Good Governance of Medicines for National
Pharmaceutical Regulatory Authorities

Country Reports

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

1

2. Malaysia

25

3. Mali82

4. Myanmar

94

5. Sri Lanka

114

Good Governance of Medicines for National
Pharmaceutical Regulatory Authorities

China

1

Good Governance of Medicines for National Pharmaceutical
Regulatory Authorities (JFY 2013)

Format for Job ReportCountry: China
Organization/Department/Division: Xi’An Food and Drug administration
1. Overview of your country and organization
1-1.
Please briefly describe legislation on pharmaceutical administration in yourcountry (Name and outline of the law(s)).
China has established a legislation of pharmaceutical administration.
Classified by the legal department, the legislation on pharmaceuticaladministration belongs to the category of administrative law, composed by thelaws, administrative regulations, departmental rules and normative documents,
which is given priority to with departmental rules. According to statistics, 90% of
the legislative documents are departmental rules issued by the Ministry of Healthand the CFDA.This system of legislation covers the administrative licensing,standard certification, pharmaceutical supervision, drug safety and administrative
enforcement and other aspects.
1. According to Administrative Permission Law, which is the main block ofpharmaceutical administrative permission, 11 transactions are involved to thepharmaceutical examination and approve, such as Pharmaceutical production
license, Pharmaceutical supply license and Pharmaceutical import and export
license.
2. The system of Good practice of pharmaceutical administration includes:
Good Supply Practice, (GSP), Good Hospital Preparation Practice(GPP), Good
Agricultural Practice (GAP), Good Laboratory Practice (GLP), Good Clinical
Practice (GCP), Good Manufacturing Practice, (GMP)
3. Pharmaceutical supervision is the backbone of pharmaceutical legislation,
which includes the supervision of pharmaceutical R&D, production, supply andemploy.
4. safety is the ultimate goal of pharmaceutical legislation, in addition to thedrug administration law and its implementation, the pharmaceutical safety
management system also includes Drug quality management norms", Drugregistration management approach", Supervision and administration of drug
production and other laws and regulations, China also established the adverse
drug reaction monitoring, such as drug recall law system.

1-2.

Please attach the organizational chart at national/state and local levels andbriefly describe each role and responsibility on pharmaceutical administration.
CFDA undertakes the following works: To formulate and monitor the policy andregulation of pharmaceutical safety administration; To formulate and monitor thepolicy and regulation of pharmaceutical safety administration; To administrate thepharmaceutical registration, draft the pharmaceutical standard, apply the ADR
monitoring; To Participate in establishment of national essential medicine list; To
supervise the pharmaceutical quality safety,
publish the information ofpharmaceutical quality safety; To invest and dispose the illegal behavior inpharmaceutical operation; To instruct the local pharmaceutical administration; To
formulate the qualification of licensed pharmacists.

2

1-3.

Please briefly describe priority issues at maximum three (3) on pharmaceuticalregulatory services in your organization. Please provide with relevant
background data.


There are loopholes in the current pharmaceutical regulation system. For
example, explicit stipulations of pharmaceutical excipients, Chinese herbal
medicine, raw material medicine are absent in the pharmaceutical researchand development.

Regulations on medical institution pharmacy practitioner’s qualification is notclear. Most of the small-size medical institutions such as village hospitals have
an issue on lack of professional pharmacist.

2. Statistical data
Please fill in with latest data in your country when availablea) Number of Pharmacists
Data(Year)b) Number of Inspector (National and Local) ：15175
Based on Data 2011 (Year)c) Number of pharmaceutical manufacturers / manufacturing sites: 19675
Based on Data 2012 (Year)d) Number of traditional medicine manufacturers / manufacturing sites: 103(when there were special category for the traditional medicine manufacturers/
manufacturing sites)
Based on Data 2012 (Year)e) Number of pharmaceutical importers: 238
Based on Data 2012 (Year)f) Number of Pharmaceutical wholesalers: 16295
Based on Data 2012 (Year)
3. Introduction of your work
3-1. Please briefly describe regulatory services that you are engaged in.
I was graduated from University of International Business and Economics in July
2007, majored in Jurisprudence and got my bachelor’s degree. I’ve got two years’
work experiences of Pharmaceutical Legislation, and two year’s work experiencesof implement emergency reuse of food and drug safety incidents.

3-2. Please describe your interests topics at maximum three (3).
 Pharmaceutical Legislation
 Pharmaceutical Inspection in Japan Pharmaceutical Advertise Regulation in Japan

3

Overview of China
pharmeceutical administration:
based on legislation andprefecture
Xi’An FDA,ShaanXi
Province

legislation on pharmaceuticaladministration in China
 China has established a legislation ofpharmaceutical administration.
 Classified by the legal department, thelegislation on pharmaceutical administration
belongs to the category of administrative law

4 The pharmaceutical legislation is composedby the laws, administrative regulations,departmental rules and regulatory
documents, which is given priority to withdepartmental rules.

Overview of pharmaceutical administration law

Laws and regulations:14
Departmental rules:68
Prefecture regulations:24
Regulatory documents:1081
OHJLVODWLRQRISKDUPDFHXWLFDO/DZVDQGUHJXODWLRQV'HSDUWPHQWDOUXOHV
3UHIHFWXUHUHJXODWLRQV
5HJXODWRU\GRFXPHQWV5Overview of pharmaceutical administration law.

Laws and regulations(issued by thecentral government)

Departmental
regulations

Regulatory
documents

Prefecture
regulations

Regulatory documents
issued by pefecture

Overview of pharmaceutical administration law

 Outlines of pharmaceutical

Administration

Law

Chapter I General Provisions
Chapter II Control over pharmaceutical Manufacturers
Chapter III Control over pharmaceutical Distributors
Chapter IV Control over Pharmaceuticals in Medical Institutions
Chapter V Control over Drugs
Chapter VI Control over Drug Packaging
Chapter VII Control over pharmaceutical Pricing and Advertising
Chapter VIII Inspection of pharmaceutical
Chapter IX Legal Liabilities
Chapter X Supplementary Provisions

6

Overview of pharmaceutical administration law

Pharmaceuticallegislation
administrative licensing

 From its contents,

the legal system canbe divided into thefollowing categories:

pharmaceutical supervision

drug standard
certification safetyadministrative
enforcement

Overview of pharmaceutical administration law
 administrative licensing7Overview of pharmaceutical administration law

 Pharmaceutical Good

practice certification

Overview of pharmaceutical administration law

 pharmaceuticalsupervision

 Pharmaceuticalsupervision is the
backbone ofpharmaceutical legislation,
which includes thesupervision ofpharmaceutical R&D,
production, supply andemploy.

8Overview of pharmaceutical administration law
 Pharmaceutical safety regulation

 safety is the ultimate

goal of pharmaceuticallegislation

Prefecture administration ofpharmacy9Prefecture administration of pharmacy

 Introduction of China’s government andadministration system: State council——CFDA Prefecture——FDA

Prefecture administration of pharmacy
The state council(central government)
CFDA(national administration)
Prefecture(province government)

Prefecture FDA

City hall(city government)

City FDA

10

Prefecture(province government)
Etc.

Prefecture administration of pharmacy
 Responsibilities of prefecture FDA are mainly

related to the categories as below:
implementation of the national standard
and drug management and the quality
control standard Responsible for first review and re-approvalof drugs
 Responsible for drugs and cosmetics safety
evaluation Ǆ Implement of ADR monitoring and reevaluationǄ
 Market access and certificationof pharmaceutical wholesalers Ǆ Registration and monitor of medical devices
Prefecture administration of pharmacy

Prefecture FDA

Drug suprevision

Department ofregistration

Department of
manufactory

Department ofmarketingMain office

Food suprevision11

Department of
medical devices

Prefecture administration of pharmacy
 Responsibilities of prefecture FDA:

department of drugs and cosmetics registration
 implement the national drug standards, including

packaging material andcontainer, medicinal requirements and standards,
 First review and re-evaluation of drug registration
 to guide the formulation of traditional medicine local
standards, supervise the implementation of Chinese
herbal medicine processing; implementation of the
TCM protection system.
 supervise the implementation of drug non-clinicalresearch, clinical trials of drug quality management
standard

Responsibilities of prefecture FDA
department of drugs and cosmetics manufactory supervision drug and cosmetic safety evaluation;
 participate in the recommendation of the national

essential drug list; implementation of drug classification
system organization;
 Monitor of radioactive
pharmaceuticals,narcotics, toxic
drugs and psychotropic drugs, pharmaceuticalprecursor chemicals
 Implement of adverse drug reaction monitor andevaluation
12

Responsibilities of prefecture FDA
department of drugs and cosmetics marketing supervision

 Monitor of GSP compliance, including

prescription drugs, OTC drugs, and Chinese
herbal medicine
 Certification of pharmaceutical wholesalers
access Supervision of local pharmaceutical market
and logistics, provide guidance to drug Supervision of cosmetics marketing.

Responsibilities of prefecture FDA
department of medical devices supervision

 Registration and supervision of local

medical devices, optimize the registration
process.
 Approval of the change request of domestic
medical devices belong to class3 which do
not change the product quality.
 Monitor and re-evaluation of medical
devices ADR
13

Thanks for your attention
and happy new year~

14Overview of Drug Supervision
System in China

Affiliation:Nanjing Food and Drug
Administration ,Jiangsu province ,China

Drug Supervision System (Ϩ)
 Central level

China food and drug administration(CFDA for short) is in charge ofadministrative supervision and technicalsupervision over the research, production,
distribution and use of drugs and medical
devices.
15

Drug Supervision System (ϩ)
 Local level

Drug regulatory departments have been
established in provincialǃmunicipal andcounty levels.

Drug Supervision System (Ϫ)
 The drugs administrated by durg

supervision system include Chinese crude
drugs, prepared slices of Chinese crude
drugs, traditional Chinese medicine
preparations, chemical drug substances
and their preparations, antibiotics,
biochemical drugs, radioactive
pharmaceuticals, serum, vaccines, blood
products and diagnostic agents.
16

Drug Supervision System (ϫ)
 According to China’s Regulations for theSupervision and Administration of
Medical Devices, these productions are
divided into 3 classes----class I, Class II
and Class III----depending on their clinicalrisks.
 Class III----high risk; Class I----low risk;
 Class II----between

Drug Supervision System (Ϭ)
 Respective Responsibilities

LevelsMain Responsibilities
registration

CFDA

Provincial drug
regulatory
departments

licensingķApproval of drugs(domestic and imported)ĸRegistration of medical
devices (class III)

Registration of medical
devices(class II)

17

To give license to:ķpharmaceuticalmanufacturesĸmedical device
manufactures (class II and III)ĹpharmaceuticalwholesalersDrug Supervision System (ϭ)
 Responsibilities respectively

Main Responsibilities

Levelsregistration

Municipal drug
regulatory
departments

Registration of medical
devices (class I)

licensingTo give license to:ķpharmaceutical retailersĸmedical device sellers

County drug
regulatory
departments

General Office

The inner structureof CFDA

Comprehensive
Department (Office of
Policy Research)

Departmentof
Emergency Management

Department
ofFood
Safety Supervision I

Department of Legal
Affairs
Department
ofFood
Safety Supervision II

China
Food
and
Drug
Administration

Department of Drugand
Cosmetics
Registration(Department of TCMs
and Ethno- Medicines
Supervision)

Department
MedicalRegistrationofDeviceDepartment
ofFood
Safety Supervision III

Department ofand Publicity

Media

Department of Drug andCosmetics Supervision

Department of Human
Resources

Department of Medical
Device Supervision

Department of Planningand Finance

Bureau of Investigationand Enforcement

Department of Science,
Technology
andStandards

DepartmentofInternational
Cooperation (Office ofHong Kong, Macao andTaiwan Affairs)

18

Drug Supervision System (Ϯ)
 The main affiliated institutions with CFDA
 1˅Center for Drug Evaluation (CDE) 2˅Center for Certification of Drug (CCD) 3˅National Center for ADR Monitoring 4˅National Institutes for Food and Drug

Control
5) Chinese pharmacopoeia commission

Drug Supervision System (ϯ)
 Center for Drug Evaluation(CDE) is anagency which is in charge of the technicalevaluation of drug approvals. (new drugs,
generic drugs, and imported drugs)

19Drug Supervision System (ϰ)
 Center for Certification of Drug (CCD) is

responsibel for conducting GMP certificationof pharmaceutical producers in China. It
also carry out GMP certification of medical
device producers, GAP (good agricultural
practice) certification, GCP certification of
medical institutions, GLP (good laboratory
practice) certification of drug research
institutions.

Drug Supervision System (ϱ)
 The missions of National Institutes for Foodand Drug Control 1) to undertake registration testing of drug 2) to carry out the post market surveillance
testing, contract testing, sampling testing,and safety evaluation of drug 3) to organize the re-testing and technicalevaluation of drug
20

Brief Flow Chart of Drug Approval(from pre-clinical research to clinical research)
After pre-clinical research,approvalforclinicalresearch is submitted
Provincial drug regulatory
departments

Provincial drug regulatory departments
conduct the preliminary review of theapplication. And a notice for the testing forregistration shall be issued to the drug
testing institute. ( Provincial level)

CDE organize pharmaceutical, medical andother technical personnel to conduct
technical review of the submitted dossiersCenter for drug evaluation(CDE)
The drug testing institute shall test the
samples according to the drug specifications
submitted by the applicant, verify thesubmitted drug specifications, and submit acertificate of analysis for drug registration to
CDE
Applicantsmaterials)

CFDA

(to

providesupplementary

Make review and and approval decisions
based on the technical review opinions by
CDE.
Issue Drug Clinical Trial Approval.

 Brief Flow Chart of Drug Approval(from clinical research to approval)
Applications

Provincial
drug
regulatory
departments conduct the preliminary
review of the application, and collectsamples for specifications verification .

Provincial
drug
regulatory
departments

CDE organize pharmaceutical,
medical and other technicalpersonnel to conduct technicalreview of the submitted dossiersCenter for Drug
Evaluation (CDE)

CenterCertification
Drug(CCD)

forof

Center for Drug
Evaluation (CDE)

Applicants(tosupplementary materials)

provideOn-site inspection of large-scale
samples production and taking
samplesmake a general opinion based on
the technical review opinions,production site inspection reports
and sample testing results

CFDA

Issue new drug
certificate

make a review and approval
decision based on the general
opinion21

Drug Safety Legal System (Ϩ)
 1. Main Laws and administrative

regulations in this field 1) Drug Administration Law
 2) Regulations for the Implementation of the
Drug Administration Law
 3) Regulations for the Supervision and
Administration of Medical Devices

Drug Safety Legal System (ϩ)
 4) Regulations for the Control of Narcotic

Drugs and Psychotropic Drugs 5) Measures for the Control of Radioactive
Drugs 6) Regulations for the Control of Blood
Products 7) Regulations for the Administration ofDistribution of Vaccines and Vaccination
22

Drug Safety Legal System (Ϫ)
 2. Outlines of Drug Administration Law
 Chapter I General Provisions

Chapter II Control over Drug Manufacturers
Chapter III Control over Drug Distributors
Chapter IV Control over Pharmaceuticals in Medical Institutions
Chapter V Control over Drugs
Chapter VI Control over Drug Packaging
Chapter VII Control over Drug Pricing and Advertising
Chapter VIII Inspection of Drugs
Chapter IX Legal Liabilities
Chapter X Supplementary Provisions

Drug Safety Legal System (ϫ)
 2. Outlines of Regulations for theSupervision and Administration of
Medical Devices
 Chapter I General Provisions

Chapter II The Administration of Medical Devices
 Chapter III Administration of Production, Distribution and Useof Medical Devices
Chapter IV Supervision of Medical Devices
 Chapter V Penalties
Chapter VI Supplementary Provisions

23

Drug Safety Legal System (Ϭ)
 3. Outlines of Chinese Pharmacopoeia(2010edition, 3 volumes)
 Volume I
2,136 monographs including
Chinese crude drugs, prepared slices of Chinese
crude drugs, herbal oil, fats and extracts, andcompound and single prescriptions
 Volume II
2,220 chemical drugs, antibiotics,
biochemicals, radioactive pharmaceuticals andpharmaceutical excipients Volume III
131 biological products

24Good Governance of Medicines for National
Pharmaceutical Regulatory Authorities

Malaysia

25

GOOD GOVERNANCE OF MEDICINESFOR NATIONAL PHARMACEUTICALREGULATORY AUTHORITIES (JFY 2013)

POSITIONNAME OF ORGANISATIONCOUNTRY: SENIOR ASSISTANT DIRECTOR: NATIONAL PHARMACEUTICAL CONTROLBUREAU, MINISTRY OF HEALTH: MALAYSIA

26

1. PHARMACEUTICAL LEGISLATION
1.1 Legislation on Pharmaceutical Administration
List of laws / regulation covering pharmaceuticalaffairs: Under the law,
the importation, manufacturing, sale and use of poisons (including
psychotropic

substancesanddangerous

drugs)

andproducts(medicines, health supplements and cosmetics)
the practice of pharmacists, andadvertisements relating to products, medical skills and services
are regulated and controlled by the following Acts and Regulations:i. Poison Act 1952 and its regulations
ii. Dangerous Drugs Act 1952 and its regulations
iii. Sale of Drugs Act 1952 (Revised 1989) & Control of Drugs andCosmetics Regulation 1984
iv. Registration of Pharmacists Act 1951 (Revised 1989) and its regulations
v. Medicines (Advertisement and Sales) Act 1956 (Revised 1983) and its
regulations
1.2 Organizational Structure
Ministry of Health Organization Chart (refer Figure 1)
National Pharmaceutical Control Bureau Organization Chart (refer Figure2)
The role of national/state pharmaceutical administrative organizations
The National Pharmaceutical Control Bureau (NPCB) is a government
agency in Malaysia that regulates pharmaceutical, natural (traditional) andcosmetic products. The NPCB is responsible for ensuring the quality,
efficacy and safety of pharmaceutical products, as well as the quality andsafety of natural (traditional) products and cosmetics marketed in the
country. With the promulgation of the Control of Drugs and Cosmetics
Regulations 1984 (CDCR), the Drug Control Authority (DCA) wasestablished in 1985. The NPCB which acts as the secretariat to the DCA
achieves its objectives through its registration and licensing scheme. The
roles and functions of NPCB are:

27

i.

To implement the drug registration / cosmetic notification scheme throughevaluation of technical data, laboratory analysis, research and information
received from international agencies.

ii.

To carry out analytical, pharmaceutical, microbiological and pharmacologicaltests on drugs and cosmetics to determine quality, efficacy and safety of suchproducts.

iii.

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

iv.

To implement the licensing scheme for pharmaceutical manufacturers, importers
and wholesalers 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 as recommended by the World Health Organization(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 arefound to be substandard or dangerous to consumers.

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 the process of on-line registration, information on registeredproducts and other queries pertaining to NPCB.

ix.

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

x.

To establish a reference standard system especially for use in this country
generally and for neighboring countries through a scheme of cooperation in thefield of pharmaceuticals among ASEAN countries.

xi.

To carry out training for pharmaceutical officers, other professional officers andother semi-professional officers who are placed in this institution from time to timethrough local training scheme orinternational

are seven centres under the NPCB:
Centre for Product Registration
Centre for Post-Registration
Centre for Compliance and Licensing

28

co-operational scheme. There

Centre for Quality Control
Centre for Investigational New ProductCentre for Organizational Development
Centre for Administration
The establishment of the Pharmaceutical Services Division in January 1974, under the
Ministry of Health Malaysia, has remarkably led to the expansion in the role andfunctions of the overall pharmacy services, which contributed towards development of
the healthcare sector. The Pharmaceutical Services Division currently undertakes threecomponent activities namely Quality Assurance of Pharmaceutical Products, Pharmacy
Enforcement and Licensing, and Pharmaceutical Care. The Pharmaceutical Services
Division in the Ministry of Health ensures that the Malaysian public is accessible toquality, safe, efficacious and affordable pharmaceutical and healthcare products
including advice in using medicines rationally.
1.3 Priority Issues on Pharmaceutical Regulatory Services
a. Handling of product complaints
The number of queries as well as complaints received by the organization iscontinuing to increase over time. This is in line with the abundance of products
promoted in the market via various channels such as the internet, newspaper,magazines, etc. With the advancement of technology, this queries and complaints arealso received through various channels such as Facebook, direct complaints,
newspaper, e-mails and so forth. As an example, via one of the methods i.e. e-mail(Pharmacy1) coordinated by the Pharmaceutical Services Division, the average
number of complaints received per month is 300 whereas direct queries received by
NPCB’s Helpdesk averages at 544 per month. A major issue that arises due to this is
how to handle and manage the high number of queries/complaints received throughsuch diverse methods.
b. Classification of interphase products
Currently, there are a vast number of products in the market, whereby some of theseproducts fall in the grey area between different categories. These are known asinterphase products. Examples of such products include beverages which contain
conventional food ingredients such as sugar and milk in addition to registrable

29

ingredients such as collagen, herbs and etc. Such products need to be classified todetermine whether they are considered as food (which is under the purview of theFood Safety and Quality Division in Malaysia) or a registrable pharmaceutical /traditional product (which is under the purview of the NPCB in Malaysia). When
more than one organization carries out product classification for such products, there is
duplication of work as well as high risk of contradicting decisions being made for aparticular product.

c. Challenges faced in product safety monitoring
The main challenges faced in product safety monitoring is the low number of reports onadverse drug reactions (ADRs) received from the private healthcare sector, especiallyretail pharmacists and general practitioners. This under-reporting will affect the detectionof ADR signals and hence national drug safety decisions. In addition, a large numberof reports received are not of good quality in terms of completeness. When
incomplete reports are received, the reporter has to be re-contacted to provide further
details to allow more accurate causality assessment. Detection of ADR signals is done
manually, resulting in slower identification of signals. Currently, there is no efficient
automated system to analyze ADR data and generate early signals which would
enable risk minimization or regulatory action to be taken on products with safetyissues. Although the number of ADR reports received has been growing steadily over theyears, the increase in the number of staff has not been proportional to the workload.
The backlog in processing cases results in difficulties in obtaining further informationand tracing reporters.
2. STATISTICAL DATA (2013)(a)

Number of Pharmacists and Inspectors
Data

(b)

Pharmacist

11,372

Inspectors

22

Number of Manufacturers / Manufacturing Sites
Pharmaceutical

Over theCounter

Traditional

Veterinary

Total

35

54

169

5

94

30

(c)

Number of Pharmaceutical Importers / Wholesalers

Importers

110

Non
Poison132

Wholesalers

602

353

Poison143

5

HealthSupplement
0

191

4

-

Traditional Veterinary

Total
390
1150

3. INTRODUCTION OF WORK
3.1

Engagement in Regulatory Services
Working in the Centre for Organizational Development which oversees
theoverallorganizational

needs

and

policyimplementation.

The

responsibility focuses on overseeing and following up all issues and aspects
regarding to ISO 9001 Quality Management System in NPCB.
Also acts as the Liaison Officer for NPCB in all matters regarding to
implementation of GGM.
Head of Internal Audit Core Team, thus manages / oversees all internal
as well as external audits.
Investigation and handling of complaints received from customers, otherrelevant agencies, relevant industries, internal staff, etc.
3.2

Interest Topics
Strengthening and enhancing the quality of services with specificfocus on ISO and quality issues.
To re-evaluate the work processes to continually improve andstrengthen the implementation of Good Governance of Medicines inthis organization.
To strengthen and improve the services delivered by the NPCB
especially with regards to handling queries and complaints.

31

Figure 1: Ministry of Health Organization Chart

32

Job Report Presentation
Good Governance of Medicines for National
Pharmaceutical Regulatory Authorities(JFY 2013)

Quality Coordination, Competency and Communication Section
Center for Organizational Development
National Pharmaceutical Control Bureau
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor
Website : www.bpfk.gov.my

WHO Collaborating Centre
for Regulatory Control of Pharmaceuticals

National Pharmaceutical Control Bureau
MINISTRY OF HEALTH MALAYSIA
Certified to ISO 9001:2008
Cert. No.: AR 2293

Member of Pharmaceutical
Inspection Co-operation Scheme

NO: SAMM 450

Non-Organisation for Economic
Cooperation And Development (OECD)33

1. Overview of the Country & Organization
1.1 Legislation on Pharmaceutical Administration
1.2 Organizational Chart & Roles
1.3. Priority Issues on Pharmaceutical Regulatory
Services
2. Statistical Data
3. Introduction of work
3.1 Roles & Responsibility in Regulatory Services
3.2 Interest Topics???

OUTLINES
1

Overview of the Country & Organization

2

Legislation on Pharmaceutical Administration

3

Organizational Chart & Roles

4

Priority Issues on Pharmaceutical Regulatory Services

5

Statistical Data

6

Introduction of work

7

Roles & Responsibility in Regulatory Services

8

Interest Topics

34

COUNTRY PROFILEE(MALAYSIA)

Malaysia : Country Profile

CapitalKuala Lumpur

Land Area

329,847 square kilometres (127,350 sq mi)
It consists of thirteen states and three federal territories

Population

28.25 million (2010)

Government TypeConstitutional Monarchy

Currency

Malaysian Ringgit (RM 3.00 to 1 USD)

Major Language

Malay (official), English, Chinese, Tamil

Major Religions

Islam, Buddhism, Taoism, Hinduism,
Christianity.

Major Imports

Manufacturing inputs, machinery &transport equipment, metal product

Major Exports

Electronic equipment, petroleum & liquefied natural gas, chemicals, palmoil, wood & wood products, rubber, textiles.

Sources: Department of Statistics, Malaysia

35

OUTLINES
1

Overview of the Country & Organization

2

Legislation on Pharmaceutical Administration

3

Organizational Chart & Roles

4

Priority Issues on Pharmaceutical Regulatory Services

5

Statistical Data

6

Introduction of work

7

Roles & Responsibility in Regulatory Services

8

Interest Topics

LEGISLATION ON PHARMACEUTICAL ADMINISTRATION
List of laws / regulation covering pharmaceutical affairs:
Poison Act 1952 and its regulations(An act to regulate the importation, possession, manufacture, compounding, storage,transport, sale and use of poisons).

Y

Dangerous Drugs Act 1952 and its regulations(An Act to make further and better provision for the regulating of the importation,
exportation, manufacture, sale, and use of opium and of certain other dangerous drugs andsubstances).
Sale of Drugs Act 1952 (Revised 1989) & Control of Drugs and Cosmetics Regulation 1984
(An Act relating to the sale of drugs-Regulation 7(1): No person shall manufacture, sell, supply
or import any product unless, the product is a registered product ; the person holds theappropriate licence issued under this regulation)
Registration of Pharmacists Act 1951 (Revised 1989) and its regulations(An Act relating to the establishment of a Pharmacy Board and the registration ofpharmacists).

Y

Medicines (Advertisement and Sales) Act 1956 (Revised 1983) and its regulations(An Act to prohibit certain advertisements relating to medical matters and to regulate the saleof substances recommended as a medicine).

36

OUTLINES
1

Overview of the Country & Organization

2

Legislation on Pharmaceutical Administration

3

Organizational Chart & Roles

4

Priority Issues on Pharmaceutical Regulatory Services

5

Statistical Data

6

Introduction of work

7

Roles & Responsibility in Regulatory Services

8

Interest Topics

37

ORGANIZATION STRUCTURE OF
NATIONAL PHARMACEUTICAL CONTROL BUREAU
DIRECTORCENTER FOR
PRODUCTREGISTRATIONCENTER FOR POSTREGISTRATION

Therapeutic
Medicine
SectionPharmacovigilance

Veterinary
Medicine
Section

Surveillance
and ProductComplaints
SectionActivePharmaceutic
al Ingredient(API) Section
Regulatory
Coordination
SectionSection

CENTER FORCOMPLIANCE
AND LICENSING
GMP Section(Pharmaceutical)

GMP Section(Complementary)

Cosmetics
SectionLicensing andCertification
SectionVariations
SectionGDP Section

CENTER FOR
ORGANISATIONAL
DEVELOPMENT
Information
Communication
Technology
SectionInterrelations
and Policy
SectionQuality
Coordination,
Competency
andCommunication
SectionBioPharmaceutical
Testing Section
Natural ProductTesting Section

Pharmaceutical
Chemistry
Testing Section

CENTER FOR
INVESTIGATIONALNEW PRODUCTInvestigational
Product
Evaluation
SectionInvestigational
Product Safety
Monitoring
Section
GCP
Compliance
SectionResearch andDevelopment
SectionLaboratory
Services Section

Quality andIndustrial
Development
SectionBiologics andComplementary
Section

CENTER FORQUALITY
CONTROLCENTER FOR
ADMINISTRATION

Finance Unit

Development
Unit
Administration
Unit
Asset
Management/ Store Unit

GLP
Compliance
SectionStandards andQuality Section

Core Functions of NPCB
Evaluate and register products (Evaluation of dossiers, BA/BE Study Reports –Prescriptions / non, Health Supplements, Traditional, NCE and Biotechnology)
Notification of Cosmetics
Analysis of samples (Pre-registration, Post-Market Surveillance, EnforcementScreening for Adulterants)

Inspect premises (surveillance, verification, investigation, pre-licensing) and issue
licenses (Manufacturers, Importers, & Wholesalers)Issue Clinical Trial Import License
Post-registration market surveillance
Adverse drug reaction (ADR) monitoring
Disseminate product information
Training (local and international visitors in areas relating to manufacturing
practices, pharmaceutical analysis, product registration, and the licensing system
practiced in the country)

Collaboration at international and regional level
The NPCB has successfully played its role as the Secretariat to the Drug Control
Authority or DCA, to ensure that therapeutic products approved for the local
market are safe, effective and of quality, and also to ensure that traditional
medicines and cosmetics approved are safe and of quality.

National Pharmaceutical Control Bureau MOH Malaysia

38

DRUG CONTROL AUTHORITY(DCA)
 Established in 1985 under The Control of Drugs andCosmetics Regulation (CDCR) 1984

 The main objective of DCA is to ensure thatpharmaceuticals, marketed in Malaysia are safe, efficaciousand of quality and that the traditional medicines, healthand personal care products are safe and of quality.
 National Pharmaceutical Control Bureau (NPCB) set up in
1978, currently serves as Secretariat to DCA

Members of DCA
Members are appointed by the Minister of Health for a period of 3 years but
eligible for re-appointment.
Members consist of the; Director General of Health (Chairman), Director of Pharmaceutical Services (Alternate Chairman), Director of NPCB,
 and 8 other members
9 A consultant physician in the public service,
9 A pharmacist in the public service,
9 3 persons from any local universities with expertise in pharmaceutical sciences
9 2 fully registered medical practitioners
9 A veterinarian in the public service

The Secretary is a pharmacist in the public service.

39

Functions of the DCA
The DCA is empowered by law to:(i) review matters related to PRODUCT REGISTRATION(ii) consider recommendations proposed by Secretariat and;

•
•
•
•
•
•

register any product subject to such conditions as it may impose
reject any application for the registration of any productgrant exemptions
issue such certification required by any country importing such a productsuspend or cancel registration of any productmake decisions related to REGULATORY POLICIES(iii) Maintain a register of the products registered(iv) Impose REQUIREMENTS for registration of products

APPROVED

Product Registration

40

ON-LINE REGISTRATION (QUEST)• On-line web-based system since:– 2002 – QUEST 2– 2010 – QUEST 3• Submission of data can be done at anytime - 24 hrs a day, 365
days a year, from any part of the world• QUEST 2 is an online registration system for all categories of
products (A, X, T and K) except for New Chemical Entity andBiotechnology products.
• It was then upgraded to QUEST 3 system starting end of 2010
– online registration for all category of products

National Pharmaceutical Control Bureau MOH Malaysia

NPCB Website www.bpfk.gov.my

National Pharmaceutical Control Bureau MOH Malaysia

41

REGISTRATION PROCESSPre-Submission ofRegistration
Application* GMP
Inspection andCertification

Submission of Registration
Application and Screening
Process

Data Evaluation** Sample testing

Meeting of the Drug Evaluation
Committee

Meeting of the Authority (DCA)
Regulatory Outcome

Approval

AppealPost-Registration Process*** Licensing

*
**
***

Rejection

Good Manufacturing
uring Practice (GMP) CertificationCer
For natural products only
Application for Manufacturer, Import and/or Wholesale License

OUTLINES
1

Overview of the Country & Organization

2

Legislation on Pharmaceutical Administration

3

Organizational Chart & Roles

4

Priority Issues on Pharmaceutical Regulatory Services

5

Statistical Data

6

Introduction of work

7

Roles & Responsibility in Regulatory Services

8

Interest Topics

42

PRIORITY ISSUES ON PHARMACEUTICAL REGULATORYSERVICES• Handling of Product Complaints– queries and complaints are received through various channels
such as face book, direct complaints, newspaper, e-mail and soforth• Classification of Food-Drug Interface Product– some of the products are not clearly marketed as “food” or“drugs” and include a variety of so-called health products. Suchproducts need to be classified before undergone the registration
process.

• Challenges in Product Safety monitoring– low number of reports on adverse drug reactions (ADRs) received
from the private healthcare sector, especially retail pharmacists andgeneral practitioners.

OUTLINES
1

Overview of the Country & Organization

2

Legislation on Pharmaceutical Administration

3

Organizational Chart & Roles

4

Priority Issues on Pharmaceutical Regulatory Services

5

Statistical Data

6

Introduction of work

7

Roles & Responsibility in Regulatory Services

8

Interest Topics

43

Statistical Dataa) Number of Pharmacists and Inspectors
Data
Pharmacist

11,372

Inspectors

22b) Number of Manufacturers / Manufacturing Sites
Pharmaceutical

Over theCounter35

Traditional

Veterinary

Total

169

5

94

54

No. of Manufacturers /Manufacturers Site

Pharmaceutical

OTC
2%

Traditional

Veterinar

13%
21%

64%

c) Number of Pharmaceuticals Importers / Wholesalers

PoisonNon
PoisonTraditional

Veterinary

HealthSupplement

Total

Importers

110

132

143

5

0

390

Wholesalers

602

353

191

4

-

1150

Pharmaceuticals Importers /Wholesalers

0
0
4
5

Wholesalers

191
143

Importers

353
132
602
110

0

100 200 300 400 500 600 700

44OUTLINES
1

Overview of the Country & Organization

2

Legislation on Pharmaceutical Administration

3

Organizational Chart & Roles

4

Priority Issues on Pharmaceutical Regulatory Services

5

Statistical Data

6

Introduction of work

7

Roles & Responsibility in Regulatory Services

8

Interest Topics

Quality Coordination, Competency andCommunication Section
Sub-section of
Resources & Training

Sub-section ofInterrelations andPolicy Section

Quality Coordination,
Competency andCommunication Section

Sub-section of
Quality Coordination

45

QUALITY COORDINATION,COMPETENCY AND COMMUNICATION SECTION• Activity:––––

Quality Management System (MS ISO 9001)
Quality Policy
Internal Audits - Planning, implementation & verification
Management Review Meeting (JKKSP) twice a year
•
•
•
•
•
•
•
•

NPCB’s Client charter (8 major Indicators)
Quality Objectives (19 indicators)
Customer complaints
Customer satisfaction survey
Human resource / projection
Work environment
Process performance and product conformity
Status of preventive and corrective actions– Document Control System (DCC_online)• Allows documents / quality procedures (QP) to be accessed by
all NPCB staff. On-line version is the only official, authorizedversion– External agency meeting• National Indicator Meeting• Innovation and Creativity Meeting• Quality Initiatives

OUTLINES
1

Overview of the Country & Organization

2

Legislation on Pharmaceutical Administration

3

Organizational Chart & Roles

4

Priority Issues on Pharmaceutical Regulatory Services

5

Statistical Data

6

Introduction of work

7

Roles & Responsibility in Regulatory Services

8

Interest Topics

46

Roles & Responsibility in Regulatory Services• Also act as a.

OUTLINES
1

Overview of the Country & Organization

2

Legislation on Pharmaceutical Administration

3

Organizational Chart & Roles

4

Priority Issues on Pharmaceutical Regulatory Services

5

Statistical Data

6

Introduction of work

7

Roles & Responsibility in Regulatory Services

8

Interest Topics

47

NATIONAL PHARMACEUTICALCONTROL BUREAUQUALITY COORDINATION, COMPETENCY AND COMMUNICATION SECTION

INTEREST TOPICS
9 Strengthening and enhancing the quality ofservices with specific focus on ISO andquality issues.
9 To re-evaluate work process to continual
improveandstrengthening
theimplementation of Good Governance ofMedicines in this organization.
9 To strengthen and improve the services
delivered by NPCB especially in handlingqueries and complaints.

www.bpfk.gov.my48

TERIMA KASIH

MALAYSIA TRULY ASIA

49

Figure 2: National Pharmaceutical Control Bureau Organization Chart

50

GOOD GOVERNANCE OF MEDICINES FOR
NATIONAL PHARMACEUTICALREGULATORY AUTHORITIES(JFY 2013)

JOB REPORTCountry:

Malaysia

Organization:

Pharmaceutical Services Division,
Ministry of Health Malaysia

51

1.

Overview of Organization

1.1

Overview of Legislations on Pharmaceutical Administration
There are five (5) Acts enforced by the Pharmacy Enforcement under the
Pharmaceutical Services Division, Ministry of Health Malaysia namely:(a)Registration of Pharmacists Act 1951 (Act 371) and Regulations - relating to theestablishment of a Pharmacy Board and the registration of pharmacists.

(b)

Poisons Act 1952 (Act 366) and Regulations - regulate the importation,possession, manufacture, compounding, storage, transport, sale and use of poisons.

(c)Sale of Drugs Act 1952 (Act 368) and Regulations - relating to the sale of drugs.

(d)Medicines (Advertisement and Sale) Act 1956 (Act 290) and Regulations prohibiting certain advertisements relating to medical matters and to regulate the saleof substances recommended as a medicine.

(e)Dangerous Drugs Act 1952 (Act 234) and Regulations - regulating the import,
export, manufacture, sale, and use of opium and of certain other dangerous drugs
and substances.

1.2

The Role and Responsibility of Pharmaceutical Administration at National/
State and Local Levels
The Pharmaceutical Services Division as one of the main divisions under the
Pharmacy programme carries out its responsibility through three (3) main activities
namely Pharmacy Policy & Management, Pharmacy Practice & Development, andPharmacy Enforcement. (Appendix A, B)(a)

Pharmacy Policy and Management is responsible for ensuring that pharmacy
services strategic plan and policies are implemented accordingly.

(b)Pharmacy Practice and Development is responsible for ensuring optimized drug
therapies and provides comprehensive pharmaceutical care.

(c)

Pharmacy Enforcement plays an important role to ensure thatpharmaceutical, traditional, and cosmetic products that are available
in the market are genuine in terms of registration and notification.

52

1.3

Priority Issues on Pharmaceutical Regulatory Services(a)Adulteration of Pharmaceutical Products and Food Supplements
The emergence of traditional medicines and food supplements which are deliberately mixed with
controlled medicine. (Appendix C)(b)Sale of Pharmaceutical Products via Internet
There are demands from retailer pharmacies to provide sale of pharmaceutical products via theinternet. Currently, there is no provision of the laws or guideline issued to regulate such kind of
sale.
(c)
Importation of Pharmaceutical Products
There are an increase number of pharmaceutical products imported via mail and courier
screened by the Pharmacy Enforcement at the entry point. (Appendix D)

2.

Statistical Data
No.

Subject

Data

Year

11,3722013(a)

Number of Pharmacists(b)

Number of Inspectors (National and Local)

22

2013

(c)

Number of Pharmaceutical Manufacturers/ Manufacturing Sites

94

2013

(d)

Number of Traditional Medicines Manufacturers/ Manufacturing Sites

169

2013

(e)

Number of Pharmaceutical Importers

390

2013

(f)

Number of Pharmaceutical Wholesalers

1,150

2013

3.

Introduction to National Regulatory Services

3.1

Description of Regulatory Services
Organization and manpower of the Pharmacy Enforcement is divided into
five (5) main activities, namely:(a)Intelligence, Operation and Audit - conduct intelligence, raids and audits based on
the information received/ gathered.

(b)

Licensing and Control at Entry Point - processing relevant licenses/ permit/
authorization, coordinate and monitor screening and inspection activities on imported
products and controlled substances at the entry points.

53

(c)

Legislation - regulate the activities of legislation involves gazette, amendments,
processing special exemptions, conduct and monitoring the progress of investigationand prosecution under the Acts in force.

(d)Advertisement and Innovation – process medicinal products and services
advertisement approval, monitor advertisements advertised, conduct and monitoring
the progress of investigation and prosecution, compile and coordinate enforcement
statistics and coordinate the activities and training of Pharmacy Enforcement officers.

(e)Protection and Consumer Awareness –coordinate and monitor consumerawareness regarding the usage of registered products, research and development
activities, conduct analysis on the sample of products available in the market andprepare and publish materials related to the consumer awareness campaign.

3.2

Interest Topics(a)Measures to Address Adulteration in Pharmaceutical Products and Food
Supplements

Identification of action and implementation of effective legislative measures taken on offenders andadulterated medicines including revised approaches to ensure that standards for quality, safety
and efficacy are implemented and distribution chains effectively controlled.

(b)

Drafting and Implementation of Legislation and Guideline to Regulate Sale ofPharmaceutical Products via Internet

The development of legislation and guideline that regulate the sale of pharmaceutical products via
internet while continuing to assure safety and efficacy of pharmaceutical products.
(c)Issuance of Guidelines Procedure
There are numbers of guidelines issued from time to time to the pharmaceutical industry players
and health care professionals relating to the updates of control of pharmaceutical products in themarket. It is crucial to identify a systematic procedure to issue these guidelines for the better
implementation.

54

1.2

(a)

Organization Chart of Ministry of Health Malaysia

Appendix A

55

(i)

State Level

Appendix B

State Health Director

DeputyDirector(Public
Health)DeputyDirector(Medical)

DeputyDirector(Oral Health)

DeputyDirector(Pharmacy)

DeputyDirector(Food Safety& Quality)

Pharmacy
Practice andDevelopment

Pharmacy
Policy andPharmacy

Licensing andInspection

DeputyDirector(Management)

Entry Point

Investigation
andProsecution

56

Protection
andConsumerAppendix C

List of Adulterants Detected in Sample Analysis

binti Mohd Zamani - J13-00832]

Page 857

Appendix D

Screening of Importation via Postal, Mail & Courier

binti Mohd Zamani - J13-00832]

Page 958

GOOD GOVERNANCE OF MEDICINES FOR
NATIONAL PHARMACEUTICALREGULATORY AUTHORITIES(JFY 2013)

JOB REPORTMALAYSIA
PHARMACEUTICAL SERVICES DIVISION,MINISTRY OF HEALTH MALAYSIA
J13-00832

CONTENTS Overview of Legislations
 Introduction to Pharmaceutical Services
Division Role and Organization Chart
 Ministry of Health Malaysia
 Pharmaceutical Services Division
 Pharmacy Enforcement Division
 Priority Issues
 Statistic
J13-00832

59

CONTENTS
 Introduction to Pharmacy Enforcement
Division Description of Activities
 Interest Topics

 Others
 Achievement

J13-00832

OVERVIEW OF
LEGISLATIONS

J13-00832

60

LEGISLATIONS There are 5 Acts enforced by the Pharmacy
Enforcement Division under the Pharmaceutical
Services Division, Ministry of Health Malaysia.
 Registration of Pharmacists Act 1951 (Act371) and Regulations - the registration ofpharmacists and the establishment of a
Pharmacy Board.
 Poisons Act 1952 (Act 366) and Regulations- the importation, possession, manufacture,compounding, storage, transport, sale anduse of poisons.
J13-00832

LEGISLATIONS Sale of Drugs Act 1952 (Act 368) andRegulations - the sale of drugs.
 Medicines (Advertisement and Sale) Act
1956 (Act 290) and Regulations - prohibiting
certain advertisements relating to medical
matters and to regulate the sale ofsubstances recommended as a medicine.
 Dangerous Drugs Act 1952 (Act 234) andRegulations - the import, export,
manufacture, sale, and use of opium and of
certain other dangerous drugs andsubstances.
J13-00832

61

INTRODUCTION TO
PHARMACEUTICAL SERVICESDIVISION, MALAYSIA

J13-00832

LOCATION MAP OF OFFICE

J13-00832

62

ROLE OF PHARMACEUTICALSERVICES DIVISION

 The Pharmaceutical Services Division (PSD) as
one of the main divisions under the Pharmacy
programme carries out its responsibility
through 3 activities namely Pharmacy Policy &Management, Pharmacy Practice &Development, and Pharmacy Enforcement.
 Pharmacy Policy and Management is
responsible for ensuring that pharmacy
services strategic plan and policies are
implemented accordingly.

J13-00832

ROLE OF PHARMACEUTICALSERVICES DIVISION Pharmacy Practice and Development is
responsible for ensuring optimised drug
therapies and provides comprehensive
pharmaceutical care.
 Pharmacy Enforcement plays an importantrole to ensure that pharmaceutical,
traditional and cosmetic products that areavailable in the market are genuine in termsof registration and notification.

J13-00832

63

J13-00832

State Health Director

DeputyDirector(Public
Health)DeputyDirector(Medical)

DeputyDirector(Oral Health)

DeputyDirector(Pharmacy)

Pharmacy
Practice andDevelopment

Pharmacy
Policy andManagement

DeputyDirector(Food Safety& Quality)

Pharmacy
Enforcement

Licensing andInspection

Intelligenceand Operation

Prosecution

J13-00832

64

Deputy Director(Management)

Entry Point

Investigation

Protection andConsumerAwareness

PRIORITY ISSUES ON
PHARMACEUTICAL REGULATORYSERVICES

J13-00832

PRIORITY ISSUES Adulteration of Traditional Products, Cosmetics
and Food Supplements
 The emergence of traditional medicines(sildenafil, tadalafil, steroids), cosmetics(hydroquinone, tretinoin, mercury, azelaicacid) and food supplements (sibutramine)
which are deliberately mixed with controlled
medicine.
 The use of these products without control orsupervision by medical practitioner or
pharmacist may lead to serious healthproblems or even death.
J13-00832

65

J13-00832

PRIORITY ISSUES Sale of Pharmaceutical Products via Internet
 There are demands from retailer pharmacies
to provide sale of pharmaceutical products
via the internet.
 The existing law states that every sale ofpoisons by retail shall be effected on thepremises specified in the licence. (Poisons
Act 1952)
 Currently, there is no law or guideline issued
to regulate such kind of sale for “over thecounter” products.
J13-00832

66

PRIORITY ISSUES
 Importation of Pharmaceutical Products
 There is an increase number ofpharmaceutical products imported via mailand courier screened by the Pharmacy
Enforcement at the entry point.
 This is due to the abundance of websites
offering cheap and “effective” products overthe internet.
 The import of these products will be seizedsince unregistered products were notallowed to be imported.

J13-00832

SEIZURES AT ENTRY POINTS
16000
14000
12000
10000
8000
6000
4000
2000
0
Passeng Passengers (Sea) ers (Air)

Passeng
Domestic Container
ers(Road)s)(Road)

Port

Airport(Kargo)Airport(Courier)

Post
OfficeNo. of Import

16

133

112

2184

39

539

47

2

13

3085

No. of Items Seized

115

611

365

7501

131

5580

444

64

0

14811

J13-00832

67

Total

STATISTIC

J13-00832

STATISTICAL DATA
No.

Subject

Data

Year

(a)

No. of pharmacists

11,3722013(b)

No. of inspectors

22

2013

(c)

No. of pharmaceutical manufacturers

94

2013

(d)

No. of traditional manufacturers

169

2013

(e)

No. of pharmaceutical importers

390

2013

(f)

No. of pharmaceutical wholesalers

1,150

2013

J13-00832

68

INTRODUCTION TO PHARMACYENFORCEMENT DIVISION

J13-00832

INTRODUCTION
 The Pharmacy Enforcement Unit was formedon 1st January 1976 under the Pharmaceutical
Services Division to carry out the enforcementof legislations pertaining to pharmacy and thepharmaceutical trade in the country in a more
efficient approach.

 There are 14 branches of Pharmacy
Enforcement Division in the country.

J13-00832

69PHARMACY ENFORCEMENT
BRANCHES

J13-00832

OBJECTIVES To ensure the pharmaceuticals, traditional
medicines and cosmetics that are available inthe market are genuine in terms of registrationand notification.
 To ensure all pharmaceutical and healthproducts are of quality, safe, efficacious.
 To ensure medicinal products and medical
services advertisements comply to the rules
and legislations enforced.
 To increase the consumers awareness on theusage of the registered products.
J13-00832

70

DESCRIPTION OF ACTIVITIES The organisation of the Pharmacy Enforcement
is divided into 5 main activities namely: Intelligence, Operation and Audit - conduct
intelligence, raids and audits based on theinformation received/ gathered.

J13-00832

DESCRIPTION OF ACTIVITIES Licensing and Control at Entry Point processing relevant licences/ permit/
authorisation, coordinate and monitor
screening and inspection activities onimported products and controlled
substances at the entry points.

J13-00832

71

CONTROL AT THE ENTRY POINTS
72

80

Number of Entry Point

70
60
50
40
22

30
20
3

3

2

10

11

6

7

1

4

2

2

6
3

ta
l

State

N

eg
e

To

Se raklanri
Se gor
m
bi
l
M an
al
ac
ca
Jo
ho
Pa r
ha
K e ng
la
nt
an
Sa
b
S a ah
ra
wa
La k
bu
an

g

Pe

na
n

da
h

Pe

Ke

Pe

rli
s

0

J13-00832

DESCRIPTION OF ACTIVITIES Legislation - regulate the activities oflegislation involves gazette, amendments,
processing special exemptions andauthorization, conduct and monitoring the
progress of investigation and prosecution
under the Acts in force.
 Advertisement and Innovation – process
medicinal products and services advertisement
approval, monitoring advertisements, conductand monitoring the progress of investigationand prosecution, coordinate enforcement
statistics, the activities and training ofPharmacy Enforcement officers.
J13-00832

72

DESCRIPTION OF ACTIVITIES Protection and Consumer Awareness –coordinate and monitor consumer awarenessregarding the usage of registered products,
research and development activities, conduct
analysis on the sample of products available inthe market and prepare and publish materials
related to the consumer awareness campaign.

J13-00832

CORE FUNCTIONS
Licensing & Control at Entry Point
Quality & Innovation

Inspections & Audit

Advertisement

Operation

Intelligence

Investigation & Prosecution
Education & Consumer Protection
J13-00832

73

INTEREST TOPICS

J13-00832

INTEREST TOPICS
 Measures to Address Adulteration in Traditional
Products, Cosmetics and Food Supplements
 In terms of identification of action andimplementation of effective legislative
measures taken on; offenders and adulterated medicines.
 including revised approaches to ensurethat standards for quality, safety andefficacy are implemented and distribution
chains effectively controlled.
J13-00832

74

INTEREST TOPICS
 Implementation of Legislation and Guidelines
to Regulate Sale of Pharmaceutical Products
via Internet
 There is a need to create guideline oramendment of current legislation to regulate
the sale of pharmaceutical products via
internet while continuing to assure safety
and efficacy of pharmaceutical products.

J13-00832

INTEREST TOPICS
 Issuance of Guidelines Procedure There are numbers of guidelines issued tothe pharmaceutical industry players andhealth care professionals from time to time
relating to the updates of control ofpharmaceutical products in the market.
 It is crucial to identify a systematic
procedure to issue these guidelines for the
better implementation.

J13-00832

75

REGISTRATION AND
NOTIFICATION

J13-00832

REGISTRATION OF PHARMACEUTICALPRODUCTS AND COSMETICS

J13-00832

76

REGISTRATION OF
PHARMACEUTICAL PRODUCTS A registered drug is a drug that is approved by
the Drug Control Authority (DCA) for sale/ use
in Malaysia.
 This drug has been evaluated and tested for its
quality, safety and efficacy.
 Every registered drug is given a registration
number, which must be printed on its label orpackage. These numbers start with MAL.
Example of a registration number is:
MAL19976399X.
J13-00832

REGISTRATION OF
PHARMACEUTICAL PRODUCTS
Control Medicine is labeled with “A” at the endof the Product Registration Number

Over the Counter Medicine is labeled with“X” at the end of the Product Registration
Number

Traditional Medicine is labeled with“T” at the end of the ProductRegistration Number

J13-00832

77

HOLOGRAM SECURITY DEVICE The requirement for the affixation ofthis security device to product label isapplicable to pharmaceuticals products,
traditional products and healthsupplements.

J13-00832

HOLOGRAM SECURITY DEVICE

Early version ofhologramSecond version ofhologram

J13-00832

78

NOTIFICATION OF COSMETICS Effective 1st January 2008, the online
registration procedure for all cosmetics
products has been replaced with the online
notification procedure.
 Companies intending to market new cosmetic
products must notify National PharmaceuticalControl Bureau (NPCB) before placing the
products in the local market.

J13-00832

ACHIEVEMENT

J13-00832

79

J13-00832

J13-00832

80

THANKYOU
J13-00832

81

Good Governance of Medicines for National
Pharmaceutical Regulatory Authorities

Mali

82

Good Governance of Medicines for National Pharmaceutical
Regulatory Authorities (JFY 2013)
Format for Job ReportCountry: MALI
Organization/Department/Division: Department of Pharmacy and Medicines

1. Overview of your country and organization
1-4. Please briefly describe legislation on pharmaceutical administration in your country(Name and outline of the law(s)).
1- DPM:The Department of Pharmacy and Medicine (DPM) was established by Ordinance No. 0039/P-RM of September 20, 2000, ratified by Law No. 01-040/NA of June 07, 2001. Its
mission is to develop elements of the national policy of medicines to ensure theimplementation, coordination and monitoring of services that contribute to theimplementation of this policy.
Decree No. 2011-753/P-RM of November 17, 2011 fixed the organization and operatingprocedures of the department of pharmacy and medicines.
2- Health Inspection:
The Health Inspection was established according to Ordinance No. 00-058/P-RM
September 28, 2000, ratified by Law No. 01-008/AN of May 28, 2001 which repeals Law
No. 94 - 014/AN of April 25, 1994 establishing the inspection of health and social action.

1-5.

Please attach the organizational chart at national/state and local levels and briefly
describe each role and responsibility on pharmaceutical administration.

1-6.

Please briefly describe priority issues at maximum three (3) on pharmaceuticalregulatory services in your organization. Please provide with relevant background data.
 The quality control in the manufacture , The pharmaceutical supply system, The quality assurance of medicines.

83

2. Statistical data
Please fill in with latest data in your country when availablea) Number of Pharmacists
Data 1150 included 178 government employees(2013)b) Number of Inspector (National and Local)
Data 04 (2013)c) Number of pharmaceutical manufacturers / manufacturing sites
Data 0 (2013)d) Number of traditional medicine manufacturers / manufacturing sites(when there were special categories for the traditional medicine manufacturers/ manufacturing sites)
Data 01 (2013)e) Number of pharmaceutical importers
Data 66 (2013)f) Number of Pharmaceutical wholesalers
Data idem (e) (2013)

3. Introduction of your work
3-1. Please briefly describe regulatory services that you are engaged in.
At the regulatory division, I am engaged to process dossiers for pharmaceuticalestablishment’s installation in the private sector, medicines marketing authorizations andimport permissions of medicines, psychotropic substances and narcotic.

3-2. Please describe your interests topics at maximum three (3).
 The quality control in the manufacture , The pharmaceutical supply system, The quality assurance of medicines.

84

PHARMACEUTICALADMINISTRATION IN MALI

Regulation Division,
Department of Pharmacy and Medicines
Mali

Ministry of
HealthNATIONAL HEALTH
ADMINISTRATION IN MALI
HealthInspectorate
Department ofPharmacy andMedicines
National Health
Laboratory
National HealthBureauHuman
Resources
BureauNational
Institute of
Public HealthResearch
HealthMaterials andFinance Bureau

Regional HealthBureaus (8)Departement of
Traditional Medicines
Research

85

GENERAL INFORMATIONS
MALI Surface area Ү 1, 241,000 kmt
 Population Ү DVRI
Graduated pharmacists: 1150 ( from 1983 to 2013)
with 178 public Employees.
Pharmaceutical Inspectors: 04 (as of December 2013)
Import and Wholesaller: 66 (as of December 2013)

Department of Pharmacy and Medicines
1/7
CREATING:
 Creating by Ordinance No. 00-039 / P-RM of
September 20, 2000, ratified by Law No. 01-040/NA
of june 07, 2001.
 Decree No. 2011-753/P-RM of November 17, 2011amending Decree No. 00-585/P-RM of November 23,
2000 laying down the operating and Organisation
procedures.
86Department of Pharmacy and Medicines
2/7

Organization
DPM
Chief Executive
Officer

Deputy CEO

Regulation Division
7Ph/1Vet

QA/ME Division
7Ph/2Ph TA

Biomedical
Laboratory Division
2Ph/2 AB

Department of Pharmacy and Medicines
3/7

MissionDevelop elements of the national policy of medicines.
Ensure the implementation, coordination andmonitoring of services that contribute to theimplementation of this policy.

26/05/2014

87

Department of Pharmacy and Medicines
4/7
Regulation Division according to Decree No. 2011 – 753/P-RM
1. Define the policy of manufacturing, storage, distribution anddestruction in case of damage of pharmaceutical products;
2. Ensure the implementation of international conventions and treaties on
narcotic drugs and psychotropic substances;
3. Initiate the regulation of the practice of pharmacy profession;
4. Instruct the installation of private pharmaceutical companies;

26/05/2014

Department of Pharmacy and Medicines
5/7
Regulation Division according to Decree No. 2011 – 753/P-RM
5. Provide administrative control of the import of products andpharmaceutical drugs manufactured at the national level andoutside the country;
6. Provide administrative control over the export of drugs
manufactured at national level.
7. Prepare elements of analysis for the revision of the national listof essential drugs.
9. Process and investigate cases of marketing authorization
application (MA).

88Department of Pharmacy and Medicines
6/7
QA/ME Division
1. Instruct the clinical trial authorization.
2. Ensure the evaluation and monitoring of clinical trials.
3. Develop pharmacovigilance.
4. Develop a national system of training, pharmaceuticals informationand communication.
5. Develop national tools to improve prescription and drugs dispensing.
6. Ensure the monitoring of essential drugs supply at all level of thenational health system (GDP).

Department of Pharmacy andMedicines7/7
Biomedical Laboratory Division :1. Define a list of essential biomedical analysis by level of national
healthcare.
2. Initiate the regulation of the practice of the profession of
biomedical analysis laboratory (GLP).
3. Develop an assessment of skills and the quality of biomedical
analysis system.
4. Define a certification system of reagents for biomedical analysis
and monitoring and periodic evaluation.

89

National Health Laboratory 1/3

Creeting:
Created by Ordinance No. 00 - 040/P-RM of
September 20, 2000, ratified by Law N ° 01 050/NA of July 02, 2001.

National Health Laboratory 2/3

Mission:According to Article 2 of this Act, the NHL is
responsible for quality control of medicines,
foods, beverages or other substances
manufactured or imported in the Republic of
Mali and for therapeutic purposes, dietetic orfood for human and animal health safety.

90

National Health Laboratory 3/3
Mission:
1. Provide technical advice to the authorization or prohibition of the useof any product, drug, food or beverage treatment, diet or food.
2. Collect and analyze samples in any unit of manufacturing, import,
distribution or storage of medications, water, other beverages, foods andother substances which can be introduced into the human and animalorganism for therapeutic, nutritional or other purposes and contributing
to the improvement or deterioration of humans and animals health safety.
3. Participate at the academic and postgraduate Training.
4. Undertake scientific and technical research.
5. Contribute to the development of standards and their enforcement.

National Inspectorate 1/2
 Creeting:
Creeted by ordinance No. 00-058/P-RM of September 28,
2000, ratified by Law No. 01-008/NA of May 28, 2001
which repeals Law No. 94 - 014/NA of April 25,1994
establishing the inspection of health and Welfare.
 Data (2013): 4 Pharmaceutical Inspectors

91

National Inspectorate 1/2
Mission:
1. Check the functioning and activities of departments and agencies ofthe Ministry of Health.
2. Monitoring the implementation of laws and regulations in both public
and private or community health professions exercise.
3. Ensure compliance and enforcement of laws and regulations relating toadministrative, financial and material management services and agenciesof the Ministry of Health.
4. Attend services and health human resources by management
consultancy or assistance to the organization or implementation of
information or training programs.

National Pharmaceutical Committees
1. National committee of Marketing Authorization (Decree No.
04-557/P-RM of December 01, 2004): 13 Members.
2. National Committee against Counterfeit and illegal trade of
medicines and narcotic drugs (Decree No. 02-075/P-RM of
February 15, 2002): 10 Members.
3. Coordination and monitoring Technical committee of
Essential Drugs Management (Ministerial Decision No. 20131582/MSHP-SG of December 27, 2013): 24 members.

92

NATIONAL PHARMACEUTICALADMINISTRATION

Thank you foryour attention

93Good Governance of Medicines for National Pharmaceutical
Regulatory Authorities

Myanmar94

Country’s Profile
Location
The Republic of the Union of Myanmar, is the westernmost country in South-East Asia,
located on the Bay of Bengal and Andaman Sea. It is bordered by the Lao, Thailand, Republic ofChina, the Republic of India and on the west by the People's Republic of Bangladesh.

Geography
The country is divided administratively, into Nay Pyi Taw Union Territory and (14)States and Regions. It consists of (70) Districts, (330) Townships, (84) Sub-townships, (398)
Towns, (3063) Wards, (13,618) Village tracts and (64,134) Villages.

Demography
The population of Myanmar in 2011-2012 is estimated at 60.38 millions. About 70
percent of the population resides in the rural areas, whereas the remaining are urban dwellers.

Religion
The Republic of the Union of Myanmar is made up of (135) national races speaking over
100 languages and dialects.

Social Development
Development of social sector has kept pace with economic development. Expansion ofschools and institutes of higher education has been considerable especially in the Regions andStates. Expenditures for health and education have raised considerably, equity and access to
education and health and social services have been ensured all over the country.

INCEPTION REPORT
Current Myanmar health care system
Myanmar health care system evolves with changing political and administrative system andrelative roles played by the key providers are also changing although the
Ministry of Health remains the major provider of comprehensive health care. It has a pluralistic
mix of public and private system both in the financing and provision. Health care is organizedand provided by public and private providers, public and private system both in the financing andprovision. Health care is organized and provided by public and private providers.
Health in transition state

The Government has embarked on a far reaching reform programme to95

transform the country into a modern, developed and democratic nation that
improves the livelihood of its people. The Government has aspired for peoplecentered development while staying focused on achievable results. It shall startmodestly, but move decisively with international assistance to enlarge capacity
and skill development to reduce incidence of poverty and achieve theMillennium Development Goals by 2015.
National Health Plan
Aiming towards the “Health for All Goal”, series of National Health Plans
based on primary health care services have been systematically developed andimplemented. The Ministry of Health has formulated four yearly People’s HealthPlans starting from 1978. From 1991 onwards, successive National Health Plans
have been formulated and implemented.
There

are eight Department under Ministry of Health .Among them

Department of Food and Drug Administration is one of them. Food and Drug
Administration (FDA) established since 1995, takes care of the safety and qualityof Food, Drugs, Medical Devices and Cosmetics. Food and drug control activities
expanded with establishment of branches in Nay Pyi Taw, Yangon and Mandalay.
Expanded branches in Muse (105) miles Border Trade Zone (near the China
border) and Myawaddy Border Trade Zone (near the Thailand border) have been
set up during September 2012.
The FDA division has been upgraded to a separate Department in April 2013.
To enable the public to have quality and safety of food, drugs, medical devices andcosmetics, Food and Drug Administration is implementing the tasks complying
with guidance from the National Health Committee, Ministry of Health andMyanmar Food and Drug Board of Authority according to National Drug Law 1992
and its provisions, National Food Law1997 and Public Health Law 1972.
FDA is responsible for issuing Heath Recommendation for local food
manufacturing businesses, import and export recommendation, import and export
health certification. Drug Control Activities have been conducting for marketing
authorization for new products, variation of existing authorization, quality control

96

laboratory testing, adverse drug reaction monitoring, Good Manufacturing Practiceinspection and licensing of manufacturers, wholesalers, enforcement activities,
drug promotion and advertisements. FDA issues notification and import
recommendation of medical devices and notification of cosmetics.
Drug Control Activities have been conducting for marketing authorization for
new products, variation of existing authorization, quality control laboratory testing,adverse drug reaction monitoring, Good Manufacturing Practice inspection andlicensing of manufacturers, wholesalers, enforcement activities, drug promotion
and advertisements. Sustainable financing is essential to promote effective drug
regulation. FDA issues notification and import recommendation of medical devices
and notification of cosmetics. During 2012, under the guidance of Drug Advisory
Committee and Central Food & Drug Supervisory Committee, Food & Drug
Administration issued Drug Registration Certificates (DRC), Importation Approval
Certificates (DIAC) and also rejected some drugs for registration from the aspect of
quality, safety and efficacy. Drug Quality Control Test in FDA Laboratory.
Under guidance of Ministry of Health, FDA regularly notifies the public aswell as State/ Regional Food Drug Supervisory Committees about alert news ofcounterfeit and illegal medicines.

Food

and

Drug

Administration

takes

necessary measures to ensure that only drugs that are registered are imported.
Food and Drug Administration is closely cooperated with Custom Department,
Directorate of Trade and Myanmar Police Force.
Ministry of health aiming for the rational use of medicine .It require thatpatient received medications appropriate to their clinical needs, in dose that meets
their own individual requirements for an adequate period of time, and the lowest
cost to them and their community.
Irrational use of medicines is very prevalent and pose a serious healthproblem that cause significant patient harm in terms of antimicrobial resistance,
unnecessary adverse drug reactions, medication errors, poor patients outcomes andwastes of resources. This contributes to enormous health loses and economic waste
both at personal and national level.
The important aspects of rational use o medicines-control medicine,97

appropriate indication, appropriate medicine considering efficacy ,safety ,suitability
for the patient ,and cost.appropriate dosage ,administration, duration. nocontraindication ,correct dispensing, including, appropriate inormation for patients,
patient adherence to treatment.

98

Drug Regulation System in Myanmar` Organization set up of FDA` Food and Drug regulation system` Duties & Responsibilities` Licensing system

99

DEPARTMENT OF FOOD AND DRUG ADMINISTRATION( upgraded in April 2013 )

FOOD

DRUG

ADMIN

COSMETIC &MEDICALDEVICESLAB

12 State branches+
3 border trade zones( April 2013 )Food and Drug Regulation System
Myanmar Food and Drug
Board of Authority
Central:FDS Committee

Ministry of HealthState/Regional: FDS Committee

Health Department(14)

Township:Health Department(325)

FDS Committee

Department of FDA(FDS Committee=Food and Drug Supervisory Committee)

100Duties & Responsibilities of FDA {Drug Division}¾ Drug Registration (new, renewal, variation, control drug)¾ Drug Manufacturing ( GMP )¾ Drug Importation¾ Advertising of Drugs{OTC}¾ Training¾ Cooperation & Coordination ( Custom, Trade, Police )¾ Product License (Drug Registration Certificate)

Validity-5yrs

¾

¾

¾

Manufacturer’s License
Validity-3yrs
Importer’s License (Drug Importation Approval Certificate)
Validity-3yrs
Drug Seller’s License (Retailer, Wholesaler)
Validity-3yrs

101

No

Drug Control Activities

2012

2013
201

1

Drug Registration application

2758

2600

2

Drug Registration approval
{New}

1643

1232

3

Drug Registration approval{Renewal}

1052

1274

4

Drug Registration approval{Variation}

306

461

5

Inspection {manufacturing
sites, storage & distribution
sites}

73

100

6Drug importation registration 18
{New}

16

7

Drug importation registration 38{Renewal}

61

8

Punishment according to NDL 1170

9Departmental coordination{Custom, Police}1684¾ Registered Drugs ( 16600 )¾ Importers ( 750 )¾ Local Manufactures ( 8 )¾ Vaccine Plant ( 1 )¾ Pharmacy ( >10000 )102Pre-market Control¾ Drug Registration- Review of Dossiers- Laboratory analysis- Clinical trials¾ Without registration, drugs cannot be imported nor sold.
¾ The registered drug bear Myanmar Registration number andcustoms authorities checked them at the port of entry.
¾ The drugs on Register books are also distributed to thesedepartments concerned with drug importation.

¾

Post Market Surveillance (PMS) was carried out by taking
random sampling from the drugs shops and tested at drug
quality control laboratory in FDA.

¾

ADR monitoring system¾

This activity is done by inspector from the Department of FDA
and health staffs.

¾

If spurious, sub-standards or counterfeit drugs wereidentified during the surveillance, action were taken according
to National Drug Law (1992 ).

103

`

Department of FDA also takes responsibilities for safety,
efficacy & quality of drugs which are manufactured by local
manufacturer according to the National Drug Law.

¾

For public awareness, the lists of unregistered and counterfeit
medicines are published in the newspapers from time to time.

¾

The information on how to differentiate between the genuine
and counterfeit medicine was also published to various levelof Food and Drug Supervisory Committee & Health care
professionals.

Destroyed Unregistered, Expired Drug and Expired Food Items

104

Thank you

105

&RXQWU\3URILOH 0\DQPHU ¾ Country Profile of Republic of Union of Myanmar¾ Health System¾ Organization set up¾ Drug law & Notification¾ Set up of Committees & their members

106IndiaChina
Bangladesh
MYANMAR
Laos PDR

Bay of Bengal

ThailandAndaman Sea

Location¾ the westernmost country in South-East Asia, located on the Bayof Bengal and Andaman Sea¾ bordered by the Lao, Thailand, Republic of China, the Republic ofIndia¾ on the west by the People's Republic of Bangladesh.

107

Geography
The country is divided administratively into
¾ Nay Pyi Taw Union Territory¾ 14 States and Regions¾ 70 Districts,¾ 330 Townships¾ 398 Towns¾ 64,134 Villages.

Demography¾

The population of Myanmar in 2011-2012 is estimated about 60.38
millions.

¾

About 70 percent of the population resides in the rural areas,
whereas the remaining are urban dwellers

108Religion¾ The Republic of the Union of Myanmar is made up of (135)national races speaking over 100 languages¾ (89.4%) of the population are Buddhists. The rest are
Christians (4.9 %), Muslims (3.9%),Hindus (0.5 %) and Animists(1.2 %).

¾

Myanmar health care system evolves with changing politicaland administrative system¾

MinistryofHealthremains

the

major

providerofcomprehensive health care.
¾

It has a pluralistic mix of public and private system both in
the financing and provision.

109

History of Food & Drug Administration¾ The Food and Drug Administration (FDA) established since

1995, takes care of the safety and quality of Food, Drugs,
Medical Devices and Cosmetics.
¾ Expanded with establishment of branches in Nay Pyi Taw,

Yangon and Mandalay. The FDA division has been upgradedto a separate Department in April 2013.In 2013,each States &Division and Border Trade(China , India , Thailand)¾

To enable the public to have quality and safety of food, drugs,
medical devices and cosmetics,¾

Food and Drug Administration is implementing the tasks
complying with guidance from Ministry of Health and Myanmar
Food and Drug Board of Authority according to
National Drug Law 1992
Public Health Law 1972
Notifications 1993
Registration ,Manuacturing ,Sales & Distribution,Importation,
Labeling & Advertisement110Ministry of Health {MOH}

Dept.
HealthDept.
Planning

Food

Dept.
Medicalscience

Drug

Dept.
FDA

Admin

Dept.
MedicalResearch(U)

Dept.
MedicalResearch(L)

Cosmetic&Medical
DeviceDept.
Traditional
medicineLab.

- 12 Branch Offices in Each States & Divisions- 3 Branch Offices in Border Trade ( India, China, Thailand )MYANMAR FOOD & DRUG BOARD OF AUTHORITY( 16 members )Central Food And Drug Supervisory Committee(6members)

Food Advisory
Committee

Drug Advisory
Committee

States & Division Food And Drug
Supervisory Committee

Township Food
&Drug Supervisory
Committee111Sixteen members(Myanmar Food And Drug
Board of Authority )-6monthly¾ Ministry of Health¾ Ministry of Defense¾ Ministry of Home Affair¾ Ministry of Livestock Breeding & Fisheries¾ Ministry of Trade¾ Ministry of Industry¾ Ministry of Agriculture¾ Experts {Medical,Pharmaceutical,pharmacological,Veterinary,chemist,
Pharmaceutical industries}

Six members(Central Food And Drug
Supervisory Committee)-3monthly¾ Dept. of FDA¾ Dept. of General Affair¾ Dept. of Health¾ City Development Committee¾ National Health laboratory

112

113

Good Governance of Medicines for National Pharmaceutical
Regulatory Authorities

Sri Lanka

114

Good Governance of Medicines for National Pharmaceutical Regulatory Authorities
Job Report as a part of Requirements of the Programme(JFY 2013)

Country- Sri Lanka
Organization-State Pharmaceuticals Corporation of Sri Lanka
I. Over view of country and organization
Sri Lanka is an Island in South Asia surrounded by the Indian Ocean with a Population of 21 675 648 and
65610 sq Km land. Politically it is country govern by parliament Democracy and headed by an Executive
President selected by people of the country.
Sri Lanka is practicing a Government provided free Healthcare System which is providing Healthcare
facilities ( including the Hospital care ) to people irrespective of their wealth , income or social status.
Apart from the Government Healthcare system, there are private Healthcare institutions also operating
all over the country where countrymen have access only on payments. Majority of the pharmaceuticals(Western Medicines) are coming as imports to the country and comparatively few items are
manufactured by local manufacturers.
1.1 Legislation Govern the Pharmaceutical Administration in Sri Lanka.
Manufacturing, Importing, Selling and Distributing of Pharmaceuticals in Sri Lanka is govern by the
Cosmetic Devices and Drugs Act No. 27 of 1980 ( CDDA Act) (with subsequent amendments) andregulations made under provisions of this Act.
Cosmetic Devices and Drugs Authority Act has provisions on regulating
1. Registration of Pharmaceuticals
2. Monitoring and approving changes to those products already approved.
3. Monitoring and Implementing good Manufacturing practices.
4. Licensing and monitoring of importation, manufacturing, sales advertisements anddistribution surveillance of quality of drugs available in the market.
5. Reviewing and approving of advertisements.
6. Approving and Monitoring of clinical trials.
7. Recalling Pharmaceuticals from the market on safety grounds and all other relevant
areas.
8. Approving, registering. Monitoring and regulating Pharmacists, wholesale and retail
outlets, distributors and stockiest.
Cosmetics Devises and Drugs Authority (CDDA) established under provisions of the Act mentioned aboveis the implementing authority of provisions of the Act.

115

1.2. Organizational chart at National/State and Local level on pharmaceutical administrationof
Policysuch

 Minister
Healthmakingas

Figure 1 Organization Chart of drug management

introducing
necessaryamendments to the act and making regulations.
 Director General of Health Services- DGHS is the “Drug Authority” of the country
responsible for forming Drug Therapeutic Committees. Functions of the committee would be
to monitor supply, distribution and consumption of drugs at national, provincial,and institutional levels. Similarly there are Drug therapeutic Committees for both provincial
levels and regional levels.
 Medical Supplies Division-The MSD of the Ministry of Health is responsible for the
consolidation of annual requirements of drugs for the institutions under the Central Ministry
and the Provincial Councils. Director, MSD and his staff periodically visit and monitor theactivities in relation to drug management in the respective provinces / institutions.
 Director Medical Technology and Supply (D/MT&S) -Issuing of certificates of registration of
the drugs and licenses to import, distribute, sell and manufacture drugs under the
regulations of the Act, are implemented by the Director/MT&S
 Director National Drug Quality Assurance Laboratory (D/NDQAL)-The primary function of
the NDQAL is to conduct laboratory tests necessary for determining compliance withproduct safety and quality requirements. Quality testing of drug products is carried out onsamples collected on random basis at different points of the distribution; namely at premarketing and post marketing stages, and issue reports/recommendations based on
the analyses/evaluations.
 State Pharmaceuticals Corporation (SPC) - The SPC has been designated as the sole
procurement agency for pharmaceuticals and surgical consumables items required by thegovernment health institutions. These items are imported or locally purchased and supplied
to the MSD of the Department of Health Services from where they are distributed togovernment health institutions.
 Regional Medical Supplies Divisions (RMSD)- MSD functions as the sole supplier of all the
medicinal items to the public sector and these items are distributed via the RMSD’S locatedin 26 divisions island wide.
1.3 Issues on pharmaceutical regulatory services –In view of State Pharmaceuticals Corporation of
Sri Lanka(i) Inflow of substandard pharmaceuticals to the country has an impact on national health caresystem, proper therapeutic administration and fair play in the market

116

(ii) Lack of sufficient number of trained personnel for regulatory affairs of the industry andissues arising out of lack of adequate actions on regulating the industry.
(iii) Lack of facilities for scientific testing /researches on acceptability of products for registration,
quality related issues, post market surveillance
2. Statistical Data
Category

Data

Year

a) Number of pharmacists

6311

2013

b) Number of inspectors

55

2013

30

2013

n/a

n/a

211

2013

57

2013

c) Number of pharmaceuticald) Manufacturerse) Number of traditional
medicine manufacturersf) Number of pharmaceuticalimportersg) Number of pharmaceuticalwholesalers
3. Introduction of work

Our organization is not directly involved in regulatory services. However being the largest
pharmaceutical importer and distributor we do control the market by setting quality standards,
controlling prices, doing post market surveillance and specially contributing to relevant policy
formulations.
4. Interest topics(i)
Prevention of Inflow of substandard products to the country.
(ii)Best practices in Pharmaceutical distribution and regulating pharmaceutical distribution(iii)

Current trends and developments in selecting and procuring best quality products and post
market surveillance.

117

'ŽŽĚ'ŽǀĞƌŶĂŶĐĞŽĨDĞĚŝĐŝŶĞƐĨŽƌEĂƚŝŽŶĂůWŚĂƌŵĂĐĞƵƚŝĐĂůZĞŐƵůĂƚŽƌǇƵƚŚŽƌŝƚŝĞƐ:ŽďZĞƉŽƌƚĂƐĂƉĂƌƚŽĨZĞƋƵŝƌĞŵĞŶƚƐŽĨƚŚĞWƌŽŐƌĂŵŵĞŽƵŶƚƌǇͲ^ƌŝ>ĂŶŬĂKƌŐĂŶŝǌĂƚŝŽŶͲ^ƚĂƚĞWŚĂƌŵĂĐĞƵƚŝĐĂůƐŽƌƉŽƌĂƚŝŽŶŽĨ^ƌŝ>ĂŶŬĂKǀĞƌǀŝĞǁŽĨĐŽƵŶƚƌǇĂŶĚŽƌŐĂŶŝǌĂƚŝŽŶ
^ƌŝ>ĂŶŬĂŝƐĂŶ/ƐůĂŶĚŝŶ^ŽƵƚŚƐŝĂƐƵƌƌŽƵŶĚĞĚďǇƚŚĞ/ŶĚŝĂŶKĐĞĂŶǁŝƚŚĂWŽƉƵůĂƚŝŽŶŽĨϮϭϲϳϱϲϰϴĂŶĚϲϱϲϭϬƐƋ<ŵůĂŶĚ͘WŽůŝƚŝĐĂůůǇŝƚŝƐĐŽƵŶƚƌǇŐŽǀĞƌŶďǇƉĂƌůŝĂŵĞŶƚĞŵŽĐƌĂĐǇĂŶĚŚĞĂĚĞĚďǇĂŶǆĞĐƵƚŝǀĞWƌĞƐŝĚĞŶƚƐĞůĞĐƚĞĚďǇƉĞŽƉůĞŽĨƚŚĞĐŽƵŶƚƌǇ͘118

,ĞĂůƚŚĐĂƌĞ ^ǇƐƚĞŵŝŶ^ƌŝ>ĂŶŬĂ^ƌŝ>ĂŶŬĂŝƐƉƌĂĐƚŝĐŝŶŐĂŐŽǀĞƌŶŵĞŶƚƉƌŽǀŝĚĞĚĨƌĞĞ,ĞĂůƚŚĐĂƌĞ^ǇƐƚĞŵǁŚŝĐŚŝƐƉƌŽǀŝĚŝŶŐ,ĞĂůƚŚĐĂƌĞĨĂĐŝůŝƚŝĞƐ;ŝŶĐůƵĚŝŶŐƚŚĞ,ŽƐƉŝƚĂůĐĂƌĞͿƚŽƉĞŽƉůĞŝƌƌĞƐƉĞĐƚŝǀĞŽĨƚŚĞŝƌǁĞĂůƚŚ͕ŝŶĐŽŵĞŽƌƐŽĐŝĂůƐƚĂƚƵƐ͘ƉĂƌƚĨƌŽŵƚŚĞ'ŽǀĞƌŶŵĞŶƚ,ĞĂůƚŚĐĂƌĞƐǇƐƚĞŵ͕ƚŚĞƌĞĂƌĞƉƌŝǀĂƚĞ,ĞĂůƚŚĐĂƌĞŝŶƐƚŝƚƵƚŝŽŶƐĂůƐŽŽƉĞƌĂƚŝŶŐĂůůŽǀĞƌƚŚĞĐŽƵŶƚƌǇǁŚĞƌĞĐŽƵŶƚƌǇŵĞŶŚĂǀĞĂĐĐĞƐƐŽŶůǇŽŶƉĂǇŵĞŶƚƐ͘DĂũŽƌŝƚǇŽĨƚŚĞƉŚĂƌŵĂĐĞƵƚŝĐĂůƐ;tĞƐƚĞƌŶDĞĚŝĐŝŶĞƐͿĂƌĞĐŽŵŝŶŐĂƐŝŵƉŽƌƚƐƚŽƚŚĞĐŽƵŶƚƌǇĂŶĚĐŽŵƉĂƌĂƚŝǀĞůǇĨĞǁŝƚĞŵƐĂƌĞŵĂŶƵĨĂĐƚƵƌĞĚďǇůŽĐĂůŵĂŶƵĨĂĐƚƵƌĞƌƐ͘>ĞŐŝƐůĂƚŝŽŶ'ŽǀĞƌŶƚŚĞWŚĂƌŵĂĐĞƵƚŝĐĂůĚŵŝŶŝƐƚƌĂƚŝŽŶŝŶ^ƌŝ>ĂŶŬĂ͘DĂŶƵĨĂĐƚƵƌŝŶŐ͕/ŵƉŽƌƚŝŶŐ͕^ĞůůŝŶŐĂŶĚŝƐƚƌŝďƵƚŝŶŐŽĨWŚĂƌŵĂĐĞƵƚŝĐĂůƐŝŶ^ƌŝ>ĂŶŬĂŝƐŐŽǀĞƌŶďǇƚŚĞŽƐŵĞƚŝĐĞǀŝĐĞƐĂŶĚƌƵŐƐĐƚEŽ͘ϮϳŽĨϭϵϴϬ;ĐƚͿ;ǁŝƚŚƐƵďƐĞƋƵĞŶƚĂŵĞŶĚŵĞŶƚƐͿĂŶĚƌĞŐƵůĂƚŝŽŶƐŵĂĚĞƵŶĚĞƌƉƌŽǀŝƐŝŽŶƐŽĨƚŚŝƐĐƚ͘ŽƐŵĞƚŝĐƐĞǀŝƐĞƐĂŶĚƌƵŐƐƵƚŚŽƌŝƚǇ;ͿĞƐƚĂďůŝƐŚĞĚƵŶĚĞƌƉƌŽǀŝƐŝŽŶƐŽĨƚŚĞĐƚŵĞŶƚŝŽŶĞĚĂďŽǀĞŝƐƚŚĞŝŵƉůĞŵĞŶƚŝŶŐĂƵƚŚŽƌŝƚǇŽĨƉƌŽǀŝƐŝŽŶƐŽĨƚŚĞĐƚ͘119ŽƐŵĞƚŝĐĞǀŝĐĞƐĂŶĚƌƵŐƐƵƚŚŽƌŝƚǇĐƚŚĂƐƉƌŽǀŝƐŝŽŶƐŽŶƌĞŐƵůĂƚŝŶŐͲZĞŐŝƐƚƌĂƚŝŽŶŽĨWŚĂƌŵĂĐĞƵƚŝĐĂůƐͲDŽŶŝƚŽƌŝŶŐĂŶĚĂƉƉƌŽǀŝŶŐĐŚĂŶŐĞƐƚŽƚŚŽƐĞƉƌŽĚƵĐƚƐĂůƌĞĂĚǇĂƉƉƌŽǀĞĚ͘ͲDŽŶŝƚŽƌŝŶŐĂŶĚ/ŵƉůĞŵĞŶƚŝŶŐŐŽŽĚDĂŶƵĨĂĐƚƵƌŝŶŐƉƌĂĐƚŝĐĞƐ͘
Ͳ>ŝĐĞŶƐŝŶŐĂŶĚŵŽŶŝƚŽƌŝŶŐŽĨŝŵƉŽƌƚĂƚŝŽŶ͕ŵĂŶƵĨĂĐƚƵƌŝŶŐ͕ƐĂůĞƐĂĚǀĞƌƚŝƐĞŵĞŶƚƐĂŶĚĚŝƐƚƌŝďƵƚŝŽŶƐƵƌǀĞŝůůĂŶĐĞŽĨƋƵĂůŝƚǇŽĨĚƌƵŐƐĂǀĂŝůĂďůĞŝŶƚŚĞŵĂƌŬĞƚ͘
ͲZĞǀŝĞǁŝŶŐĂŶĚĂƉƉƌŽǀŝŶŐŽĨĂĚǀĞƌƚŝƐĞŵĞŶƚƐ͘ͲƉƉƌŽǀŝŶŐĂŶĚDŽŶŝƚŽƌŝŶŐŽĨĐůŝŶŝĐĂůƚƌŝĂůƐ͘ͲZĞĐĂůůŝŶŐWŚĂƌŵĂĐĞƵƚŝĐĂůƐĨƌŽŵƚŚĞŵĂƌŬĞƚŽŶƐĂĨĞƚǇŐƌŽƵŶĚƐĂŶĚĂůůŽƚŚĞƌƌĞůĞǀĂŶƚĂƌĞĂƐ͘ͲƉƉƌŽǀŝŶŐ͕ƌĞŐŝƐƚĞƌŝŶŐ͘DŽŶŝƚŽƌŝŶŐĂŶĚƌĞŐƵůĂƚŝŶŐWŚĂƌŵĂĐŝƐƚƐ͕ǁŚŽůĞƐĂůĞĂŶĚƌĞƚĂŝůŽƵƚůĞƚƐ͕ĚŝƐƚƌŝďƵƚŽƌƐĂŶĚƐƚŽĐŬŝƐƚƐ͘KƌŐĂŶŝǌĂƚŝŽŶĂůĐŚĂƌƚĂƚEĂƚŝŽŶĂůͬ^ƚĂƚĞĂŶĚ>ŽĐĂůůĞǀĞůŽŶƉŚĂƌŵĂĐĞƵƚŝĐĂůĂĚŵŝŶŝƐƚƌĂƚŝŽŶ120

^ƚĂƚĞWŚĂƌŵĂĐĞƵƚŝĐĂůƐŽƌƉŽƌĂƚŝŽŶ;^WͿʹdŚĞ^WŚĂƐďĞĞŶĚĞƐŝŐŶĂƚĞĚĂƐƚŚĞƐŽůĞƉƌŽĐƵƌĞŵĞŶƚĂŐĞŶĐǇĨŽƌƉŚĂƌŵĂĐĞƵƚŝĐĂůƐĂŶĚƐƵƌŐŝĐĂůĐŽŶƐƵŵĂďůĞƐŝƚĞŵƐƌĞƋƵŝƌĞĚďǇƚŚĞŐŽǀĞƌŶŵĞŶƚŚĞĂůƚŚŝŶƐƚŝƚƵƚŝŽŶƐ͘dŚĞƐĞŝƚĞŵƐĂƌĞŝŵƉŽƌƚĞĚŽƌůŽĐĂůůǇƉƵƌĐŚĂƐĞĚĂŶĚƐƵƉƉůŝĞĚƚŽƚŚĞD^ŽĨƚŚĞĞƉĂƌƚŵĞŶƚŽĨ,ĞĂůƚŚ^ĞƌǀŝĐĞƐĨƌŽŵǁŚĞƌĞƚŚĞǇĂƌĞĚŝƐƚƌŝďƵƚĞĚƚŽŐŽǀĞƌŶŵĞŶƚŚĞĂůƚŚŝŶƐƚŝƚƵƚŝŽŶƐ͘ƉĂƌƚĨƌŽŵŝƚƐĚƵƚǇĂƐƚŚĞƐŽůĞƉƌŽĐƵƌĞŵĞŶƚĂŐĞŶƚŽĨƚŚĞŐŽǀĞƌŶŵĞŶƚŝƚŝƐŽƉĞƌĂƚŝŶŐŝŶƚŚĞŽƉĞŶŵĂƌŬĞƚĂƐůĂƌŐĞƐƚŝŵƉŽƌƚĞƌĂŶĚĚŝƐƚƌŝďƵƚŽƌŝŶƚŚĞŽƉĞŶŵĂƌŬĞƚWƌŽĐƵƌĞŵĞŶƚWƌŽĐĞĚƵƌĞŽĨ^WĨŽƌ'ŽǀĞƌŶŵĞŶƚ^ƵƉƉůŝĞƐ ZĞĐĞŝǀŝŶŐŽƌĚĞƌƐĨƌŽŵƚŚĞDĞĚŝĐĂů^ƵƉƉůŝĞƐŝǀŝƐŝŽŶŽĨƚŚĞDŝŶŝƐƚƌǇŽĨ,ĞĂůƚŚ ĂůůŝŶŐƚĞŶĚĞƌƐ ^ĞůĞĐƚŝŶŐƐƵƉƉůŝĞƌƐ /ŵƉŽƌƚŝŶŐĨƌŽŵƐĞůĞĐƚĞĚƐƵƉƉůŝĞƌƐ ^ƵƉƉůǇŝŶŐƚŽDĞĚŝĐĂů^ƵƉƉůŝĞƐŝǀŝƐŝŽŶ ƚƚĞŶĚŝŶŐƚŽƉŽƐƚĚĞůŝǀĞƌǇŝƐƐƵĞƐ121

ZŽůĞŽĨƚŚĞ^WŝŶƚŚĞŽƉĞŶŵĂƌŬĞƚ hŶŽĨĨŝĐŝĂůƉƌŝĐĞĐŽŶƚƌŽůůĞƌŝŶƚŚĞŵĂƌŬĞƚ WƌŽŵŽƚŝŶŐƵƐĞŽĨ'ĞŶĞƌŝĐƐ ĚƵĐĂƚŝŶŐƉĞŽƉůĞŽŶƌĂƚŝŽŶĂůƵƐĞŽĨWŚĂƌŵĂĐĞƵƚŝĐĂůƐ ^ĞƚƚŝŶŐĞǆĂŵƉůĞƐĨŽƌŐŽŽĚĚŝƐƉĞŶƐŝŶŐƉƌĂĐƚŝĐĞƐ ,ĞůƉŝŶŐ'ŽǀĞƌŶŵĞŶƚŚĞĂůƚŚĐĂƌĞŝŶƐƚŝƚƵƚŝŽŶƐŝŶƚŚĞŝƌĚŝĨĨŝĐƵůƚŝĞƐ/ƐƐƵĞƐŽŶƉŚĂƌŵĂĐĞƵƚŝĐĂůƌĞŐƵůĂƚŽƌǇƐĞƌǀŝĐĞƐʹŝŶ^ƌŝ>ĂŶŬĂ/ŶǀŝĞǁŽĨ^ƚĂƚĞWŚĂƌŵĂĐĞƵƚŝĐĂůƐŽƌƉŽƌĂƚŝŽŶŽĨ^ƌŝ>ĂŶŬĂ ;ŝͿ/ŶĨůŽǁŽĨƐƵďƐƚĂŶĚĂƌĚƉŚĂƌŵĂĐĞƵƚŝĐĂůƐƚŽƚŚĞĐŽƵŶƚƌǇŚĂƐĂŶŝŵƉĂĐƚŽŶŶĂƚŝŽŶĂůŚĞĂůƚŚĐĂƌĞƐǇƐƚĞŵ͕ƉƌŽƉĞƌƚŚĞƌĂƉĞƵƚŝĐĂĚŵŝŶŝƐƚƌĂƚŝŽŶĂŶĚĨĂŝƌƉůĂǇŝŶƚŚĞŵĂƌŬĞƚ ;ŝŝͿ>ĂĐŬŽĨƐƵĨĨŝĐŝĞŶƚŶƵŵďĞƌŽĨƚƌĂŝŶĞĚƉĞƌƐŽŶŶĞůĨŽƌƌĞŐƵůĂƚŽƌǇĂĨĨĂŝƌƐŽĨƚŚĞŝŶĚƵƐƚƌǇĂŶĚŝƐƐƵĞƐĂƌŝƐŝŶŐŽƵƚŽĨůĂĐŬŽĨĂĚĞƋƵĂƚĞĂĐƚŝŽŶƐŽŶƌĞŐƵůĂƚŝŶŐƚŚĞŝŶĚƵƐƚƌǇ͘ ;ŝŝŝͿ>ĂĐŬŽĨĨĂĐŝůŝƚŝĞƐĨŽƌƐĐŝĞŶƚŝĨŝĐƚĞƐƚŝŶŐͬƌĞƐĞĂƌĐŚĞƐŽŶĂĐĐĞƉƚĂďŝůŝƚǇŽĨƉƌŽĚƵĐƚƐĨŽƌƌĞŐŝƐƚƌĂƚŝŽŶ͕ƋƵĂůŝƚǇƌĞůĂƚĞĚŝƐƐƵĞƐ͕ƉŽƐƚŵĂƌŬĞƚƐƵƌǀĞŝůůĂŶĐĞ
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(JFY 2013)
Good Government of Medicines for National Pharmaceutical Regulatory Authorities
Job Report as a part of Requirements of the ProgrammeState Pharmaceutical Manufacturing Corporation of Sri Lanka-----------------------------------------------------------------------------------------------------------I. Over view of country and organization
Sri Lanka is an Island in South Asia surrounded by the Indian Ocean with a Population of andland.
Politically it is country govern by parliament Democracy and headed by an Executive President selectedby people of the country.
Sri Lanka is practicing a Government provided free Healthcare System which is providing Healthcare
facilities ( including the Hospital care ) to people irrespective of their wealth , income or social status.
Apart from the Government Healthcare system, there are private Healthcare institutions also operating
all over the country where countrymen have access only on payments. Majority of the pharmaceuticals(Western Medicines) are coming as imports to the country and comparatively few items are
manufactured by local manufacturers.
1.1 Legislation Govern the Pharmaceutical Administration in Sri Lanka.
Manufacturing, Importing, Selling and Distributing of Pharmaceuticals in Sri Lanka is govern by the
Cosmetic Devices and Drugs Act No. 27 of 1980 ( CDDA Act) (with subsequent amendments) andregulations made under provisions of this Act.
Cosmetic Devices and Drugs Authority Act has provisions on regulating
9. Registration of Pharmaceuticals
10. Monitoring and approving changes to those products already approved.
11. Monitoring and Implementing good Manufacturing practices.
12. Licensing and monitoring of importation, manufacturing, sales advertisements anddistribution surveillance of quality of drugs available in the market.
13. Reviewing and approving of advertisements.
14. Approving and Monitoring of clinical trials.
15. Recalling Pharmaceuticals from the market on safety grounds and all other relevant
areas.
16. Approving, registering. Monitoring and regulating Pharmacists, wholesale and retail
outlets, distributors and stockiest.
Cosmetics Devises and Drugs Authority (CDDA) established under provisions of the Act mentioned aboveis the implementing authority of provisions of the Act.
1.2. Organizational chart at National/State and Local level on pharmaceutical administration

Figure 2 Organization Chart of drug management123 Minister of Health- Policy making such as introducing necessary amendments to the act andmaking regulations.
 Director General of Health Services- DGHS is the “Drug Authority” of the country
responsible for forming Drug Therapeutic Committees. Functions of the committee would be
to monitor supply, distribution and consumption of drugs at national, provincial,and institutional levels. Similarly there are Drug therapeutic Committees for both provincial
levels and regional levels.
 Medical Supplies Division-The MSD of the Ministry of Health is responsible for the
consolidation of annual requirements of drugs for the institutions under the Central Ministry
and the Provincial Councils. Director, MSD and his staff periodically visit and monitor theactivities in relation to drug management in the respective provinces / institutions.
 Director Medical Technology and Supply (D/MT&S) -Issuing of certificates of registration of
the drugs and licenses to import, distribute, sell and manufacture drugs under the
regulations of the Act, are implemented by the Director/MT&S
 Director National Drug Quality Assurance Laboratory (D/NDQAL)-The primary function of
the NDQAL is to conduct laboratory tests necessary for determining compliance withproduct safety and quality requirements. Quality testing of drug products is carried out onsamples collected on random basis at different points of the distribution; namely at premarketing and post marketing stages, and issue reports/recommendations based on
the analyses/evaluations.
 State Pharmaceuticals Corporation (SPC) - The SPC has been designated as the sole
procurement agency for pharmaceuticals and surgical consumables items required by thegovernment health institutions. These items are imported or locally purchased and supplied
to the MSD of the Department of Health Services from where they are distributed togovernment health institutions.
 Regional Medical Supplies Divisions (RMSD)- MSD functions as the sole supplier of all the
medicinal items to the public sector and these items are distributed via the RMSD’S locatedin 26 divisions island wide.
1.3 Issues on pharmaceutical regulatory services –In view of State Pharmaceuticals Corporation andState pharmaceuticals Manufacturing Corporation of Sri Lanka(i) Inflow of substandard pharmaceuticals to the country has an impact on national health caresystem, proper therapeutic administration and fair play in the market(ii) Lack of sufficient number of trained personnel for regulatory affairs of the industry andissues arising out of lack of adequate actions on regulating the industry.
(iii) Lack of facilities for scientific testing /researches on acceptability of products for registration,
quality related issues, post market surveillance
2. Statistical Data
Category

Data

Year

h) Number of pharmacists

6311

2013

i)

Number of inspectors

40

2013

j) Number of pharmaceuticalk) Manufacturers

30

2013

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l)

Number of traditional
medicine manufacturersm) Number of pharmaceuticalimportersn) Number of pharmaceuticalwhole sellers

Statistical data not available
211

2013

57

2013

3. Introduction of work•

Manufacturing and quality control of productso Production department is responsible in manufacturing and quality control of tabletsand capsules in SPMC. Therefore our key objective is to carry out all the processes up
to the standards stated in the pharmacopeias without any quality defect. To obtain
the quality level we try our best to follow the Standard Operating Procedures,
implement and follow GMP regulations.

• Validation of manufacturing process
o Our ultimate goal is to manufacture a quality product. With that aim the production
department together with the formulation and quality control departments involvein validation of the manufacturing processes of tablets and capsules.
4. Interest topics• GMP audits- one of my primary interests is to learn how to carry out a GMP audit. As amanufacturing firm we are directly involved in implementing in following GMP regulations
within the factory premises. If we have a fair knowledge about GMP auditing that would be
an added advantage for us to correct our shortcomings. Also this would upgrade the level ofstandards in our organization.
• Stability studies- other than GMP audits I would also like to get the technical know-how ofaccelerated stability protocols and real time stability protocols. Such as how the samples arehandles, storing, re-analyzing procedures, interpretation of the results, shelf life calculations
using Arrhenius equation for different drug products etc.
• Product recall procedures- as manufacturers sometimes we have to recall our products. It is
mandatory to establish a correct recall procedure. Therefore, I would like to know thecorrect procedures of recalls and how we should handle a quality failure of a product.

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Good Governance of Medicine for
National Pharmaceutical
Regulatory Authorities

STATE PHARMACEUTICALSMANUFACTURING CORPORATION
6UL/DQNDOBJECTIVESy About Sri Lankay Our health care system
y Our legislations on Pharmaceutical regulationsy National organizational levels
y State Pharmaceuticals Manufacturing

Corporation (SPMC)
y Our enrollment
y Main issues

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Sri Lanka
y Small island located inIndian Oceany 65,610 km2
y Multi national, multireligious country{ Majority Sinhalese, live withharmony with Tamil andMuslim minorities,{ Mainly Buddhists, Hindus,
Catholics and Muslims

y Population around 2 billion

Sri Lankan Health Care System
y Free medical services from government hospitals{ National hospital-Colombo{ General hospitals- in all major cities{ Teaching hospitals{ District hospitals{ Base hospitals{ Rural hospitals{ Eye hospital{ Cancer hospitaly Private sector hospitals and clinics available

127

Drug distributiony For government hospitals{ Ministry of HealthÙ Medical supplies division| State Pharmaceuticals Corporation| State Pharmaceuticals Manufacturing Corporationy For private sector hospitals{ Procure from local whole sale dealers/distributors{ Procure from State Pharmaceuticals Corporationy Blood products should be procured from “ National

Blood Bank”

Legislationy Cosmetics Devices and Drugs Act No 27 of 1980y (Cosmetics Devices and Drugs Regulatory Authority){ Registration of Pharmaceuticals{ Monitoring and approving changes to those products alreadyapproved.
{ Monitoring and Implementing good Manufacturing practices.
{ Licensing and monitoring of importation, manufacturing, sales
advertisements and distribution surveillance of quality of drugs
available in the market.
{ Reviewing and approving of advertisements.
{ Approving and Monitoring of clinical trials.
{ Recalling Pharmaceuticals from the market on safety grounds and allother relevant areas.
{ Approving, registering. Monitoring and regulating Pharmacists,
wholesale and retail outlets, distributors.

128

Legislations conty Medical ordinances of 1928
y Poisons Opium and Dangerous Drug Ordinance of1936 and amended by Act No. 13 of 1984” of thesame ordinance{ Police Narcotic bureau{ National dangerous drug control board

Responsible persons
HON MINISTER

Secretary

DGHS

DDG(LS)DMSDLine ministry
health institutions

D/MT&SRMS
Provisional HealthInstitutions

129

D/NDQALSPC
PROCUREMENTADMINISTRATION OF CDDAy Cosmetics Devices and Drugs Technical Advisory

Committee{ Advise the Minister on matters arising out of theadministration of the Act and to carry out other functions
assigned to it under this Act.
{ Appointing sub committees carry out some functions or duties.
{ About 15 committee members in the committee including
pharmacologists, surgeons , physicians, representatives frommanufactures, laboratories, etc.

Figure 1: Evaluation process for Generic Drugs

130

Figure 2: Evaluation process for New Drug/ Chemical entities

Figure 1: Evaluation process for vaccines131

STATE PHARMACEUTICALSMANUFACTURING CORPORATIONA
y Manufacturers of generic pharmaceuticals
y Established in 1987 as a donation by Japanese

government with the aim of supplying essential
drugs for the Sri Lankan community.
y Currently manufacturing 64 solid dosage forms forgovernment hospitals, and local pharmacies

Our functionsy Supply essential drugs
y Affordable prices
y Maintain quality of drugs
y Maintain GMP in the premises and the processesy Comply with the CDD Act

132

Approved standards in Sri Lankay Pharmacopoeia Internationalisy The British Pharmacopoeia
y The pharmacopoeia of the United States of Americay The British Pharmaceutical Codexy The British Veterinary Codexy The Japanese Pharmacopoeia
y European Pharmacopoeia

Tenders for
packagingmaterials

Global Tenders(Planning and Procurement
Department)

Tender sample
inspection

Tender sample
inspection(In-house laboratory tests)

Pre-shipment
sample testing

Receivingconsignment(In-house laboratory
tests)

Receivingconsignment

Identification andfull analysis of theconsignment

Identification andfull analysis of theconsignment

133

Quality control of productsy Quality control tests of raw materials and finishedproducts are carried out in the following manner{ Tender samples{ Pre-shipment samples{ Consignment samples{ In-process quality testing of finished products{ Final quality testing of the finished productsy Independent quality tests are done by National Drug

Quality Assurance Laboratory (NDQAL)

R &D newformulations

Full registration

Samplemanufacturing

Re-submission ofstability data andapplication for fullregistration

Laboratory tests

Real time stability
data

Accelerated
stability testing

Manufacturing ofcommercial lots

Submission ofsample andapplication

Provisional
registration

134

Manufacturing ofcommercial lots

Main issues
y Issues{ Validation of processes are difficult
Ù Raw materials are imported from different suppliersÙ Lack of equipment{ Bioequalence studies are difficult to be carried outÙ Lack of funds and facilities{ Lack of post marketing surveillance data
Ù Still not implemented135

出典：平成 25 年度 JICA 集団研修カントリーレポート

平成 25 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

136