Regulatory Systems
on Ensuring Access to Quality
Medicines

Country Reports

Japan International Corporation of Welfare Services (JICWELS)Contents

1. Afghanistan ......................... 1
2. Kiribati ................................ 13
3. Laos ..................................... 19
4. Thailand ............................... 33
5. Timor-Leste ......................... 45

Afghanistan-1-Kiribati- 13 -

Ministry of Health & Medical Services
Kiribati
Kiribati Government Pharmacy

Biribo Kararaiti
Acting Chief Pharmacist

1. Introduction:- Kiribati Government Pharmacy within the
Ministry of Health & Medical Services (MHMS),
Republic of Kiribati
Job Tenure:I. pharmacy assistant from 2000 to 2007 – assisting in
dispensing of medicine and stock control
II. Procurement pharmacist from 2008 to 2017 –ensures that all medicines are procured annually
III. acting Chief pharmacist up to date – now involving in
health related policy making and review, budget
planning for pharmaceutical and medical annual
spending- 14 -

Introduction
Regulatory Services• National Medicine Therapeutic Committee(Secretary)• Reprductive,Maternal,Neonatal,Child,Aldol
escent Health (RMNCAH)• Surveillance committee (member)

Roles of pharmacist• Ensures rational prescribing of medicine byprescribers• Medicine information sharing to healthprofessionals• Checking of medicines availability in the country• Participating in training of nurses on basic
pharmacology• Medicine forecasting and quantification forannual order (tender)• Pharmacy to patient effective counselling- 15 -

2. Good Practice
Achievement;
Medicine Act 2018 review and updated
Establishment of New Pharmaceutical warehouse
Capacity building among pharmacy staff supported by health programs(UNFPA, UNICEF,
Establishing of clinical pharmacy to cater for a daily ward round
Developing of AMR National action Plan
Storage•Examples
9 Achievements
9 Solutions for past problems
9 On-going projects to deal with current problems
9 Successful countermeasures against problems

3. Difficulties/Lessons Learned from Past Experience

1. ADR un-reported – New Zealand help to establish
but un-successful. Up to now there was no report.
2. Stock out in the country – A chronic issue that reallyaffect the quality health care service delivery
3. Mis-use of medicine by the public or community
4. Un regulated medicine imported into the country byprivate pharmacy and general stores - No National
Regulatory Authority
5. Poor pharmacist to doctors intervention- 16 -

4. Your interests- The safety of our patient is our priority and therefore I am
more interested in acquiring technical and specialize skillsin the following;(1). Ensures that stock availability was well maintained
through out the procuring period(2). Enforcing regulations and laws in medicine importation
into the country(3). Improving work collaboration between health andNGOs to improve on the use of medicine.

Challenges• Very poor GMP – Lack of equipment, poor
manufacturing area – not meeting WHO
standard• Multiple task for pharmacy department• Lack of specialized staff – needprofessional continuous education ( due toGovernment training policy)• Demographic- 17 -

- 18 -

Laos

- 19 -

LAO PDR

Food and Drug Department, MoH

Ms. Davone Duangdany

1. Organization Chart of Ministry of Health

Food and Drug Department is thegovernment agency which is under the
Ministry of Health of Lao PDR, is
responsible for protecting the public healthby ensuring the safety, efficacy and securityof human drugs, medical devices, cosmetics
and food products.

- 20 -

2. Food and Drug Department (FDD)

Drug and Medical Devices Control Division
is a division within Food and Drug
Department which is responsible for:
1. Drug registration
2.

manufacturer, pharmaceutical products
import-export

companies

andcommunity pharmacies licensure
3. Import permission of pharmaceuticalproducts and medical devices.

My current position is a deputy head ofDrug and Medical Device Control Division,and my major responsibility is:
1. Drug registration dossier evaluation
2. Medical device import permission anddevelopment of related to drug
registration regulations.
My current project is to participate in thedevelopment of online system for drug
registration and the establishment ofPharmacists Association.

3. Role of pharmacists in Lao PDR- In Lao PDR, the role of the pharmacist in
the health care system has been neglected
and is not well defined.
- In current, Food and Drug is working on theestablishment of Pharmacists Association inorder to improve the pharmacists licensing
system and to give the pharmacists rightful
position in the society.

- 21 -

4. Good Practice• In the area of drug registration
In the situation of shortage of human resources,
the dossier evaluation could not be completed as
the appointed timeline.
In order to improving the efficiency while
maintaining standard for evaluating the quality,
safety and efficacy of pharmaceutical products,
there is a need to have a greater and more
effective technology. Therefore, the online systemfor drug registration and guidelines aredeveloping.

4. Good Practice• In the area of medical device regulation
Medical device registration is still not
implemented in Lao PDR. In the period of
COVID-19 pandemic, to assure the availability
and accessibility to good quality facemask anddisinfectants, the temporary requirement for
testing and analysis, the temporary for local
production of facemask and disinfectant weredeveloped and the role of community
pharmacy in prevention of COVID-19 were
established.

- 22 -

5. Difficulties/Lessons Learned from Past Experience• Unqualified Licensed pharmacists (Pastexperience learned)• How to improve the time efficiency on dossier
evaluation (Should we have the list of priority
drugs for registration?) (Past experience learned)• The effort on establishment of Pharmacists
Association, which need to have the pay
attention from social and the awareness ofpharmacists role.(Difficulties)

6. My interests(1) The drug approval process in Japan,
especially for the biological products suchas: vaccine.
(2) The pharmacist licensing in Japan, thehistory and lesson learn of the national
licensing examination.
(3) GMP and Quality regulation in Japan- 23 -

- 24 -

Part I: INFORMATION SHEETRegulatory Systems on Ensuring Access to Quality Medicines （JFY 2020）
Name: Ms. Davone DUANGDANYCountry: Lao PDR
Organization/Department/Division:Drug and Medical Device
Control Div, Food and Drug Department, Ministry of Health① Organizational Chart
 The organization chart of Ministry of Health- 25 -

The organization chart of Food and Drug Department-

Food and Drug Department is the government agency which is under the Ministry of
Health of Lao PDR, is responsible for protecting the public health by ensuring the safety,
efficacy and security of human drugs, medical devices, cosmetics and food products.

-

Drug and Medical Devices Control Division is a division within Food and Drug
Department which is responsible for the drug registration, manufacturer, pharmaceuticalproducts import-export companies and community pharmacies licensure and importpermission of pharmaceutical products.

② Legislation on pharmaceutical administration- 26 -

•

Lao National Drug Policy (First Revision, 2003)•

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

Regulation on Business Establishment for Medicine and medical Product Company
No. 1820/MoH, (Revision dated 25 August 2017)•

Regulation on Drug registration No.1441, dated 13 August 2003.

•

Regulation on the manufacturing of medicine and medical products No. 937/MoH,
dated 12 May 2004.

•

Regulation on Pharmacy No.2922 (Revision dated 21 September 2016)•

Regulation on Good Manufacturing Practice and Quality Control of Drugs No.
1021, dated 11 Aug 1999.

•

Regulation on Drug and Medical Products Donation No. 2579/MoH, dated 12
November 2003.

•

Regulation on Drug and Medical Products Diposal No. 1862, dated 5 August 2016.

•

Lao National Essential Drug List 2019


PIC/S
Yes
OR

No (Non PIC/S member)③ Regulatory Services◆Pharmaceutical Manufacturing•

Pharmaceutical Manufacturing regulated by Law on Drug and Medical Products
No. 07/NA, dated: 21 December 2011, Regulation on the manufacturing of
medicine and medical products No. 937/MoH, dated 12 May 2004 and Regulation
on Good Manufacturing Practice and Quality Control of Drugs No. 1021, dated 11
Aug 1999. (Administration by National central level: Food and Drug Department,
Licensing Approval by Ministry of Health)◆Drug Import/Export- 27 -•Drug Import/Export regulated by Law on Drug and Medical Products No. 07/NA,
dated: 21 December 2011 and Regulation on Business Establishment for Medicine
and medical Product Company No. 1820/MoH, (Revision dated 25 August 2017).

•

Import/Export permit is issued by Food and Drug Department, the Import/Export at
the border checkpoint is inspected by inspectors of Bureau of Food and Drug
Inspection.

◆Marketing Authorization•

Marketing Authorization regulated by Law on Drug and Medical Products No.
07/NA, dated: 21 December 2011 and Regulation on Drug registration No.1441,
dated 13 August 2003. (Administration by Food and Drug Department)•

The procedure of registration is divided into 2 steps:
Step 1: Application for the permission to import or manufacture drug sample
intended to be registered
Step 2: Application for the Drug Registration approval The registration certificate is to be renewed every 3 years◆Drug Distribution (including drug selection, procurement, sale)•

Drug distribution is administrated by Medical Products Supply Center, while the
distribution is followed the Good Distribution Practice (GDP).

•

The selection of drug is done by committee, which the national essential medicines
list is publicly available criteria and transparent procedures for the selection process forinclusion in or deletion from the list.

•

The procurement of pharmaceutical products regulated by Procurement Manual,
Ministry of Finance, dated: April 2009. The procurement committee is to makedecision on procurement. Most of time price comparison is being used.

•

The sale of pharmaceutical products regulated by Law on Drug and Medical
Products No. 07/NA , dated: 21 December 2011, Regulation on Business
Establishment for Medicine and medical Product Company No. 1820/MoH,- 28 -

(Revision dated 25 August 2017) and Regulation on Pharmacy No.2922 (Revision
dated 21 September 2016).
◆Medicine Safety (post-marketing)

Post- marketing surveillance is responsible by the Bureau of Food and Drug
Inspection.



The pharmacovigilance is regulated by Law on Drug and Medical Products No.
07/NA, dated: 21 December 2011 and the guideline on pharmacovigilance
practice (administration by Food and Drug Department, implemented by
Hospital Pharmacy Management and Adverse Reaction Committee).

◆Relief System for Adverse Drug Reactions


Vigilyze is used and ADR is reported to VigiFlow (the relief System is not
yet to develop)④ Drug pricing
Drug price control is regulated by Law on Drug and Medical Products
No. 07/NA, dated: 21 December 2011, which is mentioned in Chapter
3: Price control of drug and medical products, but there is no instituted
mechanisms intended to control drug price. There is the need todevelop the mechanisms to control factory-gate price and measures atthe provincial level and reference-based pricing. The drug distributedin public sector is limits of markup not more than 20%. However, theprice control in Lao PDR faced challenges by all of API and more than
50% of drugs are imported and the pharmaceutical industries in Laosare small production scale.

⑤ Statistic data
1.

Number of pharmacists
2300 (2020)* In current, there is just the data on licensing pharmacists who established thepharmacy, pharmaceutical company and pharmaceutical manufacturing which licensing
issued by Food and Drug Department available, not included the pharmacists who workin another field such as: hospital pharmacy, education facilities and others, since thelicensing is not a requirement for their career.

- 29 -

2.

3.
4.
5.
6.

Number of GMP inspector (National & Local)
14 (2020)*The GMP inspectors are from the GMP inspection committee which is approved by
Ministry of Health, of them 9 inspectors are Modern drug GMP inspectors, 5 are
Traditional and Health Supplements GMP inspectors.
Number of pharmaceutical manufacturers / manufacturing sites
10 (2020)
Number of traditional medicine manufacturers / manufacturing sites
4 (2020)
Number of pharmaceutical importers
86 (2020)
Number of pharmaceutical wholesalers
11 (2020)⑥ Education and License of Pharmacists in your country（１） Number of years in primary, secondary and high school education
Primary
5 years
Secondary
3 years
High school
4 years（２） Number of years / weeks in the following categories during university or college
University / college:
5 years
Professional education:
years
Practical training:
years
Duration of training by each facility:
years
Hospital pharmacy:
weeks
Community pharmacy:
weeks
Pharmaceutical company:
weeks
Others:weeks
Age at graduation:
22 years old* There is no specific pharmacy training center in Lao PDR, the training on pharmacy for
hospital and community pharmacy is trained by Food and Drug Department, regularly 2 times per
year on specific title such as: rational use of drug, Good Pharmacy Practice and drug regulations.
（３）Are there any national examinations for pharmacists in your country?
Yes
Academic Exams
days
Clinical Exams
days
No:* There is no any national examination for pharmacists, the pharmacist who licensed by
FDD are intend to establish the pharmacy, pharmaceutical import/export company
or pharmaceutical manufacturing factory, the license approval base on their working
experience on the field of pharmacy and others document evaluation without theexamination.
（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)*
There is no any training required in order to obtain a pharmacist’s license,
but after license approve, the training is provided by FDD annually.
（５）Number of pharmaceutical university or college graduates:
150 people / per year
The alumni's placement rate (%)
a. Hospital:%- 30 -

b.
c.
d.
e.

Community Pharmacy:
Government Organization:
Enterprise:
Others:%%%%- 31 -

- 32 -

Thailand- 33 -

THAILANDTHE GOVERNMENT PHARMACEUTICAL ORGANIZATION

Ministry of Public Health
Narisa Chalaemvaree
Pharmacist, Registration Section, Drug Registration and Pharmacovigilance Division

Introduction of the work
Roles and Position of Pharmacists in Thailand
Research pharmacist

Education pharmacist• Drug formulation development• Clinical research• Drug import / registration

Hospital pharmacist• Drug warehouse• Extemporaneous preparation• Therapeutic drug monitoring• Drug dispensing

Industrial pharmacist• Drug manufacturing control• Quality assurance and quality control

Drugstore pharmacist

Marketing pharmacist• Drug distribution and dispensing• Follow up and patients visit• Medical representative- 34 -

Introduction of the work
Organization and Department
The Government Pharmaceutical Organization
Research &Development Institute
Biological & Sterile
Product Department

Drug Manufacturing Department
Beta-Lactam
Division

Non-Sterile Product
Division- Bacterial Vaccine Division - Penicillin Section - Tablets Section- Viral Vaccine Division- Capsules Section- Laboratory Animals Division- Semisolid Section- Carbapenem Division- Solution Section

Quality Assurance
Department
Drug Registration andPharmacovigilance
Division
Validation Division
Quality Control

Marketing Department
Warehouse
Drugstore
Foreign Affairs
Division

Quality Assurance

Introduction of the work
My Roles and Positions

Organization and Department• Drug Registration andPharmacovigilance
Division, Registration
SectionJob Tenure• Drug registration,and variation
technical dossier
preparation andsubmit to FDA- 35 -Engaging Regulatory Service• Pre-Market Registration• Post-Market Monitoring• Export / Import Products

Good practiceExperiences About Good PracticeRegistration Section

Technical drug
dossier (CTD / ACTD)
preparation andsubmission

Variation of drug dossier
Post - marketingcompliance

Import / export
products submission &regulatory compliance

Developelectronics drug
submission system

Difficulties / Lessons learned from past experiences
Difficulties or Struggled• Utilization of drug database• Harmonization of drug registration data between Thailand and overseas• Data storage and management of registered data
• Handling post-marketing control• Estimate variations- 36 -

Interests
Expected Issues to This Program
1. Related regulation in drug research and development

2. Post - marketing control system for drug manufacturer

3. Change Control System and Variation for Dossiers in Japan- 37 -

Part I: INFORMATION SHEETRegulatory Systems on Ensuring Access to Quality Medicines （JFY 2020）

Name: NARISA CHALAEMVAREECountry: Thailand
Organization/Department/Division:
Drug Registration Section,
Drug Registration and Pharmacovigilence Division
The Government Pharmaceutical Organization

 Organizational Chart

Chart: Thailand’s National Drug system

Pharmaceutical Administration
Food and Drug Administration (FDA) responsibilities including of;• Pre-marketing Control: This includes control of manufacturing facilities, product quality and advertising
before product-launch to the market.
• Post-marketing Control: To maintain compliance with approved products and with legislation and regulations.
• Surveillance Program for Consumers' Safety Operational centers, e.g. Adverse Product Reaction Monitoring
Center (APRMC), exchanged with other agencies at local and international level to detect any adverse effects or
unexpected outcomes from consumer use of products.
• 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.

- 38 -

Chart: The Government Pharmaceutical Organization

Pharmaceutical Research, Manufacturing and Marketing
The Government Pharmaceutical Organization (GPO)• To manufacture, sell, and supply drug products and medical supplies.
• To maintain necessary price level of drugs and medical supplies for the Thai society to ensure people's
accessibility.
• To research and develop new pharmaceutical products and medical supplies to respond to the need of the Thai
society.
 Legislation on pharmaceutical administration◆ National Level
・Drug Act, 1967 (B.E.2510) revised 2019
・The Narcotics Act 1979 (B.E.2522) revised 2019・Psychotropic Substances Act 2017 (B.E.2559)◆ Local Level
・Ministerial Regulation by Ministry of Public Health・Ministry Announcement◆ PIC/S・Yes since August 1st, 2016

administered by Bureau of Drug Control
administered by Narcotics Control Divisionadministered by Narcotics Control Divisionadministered by FDA & Public Health Officeadministered by FDA & Public Health Office- 39 -

 Regulatory Services◆ Pharmaceutical Manufacturing
・Good manufacturing practice・Good laboratory practice・Good clinical practice・Drug registration

administered by FDA, TIPA, TPMA
administered by FDA, TIPA, TPMA
administered by FDA, TIPA, TPMA
administered by FDA, RAPAT◆ Drug Import/Export
・Drug registration
・Knowledge sharing from FDA

administered by FDA
administered by PREMA, RAPAT◆ Marketing Authorization
・National Median Drug Price administered by National Drug System Development Committee
・Drug advertisement control administered by FDA, MPAT, PREMA◆ Drug Distribution (including drug selection, procurement, sale)・Drug procurementadministered by National Drug System Development Committee , FDA
・Good distribution practiceadministered by FDA・Good storage practiceadministered by FDA◆ Medicine Safety (post-marketing)・National List of Essential Medicines administered by National Drug System Development Committee
・Hospital Accreditation
administered by FDA, HP
・Safety Monitoring Program administered by FDA, Drug manufacturer
・Post-Market surveillanceadministered by FDA, HPVC
◆ Relief System for Adverse Drug Reactions
・Safety Monitoring Program administered by Drug manufacturer, Hospital・Spontaneous ADR reportadministered by Drug manufacturer, CPA
・Post-Market surveillanceadministered by FDA, HPVC
Abbreviation and Acronyms
MoPH
Ministry of Public Health
NDI
National Drug System Development Institute
FDA
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 Association- 40 -

 Drug Pricing Please describe about price control and drug price mechanism at public sector in your country.
National Drug System Development Committee is the coordination group between Ministry of Public Health,
Ministry of Commerce, and Ministry of Finance; aim to support patients to access the medicines, rational drug
use and reduce the rate of drug resistance. The Committee announced The National list of Essential Medicines(NLEM) since 2013 and has been annually revised. 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.
In 2018, the committee announced the National Drug Median Price to maximize cost-effectiveness for thehospital. The drug median price and NLEM works together to reduce the drug price for better access.
National Drug Median Price affected only at the government hospital. For private sectors, the median price or
ceiling is not set. But the drugs’ price must have been announced to the patients, including of purchased priceand selling price.
The drug median price list will be revised annually in the same way as NLEM. Latest announcement of target
drug groups including of H2RA / PPI, NSAIDS, Antilipidemia, ACEI, ARB, Antiplatelet, Glucosamine, Drugaffecting bone metabolism, and Anticancer.
 Statistic Data
1. Number of pharmacists
2. Number of GMP inspector (National & Local)
3. Number of pharmaceutical manufacturers / manufacturing sites
4. Number of traditional medicine manufacturers / manufacturing sites
5. Number of pharmaceutical importers
6. Number of pharmaceutical wholesalers- 41 -

40,152 (2019)
National
38(2019)
142(2020)
481(2019)
GMP accredited 53(2020)
649(2019)
194(2018)

 Information on your industrial pharmacy
Regulatory Affairs
Division
Microbiological
Analysis Division

Biological ProductsStandards Division

Pharmacovigilance
Division

Quality Assurance
Department

Finished ProductsStandards Division
Raw Materials
Standards Division

Validation Division

Quality System
Development
Division(1) Organization chart of the pharmaceutical department or the pharmacy to which you belong.
a. Number of department director: 14
b. Number of division manager: 14
c. Number of section header: 60(2) Number of staff
a. Number of pharmacists: 374
b. Number of R&D pharmacists: 85
c. Number of PD pharmacists: 118
d. Number of QA & QC pharmacists: 95
e. Number of Marketing Pharmacists: 18(3) Number of the kinds of drug productsa. Oral medicine: 139
b. Injections: 10
c. Medicines for external use: 14- 42 -

 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
4 years
Practical training:
1 yearDuration 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 - 18 weeks
Age at graduation:
23 - 25 years old(3) Are there any national examinations for pharmacists in your country?
Yes
Academic Exams(MCQ)
2 daysClinical Exams(Practical)
1 day(4) Which of the followings must you fulfill to obtain a pharmacist's license?
• Every pharmacy students:
At least 6 weeks on hospital clerkshipAt least 6 weeks in drugstore clerkship• Clinical pharmacy students: At least 6 weeks inpatient care clerkshipAt least 6 weeks outpatient care clerkship• Industrial pharmacy students: At least 6 weeks quality assurance clerkshipAt least 6 weeks manufacturing clerkship(5) Number of pharmaceutical university or college graduates: (approx.) 2,000 people / per year
The alumni's placement rate (%)
a.
Hospital
35 %b.
Community Pharmacy
15 %c.
Government Organization
20 %d.
Enterprise
25 %e.
Others5%
 Side effect report
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.
ADR data has been collected from hospitals, clinics, drugstores, manufacturers, and international organization.
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.
Surveillance system including of;
1. Spontaneous reporting of ADRs (passive surveillance) received from hospitals, manufacturers,
drugstores or international organization.
2. Stimulated passive surveillance- Safety Drug Monitoring Program conducted by drug manufacturer
3. Active surveillance- Intensive Drug Monitoring (Drug Event Monitoring) in high alert drugs. Patients should bemonitored in hospital during the medicine course.

- 43 -

- 44 -

Timor-Leste- 45 -

TIMOR LESTESAMESSATURLINA XIMENES
0

WAREHOUSE MANAGEMENT AND
DISTRIBUTION.

1- 46 -

1. Introduction of the work
• SAMES is an autonomous institution, which isengaged in the health sector, responsible for
procurement, storage and Distributionof medicines, consumables and reagents.
• I am the Director of Warehousing and Distribution• SAMES has regulation of Ministry of Health number
21/2016, 9 March which was recently changed to
36/2020, 8 March.
• Pharmacist hold multiple roles in SAMES, DNFM,
hospitals and pharmacies in TL.
@@

.@@

2

2. Good Practice• We use mSupply to assist us in managing ourstock.
• ※⁦‒⁛⁥‒⁓⁠‒⁗⁞⁗⁕⁦⁤⁡⁠⁛⁕‒⁥⁫⁥⁦⁗ ‒⁦⁚⁓⁦‒⁓⁥⁥⁛⁥⁦⁥‒⁛⁠‒⁢⁤⁡⁕⁧⁤⁗ ⁗⁠⁦„‒⁤⁗⁕⁗⁛⁢⁦‒⁓⁠⁖‒⁖⁛⁥⁦⁤⁛⁔⁧⁦⁛⁡⁠„‒⁥⁦⁡⁕⁝‒⁦⁓⁝⁛⁠⁙„‒⁗⁪⁢⁛⁤⁗⁖‒ ⁗⁖⁛⁕⁛⁠⁗⁥‒⁓⁠⁖‒⁤⁗⁢⁡⁤⁦⁛⁠⁙†

3- 47 -

Good Practice Continue• ⁉⁗‒⁓⁤⁗‒⁗⁪⁢⁓⁠⁖⁛⁠⁙‒ ⁅⁧⁢⁢⁞⁫ ⁦⁡‒⁚⁡⁥⁢⁛⁦⁓⁞⁥‒⁓⁠⁖‒⁡⁦⁚⁗⁤‒⁘⁓⁕⁛⁞⁛⁦⁛⁗⁥‒⁛⁠‒⁆‾‒⁦⁡‒⁚⁗⁞⁢‒⁦⁚⁗ ‒ ⁓⁠⁓⁙⁗‒⁦⁚⁗‒⁥⁦⁡⁕⁝⁥‒ ⁗⁖⁛⁕⁛⁠⁗⁥„‒‵⁡⁠⁥⁧ ⁓⁔⁞⁗⁥‒⁓⁠⁖‒⁄⁗⁓⁙⁗⁠⁦†• ⁅″‿‷⁅‒⁗⁥⁦⁓⁔⁞⁛⁥⁚⁗⁖‒‥‒⁩⁓⁤⁗⁚⁡⁧⁥⁗⁥‒⁛⁠‒⁗⁓⁕⁚‒⁤⁗⁙⁛⁡⁠‒⁦⁡‒⁥⁢⁗⁗⁖‒⁧⁢‒⁖⁛⁥⁦⁤⁛⁔⁧⁦⁛⁡⁠‒⁦⁡‒⁚⁡⁥⁢⁛⁦⁓⁞⁥‒⁓⁠⁖‒⁚⁗⁓⁞⁦⁚‒⁘⁓⁕⁛⁞⁛⁦⁛⁗⁥‒⁛⁠‒⁦⁚⁗‒⁖⁛⁥⁦⁤⁛⁕⁦†
4

3. Difficulties/Lessons Learned from Past Experience• One of the challenges in SAMES is not being
able to test the quality of medicines.
• Sometimes we have items where we areconcerned about the quality but cannot test.
• Therefore, we are looking to establish
medicines testing in TL
5- 48 -

4. Your interests(1)Warehouse stock management systemand Distribution.
(2) Quantification(3) Test Quality of Medicines

6

THANK YOUOBRIGADO

7- 49 -

出典：2020 年度 JICA 課題別研修カントリーレポート
2020 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」

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

2021 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- 50 -