The Study Programme
for the Good Governance of Medicines for Pharmaceutical
Regulation Authorities

Country Reports

Japan International Corporation of Welfare Services (JICWELS)Contents
1. China

1

2. Laos

12

3. Malaysia

23

4. Philippines

47

The Study Programme
for the Good Governance of Medicines for Pharmaceutical
Regulation Authorities

China

-1-

Country Report

Position and Name of Organization: Xi’an Food and Drug Administration
Name of Country: China

1. Statistical Dataa) Number of medical professionals
Physicians

Dentists Auxiliary medical personnel

Nurses(RN, CN, PHN)

Data 2466094

65000

6535882244020

Year 2011

2011

2011

2011

b) Number of Pharmacists
Data 363993
Year 2011c) Number of pharmaceutical manufacturers/manufacturing sites
Data 4678
Year 2011d) Number of traditional medicine manufacturers/ manufacturing sites
Data About 3000

-2-

Year 2011e) Number of Pharmaceutical importers
Data
Year

f) Number of Pharmaceutical wholesalers
Data 13461
Year 2011

2. Pharmaceutical legislation and regulatory systems
1) What legislation on pharmaceutical administration has been enacted in yourcountry? (Name and outline of the laws)a) Drug Administration Law of the People’s Republic of China
Chapter1 General Provisions
Chapter2 Administration of Pharmaceutical Producing Enterprises
Chapter3 Administration of Pharmaceutical Trading Enterprises
Chapter4 Administration of Pharmaceuticals at Medical Organizations
Chapter5 Pharmaceutical Administration
Chapter6 Administration of the Packaging of Pharmaceuticals
Chapter7 Administration of the Prices and Advertising of Pharmaceuticals
Chapter8 Supervision over Pharmaceuticals-3-Chapter9 Legal Responsibility
Chapter10 Supplementary Provisionsb) Regulations for Implementation of Drug Administration Law of the People’s
Republic of China
Chapter1 General Provisions
Chapter2 Administration of Pharmaceutical Producing Enterprises
Chapter3 Administration of Pharmaceutical Trading Enterprises
Chapter4 Administration of Pharmaceuticals at Medical Organizations
Chapter5 Pharmaceutical Administration
Chapter6 Administration of the Packaging of Pharmaceuticals
Chapter7 Administration of the Prices and Advertising of Pharmaceuticals
Chapter8 Supervision over Pharmaceuticals
Chapter9 Legal Responsibility
Chapter10 Supplementary Provisionsc) Good Manufacture Practice
Chapter1 General Provisions
Chapter2 Quality Management
Chapter3 Organization and Personnel
Chapter4 Building and Facilities
Chapter5 Equipments
Chapter6 Materials and Products
Chapter7 Qualification and Validation-4-

Chapter8 Documentation
Chapter9 Production Management
Chapter10 Quality Control and Quality Assurance
Chapter11 Commissioned Production and Commissioned Determination
Chapter12 Product Distribution and Recall
Chapter13 Self Check
Chapter14 Supplementary Provisionsd) Good Supply Practice
Chapter1 General Provisions
Chapter2 Quality Management of Drug Wholesale
Management Responsibility
Personnel and Training
Facilities and Equipments
Purchase
Acceptance and Inspection
Storage and MaintenanceWarehousing and Transportation
Distribution and After-sale Service
Chapter3 Quality Management of Drug RetailManagement Responsibility
Personnel and Training
Facilities and Equipments-5-

Purchase and Acceptance
Display and Storage
Distribution and Service
Chapter4 Supplementary Provisions

2) Organizational structure; What regulatory framework on pharmaceuticaladministration are formulated in your country? (Describe the organizational chart atnational/state and local levels)
There are four levels of pharmaceutical administration in our country: national level,
province level, municipal level and district/county level. Each level of pharmaceuticaladministration is responsible for the pharmaceutical administration within theiradministrative regions.
a) National organizational structure:
State Food and Drug
Administration

OfficePolicyDrug

Healthy

Food Safety

Inspection

Drug Safety

Personnel

International

Party

MedicalSupervision

RetiredandRegistration

Food and

Regulatory

BureauRegulatory

Department

Cooperation

Committee

DeviceBureauCadresLaw

Department

Cosmetic

Department

Depart-Regulatory

ment

Department

Department

Department

BureauRegulatory
Department

Traditional

Chemical

BiologicalResearch

Drug

Drug

Drug

Specific

Manufacture

Research

Registration

Registration

Chinese

Medicine

Product

andManufacture

SupplyVigilance

Drug

and Supply

andDivision

Division

Medicine

Division

Division

Supervision

Regulatory

Regulatory

andRegulatory

Regulatory

Supervision

No.1

No.2

Division

Division

Division

Evaluation

Division

Division

Division

Division

Division-6-

There are several institutions directly under State Food and Drug Administration:
National Institutes for Food and Drug Control, National Pharmacopoeia Committee,
Center for Drug Evaluation, Center for Certification of Drug, Center for Drug
Reevaluation (National Center for ADR Monitoring), Center for Qualification ofLicensed Pharmacist and so on.

b) Local organizational structure:

Xi’an Food and Drug
Administration

OfficeOrganizati-

Policy andFood Safety

Food

Food Safety

Healthy

Drug

Drug

MedicalSupervision

Party

on andLaw

Comprehens

SafetyEmergency

Food and

SafetySupplyDeviceOfficeCommittee

Personnel

Division-ive

Regulatory

Inspection

Cosmetic

Regulatory

Supervision

Regulatory

Coordination

Division

Division

Regulatory

Division

Division

Division

Division

Division

Division

There are several institutions directly under Xi’an Food and Drug Administration:
Drug Inspection Bureau, Food Inspection Bureau, Center for Complaint of Food andDrug and Xi’an Institute for Food and Drug Control.

3) What department/division is in charge of the following pharmaceutical regulatory
services respectively? How many officials/staffs are engaged in each service?
a) Licensing of manufacturing site and product qualification/registration-7-

Licensing of manufacturing site: Drug Safety Regulatory Department, about 3000
officials.
Product qualification/registration: Drug Registration Department, about 2000
officials.

b) Regulation on clinical trials conducted in your country
Drug Registration Department, about 2000 officials.

c) Pharmaceutical inspection for compliance with Good Manufacturing Practice(GMP)
Drug Safety Regulatory Department and Center for Certification of Drug, about
4500 officials and near 3000 GMP inspectors.

d) Prevention and control for substandard, spurious, falsely-labelled, falsified,counterfeit medical products
Inspection Department, about 3000 officials.

e) Post-Marketing Surveillance (PMS) for monitoring adverse drug reaction
Center for Drug Reevaluation (Center for ADR Monitoring), about 1500 officials.

f) Sale and distribution of ethical/OTC medicines (including traditional medicines)
At national level: Drug Safety Regulatory Department-8-

At province and municipal level: Drug Market Supervision Division
Totally about 4000 officials.

g) Licensing pharmacist and pharmacy
Center for Qualification of Licensed Pharmacist, about 1500 officials.

h) Public awareness for rational use of medicines
Center for Drug Reevaluation (Center for ADR Monitoring), about 1500 officials.

4) Does your country have its own pharmacopoeia? If not, what kind ofpharmacopoeia do you refer to as an official pharmacopoeia?
Yes. Pharmacopoeia of the People’s Republic of China, updated every five years. The
latest edition is 2010 edition, consisted of three volumes: Traditional Chinese
Medicines, Chemical Medicines and Biological Products.

5) Does National Regulatory Authority in your country have any additional
requirements for vaccines and other biological products such as National Test
System (if any)
Yes. There is a law named Regulation for Batch Release of Biological Products. As
referred to the law, before distribution and import, every batch of vaccine andbiological product must be examined and verified. The examination is implemented
by National Institutes for Food and Drug Control.

-9-3. Present situation and future plan of the National medicine policy, including
essential medicine and traditional medicine
The National Medicine Policy consists of several aspects:
1) Essential Medicine. Selection of Essential Medicine is the most important part ofNational Medicine Policy. The first edition of National Essential Medicine Catalogue
was published in 1981. The latest Catalogue is 2009 edition. This catalogue consistsof 205 chemical drugs and biological products, 102 traditional Chinese patent
medicines and simple preparations and Traditional Chinese Medicine decoction pieces.
The essential medicines are of clinical necessity, safety, efficacy, reasonable price andconvenience for use.
2) Reasonable Price. It’s very important for peoples’ affordability.
3) Drug Financing.
4) Supply System.
5) Drug Regulation. It’s important to assure the safety, efficacy and quality of drugs.
6) Rational Use of Drugs.
Future Plan: The National Medicine Policy would be developed and improved in the
future. The targets include: strengthening the regulation of the whole processes ofdrugs, improving drug quality and rational use of medicines, promoting thesustainable development of pharmaceutical industry and accelerating the developmentof Traditional Chinese Medicine. The final target is to protect and advance the publichealth.

-10-

4. Pharmaceutical supply in health system and pharmaceutical pricing
mechanism for universal health coverage in your country
Pharmaceutical supply in health system is implemented through a way called drug
centralized purchasing. Drug centralized purchasing is implemented in each province.
Nonprofit medical organizations must purchase medicines through this way. Drugcentralized purchasing in other medical organizations is encouraged. The healthregulatory authorities are responsible for drug centralized purchasing in health system.
All the information is displayed on the drug centralized purchasing platform.
Generally, there is a national health coverage drug catalogue. The prices of the drugs
in this catalogue are fixed by National Development and Reform Commission. Eachprovince has its own health coverage drug catalogue based on national healthcoverage drug catalogue. The prices of the drugs in the province’s health coveragedrug catalogue but not in national health coverage drug catalogue are fixed by thisprovince. Other drugs which are not in the catalogues are independent pricing.

-11-The Study Programme
for the Good Governance of Medicines for Pharmaceutical
Regulation Authorities

Laos

-12-

Country Report
Good Governance of Medicine for Pharmaceutical Regulation Authorities (J120694)

Food and Drug Department
Lao PDR

1. Statistical dataa) Number of medical professional(Average number of medical professionals by category (Data year 2009-2010))
Item

Number- Physicians

1,211- Dentists

228- Nurse and midwife

5,322b) Number of Pharmacists in public sector (Data available in 2010 )Item

Number- High

366

- Mid

3,975

- Low

182

c) Number of pharmaceutical manufacturer/Manufacturing sites
Data
7
Year
2012
d) Number of traditional pharmaceutical manufacturer/Manufacturing sites
Data
3
Year
2012
Training course in “Good Governance of Medicines for Pharmaceutical Regulation Authorities (J1200694)-13-e) Number of pharmaceutical importers
Data
45
Year
2012
f) Number of pharmaceutical wholesales
Data
5
Year
2012

2. Pharmaceutical Legislation and regulatory system:1). Legislation on pharmaceutical administration:
The Legislation establishment is one of thirteen elements (priorities) in the National Drug Policy to assurethat the successful implementation of the Drug Policy through using the related, updated appropriate law
and regulations. The first Law on Drug and Medical Product endorsed and promulgated in the late year
2000, the law consist 8 sections and 45 articles. Based on this law, many related regulations as listed
below had been formulated and revised in order to facilitate the control and management on the quality
safety and efficacy of medicine.
1. Revised National Drug Policies, dated on 13/8/2003
2. Regulation number 482/MOH, 19/4/2002 on the pharmacy.
3. Regulation Number 1442/MOH on Establishment of Drug and Medical Equipment Import-Export
Company in 2003
4. Regulation Number 1441/MoH endorse 13/08/2003 on Drug Registration in Lao P.D.R
5. Regulation Number 1018/MOH in 2003 on the banned drugs in Laos
6. Regulation No.2580/MOH, on 25/11/2002 on specific controlled medicine and uncontrolled andOTC drugs.
7. Regulation Number 2580/MOH, on 12/11/2003 on Control Cosmetic Products.
8. Regulation number 2581/MOH in2003concerning the Food, Drug and Medical Equipment
Advertisement.
9. Regulation Number 2579/MOH, 12/11/2003 concerning Drug and Medical Equipment Donation.
10. Decree of PM Number 155/PM, on 30/9/2003 concerning Natural Medicinal Plant.
11. Regulation on Good Manufacturing Practice No.937 / MOH, 12/07/2004.
12. Regulation on Drug Donation No. 1189 / FDD, 02/01/ 2009.
So far, based on the Scio-economic growth, and integrations to ASEAN harmonization in pharmaceuticalareas, the Law on Drug and Medical Product has been revised, endorsed end of 2011. This revised law
has been added new five articles regarding Monitoring Quality of Drug and Medical Product (PostMarketing Surveillance); Classification of Medical Device, Intellectual Property Right Protection;
Clinical Trial Test in the Laboratory and ete... the revise Law has 50 articles. The above existing
regulation need to be revised.
Training course in “Good Governance of Medicines for Pharmaceutical Regulation Authorities (J1200694)-14-

Lay out of the LAW ON DRUGS AND MEDICAL PRODUCTS
Part I
General Provisions
Article 1
Objective
Article 2
Drug and Medical Product
Article 3
Definition of terms
1. Modern drug
2. Traditional medicine
3. Counterfeit drugs
4. Sub-standard drug
5. Deteriorate drug New drug Medicinal natural resources;
6. Health Supplement;
7. Medical device;
8. Cosmetic product9. Dangerous chemical
10. Controlled chemical
11. Pharmacist
12. List of essential drugs
13. Generic name
14. Business unit.
Article 4
Article 5
Article 6
Article 7

Policy on Drugs and Medical Products Activities
Principles of Drug and Medical Product Activities
Scope of Application
Internal Cooperation

Part II
List and Classification ofDrugs and Medical Products
Article 8
List of Drugs and Medical Products
Article 9Classification of Drugs
Article 10
Drugs in Possession
Article 11(New) Classification of Medical Device
Part III
Drug and Medical Product Business
Section I
The management of Drug and Medical Product BusinessTraining course in “Good Governance of Medicines for Pharmaceutical Regulation Authorities (J1200694)-15-

Article 12
Article 13
Article 14
Article 15
Article 16
Article 17
Article 18

The management of Drug and Medical Product Business
Registration of Drugs and Medical Products
Conditions for Business on Production, Export, Import and Wholesale of Drugs andMedical Products
Production of Drugs and Medical Products
Export and Import of Drugs and Medical Products
Wholesale of Drugs and Medical products
Retail of Drugs and Medical Products

Section 2
Advertisement ofDrugs and Medical Products
Article 19
Article 20

Advertisement
Conformity of Advertisement

Section 3
Prices of Drugs and Medical Products
Article 21
Article 22

Pricing
Price Control

Part IV
Supply, Acceptance ofDonation and Intellectual Property
Section 1
Supply of Drugs and Medical Products
Article 23
Supply of Drugs and Medical Products
Article 24
Procurement of Drugs and Medical Products
Article 25
Budget Provision
Article 26 (New) Storage and Destruction
Section 2
Acceptance of Donation ofDrugs and Medical Products
Article 27
Acceptance of Donation of Drugs and Medical Products
Article 28 (New) Sectors Accepted the Donation of Drugs and Medical Products
Training course in “Good Governance of Medicines for Pharmaceutical Regulation Authorities (J1200694)-16-

Section 3Intellectual Property
Article 29 (New)Article 30(New)Protection of Intellectual Property
Rights of Import and Production of Intellectual Property-related Drugs and Medical
Products

Part V
Clinical Trial Research
Article 31
Article 32

Clinical Trial Research
Report of the Results from the Clinical Trial ResearchPart VI
Toxicology Information Centre andCollection of Adverse Effects of Drugs and Medical Products
Article 33
Article 34

Toxicology Information Centre
Collection of Adverse Effects of Drugs and Medical Products

Part VII
Rights and Obligations of Users, and Responsibility of Suppliers of Drugs and Medical Products
Article 35(New)Article 36(New)Article 37 (New)Rights of Users
Obligations of Users
Responsibilities of SuppliersPart VIII
Prohibitions
Article 38(New)Article 39(New)Article 40(New)Prohibitions for Pharmacists and other Health Technicians
Prohibitions for Business Operators
Prohibitions for Users

Part IXManagement and Inspection ofDrugs and Medical Products
Article 41
Management and Inspection Organizations of Drugs and Medical Products
Training course in “Good Governance of Medicines for Pharmaceutical Regulation Authorities (J1200694)-17-

Article 42
Article 43
Article 44
Article 45
Article 46

Rights and Duties of Ministry of Health
Rights and Duties of Provincial, City Health Department
Rights and Duties of District, municipality Health Offices
Monitoring and Inspection of Drugs and Medical Products
Forms of Inspection

Part X
Policies towards Persons with
Outstanding Achievements and Measures against Violators
Article 47
Article 48

Policies towards Persons with Outstanding Achievements
Measures against Violators

Part XI
Final Provisions
Article 49

Implementation

Article 50

Effectiveness2). Organizational Structure:
The new organizational structure of the Food and Drug Department (FDD) has been change a little bit
since beginning of 2010, in order to ensure the establishment and role of FDD match to current situation.
There are seven divisions in the organization chart namely: Drug Business Control Division; Traditional
Medicine Control Division; Food Control Division; Narcotic, Chemise, and Cosmetic Control Division;
State/Private Pharmacy Hospital Control; Information, Education and Communication Control Unit;
Administration Division.

Training course in “Good Governance of Medicines for Pharmaceutical Regulation Authorities (J1200694)-18-

Organizational Structure of the Food and Drug Department
Food and Drug Department
Drug Business Control Division
Licensing Unit

Drug Registration
Traditional Medicine Control Unit Division
Food Control Division
Narcotic-Chemise-Cosmetic Control Division
State, Private Hospital Pharmacy Control Division
IEC Division
Administration Division
Bureau of Food and Drug Inspection
Food and Drug Quality Control
Center(Laboratoryy X(Laboratory)

Medical Product Supply Center

Provincial Food and Drug unit

Vision:To ensure good quality, safety and efficacy of drug as well as rational use for Lao people.
Mission:Develop and implementing strategy and Policy
Develop, implementing and enforcement of law and regulation governing drug, Medical
Devices and Cosmetic
Pre-marketing and Post marketing surveillances for drug Medical Devices and Cosmetic
product
Strengthening drug quality assurance system including quality control
Continue education for both public and private providers
Promotion of rational use of drug amongst health worker as well as communities
Promotion of local production to comply with GMP internationally.

3). Division is in Charge of the Pharmaceutical regulatory services respectively:
A. Licensing of manufacturing site and product qualification/registration
Licensing and registration is a premarketing authorization activity with belong to the responsibility ofBusiness Control Division. Within this Division, the licensing for manufacturing site and thequalification of the product activities are under to control of the Licensing Unit, and Product registrationis under responsibility of Drug Registration Unit. Total member staffs of Business Control Division now
are 8 people.
Training course in “Good Governance of Medicines for Pharmaceutical Regulation Authorities (J1200694)-19-

B. Registration on clinical trial conducted country:
Legal provision regarding the Clinical Trial Research is contained in article 31 and 32 of the Law on Drugand Medical Product. The clinical trial of drugs or medical products is the test of the drugs and medical
products on animals or human beings in order to prove their effectiveness and safety for the users. The
clinical trial of drugs or medical products can be conducted if only it is authorized by the health sector.
And the results from the clinical trial of drugs or medical products in the Lao PDR shall be reported tohealth their relevant sectors. In the case that harmful effects to health are found, the result shall bereported immediately to health sector and other relevant sectors in order to officially remedy or terminate
such trial.
So far, there is no any state and private organization in Laos doing the clinical trial research.
C. Pharmaceutical inspection for compliance with Good Manufacturing (GMP).
- GMP compliance inspection post-marketing activity of the quality assurance system of the Food andDrug Department in order to ensure quality safety of medicinal product producing throughout GMP
establishment. FDD in collaborating with the Bureau of Food and Drug Inspection (BFDI) do the GMP
auditing all manufacturers at least twice years.
- As the MRA in GMP and the five year action plan of FDD, 3-4 local pharmaceutical factories should becomplied with GMP standard thus the Ministry of Health composed specific committees (GMP
committees) to provide the technical assistance particularly provided regular training on basis of GMPand help establishing documentation for manufacturers.
- So far, FDD in collaborating with BFDI have provided the training to manufacturer in many subjects of
GMP and we have 13 GMP committees working as GMP taskforce.
D. Prevention and control of substandard, spurious, falsely-label, falsified, counterfeit medical
product:
Post-Marketing Surveillance (PSM) is very crucial of the quality assurance system, and the Monitoring
Quality of Medicine (MQM) activity is a part of PSM which implemented since 2003 in collaboration
between FDD, BFDI and provincial Food and Drug and with the technical and financial support from
NGOs. Each year, some prioritized medicine samples (Anti-biotic, Anti-Malarial, TB, HIV/AIDS) havebeen taken in country to check the quality in provincial and central Laboratory. The substandard andcounterfeit of anti-malarial medicines have been found.
E. Post-Marketing Surveillance (PMS) for monitoring adverse drug reaction:
In year 2000, we organized training course for ADR to the pharmacists and Drug Therapeutic Committee
of central and provincial levels whole country, and the ADR forms were developed and distributed to all
hospital, but the reporting was not very actively. Thus in the year 2012, the FDD is implementing the pilot
project on PV focus on retroviral medicines. So far Drug controls Division responsible for
implementation of this activity.

Training course in “Good Governance of Medicines for Pharmaceutical Regulation Authorities (J1200694)-20-

F. Sale and Distribution of ethical/OTC (including traditional medicine)
According to the legislation of Lao PDR drug and medical products sold in Lao PDR must be registeredat Food and Drug department Ministry of Health. However exception for registration does exist. Some
medicines are waived for registration, e.g. donated medicines, medicines used for research/analysis andmedicines used in the embassies. However, some important documents such as medicines registration,
GMP compliance and medicine analysis for finished products of related batch certificates need to beprovided.
G. Licensing pharmacist and pharmacy:
The Licensing for pharmacist to operate pharmacy is belong to Drug Business Control Division
responsible for evaluating the compliance with law and regulation before issuing the license for thepharmacist for instance, we check pharmacist qualification and appropriate room and location ofpharmacy . According to the article number 18 of Law and Medical Product, The sale at retail of drugs
and medical products shall be conducted by authorized retail pharmacies only.
The conditions and procedures of drugs and medical products retail business operations are determined in
the regulation number 482/MOH, 2003.

H. Public awareness for rational use of medicine
Currently, the IEC division takes responsibility for promoting the Ration Use of Medicines. There are 10
among
indicators for has been developed use us reference and monitoring tool for Prescription
physicians at hospital at central and some district levels; organized the training to the RUM taskforces.
The posters on RUM were produced and distribute to all hospitals regularly.
4). Pharmacopeia:
So far Lao PDR has no pharmacopoeia yet, but in quality control test and reference document for theevaluation, we base on JP, USP, and BP as the official pharmacopoeia.
5). Requirement for Vaccine and other biological product of National Regulatory Authority incountry.
Not have additional requirement.

3. Present situation and future plant in the National drug policy including essential
medicine and traditional medicine.
The Food and Drug Department have established national pharmaceutical framework together with therelated institutions which be based on the national drug policy in order to reach the main goal and it
elements. The national pharmaceutical strategy have been set up for 5 years, the strategic plan addressedon the law and regulations development, human resource development, improvement of capacity for local
Training course in “Good Governance of Medicines for Pharmaceutical Regulation Authorities (J1200694)-21-

pharmaceutical manufacturers and GMP promotion, post marketing surveillance, improvement ofprocurement and distribution system, promotion on the use of traditional medicine, rational use of drug…
The GMP promotion was set as priority task for pharmaceutical in Laos. There are 7 local factories which
not yet complied with the GMP standard of regional level. The Food and Drug Department has nominated
GMP inspection committee to inspect and assist local manufacturers in order to reach GMP standard by
two sites during the 5 years strategic plan.

4. Pharmaceutical supply in health system and pharmaceutical price mechanism
including local products, imported drug
At each health facilities in Laos have been applied revolving drug fund, the procurement practice has been
performed by health facility procurement unit. Recently, the Medical Product Supply Center isorganization in the Ministry of Health has responsibility for procurement of health products for healthfacilities in collaboration with provincial level. The pilot project launched with the 4 central hospitals toorganize centralization of the procurement based on the items of drug product and medical devices wererequested by the hospital. For the procurement at provincial level, there were organized by the
procurement committee. The price of drugs was indicated by increasing of 25% of the procurement price.
The imported drug have no price mechanism was indicated.

Training course in “Good Governance of Medicines for Pharmaceutical Regulation Authorities (J1200694)-22-

The Study Programme
for the Good Governance of Medicines for Pharmaceutical
Regulation Authorities

Malaysia-23-

GOOD GOVERNANCE OF MEDICINES FOR
PHARMACEUTICAL REGULATIONAUTHORITIESPOSITION AND NAME

: SENIOR PRINCIPAL ASSISTANT DIRECTOR

OF ORGANIZATIONPHARMACEUTICAL SERVICES DIVISIONMINISTRY OF HEALTHPOSITION AND NAME
OF ORGANIZATION: PRINCIPAL ASSISTANT DIRECTOR
NATIONAL PHARMACEUTICAL CONTROLBUREAU , MINISTRY OF HEALTH

NAME OF COUNTRY: MALAYSIA

1
-24-

1.

STATISTICAL DATA

A) Number Of Medical Professionals
DATA

YEAR

Doctors

36,6072011

Dentists

4,253

2011

Opticians

2,512

2011

Optometrists

899

2011

Asst. Medical Officers

11,162

2011

Asst. Pharmacy Officers

3,534a2011

Asst. Environmental Health Officers

3,394a2011

Medical Lab. Technologists

5,310a2011

Occupational Therapists

663a

2011

Physiotherapists

818a

2011

Radiographers

2,167a2011

Nurses74,7882011

Dental Nurses

2,528a2011

Community Nurses

22,2662011

Dental Technologists

1,559

2011

Dental Surgery Assistants

3,279

2011

Traditional & Complementary Medicine

13,202b

2011

Practitioners
Note:a: Ministry Of Health only (Government)b: Refers to registration of local and foreign practitioners-25-b) Number of Pharmacists
DATA

YEAR

Public Sector

5,288

2011

Private Sector

3,344

2011

Total

8,632

c) Number Of Pharmaceutical Manufacturers/ Manufacturing Sites
DATA

YEAR

Pharmaceutical

177

June 2012

Veterinary

3

June 2012

Total

180

d) Number Of Traditional Medicine Manufacturers/ Manufacturing Sites

DATA

YEAR

74

June 2012

DATA

YEAR

Pharmaceutical232

June 2012

Traditional

144

June 2012

Veterinary

1June 2012

Traditionale) Number Pharmaceutical Importers

Total

377

-26-

e) Number Pharmaceutical Wholesalers
DATA

YEAR

Pharmaceutical

924

June 2012

Traditional

175

June 2012

Veterinary

1June 2012

Total

1100

-27-

2. PHARMACEUTICAL LEGISLATION AND REGULATORY SYSTEMS
1. Legislation on Pharmaceutical Administration
The following legislations and all their regulations are being enforced by licensing andenforcement activities:
1) Poisons Act 1952 (Revised 1989) & Regulations
 An act to regulate the importation, possession, manufacture,compounding, storage, transport, sale and use of poisons.
2) Dangerous Drugs Act 1952 (Revised 1980)
 An Act to make further and better provision for the regulating of theimportation, exportation, manufacture, sale, and use of opium and of
certain other dangerous drugs and substances, to make special
provision relating to the jurisdiction of courts in respect of offences
thereunder and their trial, and for purposes connected therewith.
3) Sale of Drugs Act 1952 (Revised 1989) & Control of Drugs And Cosmetics
Regulation 1984
 An Act relating to the sale of drugs.
4) Registration of Pharmacists Act 1951 (Revised 1989) & Regulations
 An Act relating to the establishment of a Pharmacy Board and theregistration of pharmacists.
5) Medicines (Advertisement and Sales) Act 1956 (Revised 1983) & Regulations
 An Act to prohibit certain advertisements relating to medical mattersand to regulate the sale of substances recommended as a medicine.

-28-2. Organizational Structure

DIRECTOR GENERALOFHEALTHSENIOR DIRECTOR OF
PHARMACEUTICAL PROGRAMREGULATORYDIVISION

ENFORCEMENTDIVISION

DIRECTORPHARMACEUTICALCAREDIVISION

Pharmacy
Practice

CENTRAL LEVEL

Licensing &Entry Point

Operation &Investigation

Pharmacy
Development

STATES LEVEL

Prevention&
protection

Legislation

LicensingIntelligence
andOperation

Inspection

Innovation andAdvertisement

Centre For ProductRegistration

Centre For Post
Registration

Centre For Compliance &Licensing

Investigation
andProsecution

Centre For
Organizational
Development

Centre For Quality Control-29-

Centre For
Administration

Entry Point

Centre Investigational
New Product

The role of national/state pharmaceutical administrative organizations
The Pharmaceutical Services Division (PSD) is an independent division in the Ministry of Health.
The Senior Director of the PSD is directly responsible to the Director-General of Health.
Assisting the Senior Director of PSD at the headquarters are three Directors for Enforcement andLicensing, Pharmacy Practice and Organisational Development and Regulatory.
The 14 states have a PSD office at each of the major cities/towns and a Deputy Director of
Health (Pharmacy) oversees the administration of the pharmacy services of each state (inclusiveof hospital, clinics and enforcement and licensing activities).
The roles of PSD are:i.

Contributes directly to public health by establishing and implementing the national drug
registration system besides regulating the pharmaceutical industry through the National
Pharmaceutical Control Bureau (NPCB) that assures the quality of medicines in the
country.

ii.

Protects consumers from hazardous drugs, misleading medicine advertisements andunscrupulous practices through the enforcement of related drug and pharmacy legislationthat control the importation, sale and advertisement of drugs and the practices ofpharmacy in the country.

iii.

Provides comprehensive pharmaceutical care by ensuring efficient selection, procurement,
distribution of pharmaceuticals; ensuring rational, cost-effective and optimal use of
medicines through effective up-to-date clinical and professional pharmaceutical services
in tandem with the current global development.

iv.

Consolidates the pharmaceutical sector activities through the implementation of the
National Medicines Policy.

-30-

3. Pharmaceutical Regulatory Services
Regulatory control of pharmaceuticals
The National Pharmaceutical Control Bureau (NPCB) carries out the regulatory control ofpharmaceutical. The function of NPCB is to ensure safety, efficacy and quality of drugs; safety
and quality of traditional medicines and cosmetics marketed locally.
of products, investigation on complaints and monitoring of adverse drug reaction.
Roles and Functions of NPCB are:i.

To implement the drug registration / cosmetic notification scheme through evaluationof technical data, laboratory analysis, research and information received frominternational agencies.

ii.

To carry out analytical, pharmaceutical, microbiological and pharmacological tests on
drugs and cosmetics to determine quality, efficacy and safety of such products.

iii.

To implement the regulatory scheme on quality of pharmaceutical products in the market
through random sampling and carrying out analytical tests.

iv.

To implement the licensing scheme for pharmaceutical manufacturers, importers andwholesalers including a licensing scheme for clinical trial.

v.

To encourage and assist local pharmaceutical manufacturers to upgrade manufacturing
standards to levels equivalent to the requirements of Good Manufacturing Practice asrecommended by the World Health Organisation (WHO).

vi.

To manage the Adverse Drug Reaction Monitoring Program and participate in the WHO
International Adverse Drug Reaction Monitoring Program.

vii.

To manage the product recall scheme for pharmaceutical products which are found to be
substandard or dangerous to consumers.

-31-

viii.

To disseminate information on policies/news of the Drug Control Authority (DCA) via
the newsletter as well as provide service in the aspect of explaining to the public on theprocess of on-line registration, information on registered products and other queries
pertaining to NPCB.

ix.

To carry out research on methodology and basic research for the purpose of evaluating
quality, efficacy and safety of drugs/ cosmetics.

x.

To establish a reference standard system specially for use in this country generally andfor neighbouring countries through a scheme of cooperation in the field ofpharmaceuticals among ASEAN countries.

xi.

To carry out training for pharmaceutical officers, other professional officers and othersemi-professional officers who are placed in this institution from time to time throughlocal training scheme or international co-operational scheme.

There are seven centers under NPCB:
No.

CenterNumber of Staff

1.

Centre For Administration

18

2.

Center For Product Registration

59

3.

Center For Post Registration

29

4.

Center For Compliance And Licensing

18

5.

Centre For Quality Control

47

6.

Centre For Organizational Development

14

7.

Centre Investigational New Product

11

-32-

3(a) Licensing of Manufacturing site and product qualification/registration

Licensing of manufacturing

The Drug Control Authority (DCA) is the executive body established under the Control of Drugs
and Cosmetics Regulations 1984.The main task of this Authority is to ensure the safety, quality
and efficacy of pharmaceuticals, health and personal care products that are marketed in Malaysia.

This objective is being achieved through the following:Registration of pharmaceutical products and cosmetics

Licensing of premises for importer, manufacturer and wholesaler

Monitoring the quality of registered products in the market

Adverse Drug Reaction Monitoring

According to the Controls of Drugs and Cosmetics Regulations 1984, any company that want tomanufacture any registered products need to have Manufacturer’s Licence with the Drug Control
Authority (DCA). A premise with Manufacturer’s Licence is allowed to manufacture registeredproducts and to sell by wholesale or supply their products.

Product qualification/registration
The Control of Drugs and Cosmetics Regulations 1984 empowers the DCA to implement theregistration scheme in phases i.e.
Phase 1: Pharmaceutical products which contain scheduled poisons as defined in the Poisons
Act 1952 (1st November 1985).
Phase 2: Pharmaceutical products that do not contain scheduled poisons, other than traditional
medicines (1st August 1988)
Phase 3: Traditional medicines (1st January 1992)-33-

Phase 4: Cosmetics


hair dyes containing phenylenediamine, toluenediamine, salt and derivatives (1 st August,
1991)



tooth whiteners containing hydrogen peroxide / carbamide peroxide (1st February,1996)

all cosmetic products other than listed above (1st February 2002)

Cosmetics registration was replaced by the Notification Procedure as of 1 Januari 2008
Phase 5: Registration - Veterinary (Aug 2007)
Phase 6: Registration beginning with NCE (Jan 2012)
The DCA also ensures that all registered / notified products are labelled according to stipulated
labelling requirements.

3(b) Regulation on clinical trials conducted
Clinical trials that is conducted in Ministry of Health (MOH) facility or involve MOH personnel
or funded by MOH research grant must be register with National Medical Research Register(NMRR). Registration of clinical trials is very much an international norm and is endorsed byboth the International Committee of Medical Journal Editors and the World Health Organization.
This is to ensure transparency and to increase public trust and confidence in the conduct of
medical research as well as to inform physicians and prospective volunteers about ongoing/future
research in which they may wish to enroll.
The registration schemes enable MOH management to document the level of research activity in
the MOH, and also to track the progress of the researches it has approved and/or provided
support such as funding
3(c) Pharmaceutical Inspection for Compliance with Good Manufacturing Practice (GMP)-34-

According to the Control of Drugs and Cosmetics Regulations 1984, compliance to Good
Manufacturing Practice is a pre-quisite for the application of a manufacturing license as well as
product registration/ cosmetic notification.
Good Manufacturing Practice (GMP) is a standard that should be followed by manufacturers ofregistered pharmaceutical/ traditional products and notified cosmetics to ensure that the productmanufactured is safe, efficacious and of quality.
Centre for Compliance and Licensing (CCL) of NPCB is responsible for the Good
Manufacturing Practice (GMP) inspections of manufacturers of registered products and notified
cosmetics to ensure manufacturers compliance towards the current GMP requirements. CCL,
with the assistance of the State Pharmacy Enforcement Division, is responsible for ensuring theimporters and wholesalers of registered products adhere to the current Good Distribution Practice(GDP) requirements.
Generally, GMP compliance is rated as Good, Satisfactory or Poor. The level of compliance isdetermined by the weaknesses / non-conformances found during an inspection. The frequency
for inspection is determined according to the level of risk of the product manufactured, as well as
the latest GMP compliance rating.

3(d) Prevention and control of substandard , spurious, falsely-labeled, falsified, counterfeit
medical products.
All products in Malaysia must undergo registration process with the Drug Control Authority.
Product means:(a) a drug in a dosage unit or otherwise, for use wholly or mainly by being
administered to one or more human beings or animals for a medicinal purpose; or-35-

(b) a drug to be used as an ingredient of a preparation for a medicinal purpose.
Registered products will carry a registration number and hologram stickers. The number is
uniquely given for each product. The number can be checked through NPCB website where theregistered products are listed. A decoder was used to identify the genuine hologram.
Public and private pharmacists were given the awareness on the usage of hologram and decoder
to identify the genuine medicines. A total of 1700 private pharmacies were provided withmeditag hologram decoder for public use
The State Pharmacy Enforcement Division is responsible for ensuring all products in market areregistered products through routine inspections, raiding, and sampling on the premises that sell
products. Premises which sell unregistered will be charged in court.

3(e) Post-Marketing Surveillance (PMS) for monitoring adverse drug reaction.

Active product monitoring via the Post Market Surveillance (PMS) program is conducted by theauthority to ensure that only safe products are being marketed. The activities consist thefollowing:

1. Screening of product formulation and information
2. Audit on the Product Information File (PIF) for compliance with the regulations
3. Sample collection, testing and monitoring of label compliance
4. Audit of premises to ensure compliance with Guidelines Investigation of complaints
5. Initiation of warning and information sharing system between ASEAN countries
6. Monitoring of adverse reactions reported by Healthcare Professionals or consumers.
7. Monitoring of product advertisement-36-

3(f) Sale and distribution of ethical/OTC medicines (including traditional medicines).
Registered products including OTC medicines and traditional medicines can only be distributedby a licensed wholesaler whose license is issued by DCA but, the sale of these products is notcontrol. Any premise or individual can sell these medicines as long as they are registered.

3(g) Licensing pharmacist and pharmacy.
All pharmacists in Malaysia must be registered with the Board of Pharmacy with a practicecertificate renewed annually. A license called Type A license is issued to a pharmacist to import,
store and deal generally by wholesale and retail or by wholesale only or by retail only in all
poison listed in Schedule 1 of The Poisons Act 1952. Type A license is issued to a pharmacist at
a premise by the Enforcement Branch of each state after a satisfactory inspection been conducted.
The premise must be registered with the local council/authority or Companies Commission of
Malaysia before it can be operated as a business premise.
Pharmacists working with the Government of Malaysia are required to apply for a Type A
license but they still need to have a practice certificate renewed yearly.

3(h) Public awareness for rational use of medicines.
Continuous educational activities were conducted for the public in both urban and rural area toempower consumers with knowledge and information towards rational use of medicines.
Dissemination of information via electronic and printed media increased the knowledge andawareness or targeted groups.

-37-

The Quality Use of Medicine-Consumer (QUM-C) is a strategy to support the forth componentof Malaysian National Medicines Policy (MNMP) which is Quality Use of Drugs. The main
objective of QUM-C is to educate consumers on the rational use of medicine. This will increase
their knowledge and skill so that they are able to make informed decisions. Further objective isto encourage consumers to play a more active part on drug related issues and subsequently be
responsible to their own. The activities have been actively carried out as state level so thatproject impact can be spread out to each and every public stratum.
In year 2009 the Know Your Medicine campaign has been implemented actively and widely atstate level in order to ensure awareness activities and information on medicines are welldisseminated to the public. The activities conducted are in the form of campaign launchings,
seminars, exhibitions, dialogues and radio talks.
The Training of Trainers Workshop has been organized in every state since 2007 to train andlead pharmacist of every state to carry out the activities in a standard and structured manner.

4. Pharmacopoeia
Malaysia has no pharmacopeia of her own. For reference the following pharmacopoeias are usedi) British National Pharmacopoeiaii) United States Pharmacopoeiaiii) The Martindale.

5. Additional Requirement for vaccines and other biological products-38-

1. Guidelines for the Pharmacovigilance on Safety of Vaccines in Malaysia. These
guidelines encompass the operation of the Pharmacovigilance Program on the
Safety of Vaccines. The National Immunization Technical Committee isestablished by the Ministry of Health (MOH) Malaysia to plan, monitor andreview strategies, programs, targets and achievements of the immunization
programs in the country.
2. Guidelines for application for registration of biological/ biotechnology product:
The additional requirements for registration of Biotechnology Products, Vaccines
and Blood Products
Comply with WHO requirements for the product as can be found in the WHO
Technical Report Series, including:Control of starting materials, including baseline data both on the hostcell and on the source, nature and sequence of the gene used in the
production. A well-characterized, clean starting material.

Control of the manufacturing process.



Control of the final product.

Stabilisation and storage.



Viral Safety Evaluation.

-39-

3. PRESENT SITUATION AND FUTURE PLAN OF THE NATIONAL MEDICINEPOLICY, INCLUDING ESSENTIAL MEDICINE AND TRADITIONALMEDICINE
National Medicines Policy (NMP) has been approved to become the country’s Medicines Policyin October 2006 with aims to promote equitable access to, and rational use of, safe, effective andaffordable essential drugs of good quality to improve health outcomes of the people. The fullterm review of NMP has been conducted to present the activities accomplished throughout thefirst term of Malaysian NMP 2006-2012.
The NMP consists of five main components with aim and strategies as below:-40-

Main Component
1.

Aim

Strategy

Quality, Safety and Efficacy To ensure that drugs marketed for patient Strengthening
of Drugs

Drug

drug

regulatory

systemthroughacare are safe, effective and of high quality so comprehensive drug legislation framework and enhancement ofas to meet the health needs of the nation

2.

the

Availabilityand 

Affordability

pharmaceutical quality assurance measures.

To ensure an equitable, adequate and 

Careful selection of medicines, improvement in thecontinuous availability of safe, effective

management of drug procurement and the supply chain, andand quality essential drugs to the entire

through optimal utilization of available financial resources.


population
To

ensurecontinuous

accessandfinancial sustainability of essential drugs

Implementing cost-containment measures and developing
appropriate and reliable financing mechanisms to ensure
equitable access to essential drugs for the population.

at prices affordable to all
3.

Quality Use Of Drugs

To contribute towards quality of care and Training and education for healthcare providers and public,
cost-effective therapy

provision of independent and evidence-based drug information
establishment of therapeutic committees, development ofstandards of professional practice, ethical promotion of drugs
and provision of relevant legislation

-41-

4.

Human
Development,
Development,

Resources To ensure partnership and collaboration of The aim shall be achieved by:
Research& all stakeholders in the healthcare industry 1. Early

Technical conforms to best practices and standards

Cooperation

andcontinuous

engagement

of

all

relevant

stakeholders.

pertaining to medicines at national, regional 2. Ensuring sustainability of qualified, competentand international levels.

andeffective human resource based on needs through:

Training and development



Development and advancement of professional
career pathway

3. Sharing of information, expertise, skills and facilities.
4. Developing and updating legislation, regulation andguidelines to sustain the applicability of the policy.

5.

Governance in Medicines

To have appropriate governance that 

Health professional bodies and relevant stakeholders should

ensures the provision of safe, effective

have code of conducts and be responsible to ensure

and affordable medicines within the bestcompliance by its members with the codepractice environment.

-42-

Stakeholders perform in accordance with standard of





are

practice developed by appropriate authorities/ relevant

responsible in conducting themselves in

professional bodies. Compliance with the standards should

an ethical and professional manner

be supported by legislation where appropriate.

To ensure regulations facilitate and 

Relevant legislations/ regulations should be developed

support the provision of safe, effective

and/or reviewed to ensure and efficient and integrated

and affordable medicines

medicines management and supply chain network thatTo

ensureallstakeholders

protects the public.

-43-

4. PHARMACEUTICALSUPPLYIN
HEALTHSYSTEM
AND
PHARMACUETICAL PRICING MECHANISM FOR UNIVERSAL HEALTH
COVERAGE IN THE COUNTRY
Pharmaceutical Supply in Health System
The pharmaceutical service in hospitals and health clinics under the Ministry of Health Malaysia
aims to provide comprehensive patient-centred pharmaceutical care.
Pharmacy Ambulatory Services stress on quality use of medicines, promotion of healthy lifestyleand provision of innovative services to give a positive impact in view of the patients’perspectives and expectations. Various activities and drug delivery systems have been introduced
to minimize medication errors, promote patients’ compliance and assist patients in getting accessto their medications.
The Clinical Pharmacy Services have also been expanded to include Medication Therapy
Adherence Clinic, Methadone Dispensing and Counseling, Ward Pharmacy Service, Drug
Information Service, Clinical Pharmacokinetic Service, Total Parenteral Nutrition Service,
Oncology Pharmacy Service and Nuclear Pharmacy Service.
The pharmacy services in primary care facilities include Basic Pharmacy Services: Include
prescriptions screening, drug dispensing, patient counseling, procurement, health promotion,
health education and drug information. Extension and Expansion of Pharmacy Services; include
Medication Therapy Adherence Clinic, Methadone Maintenance Therapy Programme and Home
Medication Review
There are also other types of supply systems include:
The Integrated Drug Dispensing System introduced in the year 2005 to facilitate the supply ofrefill medicines to patients on long term therapy. Through these dispensing systems patients can
get their refill medications from any Ministry Of Health facilities of their choice.

-44-

Other supply systems: Appointment Card System, Phone & Take System, SMS & Take System,
Pharmacy Drive Thru System and Pharmacy Home Delivery System via Courier Service. These
dispensing systems aim to reduce patient waiting time and facilitate patients on chronic therapy
who received monthly supplies of their medications.

Pharmaceutical Pricing Mechanism for Universal Health Coverage
As drugs price is a contentious issue the government is of the opinion that it should be handledvery carefully. The Pharmaceutical Services Division (PSD) has set up a Price Monitoring Unit
to conduct price monitoring for the country.

Expert was brought to the country to train

pharmacists on how to conduct price monitoring.
The price monitoring activities will ensure that as the price of drugs become transparent toprescribers and users, and this will encourage self-regulation by the distributors. At the sametime, the authorities are also looking into other mechanisms of drug control.
The Medicine Price Database is being developed. Currently, the medicines price data,comprising of categories as below, are continuously compiled and updated.
i.

Fee Act (Full Paying Patient)vi

National Essential Drug Price List (Public)ii

Private Retail Pricevii

National Essential Drug Price List (Private)iii

Public Wholesale Priceviii

Traditional Wholesale Priceiv

Private Wholesale Priceix

Recommended Retail Price (RRP)x

Government Procurement (GP) Price(Controlled Medicines)v

Private Wholesale Price (OTC)-45-

Newly listed medicines in the Ministry of Health (MOH) Drug Formulary are subjected to pricemonitoring. To further strengthen this monitoring procedure, firms requested for their medicines
to be listed in the MOH Drug Formulary are required to submit their quotation of selling price to
MOH facility if the aforementioned medicines have been successfully listed in the MOH Drug
Formulary. The medicine price sold to MOH facilities should not exceed the said quotation for atleast one a year. After that, any price increments will be monitored by the Medicines Price
Determination Unit. The review is done once a year continuously by obtaining feedback from
MOH hospitals. In the event where the medicines price is more than the predetermined price, therelated firm is obliged to provide explanation regarding this issue and take corrective actions
such as credit notes provision or reimbursement in the form of medicines-46-

The Study Programme
for the Good Governance of Medicines for Pharmaceutical
Regulation Authorities

Philippines-47-

REPUBLIC OF THE PHILIPPINESCOUNTRY REPORT

Training on Good Governance ofMedicines for Pharmaceutical
Regulation Authorities

04 November to 29 November 2012

Food-Drugs Regulation Officer- III
Food and Drug Administration
Department of HealthPhilippines-48-

I. The Philippines: Background
The Philippines is located in Souteast Asia and divided by 7,107 various islands and speaks
the varied attitude but with a common culture of being hospitable. This is located in between
the South China Sea on the west and the Philippine Sea on the east. The major islands are
Luzon in the north, the Visayan Islands in the middle, and Mindanao in the south. The total
area is about 300,000 square kilometers, including about 298,000 square kilometers of land
and about 2,000 square kilometers of water.

The Philippines has a tropical marine climate, with the northeast monsoon, which produces acool, dry season from December to February, and the southwest monsoon, which brings rain
and high temperatures from May to October. Between March and May, hot, dry weather
prevails. Manila is the capital city and Baguio City as the summer capital of this country.
Temperatures in Manila range from 21˜2˜C to 3C, with an average annual temperature of 27˜C.
Temperatures elsewhere in the Philippines have been recorded at more than 37˜C. The
average monthly humidity ranges from 71 percent in March to 85 percent in September.
Annual rainfall is heavy but varies widely throughout the Philippines, ranging from 965
millimeters in some sheltered valleys and the southern tip of the island of Mindanao to 5,000
millimeters along the mountainous east coasts of the islands of Luzon, Samar, and thenorthern tip of Mindanao. The Philippines lies astride the typhoon belt and experiences 20 to
25 typhoons a year from July through October, of which five or six may cause serious
destruction and death. About 83 percent of the population is Roman Catholic; 9 percent
Protestant, including Presbyterian, Methodist, Philippine Independent Church, and Philippine-49-

Church of Christ; 5 percent Muslim; and 3 percent Buddhist and other religions. The
constitution guarantees freedom of religion and separation of church and state. But Christianity
predominates, and Muslims historically have been marginalized.

The group constituting more than 90% of the population is predominantly Roman Catholic,although the Philippine Independent Church and the Iglesia ni Cristo command significant
followings. The hill tribe practice tribal religions and Islam is strongest in the Sulu Archipelago,
Southern Palawan, and parts of Southern Mindanao.

The Philippines has two official languages, Pilipino (Tagalog) and English, while in Visayas
and Mindanao the common language is Bisaya (or Cebuano speaking). Filipinos has eight
major dialects, in order of use: Tagalog, Cebuano, Ilocano, Hiligaynon or Ilonggo, Bicol,
Waray-waray, Pampango, and Pangasinense. Filipino, based on Tagalog, is related to Malay
and Indonesian and is part of the Malayo-Polynesian subgroup of the Austronesian language
family. Filipino is the common language used between speakers of different native languages,
which are closely related but not mutually intelligible. English and Pilipino are used in thegovernment and as the medium of instruction in higher education.

This year, Department of Education commenced Grade Seven making it seven years ofprimary education which is basically free and compulsory; the four-year secondary education
program is free but not compulsory. The Philippines has one of the highest literacy rates in
Asia. The many colleges and universities include the University of the Philippines (1908) and-50-

the University of Sto. Tomas (1611). Higher education is greatly valued, although the economy
cannot absorb all college graduates.

Article II of the 1987 Constitution of the Republic of the Philippines explicitly states that theFilipino political system is both democratic and republican, placing the right to govern with thepeople. The Philippines has a government that is elected by the people who retain some formof control over the running of the state.

Republican - Article VI of the Philippines Constitution vests "legislative power" in the Congress,
giving Congress the power to create laws. The President's power is derived from Article VII of
the Constitution, allowing him the authority to appoint Congressmen during recesses as well as
the executive departments similar to the President's cabinet in the United States. As
commander-in-chief, the Filipino President ensures civilian control of the military.

Democratic - The government of the Republic of the Philippines is elected by the people, andany authority given to the government comes from the people as stated in the Philippine
Constitution. Members of the executive and legislative branches of government are elected by
the people to serve predetermined terms of office. Article VII mandates that the President andVice President of the Philippines be elected through a direct election by the people. The
President may only serve one six-year term. Members of Congress are elected by the citizens
in their individual districts.

All economic activities in the country give yearly a final output of goods and services. This
'GNP per capita' shows the general economic achievement of a country. The figure of the-51-

GNP for the Philippines shows that the country is ranking somewhere in the middle position of
all countries in Pacific Asia.

The rich body of indigenous artistic traditions includes folktales, music, and the folk dances
made famous by the Bayanihan Dance Troupe. Painting and Sculpture often combine Asian &Western elements. Spanish and English have been the vehicles for such writers as Jose Rizal,
N.V.M. Gonzalez, Bienvenido Santos, and F. Sionil Jose.

II. STATISTICAL DATA
II.A. Philippines Demographics Profile as of 2012
Population
Age structure

Median age

Population Growth Rate
Net migration rate
Urbanization

Sex ratio

Total fertility rate
HIV/AIDS - adultprevalence rate
HIV/AIDS - people living

103,775,002 (July 2011 est.)
0-14 years: 34.6% (male 17,999,279/female 17,285,040)
15-64 years: 61.1% (male 31,103,967/female 31,097,203)
65 years and over: 4.3% (male 1,876,805/female 2,471,644)(2011 est.)
total: 22.9 years
male: 22.4 years
female: 23.4 years (2011 est.)
1.873% (2011 est.)-1.27 migrant(s)/1,000 population (2011 est.)
urban population: 49% of total population (2010)
rate of urbanization: 2.3% annual rate of change (2010-2015
est.)
at birth: 1.05 male(s)/female
under 15 years: 1.04 male(s)/female
15-64 years: 1 male(s)/female
65 years and over: 0.76 male(s)/female
total population: 1 male(s)/female (2011 est.)
3.15 children born/woman (2011 est.)
less than 0.1% (2009 est.)
8,700 (2009 est.)-52-

with HIV/AIDS
HIV/AIDS - deaths
Major infectious
diseasesNationality
Ethnic groups

Religions

Languages

Literacy

School life expectancy(primary to tertiary
education)
Education expenditures
Health Expenditures

fewer than 200 (2009 est.)
degree of risk: highfood or waterborne diseases: bacterial diarrhea, hepatitis A,
and typhoid fever
vectorborne diseases: dengue fever, malaria, and Japanese
encephalitis
water contact disease: leptospirosis (2009)
noun: Filipino(s)adjective: Philippine
Tagalog 28.1%, Cebuano 13.1%, Ilocano 9%, Bisaya/Binisaya
7.6%, Hiligaynon Ilonggo 7.5%, Bikol 6%, Waray 3.4%, other
25.3% (2000 census)
Roman Catholic 80.9%, Muslim 5%, Evangelical 2.8%, Iglesia ni
Kristo 2.3%, Aglipayan 2%, other Christian 4.5%, other 1.8%,
unspecified 0.6%, none 0.1% (2000 census)
Filipino (official; based on Tagalog) and English (official); eight
major dialects - Tagalog, Cebuano, Ilocano, Hiligaynon orIlonggo, Bicol, Waray, Pampango, and Pangasinan
definition: age 15 and over can read and write
total population: 92.6%
male: 92.5%
female: 92.7% (2000 census)
total: 12 years
male: 12 years
female: 12 years (2008)
2.8% of GDP (2008)
3.8% of GDP (2009)-53-

II.B. VITAL STATISTICS
1. Rate of vital Statistics (per 1,000
population)

1.1 Infant Mortality Rate

total: 18.75 deaths/1,000 live births
male: 21.21 deaths/1,000 live births
female: 16.18 deaths/1,000 live births(2011 est.)

2. Five Main Diseases Causing Morbidity
2.1.
Acute Lower Respiratory Tract
Infection & Pneumonia
2.2.
Bronchitis/Bronchiolitis
2.3.
Acute Watery Diarrhea
2.4.
Influenza
2.5.
Hypertension
3. Five leading causes of mortality
3.1.
Diseases of the Heart
3.2.
Diseases of the Vascular System
3.3.
Malignant Neoplasms
3.4.
Pneumonia
3.5.
Accidents
4. Life expectancy at birth

No. of Cases

Rate/100,000

776,562971.6

719,982
577,118
379,910342,284
No. of Cases
70,13849,51938,821
34,21833,617

900.8
722.0
475.3
428.2
Rate / 100,000
17.7
12.5
9.8
8.6
8.5

Total population: 71.94 years
male: 68.99 years
female: 75.03 years (2011 est.)
94 deaths/100,000 live births (2008)

5. Maternal Mortality Rate
6. Children under the age of 5 years
underweight

20.7% (2003)

7. Physician’s Density
8. Hospital Bed Density

1.153 physicians/1,000 population(2004)
0.5 beds/1,000 population (2006)

9. Obesity - adult prevalence rate

4.3% (2003)-54-

2 MEDICAL CARE POLICY
1.1 Estimated No. of Patients who Received
Medical Treatment on the Specified Date
3.1.1. Government Hospital
3.1.2. Public Hospital
3.1.3. Private Hospital
1.2 No. of Hospitals by Establishing Organ(1999-2009)
721
3.2.1. Government Hospitals
1,074
3.2.2. Private Hospitals
1.3 No. of Health Manpower
3.3.1. Physicians (year)
2005-2010
3.3.2. Dentists (year)
2005-2010
3.3.4. Pharmacists (year)
2005-2010
3.3.5. Nurses (year)
2005 - 2010
3.3.6. Medical Technologists (year)
2005- 2010
3.3.7. Midwives (year)
2005 -2010
3.3.8. (Licensed)Pharmaceutical
Manufacturing(year)
2012
3.3.9. (Licensed) Traditional Medicine
Manufacturers (year)2012
3.3.10. (Licensed) Drug Importers(year)
2012
3.3.11. (Licensed) Wholesalers (Year)
2012

-55-

106,450
47,33752,312
382,624
49,605
242

302

8

748
5,090

3 PHARMACEUTICAL AFFAIRS ADMINISTRATION
IV.1. ADMINISTRATIVE ORGANIZATION CHARTS(Please see attached pages)
IV-1.1 DEPARTMENT OF HEALTH
IV-1.2 FOOD AND DRUG ADMINISTRATION

-56-

-57-

ORGANOGRAM OF FOOD AND DRUG
ADMINISTRATION

 Bureau of Food and Drugs (BFAD)•

Republic Act No. 3720 was passed into law known as the “ Food, Drug andCosmetics Act” on June 22, 1963 ; “ To ensure the safety, purity, and quality offoods, drugs and cosmetics being made available to the public”

 Legal Basis•1987 Philippine Constitution-58-Sec. 12, Article XIII “The state shall establish and maintain an effective food and drug
regulation system and undertake appropriate health, manpower development, and research,
responsive to the country’s health needs and problems.”
 STRATEGIESInspection and licensing of establishments dealing with food, drugs, medical
devices, cosmetics, in vitro diagnostic reagents, and household hazardous
substances.



Evaluation, testing and registration of products.

Approval of product label prior to marketing.



Monitoring of quality of products in the market.



Evaluation and monitoring of sales promotion and advertisements of regulated
products and establishments.

 FUNCTIONSDevelops plans, policies and programs pertaining

to the regulation ofprocessed foods, drugs, and other related products.
Provides technical information and assistance to clients and the general public
on matters pertaining to food drug, and cosmetics laws, regulations, functions
and services.

 Republic Act No. 9711
 An Act Strengthening and Rationalizing the Regulatory Capacity of the Bureau of Foodand Drugs (BFAD) by Establishing Adequate Testing Laboratories and Field Offices,
Upgrading its Equipment, Augmenting its Human Resource Complement, Giving-59-

Authority to Retain Its Income, Renaming it the Food and Drug Administration (FDA),
Amending Certain Sections of Republic Act No. 3720, As Amended, and Appropriating
Funds Thereof.

3.1

LAWS/REGULATIONS COVERING PHARMACEUTICAL AFFAIRS

3.1.1 PRODUCT REGULATIONS
3.1.1.1

Republic Act 3720 - Food, Drug and Cosmetic Act later amended by EO 175
otherwise known as Foods, Drugs, and Devices and Cosmetics Act- an act toensure the safety and purity of food and cosmetic and the purity, safety, efficacy andquality of drugs and devices being made available to the public vesting BFAD withthe authority to administer and enforce the law.

3.1.1.2

Republic Act 6675 - Generics Act of 1988- it is an act to promote, require to ensure
the production of an adequate supply, distribution, use and acceptance of drugs andmedicines identified by their generic name.

3.1.1.3

Republic Act 8203 - Special Law on Counterfeit Drugs - it is the policy of the state
to protect andpromote the right to health of the people and still healthconsciousness among them. It further declared the policy of the state that in order tosafeguard the health of the people, the State shall provide for their protection against
counterfeit drugs.

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3.1.2 PROFESSIONAL REGULATIONS
3.1.2.1

Republic Act 5921 - Pharmacy Act as amended by E.O. 174 s. 1987 - the act
regulating the practice of pharmacy and setting standard of pharmaceuticaleducation in the Philippines and other purposes.

3.1.3 HEALTH PROMOTION & REGULATIONS
3.1.3.1

Health Establishments Regulations

3.1.3.1.1 Republic Act 4226- an act requiring the licensure of all hospitals in the Philippines
and authorizing the Bureau of Licensing and Regulations.
3.1.3.1.2 Administrative Order 55- ( for laboratory clinics )- revised rules and regulation in
the licensing of laboratory performing HIV testing. The licensure of laboratory clinic
is done by the Bureau of Research and Laboratory.
3.1.3.1.3 Administrative Order No. 56 s. 1989- Licensing requirements for securing BFAD
License to Operate.
3.1.3.1.4 Administrative Order No. 43- s. 1999- an amendment of A.O. 220 s. 1974,
Current Good Manufacturing Practice. With the development in the Science andtechnology, industry and public health interest, the Current Good Manufacturing
Practice Guidelines for Drugs was adopted and implemented.
3.1.3.1.5 Administrative Order No. 90 s. 2002- current Good Manufacturing Guidelines for
Cosmetics Products- linient guidelines for cosmetics as compared with A.O. 43-A s.
1999.

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3.1.3.2

TRADITIONAL MEDICINES

3.1.3.2.1 Republic Act 8423- an act creating the Philippine Institute of Traditional Medicine
and Alternative Health Care to accelerate the developments of traditional andalternative health care in the Philippines.
3.1.3.2.2 Administrative Order 12 s. 1993- Traditional Medicine Program for promotion anddevelopment of traditional medicines that has been found safe and effective.
3.1.3.3

HEALTH ECONOMICS

3.1.3.3.1 Section 2.3 BFAD Regulation No. 5 s. 1987 and A.O 65 s. 1989- No
pharmaceutical products classified by BFAD as a Prescription or Ethical Drug shallbe advertised or promoted in any form of mass media except through medical
journals, publications and/or literature solely intended for medical and allied
professions.
3.1.3.3.2 Article 116 of Republic Act 7394 or the Consumer Act of the Philippines- That
any sales promotion campaign using medical prescriptions in any part thereof or
attachment thereto for raffles or a promise of reward shall not be allowed, nor permit
be issued thereof.
3.1.3.3.3 Section 4 of BFAD regulation No. 5 s. 1989- Press releases, editorials, healthcolumns and features and public service announcements on health and medicines
shall not specify brand/ trade names. Generic names are, however, permissible. For
prescriptions drugs, it should be clearly stated that this product can be bought onlywith a prescription and a doctor’s advice shall be sought.

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3.1.3.3.4 A.O 119 s. 2000 (item no. 1)- Consistent with the rational drug use policy, thepromotion of OTC drug to the public will only be allowed if its known adverse effectare also cited. Moreover, it is the intention of R.A 6675 or the Generic Act of 1988, to
promote drug safety by minimizing duplication medications and/or use of drugs withpotentially adverse drug reaction.

3.2

LICENSING SYSTEM

4.3.1. PHARMACEUTICAL INSPECTION AND GMP
The Food and Drug Administration is the regulatory agency under the Department of Health,
responsible for ensuring that the products distributed in the market by licensed establishments
has met the basic GMP requirements based on A.O. 43 s. 1999 and the ASEAN Code of GMP.
Through the assistance of AUSAID, a Senior GMP Auditor of Therapeutic Good Administration(TGA) came to Manila to conduct a comprehensive training on GMP and other relevant codes
were extensively renewed and discussed. It was in this occasion that drug inspectors realizedthat the written supplement to the existing guidelines was deemed vital both to thepharmaceutical industry and the regulators since BFAD also envisions to be a world class
regulatory agency.

Basic GMP Guidelines:
4.3.1.1. Personnel – should be adequate in number and qualified at all levels and provided
with skills and capabilities relevant to their respective functions.
4.3.1.2. Premises – it must be of suitable size, design, construction and location to facilitate
proper operation, cleaning and maintenance.

-63-4.3.1.3. Equipment – it shall be of appropriate design, construction, size and suitably located inorder to assure product quality, process reproducibility and facilitate cleaning & maintenance.
4.3.1.4. Sanitation & Hygiene – high level of sanitation shall be practiced in every aspect ofmanufacturing drug products.
4.3.1.5. Storage of Starting & Packaging Materials, Intermediate Bulk Products & Finished
Products
4.3.1.6. Production
4.3.1.7. Packaging
4.3.1.8. Finished Product Quarantine & Delivery to Warehouse – the finished product isquarantined before the product is transferred to the warehouse and becomes available for
distribution to the market.
4.3.1.9. Quality Control - it is essential part of GMP to provide assurance that products will beconsistently of quality appropriate to their intended use.
4.3.1.10. Documentation it is part of management information system, which includes –specifications, procedures, methods and instructions, reports & records & other documents
required for planning, organizing & controlling & evaluating the whole activities of drug
products manufacturing
4.3.1.11. Self – Inspection – the purpose of self-inspection is to evaluate the manufacturer’s
compliance with GMP on all aspects of production and quality control
4.3.1.12. Guidelines for Handling of Product Complaint, Product Recall and/or Returned
Product – a system for handling each of these shall be designed and include written standard
operating procedures, stating who is responsible, the investigation conducted & results-64-evaluated and actions taken up and shall record all details relevant to the product complaint,
product recall or product returned.

4.3.2. PHARMACEUTICAL INSPECTION AND GUIDANCEIn the Philippines, there are about 117 drug inspectors stationed all over the country. There are
36 inspectors from the National Capital Region (central office) and 81 inspectors detailed in the
different regions. In the National Capital Region, drug inspectors are assigned in two (2)Divisions:
Regulation Division I - drug inspectors are responsible for the inspection of retail drugstores,
non-prescription drug retail outlets, Chinese drugstores, hospital pharmacies, drug distributors(importers,

exporters and wholesalers) of food, drug, cosmetic, medical devices andhousehold hazardous substances.
Regulation Division II - drug inspectors are responsible for the inspection of establishmentsthat deals with the manufacture and repacking of foods, drugs, cosmetics, medical devices andhousehold hazardous substances.
Inspectors regularly make on the spot inspection on all licensed establishments andestablishments applying for a license. Based, on the outcome of the inspection, if there is noncompliance with CGMP, they will require the establishment to correct the deficiencies noted
within the specified period. A follow- up inspection will be made and if there were no changes
or corrections done, the inspector will recommend for the suspension of license to operate of
the establishment to the Bureau’s Legal and Compliance Division.

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4.3.3 POST MARKETING SURVEILLANCE (PMS)
One of the functions of the Food and Drug Administration is Post Marketing Surveillance. PMS
is a close observation of drug effects, whether beneficial or adverse, following the marketing ofa drug. The Bureau ensures that all products regulated by the agency conform to thestandards and its specifications. One way of surveillance is by routine sampling of products inthe market during inspection. Samples are submitted to the laboratory for testing. Appropriate
actions or product recall is decided by the legal division depending on the result of the analysis.
4.3.4

DRUG DISTRIBUTION SYSTEM

4.3.5 Drug distribution is done by a Licensed Drug Distributor (importer, exporter, andwholesaler) by licensed Drug manufacturer and Drug Traders. Usually, the Drug
Distributors are authorized by Drug Manufacturers and Traders to distribute theirproducts. Distribution Agreement between each client is provided. Documentation
system such as records of delivery receipts and invoices are required between the
distributor and the supplier. Such records are needed for easy traceability in case ofa product recall.

(Same as to from distributors to retail drugstores/ hospital

pharmacies)
No medicine, pharmaceutical or drug whatever nature and kind or devices shall becompounded, dispensed, sold or resold, or otherwise be made available to theconsuming public except through a prescription drugstore or hospital pharmacy duly
established in accordance with the provision of Republic Act 5921 section 25.
Pharmaceutical, drug or biological manufacturing establishments, importers and-66-

wholesalers of drugs, medicines or biological products are authorized to sell theirproducts only at wholesale to duly established retail drugstore or hospital pharmacy.
Every pharmacy, drugstore or hospital pharmacy whether owned by the government
or a private person or firm shall at all times when open for business be under thesupervision of a registered pharmacist. In cases, when a drug establishment
operates in more than one shift, each shift must be under the supervision andcontrol of a registered pharmacist.
Products distributed should always be registered by the Bureau and should have an
individual distribution record regardless of dosage strength and availability. The
purpose of providing

distribution records is to assure a systematic procedure of

distribution and a prompt recall from outlets if products are found to be defective
and violative.
Proper generic dispensing of drugs and pharmaceuticals in retail outlets should
always be evaluated by the pharmacist. Incorrect prescriptions are not to bedispensed and patients/customers should be instructed to secure a properprescriptions from physicians.
4.4.5 STABLE SUPPLY OF VACCINES
The Philippines has only one manufacturer of vaccines- the Biological and Vaccine
Production Division which is directly under the Department of Health. Currently theagency has produced the BCG vaccine. The vaccines are already imported tosupplement the needs of the people.

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10.
PRESENT SITUATION IN THE NATIONAL DRUG POLICYINCLUDING ESSENTIAL DRUGS AND TRADITIONAL MEDICINES
From the continuous implementation of the GMP in the Philippines, FDA still finds some
Drug Companies not in compliance to the guidelines. Due to the economic crisis arisingfrom the country, more drug companies opted to just have their products toll
manufactured. The issue of the local pharmaceutical laboratories is that they cannot
easily cope up with the advanced technology of the multinationals. The knowledge,
skills and capability of the personnel in every manufacturing facility can be pirated byother laboratories or they may have the opportunity to go to other countries. Other
manufacturing companies still have not improved or established quality management
system. The proliferation of the counterfeit drugs by unknown “fly by night”
manufacturers still exists.

On the part of the implementing agency both in the FDA Central and Regional Health
Offices, the main problem is the insufficient number of food and drug regulation officers
particularly in the regions. The expertise is not fully acquired due to the limited budget of
the FDA Central to conduct seminars to reecho the latest updates on the GMP
inspections. Insufficient numbers of vehicles to locate and reach some drug
manufacturing facilities is also a problem.

At the moment, FDA Philippines is on the strengthening process to be able to function
as mandated by R.A. 3720, as amended, and RA 9711, to fulfill the vision. The agency
is very strict in issuing License to Operate to Drug Establishments and Outlets. The-68-

continuous coordination of the Central Office to the Regions has been done using thezonal approach.

Other solutions, being considered by FDA Philippines are the additional plantilla,
technical training and technical competency enhancement, and competitive salarystandards.

11.

DRUG PRICE MECHANISM

In the Philippines, high prices of drugs and other products do not only alarm the public
but also the government. High prices are usually based by manufacturers on the cost ofimported raw materials, taxes, labor fee, etc. For this, the government has createdRepublic Act 7581 on June 7, 1992, otherwise known as the “Price Act.” The Act
provides protection to consumers by stabilizing the price and supply of the basic
necessities and prime commodities and by prescribing measure against undue priceincrease especially during the emergency situation.

The Department of Trade & Industry controls the prices of medicines. The Republic Act
7432 - the Senior Citizen Act gives a 20% discount on all senior citizens card holders.
In 2009, Republic Act 9502, otherwise known as the Universally Accessible andCheaper Medicines Bill, which reduced the prices of 21 drug products to 50% of their
original prices, hence, is making them more affordable and accessible to the consuming
public.

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The Food and Drug Administration and the National Drug Policy conduct monthly
monitoring of prices of drugs, especially essential drugs.
The Department of Health also, through the National Center for Pharmaceutical Accessand Management (NCPAM) conducts monthly monitoring of drug prices through electronic
Drug Price Monitoring System where in all community and hospital pharmacies both private
and government upload the drug

prices of essential drugs after registering their drug

establishments through the Data Encoder hired by DOH Central Office and assigned ineach Regional Offices. (Dept. Order No. 2010-007)

12.

PHARMACOPOEIAThe Philippine Pharmacopeia Project is an undertaking of the Department of Health andis being implemented by FDA Philippines, in collaboration with various government andnon-government organizations.

Under Executive Order No. 302 dated 29 March 2004, the Philippine Pharmacopeia(PP) 1st edition 2004 and any supplement thereto, has been declared and adopted as theofficial book of standards and reference for the determination of the identity, purity, andquality of pharmaceutical products and crude plant drugs in the Philippines. Thirty (30)synthetic pharmaceutical products, thirty - one (31) crude plant drugs and twenty - two (22)crude powdered drugs have been identified for monograph development.

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The Government of Japan, through the Japan International Cooperation Agency (JICA)
extends technical assistance and financial support to the Project.

13.

LIST OF REFERENCESCountry Report on the study programme on Manufacturing Control of Essential Drugs,
Mary Ann R. Malicse, 2008
National Demographic and Health Survey - 2008
List of Licensed Establishments and their classification under Regulation Division I 2012 –Food and Drug Administration, Philippines.
List of Licensed Drug Manufacturers 2012 – Food and Drugs Phil. Regulation Division II
Philippines.
List of accredited Government Hospitals and Private and Other Health Facilities for the
Calendar Year 2006 – Department of Health Philippines.
National Objectives for Health Philippines 1999 – 2004, Department of Health Philippines.
National Health Plan 1995 – 2020, Department of Health Philippines
National Health Statistics 2002 – 2004, Department of Health Philippines.
Compilation of Administrative Orders and Memorandum Circulars with Summaries andAnnotations 1992 Edition.

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出典：平成 24 年度 JICA 集団研修カントリーレポート

平成 24 年度 JICA 集団研修「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 contributiing to the promotion of health and social welfare
activities in the friendly nations.
Japan International Corporation of Welfare Services (JICWELS)
Toranomon YHK Bldg. 4F, 2-3-20, Toranomon
Minato-ku, Tokyo 105-0001 JAPAN
Phone: +81-(0)3-6206-1137
Fax: +81-(0)3-6206-1164
http://www.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。

広報活動委員会〒105-0001
東京都港区虎ノ門 2-3-20 虎ノ門ＹＨＫビル 4 階
電話 03-6206-1137（事業部） Fax03-6206-1164
http://www.jicwels.or.jp