Chart−Please attach the organizational chart of pharmaceutical administration at national/state & local levels aboutpharmaceutical administration in your country.
Ministry of HealthGeneral Directorate of Pharmacy
GDP

Registration Dept.
Pharmaceutical Policy Dept.

Pharmaceutical Quality Dept.
Dangerous Drug Dept.

Drug Control Dept.

Drug Information Dept.

Import & Export Dept.

−Please briefly describe each role and responsibility on pharmaceutical administration.
The GDP is an active Directorate in the MOH composed of seven departments:
 Registration Department
 Pharmaceutical Quality Department
 Drug Control Department
 Pharmaceutical Policy Department
 Dangerous Drug Department (narcotics and psychotropic drugs)
 Drug Information Department
 Import & Export Department

38

Palestine

The GDP is responsible for several activities concerning the whole pharmaceutical sector by coordinating with
the Drug Technical Committee (DTC) and other subcommittees like: registration, pricing, drug and therapeutic
medicine promotion/ advertising, and pharmacy profession licensing exam committees.
The GDP is concerned of all pharmaceutical sectors:(i) The public sector: GDP, Central Medical Stores (CMS), all hospitals and Primary Health Care
(PHC) pharmacies.
(ii) The private sector: private pharmacies, wholesalers which are importers of medical andpharmaceuticals goods, General drugstores which are the retailers to private pharmacies andpharmaceutical manufacturers.
(iii) The nonprofit sector, NGOs and especially UNRWA for the care to the refugees.
Main Responsibilities of each department in GDP:

1. Drug Registration Dept.: registration of pharmaceutical products
2. Pharmaceutical Quality Dept.: licensing and conducting GMP inspection on local pharmaceuticalmanufacturers, lot release and follow up complaints and issuing recalls.
3. Drug Policy Dept.: medicines pricing, follow up strategic plans and drug dispensing guidelines.
4. Drug Control Dept.: inspection on pharmacies, general drug stores, hospitals, importers.
5. Drug Information Dept.: PV activities and ADR reporting, regulating the promotion ofpharmaceutical products, updating EDL and issuing national drug policy and treatment guidelines
and protocols.
6. Export & Import Dept.: grant the permission for Export & Import processes of pharmaceuticalproducts.
7. Dangerous Drug Dept.: grant the permission for purchasing narcotics and updating the lists ofNarcotics & psychotropic.
※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.
The role of pharmacist in medical care system in Palestine can be summarized as follows.
- To ensure the quality of medicines supplied to patients.
- Ensuring that the supply of medicines is within the law.
- Ensuring that the medicines prescribed to patients are suitable to their needs.
- Advising patients about medicines, how to take them, reactions may occur and answering patients' questions.
- Supervise the medicines supply chain and ensure pharmacy premises and systems are fit for purpose.
- Advise healthcare professionals about safe and effective medicines use, and safe and secure supply of
medicines.
- Receiving complaints related to medicines from related parties.
- The specialty of a pharm D or clinical pharmacist role in MOH centers is still underutilized due to lack of
employment of clinical or Pharm-D pharmacists.

39

Palestine② Legislation on pharmaceutical administration−Please briefly bulletined major laws/ acts
◆National LevelPublic Health Law 2014 administered by MOH.

Pharmacy Practice Ordinance 2006 & Pharmacists Syndicate Law 2016administered by MOH &Pharmacists Syndicate.

Decision by Law No. (26) of 2018, amending by Law No. (18) of 2015 regarding Combating narcotic
drugs and psychotropic substances administered by GDP-MOH with related parties.



Decision by Law No. 21 of 2016 regarding conducting pharmacological studies administered by GDPMOH with related parties.

◆Local Level◆International Level:
・ PIC/S: No

X

If yes, joined when・ Others if any
by③ 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
Systems, Regulations, etc.
 Good Manufacturing Practice Inspection guide (GMP).
 Instructions for licensing Cosmetic products.
 Instructions for licensing pharmaceutical laboratories.
 Instruction for licensing herbal and food supplement manufacturers.
 Instruction for licensing sterilizers/ disinfectants manufacturers.
 Instructions for licensing pharmaceutical research and development centers.
All Administered by Pharmaceutical Quality department.
◆Drug Import/ Export
Systems, Regulations, etc.

 Instructions for importing and exporting pharmaceutical products which is administered by drug
import and export department.
◆Marketing Authorization
Systems, Regulations, etc.
Instructions for the principles and requirements necessary for licensing agencies.



Human Medicines Registration Instructions.



Herbal products registration instructions.



Biological products registration Instructions.



Cosmetic products registration instructions.
40PalestineMedical devices and materials registration Instructions.



Mandatory technical instructions 2017- 74 for cosmetics products.



Instructions for civil responsibility insurance arising from conducting drug studies.

Terms and conditions for commercial agencies.



Instructions for variations to registered drugs 2018.



Instructions for labeling products 2018.



Instructions regarding Bioequivalence Studies in Palestine.



Instructions for registering veterinary medicines.



Mandatory technical instructions for nutritional supplements.

Decision by Law No. 21 of 2016 regarding conducting pharmacological studies.

Instructions for preparing patient leaflet for locally manufactured generic product.

All are administered by Registration department.
◆Drug Distribution (including drug selection, procurement, sale)
Systems, Regulations, etc.


Pharmacy Practice Ordinance 2006 & Pharmacists Syndicate Law 2016/ Technical conditions forlicensing a pharmacy/ a medicine store/ administered by Drug Control Dept. & Pharmacists
Syndicate.

Instructions for choosing a list of essential medicines/ updated EDL administered by Pharmaceutical
Information Department.

Medicine pricing instructions/ National drug policy/Updated instructions for dispensing essential
medicines in pharmacies of primary care centers and hospitals administered by Drug Policy
department.



Instructions for handling dangerous drugs in hospitals and medical centers/ pharmaceuticalinstitutions administered by Dangerous Drug department.



Schedules of narcotic drugs and psychotropic substances administered by Dangerous drugs
department.

◆Medicine Safety (post-marketing).
Systems, Regulations, etc.






Pharmacovigilance guidelines administered by pharmaceutical information department.
Medicine promotion and advertising committee which supervised by pharmaceutical information
department.
Instructions for medicine Promotion and advertising.
List of OTC medicines.
◆Relief System for Adverse Drug Reactions
Systems, Regulations, etc.
Not Available.

④ Drug Pricing

The pricing division at Drug Policy department is responsible for pricing the medicines according to
medicine pricing instructions and publishing the prices on the website of the General Directorate ofPharmacy.

41

Palestine

During inspection, the price is controlled by checking the price on medicine and if it was different from thepublished lists, the medicine will be seized.

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

nearly 5000

(2021)

2.

Number of GMP inspector (National & Local)

3(2021)

3.

Number of pharmaceutical manufacturers / 6 medicine / 31 cosmetic/ 7 veterinary (2021)

4.

Number of traditional medicine manufacturers /3(2021)

5.

Number of pharmaceutical importers

200(2021)

6.

Number of pharmaceutical wholesalers

250(2021)※Hospital pharmacy only⑥

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

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

b.

㎡

No

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

/

No

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

Does the pharmacy have computers?

42

Palestine

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

10

years

Secondary

2

years

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

5

years

Professional education:
Practical training:

years
1440

hours

Duration of training by each facility:
Hospital pharmacy:

years

about one year for pharm D.

Community pharmacy:

weeks

Pharmaceutical company:

weeks

Others:weeks

Age at graduation:

23

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

2

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.
43

Palestine

It is mandatory to have training on pharmacy practice pharmaceutical, legislations, pharmaceuticalproducts that are available in Palestine.
The period of training is 1440 hours. After completing the training, the pharmacist should pass thenational exam (that held in coordination between MOH & Pharmacist’s Syndicate) in order to obtain thelicense.

* 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:
400 people / per year
The alumni's placement rate (%)
a. Hospital:

10%b. Community Pharmacy:

60 %c. Government Organization:

5%d. Enterprise:

15 %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 reporter can inform the general directorate of pharmacy (GDP) about the side effects of medicines, herbal
preparations or nutritional supplements, or any problems related to their use (lack of effectiveness, drug errors,
drug interactions, etc.).


Reporting should be by filling out the adverse reactions reporting form "yellow card" approved by
GDP

that

is

availableinArabicandEnglishon

GDPwebsite(http://pharmacy.moh.ps/index/Forms/Language/ar).


Healthcare professional (doctor/ pharmacist/ nurse) in the health institution should fill the form
through the website and upload it then it should be approved by the director of the institution andthen the general director, who in turn will send it to the GDP by person / via fax or/ by e-mail(gdp@moh.ps) if the institution is in the private sector.



The form is reviewed and audited by pharmaceutical information department in GDP and recordedin the department's database.
44

PalestineIn the event that the number of reports increases a certain medicine, the director of the department
instructs the head of the pharmacovigilance division to develop an action plan to evaluate thereports and make a study of them.

The department may send a pharmacovigilance representative to the manufacturer or to the supplierof the medicine in order to follow up patients who have had side effects of the drug and to provide
the department with follow-up reports.

The head of the pharmacovigilance division submits the study and recommendations to thedepartment director for review and approval.

The department director, after studying, verifying and evaluating the reports, shall take a decision,
including preventing circulation or banning the import, suspending registration or recall of the drug,or amending the internal leaflet or the method of dispensing the drug.

The company must implement decisions of GDP, including, but not limited to:

1. An amendment to the internal leaflet or other safety measures in response to the new available drug
safety information.
2. Withdrawal of the medicine
3. Restrictions on use…, etc.


The company must inform health care providers and recipients of all measures and changes taken
regarding the medicine.

45Palestine46

4. South Africa

47

48

49

50

51

South Africa

Regulatory Systems on Ensuring Access to Quality Medicines （JFY 2021）
Name:

Daphney Fafudi

Country: South Africa
Organization: SAHPRA: Regulatory Compliance① Organizational Chart−Please attach the organizational chart of pharmaceutical administration at national/state & local levels aboutpharmaceutical administration in your country.
The SAHPRA Board reports to the Minister of Health−Please briefly describe each role and responsibility on pharmaceutical administration.
Health Products Authorisation
Provides administration support necessary for SAHPRA to deliver on its mandate and comply with the relevant
legislative requirements. It coordinates process of registration/amendment of applications in respect of medicines
within a legislative framework that defines the requirements necessary for application to the Authority, to receive
record and distribute all documents submitted to SAHPRA, and to manage and maintain SAHPRA’s main registry.
Inspectorate and Regulatory Compliance
Ensures the public access safe health products through inspections, market surveillance and control activities. The
focus of this programme includes assessment of site compliance, with good regulatory and vigilance practices
Medicines Evaluation and Registration (Clinical and Pharmaceutical Evaluation)
Evaluates the safety, quality and therapeutic efficacy of medicines and register them for use. Units included in thisfunction include:-

Clinical Evaluation

52

South Africa-

Clinical Trials-

Pharmaceutical Evaluation-

Authorisation of sale of unregistered medicines-

Pharmacovigilance-

Complementary and Alternative Medicines-

Veterinary Medicines

Medical Devices and Radiation Control
regulatory oversight of medical devices, ionizing and non-ionizing radiation emitting devices; and radioactive
nuclides.
※Hospital pharmacy only

−Please briefly describe the role of pharmacist in medical care system in your country. If possible, focus on theposition of the pharmacist in medical institutions.
② Legislation on pharmaceutical administration−Please briefly bulletined major laws/acts◆National LevelNational Health Act 61 of 2003 Administered by Department of Health (NDOH)The Medicines and Related Substances Act (previously Drugs Control Act) 101 of 1965 administered by
SAHPRA and NDOH)Pharmacy Act 53 of 1974 administered by South African Pharmacy Council and DOH

National Drug Policy for South Africa administered by NDOH

drugs and drug trafficking act 140 of 1992 administered by Department of Justice and Constitutional
development◆International Level:
・ PIC/S:

Yes 2007

If yes, joined when・ Others if any
INCB administered by UN③ 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
・Systems, Regulations, etc.
・GMP, GDP, GWP, GCP, GLP administered by SAHPRA※Example: Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice◆Drug Import/Export
・Systems, Regulations, etc.

53South Africa

・Permit Application and Approval administered by SAHPRA◆Marketing Authorisation
・Systems, Regulations, etc.
・Good Regulatory Review Practiceadministered by WHO※Example: Good Quality Practice◆Drug Distribution (including drug selection, procurement, sale)・Systems, Regulations, etc.
・Good Wholesaling Practiceadministered by

SAHPRA◆Medicine Safety (post-marketing)・Systems, Regulations, etc.
・Market Surveillance and Control administered by SAHPRA※Example: Good Pharmacovigilance Practice◆Relief System for Adverse Drug Reactions
・Systems, Regulations, etc.
・Pharmacovigilance and Market Surveillance administered by SAHPRA④ Drug Pricing−Please describe about price control and drug price mechanism at public sector in your country.
South Africa applies the single exit price (SEP) mechanism which lists the maximum price that a medicine canbe charged at. This is regulated under Section 22G of the Medicines Act.

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<600(year)

2.

Number of GMP inspector (National & Local)

13(year)

54

South Africa

3.

Number of pharmaceutical manufacturers / manufacturing sites

127(year)

4.

Number of traditional medicine manufacturers / manufacturing sites

Unknown5.

Number of pharmaceutical importers

155(year)

6.

Number of pharmaceutical wholesalers

153(year)(year)※Hospital pharmacy only⑥

Information on your hospital pharmacy（１） Organization chart of the pharmaceutical department or the pharmacy to which you belong
a. Number of section chiefs:
b. Number of deputy chiefs:
c. Number of managers:（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:55

South Africad.

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

8 years

Secondarypart of primary years

High school

5 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 years

Duration of training by each facility:

1 years

Hospital pharmacy:(400hrs)weeks during & post university but during pre-reg year

Community pharmacy:(400hrs) weeks during & post university but during pre-reg year

Pharmaceutical company:(400hrs) weeks during & post university but during pre-reg year

Others:weeks

Age at graduation:

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

1year pre-registration exam to test competence with
Submission of Continued Professional Developments for competence evaluation（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.
1year pre-registration Internship at either a hospital, manufacturing, academia or community
pharmacy. The curriculum includes medicines management, good pharmacy practice (sector specific),

56

South Africa

medicine supply management, dispensing, human resources and application of medicines policies &
legislations.
* 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:
600 / per year
The alumni's placement rate (%)

98-100%a. Hospital:

40 %b. Community Pharmacy:

50 %c. Government Organization:

5 %d. Enterprise:

4 %e. Others:

1 %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 Marketing Authorisation holder is responsible for receipt of the complaint and for liaising with SAHPRA.
There are also mechanisms for the public and users of the health product to contact SAHPRA directly and report.

57

5. Thailand

58

59

60

61

62

Thailand

Regulatory Systems on Ensuring Access to Quality Medicines （JFY 2021）
Name: ATIT SODSANGAROONNGAM.
Country: Thailand.
Organization/Department/Division:.
The Government Pharmaceutical Organization.
Regulatory Affair Department, Regulatory Operation Division .
① Organizational Chart
Figure 1: Thailand’s National Drug System

Pharmaceutical Administration
Thai Food and Drug Administration (Thai FDA) under supervision of the Ministry of Public Health which
responsibilities include but are not limit to;• National Drug Policy: To prepare and publish the National List of Essential Medicines, Guide to Rational
Use of Drug and Pharmaceutical Reference Price.
• Pre-marketing Control: This includes control of drug registration (eCTD/ACTD), product quality andadvertising before product-launch to the market.
• Post-marketing Control: To maintain compliance with approved manufacturing facilities, products and withlegislation and regulations, and recall and alert system.
• Health Product Vigilance Centre (HPVC) established the system for Adverse Drug Reaction (ADR)
monitoring, signal detection and assessment.
• Consumer Education: To provide health products’ information.
• Technical Support and Cooperation with other agencies: conduct seminars and workshops, with participantsfrom both public and private sectors.

63

Thailand
Figure 2: The Government Pharmaceutical Organization

The Government Pharmaceutical Organization (GPO) is a Thai state enterprise under supervision of the
Ministry of Public Health which manufactures pharmaceutical products in Thailand.
• To manufacture, import, and supply drug products to public and private sectors.
• To research and develop new generic pharmaceutical products and medical supplies to respond to the need of theThai society.
• To maintain price level of pharmaceutical products and medical supplies necessary for the Thai society to ensure
people's accessibility.
② Legislation on pharmaceutical administration◆ National Level
・Drug Act, B.E.2510 (1967) and its amendments administered by Drug Control Division,
Thai FDA
・Act Promulgating the Narcotic Code, B.E. 2564 (2021) administered by Narcotics Control Division,
Thai FDA and the Office of Narcotics Control
Board, Ministry of Justice・Pharmaceutical Profession Act, B.E. 2537 (1994) administered by the Pharmacy Council of Thailand◆ Local Level
・Ministerial Regulation by Ministry of Public Health administered by Thai FDA and Provincial
Public Health Office・Ministry Announcementadministered by Thai FDA and Provincial
Public Health Office◆ International Level:
・ PIC/S since August 1st, 2016
③ Regulatory /Administrative Services◆Pharmaceutical Manufacturing
・Good Manufacturing Practiceadministered by Thai FDA・Good Laboratory Practiceadministered by Thai FDA・Good Clinical Practiceadministered by Thai FDA・GXP Knowledge sharing
administered by TIPA, TPMA
・Drug Registration
administered by Thai FDA, RAPAT

64

.
.
.
.
.
.
.
.
.

Thailand◆Drug Import/Export
・Drug registration
・Knowledge sharing from FDA

administered by Thai FDA
administered by PReMA, RAPAT◆Marketing Authorization
・National Reference Prices
・Drug advertisement control

administered by National Drug System Development Committee
administered by Thai FDA, MPAT, PReMA◆Drug Distribution (including drug selection, procurement, sale)・Drug procurementadministered by National Drug System Development Committee
・Good distribution practiceadministered by Thai FDA◆Medicine Safety (post-marketing)・National List of Essential Medicines administered by National Drug System Development Committee
・Hospital Accreditation
administered by Thai FDA, HP
・Safety Monitoring Programadministered by Thai FDA, Drug manufacturers
・Post-Market surveillanceadministered by Thai FDA, HPVC
◆Relief System for Adverse Drug Reactions
・Safety Monitoring Programadministered by Drug manufacturers, Hospitals
・Spontaneous ADR reportadministered by Drug manufacturers, CPA
・Post-Market surveillanceadministered by Thai FDA, HPVC
Abbreviation and Acronyms
Thai FDA
Thai Food and Drug Administration
GPO
The Government Pharmaceutical Organization
RA
Regulatory Affairs / Regulatory Authorities
PAT
Pharmaceutical Association of Thailand under Royal Patronage
RAPAT
Regulatory Affairs Pharmacist Association
PReMA
Pharmaceutical Research and Manufacturing Association
TPMA
Thai Pharmaceutical Manufacturing Association
MPAT
Marketing Pharmacist AssociationHP
Hospital Pharmacist Association
CPA
Community Pharmacist Association④ Drug Pricing
National Drug System Development Committee (NDSDC) is which consist of governmental authorities,
independent technical experts and other stakeholders. NDSDC give measures for pharmaceutical cost containment
in order to save pharmaceutical expenditure as well as increase access to medicines.
The Committee announced The National list of Essential Medicines (NLEM) since 2013 and has been annuallyrevised. NLEM can be divided into 6 groups including of
A: First line drug complied with medical guideline
B: Second line drug, after the first line drug was ineffective or ADR occurred
C: Drugs with multiple indications, must have been prescribed by medical specialist
D: Drugs with multiple indications, higher price than A and B lists. The drug may have chance ofimproper drug use. This drug group must have been prescribed by medical specialist
E1: The drug is in clinical researching, all patients must be monitored
E2: Patients need a special management to access the drug.

65Thailand
There are 2 importantly measurable projects which involved drug prices:・ Reference Prices (RPs) for Public Procurement
RPs are setting for conventional and traditional & herbal medicines both NLEM medicines and non-NLEM
medicines. RPs were set on the calculation basis of “median”. The RPs measures introduce maximum purchasing
prices which means that medicine procurement is now actually purchased at lower prices than the RPs due to thenegotiating and bargaining power of hospital purchasers.
・Targeted List of Priority Medicines (PRIMEs)
The PRIMEs were selected mainly based on essential medicines with local unavailability or with a single brand andimported high-cost medicines for which government support were necessarily needed to motivate and incentivize
local manufacturers. To encourage the availability of generic drugs, the Thai FDA issued 2 announcements putting
integrated inventions in place to enhance local production and importation including provision of drug patent
information to local manufacturers to induce their interests on generic production, 50% reduction in registration
fee, fast-track drug approvals and RP setting for fast-track registered drugs.
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
GMP Accredited 53(2020)
5. Number of pharmaceutical importers
6. Number of pharmaceutical wholesalers⑥ Education and License of Pharmacists in your country（１） Number of years in primary, secondary and high school education
Primary
SecondaryHigh school

45,70617151762(2021)(2021)(2021)(2021)

667
614(2021)(2021)

6
3
3

years
years
years

（２） Number of years / weeks in the following categories during university or college
University / college:
6
years
Professional education:4
years
Practical training:
1
year
Duration of training by each facility:
6 – 12 weeks
Hospital pharmacy:
at least 6 weeks
Community pharmacy:
at least 6 weeks
Pharmaceutical company:
24 – 42 weeks
Others:6 – 12 weeks
Age at graduation:
23 – 25 years old（３）Are there any national examinations for pharmacists in your country?
√ Yes
Academic Exams
Multiple Choice Question (MCQ)
2 days for 4th year pharmacy student
and 1 day for 6th year pharmacy student
Clinical Exams
Objective Structured Pharmacy Examination (OSPE) 1 day for 4th year pharmacy student
Case presentation
1 day for 6th year pharmacy student（４）Which of the followings must you fulfill to obtain a pharmacist's license?
Every pharmacy student must obtain clerkship training not less than 2,000 hrs.
(Mandatory Clerkship in hospitals/drug store 400 hrs. andProfessional Clerkship in pharmaceutical industry or pharmaceutical care 1,600 hrs.)

66.

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

1,500

people / per year

35 %
15 %
20 %
25 %
5 %

⑦ ADR(Adverse Drug Reaction) report
Figure 3: Thailand Vigilance Network

Abbreviation and Acronyms
HPVC Health Product Vigilance Centre
ADRs Adverse Drug Reactions
AEs
Adverse Events
AEFI Adverse Event Following Immunization
1. Medical institution (government and private hospital): Multidisciplinary collaboration team must assign at least 1
pharmacist for evaluate the relationship between the suspected drug and the observed symptoms/ adverse eventsand then ADR spontaneous report to HPVC by using designated HPVC forms.
2. Provincial and regional network: To promote and support surveillance systems, develop teams and solve
problems by network meeting and knowledge sharing.
3. Manufacturer and Importer: To report every ADRs to HPVC.
4. Health Product Vigilance Center (HPVC), under supervision of Ministry of Public Health responsible forcollecting ADR report from other local and international sections. Health products surveillance program areincluding drugs, medical devices, herbal medicine, vaccines and biologics drugs.
After collecting of report, HPVC collaborates with FDA to monitor safety of health products, including recall
and alert system. Classification of ADRs can be divided into Non-serious ADR, and Serious ADR including;
Death, Life threatening, Comorbidity, Teratogenicity.

67Thailand
Surveillance system consists of;
1. Spontaneous Reporting
2. Intensified (Stimulated) Reporting
3. Targeted Spontaneous Reporting
4. Cohort Event Monitoring
5. Registry which only on case pure red cell aplasia (PRCA) in renal failure patient who treated with erythropoiesis
stimulating agents (ESAs)

68

69

70

71

Thailand

Regulatory Systems on Ensuring Access to Quality Medicines （JFY 2021）
Name: Sataporn Lumpaiboonsuk (Job ジョブ)
Country: Thailand
Organization/Department/Division: Thai FDA① Organizational Chart−Please attach the organizational chart of pharmaceutical administration at national/state & local levels aboutpharmaceutical administration in your country.
Medicines Regulation Division, Thai FDA
Director

Senior expert 1

Senior expert 2

Deputy director

Pre-marketing
control group

Chemical drug
group

Systemdevelopment
group

Post-marketing
control group

Standards guidelines
development group

Investigational
new drugs unit

Bioequivalenceunit

GMP inspection
unitInternational andquality system
unit

Biologicalproducts unit

Pre-market
authorization
unit

GSP/GDPinspection unit

Government planand mangement
unit

Animals' products
and drug
substances unit

Post-approvalchange unit

GPP inspection
unit

Systemdevelopment unit

Rapid alert andrecall unit

Drug informatic
unit

Advertisement
unit

Licence services
unit

Quality systemunit

Law enforcement
unit

72

Administrationgroup

Thailand−Please briefly describe each role and responsibility on pharmaceutical administration.
Chemical drug group, biological products unit, and animals’ products and drug substances unit-

To authorized the registration of drug products-

To approve and monitor any changes/variations to those products that are already approved and granted
marketing authorization

Investigational new drugs unit-Advertisement unit
-







To approve and monitor clinical trial studies that involve drugs
To review and monitor of advertisements for drugs

Post-marketing control group-

To surveillance drug in the market-

To inspect and monitor the compliance of GMP, GSP/GDP and GPP-

To comply with PIC/S standard-

To enforce the law-

To license and monitor drug importation and distribution-

To issuance the WHO-format Certificates of Pharmaceutical Product for the purposes of export

System development group-

To ensure quality system of the division-

To make plans and arrange the management

Standards guidelines development group-

To develop standard and new regulation※Hospital pharmacy only

−Please briefly describe the role of pharmacist in medical care system in your country. If possible, focus on theposition of the pharmacist in medical institutions.
② Legislation on pharmaceutical administration−Please briefly bulletined major laws/acts◆National Level
・The Drug Act of B.E. 2510

administered by Thai FDA・administered by・The Drug Act of B.E. 2510

administered by Thai FDA・administered by◆Local Level◆International Level:
・ PIC/S:

Yes

OR

No
st

If yes, joined when August 1 , 2016
・ Others if any
by73Thailand③ 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
・Systems, Regulations, etc.
・Good Manufacturing Practiceadministered by

ThaiFDA・Good Distribution Practiceadministered by

ThaiFDA・Good Storage Practiceadministered by

ThaiFDA・Good Clinical Practiceadministered by

ThaiFDA・Good Laboratory Practiceadministered by

DMSC※Example: Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice◆Drug Import/Export
・Systems, Regulations, etc.
・Good Storage Practiceadministered by

ThaiFDA・Good Distribution Practiceadministered by

ThaiFDA◆Marketing Authorization
・Systems, Regulations, etc.
・N/Aadministered by・administered by※Example: Good Quality Practice◆Drug Distribution (including drug selection, procurement, sale)・Systems, Regulations, etc.
・Good Pharmacy Practiceadministered by・administered by

ThaiFDA◆Medicine Safety (post-marketing)・Systems, Regulations, etc.
・Rapid Alert and Recall systemadministered by・administered by

ThaiFDA※Example: Good Pharmacovigilance Practice◆Relief System for Adverse Drug Reactions
・Systems, Regulations, etc.
・Health Product Vigilance Systemadministered by・administered by

ThaiFDA④ Drug Pricing−Please describe about price control and drug price mechanism at public sector in your country.
The drug price for government reimbursement is controlled by a list of drug prices published on the website
and everybody can get access to it. The government hospitals must purchase the drugs by using this price list as
ceiling prices. However, for the private hospitals which are optional for patients, there is no standard price for74Thailand
both buying and selling. Therefore, the drug price in private hospitals will be higher. For community pharmacy,

the price of the drugs varies but generally it is about the same price as that in government hospital or a little bit
higher. There is no control on selling and buying price for community pharmacy.
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

45,706

people2.

Number of GMP inspector (National & Local)

17

people3.

Number of pharmaceutical manufacturers / manufacturing sites

178

sites

4.

Number of traditional medicine manufacturers / manufacturing sites

762

sites

5.

Number of pharmaceutical importers

110

sites

6.

Number of pharmaceutical wholesalers

1,050

sites

※Hospital pharmacy only⑥

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

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

b.

㎡

No

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

/

No

If "Yes", please describe it in detail75Thailand

Detail:c.

Does the pharmacy have computers?
Yes

/

No

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

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

e.

/

Do you prepare TPN (Total Parental Nutrition)
Yes

f.

No

/ No

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

/ No

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

⑦

Education and License of Pharmacists in your country（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:

6

years

Professional education:variesyears

Practical training:variesyears

Duration of training by each facility:

variesyears

Hospital pharmacy:

6

weeks

Community pharmacy:

6

weeks

Pharmaceutical company:

6

weeks

Others:-weeks

Age at graduation:

24

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

2

76

days

Thailand

Clinical Exams

1

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 a part of university education.
* 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

1,700

people/ per year

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

N/A%b. Community Pharmacy:

N/A%c. Government Organization:

N/A%

d. Enterprise:

N/A%e. Others:

N/A%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.
Thai Health Product Vigilance Center (HPVC) is the main center under ThaiFDA. They take care of the ADRs
or AEs reported from any sources of information. After getting the data, the staff will use the Thai Vigibase as a
database for collecting data. The data may be sent to WHO Vigibase for further collection. After that, theinformation they get will be evaluated and assessed. If they find a relationship with medical products, the data
will be distributed to related parties. Sometimes, law enforcement such as labeling change, limitation of use,recall and withdrawal will be implemented by related organizations to ensure safety of medical products for
public. Generally, HPVC will contact an agency for each product for further actions.

77

Thailand

ADR reporting flow chart
ADRs, AEs

Health Product
Vigilance Center(HPVC)

Thai Vigibase

WHO Vigibase

Signal detection andassessment
Communication

Law enforcement

Labeling change

RecallLimitation of usage

78

Withdrawal

6. Timor-Leste

79

80

81

82

83

84

Timor-Leste

Regulatory Systems on Ensuring Access to Quality Medicines （JFY 2021）
Name: Alipio Gusmao Lopes
Country: Timor-Leste
Organization: Ministry of Health National Directorate of Pharmacy and Medicines National Regulatory Authority① 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.
1. Dept. of Authorization, Introduction and Marketinga) Draw up technical rules for the installation and operation of pharmaceutical establishments, namely
manufacturers and wholesalers, workshop pharmacies, pharmaceutical services of public and private
hospitals and clinics, as well as drug sales outletsb) Ensure the procedures for issuing marketing authorizations for medicinal products and maintain therespective records;c) Ensure inspection for the purposes of licensing pharmaceutical and laboratory activitiesd) Issue authorizations for the licensing of industrial and commercial establishments for the production andsale of medicines, consumables and medical equipment

85

Timor-Leste

2. Dept. of Pharmacovigilance and controla) Ensure compliance with international obligations assumed within the scope of pharmaceutical activities,
namely protocols relating to medicines and other potentially toxic, narcotic and psychotropic
substances,b) Control of adverse reaction, falsified and sub-standard medicines.
3. Dept. of Planning, administration and acquisitiona) Plan the needs in medicines, consumables and medical equipment to meet the needs of the National
Health Service institutions;b) Request from SAMES, the supply of medicines, reagents, medical consumables and health equipment
for the institutions of the National Health Service;※Hospital pharmacy only

−Please briefly describe the role of pharmacist in medical care system in your country. If possible, focus on theposition of the pharmacist in medical institutions.
② Legislation on pharmaceutical administration−Please briefly bulletined major laws/acts◆National Level
Decree Law number 12/2004

・

administered by・administered by・administered by・administered by

Ministry of Health◆Local Level◆International Level:
・ PIC/S:

Yes

OR

No

If yes, joined when・ Others if any
by③ 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

86Timor-Leste

・Systems, Regulations, etc.
None・

administered byadministered by・※Example: Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice◆Drug Import/Export
・Systems, Regulations, etc.
Authorized by Ministry of Health・

administered by

NDPM

administered by・◆Marketing Authorization
・Systems, Regulations, etc.
Drugs registration with other documents・

administered by

NDPM

administered by・※Example: Good Quality Practice◆Drug Distribution (including drug selection, procurement, sale)・Systems, Regulations, etc.
・Essential Medicines List for Timor-Lesteadministered by

NDPM

administered by・◆Medicine Safety (post-marketing)・Systems, Regulations, etc.
None・

administered byadministered by・※Example: Good Pharmacovigilance Practice◆Relief System for Adverse Drug Reactions
・Systems, Regulations, etc.

Investigate and recall if have any problem

・

administered by

NDPM

administered by・④ Drug Pricing−Please describe about price control and drug price mechanism at public sector in your country.
Not yet established mechanism for control drugs price.
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( Technical pharmacy

200 and pharmacist 20)

2.

Number of GMP inspector (National & Local)

None

3.

Number of pharmaceutical manufacturers / manufacturing sites

None

87

(year) 2021
(year) 2021
(year) 2021

Timor-Leste

4.

Number of traditional medicine manufacturers / manufacturing sites

Unregister (year) 2021

5.

Number of pharmaceutical importers

23importers (year) 2021

6.

Number of pharmaceutical wholesalersmore than 50 (year) 2021

※Hospital pharmacy only⑥

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

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

b.

8

㎡

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.

Ensure the data for report and request

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

/

No

88

Timor-Lestee.

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（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

Practical training:

6 months

Duration of training by each facility:

Monthly

Hospital pharmacy:

4

weeks

Community pharmacy:

4

weeks

Pharmaceutical company:

4

weeks

Others:weeks

Age at graduation:

24 -26

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

days

Clinical Exams

days

No, Not yet established the mechanism（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)

89

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

20-50 people / per year

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

30%

b. Community Pharmacy:

50%c. Government Organization:

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

5%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.
ADR is detected in a hospital or health facilities, the pharmacists should fill the form and send it to the NDPM,
based on that from National directorate technically investigate and will decide for the medicines that detected
ADR.

90

7. Uganda

91

92

93

94

UgandaRegulatory Systems on Ensuring Access to Quality Medicines （JFY 2021）
Name: RODNEY TABARUKA TIBARUHACountry: UGANDA
Organization: KABALE REGIONAL REFRRAL HOSPITAL① Organizational Chart−Please attach the organizational chart of pharmaceutical administration at national/state & local levels aboutpharmaceutical administration in your country.
−Please briefly describe each role and responsibility on pharmaceutical administration.
※Hospital pharmacy only

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

Key Responsibilities and accomplishments• Requisitioning and ensuring that medical supplies are available.
• Advising and updating clinicians on prescriptions.
• Liaising with Ward management in ensuring that drugs are properly recorded and stored.
• Participating in planning and budgeting for the pharmacy unit and accounts for the medicines andinfusions.
• Participating in drugs and clinically related research.
• Compiling reports to the Hospital Director• Ensuring equipment are functional and well maintained.
• Liaising with National Drug Authority in ensuring that all medicines conform to prescribed standards.
• Advising patients and communities on the proper use and storage of drugs and vaccines.
• Imparting knowledge and skills to students and Staff.

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

administered by・administered by95

Uganda◆Local Level・

administered by・administered by◆International Level:
・ PIC/S:

Yes

OR

No

If yes, joined when・ Others if any
by③ 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
・Systems, Regulations, etc.
・

NATIONAL DRUG AUTHORITY

・INSPECTORATE

administered byadministered by※Example: Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice◆Drug Import/Export
・Systems, Regulations, etc.
・

NATIONAL DRUG AUTHORITY

administered byadministered by・◆Marketing Authorization
・Systems, Regulations, etc.
・

NATIONAL DRUG AUTHORITY

・

DRUG ASSESSMENT

administered byadministered by※Example: Good Quality Practice◆Drug Distribution (including drug selection, procurement, sale)・Systems, Regulations, etc.
・・

NATIONAL DRUG AUTHORITY
INSPECTORATE

administered by

DEPARTEMNT

administered by◆Medicine Safety (post-marketing)・Systems, Regulations, etc.
・・

NATIONAL DRUG AUTHORITY

administered by

PRODUCT SAFETY DEPARTMENT

administered by※Example: Good Pharmacovigilance Practice96

Uganda◆Relief System for Adverse Drug Reactions
・Systems, Regulations, etc.
NATIONAL DRUG AUTHORITY・

administered by・DEPARTMENT OF PHARMACOVIGILANCE

administered by④ Drug Pricing−Please describe about price control and drug price mechanism at public sector in your country.

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

1045(year)

2.

Number of GMP inspector (National & Local)

54(year)

3.

Number of pharmaceutical manufacturers / manufacturing sites

12(year)

4.

Number of traditional medicine manufacturers / manufacturing sites(year)

5.

Number of pharmaceutical importers(year)

6.

Number of pharmaceutical wholesalers(year)※Hospital pharmacy only⑥

Information on your hospital pharmacy（１） Organization chart of the pharmaceutical department or the pharmacy to which you belong
a. Number of section chiefs: 3
b. Number of deputy chiefs: 5c. Number of managers:

9（２） Number of staff
a. Number of pharmacists: 2
b. Number of clinical pharmacists: 0
c. Number of technicians: 2（３） Number of the kinds of drugs managed in your pharmacy or hospitala. Oral medicine:88

b. Injections: 72
c. Medicines for external use: 12（４） Number of prescriptions dealt in your pharmacy per day
a. For inpatients:

145

b. For outpatients:

70（５） Equipment of the pharmacy in your hospitala.

Does your hospital have a dispensary room?

97

UgandaIf "Yes", how large is it?
Yes 
b.

22 ㎡

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:SUPPLY CHAIN MANAGEMENT, REQUISITIONS/ ISSUES,ACCOUNTABILITIES※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

7

years

Secondary

4

years

High school

2

years

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

4 years

Professional education:

4 years

Practical training:

1 years

Duration of training by each facility:

4 years

Hospital pharmacy:

1 weeks

98

UgandaCommunity pharmacy:

8 weeks

Pharmaceutical company:

8 weeks

Others:

8 weeks

Age at graduation:

24/25 years old（３）Are there any national examinations for pharmacists in your country?
Yes
Academic Exams

2

days

Clinical Exams

2

days

No
（４）Which of the followings must you fulfill to obtain a pharmacist's license?
* If practical training is mandatory, give the subjects and training period.
HOSPITAL CLINICAL PHARMACY, SUPPLY CHAIN MANAGEMENT, INDUSTRIAL
PHARMACY,

REGULATORY AFFAIRS(NATIONAL DRUG AUTHORITY)* If practical training is optional, give the reasons.
(i.e. Training is necessary to prepare for the national examination)
ITS MANADATORY（５）Number of pharmaceutical university or college graduates:
120

people/ per year

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

1%b. Community Pharmacy:

91%

c. Government Organization:

2%d. Enterprise:5%e. Others:

1%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.
When we detect an adverse drug Reaction, it’s reported to the department of Pharmacy which is the official
liaison office with the National Drug Regulator, The National Drug Authority. The Pharmacy department first
constitutes local investigations using the Pharmacovigilance Subcommittee of the Medicines. After theseinvestigations are complete, a form is filled detailing the adverse event and the probable drugs behind the drug
event and submitted online to the National Drug Authority Pharmacovigilance office under the product safety
department. This department collects all reports from across the country on the same issue and if found to be a
widely occurring side effect, its investigated by the National Drug Authority and its supply is halted in the country,
and also sometimes issues a product recall, to ensure the safety of the population.

99

出典：2021 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」カントリーレポート

Japan International Corporation of Welfare Services (JICWELS) was established with the sanction of
the Minister for Health, Labour and Welfare in July 1983 and implements international technicalcooperation programmes with purpose of contributing to the promotion of health and social welfare
activities in the friendly nations.
Japan International Corporation of Welfare Services (JICWELS)
Matsuoka Ginnana BLDG. 3F
7-17-14 Ginza Chuo-ku, Tokyo 104-0061 JAPAN
Tel: +81-(0)3-6206-1137
Fax: +81-(0)3-6206-1164
https://jicwels.or.jp
公益社団法人国際厚生事業団（JICWELS）は、国際的な保健・福祉分野の国際協力に貢献することを目的として、1983 年（昭和 58 年）7 月 7 日に厚生省（現厚生労働省）から社団法人の認可を受け設立されました。開発途上国の行政官研修や WHO フェローの受け入れ、調査企画や研究開発並びに情報の交換及び広報活動など、海外諸国との国際交流活動を推進し
ています。
発行日

2022 年 3 月 31 日
〒104-0061
東京都中央区銀座 7 丁目 17-14 松岡銀七ビル 3 階

広報チーム

電話 03-6206-1137 (国際協力チーム)
Fax 03-6206-1164
https://jicwels.or.jp