The Study Programme
for the Pharmaceutical Affairs Experts
Nobember, 2009, Tokyo, JapanCountry Reports

Ministry of Health, Labour and Welfare (MHLW)Japan International Cooperation Agency (JICA)
Japan International Corporation of Welfare Services (JICWELS)CONTENTS
1. Botswana
2. Indonesia
3. Iraq
4. Malaysia Noorul
5. Papua New Guinea
6. Philippines
7. Thailand

The Study Programme
for the Pharmaceutical Affairs Experts

Botswana

－1－

－2－

－3－

1. Geographical and political features
Formerly the British protectorate of Bechuanaland, Botswana adopted its new name after
independence in 1996. The country which is located in Southern Africa is landlocked andforms borders with South Africa, Zimbabwe, Namibia, Angola and Zambia. It has a total
area of 600, 370 square kilometers (585, 370sq km land and 15,000 sq km water) with apopulation of 1, 640, 115 people. Most of the population is concentrated on the easternside of the country as the west is desert. Though most of the country is desert, it has a lotof areas of tourist interest and these include the national parks with a vast array ofwildlife, the Okavango delta and Makgadikgadi salt pans. The country is democraticallyruled.
After four decades of independence, Botswana is one of the most dymanic economies inAfrica. Economic activities include mineral extraction, tourism and agriculture. Therefore
Botswana is one of the largest exporter of diamonds and beef in the world.
Over the years Botswana has seen an increases in the number of humanimmunodeficiency virus which leads to acquired immunodeficiency syndrome(HIV/AIDS) infections (with about 350 000 people living with the disease in 2003) andhence became one of the countries of the highest rates of infections in the world. Thiscalled for progressive and comprehensive programs for dealing with the disease.
English is the official language and Setswana is the national language. Because of the
migration of people into the country and from internal movements the Setswana language
has many different dialects. There are also several other languages spoken in different
parts of the country. The term “Batswana” is used to refer to all people who speak the
Setswana language and all citizens of the country regardless of their ethic background.
There are about eleven tribes in the country.
The arrival of missionaries from Europe and America in the 19th century saw the
introduction of Christianity as a religion which continued to the present time. Prior to themissionaries, most Batswana believed in “Badimo” (ancestors) and a few still believe inthem up to today. The migration of other people into the country saw the introduction ofother religions such as Islam, Muslim and Hinduism.
The school system is 12 years (7 years of primary and 5 years of secondary) from which
one can go to a tertiary. The literacy rate is 81.2% as of 2004 statistics with an enrolment
rate of 49.5% for females and 49.3 for males as of 2004 statistics.
2. Statistical data
2.1 Population
a. Population density per 1 km
Data: The population is unevenly distributed with more than 80% along theeastern and north of the country
Year: 2005

－4－

b. Number of population
Male
Total
Data: 1, 640,115
802,013
Year:
2005

Female838,102c. Percentage distribution by three broad age groups [%]15-64
65 years and over
0-14
Data: 38.8%
57.5%
3.8 %
Year: 2005
d. Rate of natural increase of population [% per annum]
Data: Total 1.7 %Year: 2008
2.2 Vital Statistics
a. Rate of vital statistics [per 1000 population]
Live births
Death
Infant death
rate
rate
rate
Data: 23.33
29.36
54.58
Year: 2005
b. Five main diseases causing morbidity
2001
Causes and numbers
1.
Ill-defined
intestinal
infections [IDII]
7,230
2. Pneumonia
6,998

2003
Causes and numbers
AIDS
7,854

2004
Causes and numbers
Diarrhoea
andgastroenteritis
6,196
intestinal Pneumonia
4,332

Ill-defined
infections [IDII]
6,768
3. Other direct obstetric causes Other direct obstetric causes
6,315
6,129
4.Pulmonary
tuberculosis Pneumonia[PTB] 6,117
6,068
5. Abortions
4,870

Retrovirus infections
4,321
Pulmonary tuberculosis
[PTB]
3,361
Pulmonary tuberculosis [PTB] Ill-defined conditions
4,859
1,985

Total all diseases: 96,796

Total all diseases: 98,452

－5－

Total
all
102,980

diseases:c. Five leading causes of mortality
2001
Causes and numbers
1. Pneumonia
1,378
2.
Pulmonarytuberculosis [PTB]
1,274
3. Ill-defined intestinal
infections [IDII]
938
4. AIDS920
5. Ill-defined conditions
446
Total all diseases: 9,387

2003
Causes and numbers
AIDS
2,688
Pneumonia
1,064

2004
Causes and numbers
Pneumonia
925
AIDS
923

Ill-defined
intestinal
infections [IDII]
901
Pulmonarytuberculosis
[PTB]
895
Ill-defined conditions
462
Total all diseases: 10,062

Retrovirus infections
905
Diarrhoea and gastroenteritis
892
Pulmonary tuberculosis [PTB]
630
Total all diseases: 11,041

d. Life expectancy
Female
57.4

Male
Data:
52.3
Year: June 2008
2.3 Medical carea. Number of hospitals by establishing organ
Government
Primary
Hospitals
Referral Hospitals
Data:
3
34
Year: 2008
b. Number of health manpower
Physicians
Data:
478
Year:
2007

Dentists42
2004

c. Number of pharmacists
Data: 260
Year: 2008
d. Number of drug manufacturers
Data: 0Year: 2007

－6－

Total
55.6

PrivateHospital3

Nurses4,468
2007

Clinics277

e. Number of traditional medicines manufacturers
Data: 0Year: 2007
f. Number of cosmetic products manufacturers
Data: 0Year: 2007
g. Number of drug importers
Data: 105
Year: 2009
h. Number of drug wholesalers
Data: 15
Year: 2009
i. Number of pharmacies
Data: 96
Year: 2008
j. Number of registered drugs
Data: around 1550
Year: August 2009
k. Registered drugs according to therapeutic classification• Antiretrovirals = 109• Antifectives = 301• Antihypertensives = 117• Antidiabetics = 38
• Antimalarials = 13
• Anti- TB = 16
• Others = 938
2.4 Educational information for pharmacists
a. System of education
Primary school:
seven [7] years
Age of enrollment:
six [6] years old
Secondary school:
five [5] years
b. System of university or college education
Currently there are no pharmacy schools in Botswana. All pharmacists in the
country were trained at different universities around the world (e.g. USA, UK,
Australia, Canada, India, Nigeria, Lesotho, South Africa, Ireland etc) and thelength of training at these universities varies between five and seven years post
secondary/high school.

－7－

After completion of the Pharmacy degree, all pharmacists are expected to do one
year of internship (practice) which can be done in the country of training or they
can be done in Botswana covering different areas of pharmacy (about six months
hospital pharmacy). The internship’s objective is to familiarize the pharmacy
graduates on the conditions of service (pharmacy) in Botswana.
c. National examinations for pharmacists
There is the Botswana Health Professions Council whose mandate is to ensurethat all health professionals, including pharmacists, practicing in Botswana are
dully registered. Therefore the examinations are carried out by the Council in theform of a written and oral exam over a two days period. The exams are for boththe nationals and the expatriates, with the nationals taking them before
commencing with internships and the expatriate before commencing with workwith their different employers. Upon successful completion of the exams one isregistered as a pharmacist and can therefore practice in Botswana.
d. Requirements to obtain pharmacy license
X be a university graduate
X passes the national exams
X concludes practical training as described above.
3. Historical Development of Pharmaceutical Services
a. History of Traditional (Herbal) Medicines in Botswana
Traditional medicines were the only medicines known to Batswana centuries ago.
These medicines however still form an important number of peoples’ lives. Thereis little documentation/ literature references of these medicines because thepractice was kind of hereditary in the past, it was always handed down familylines and for the most part this is done verbally and on hands type of training.
Today, because of the HIV/AIDS scourge a lot of researches are in the pipeline tosee if the traditional medicines used with modern medicine can’t be helpful inmanaging the disease, or even cure it.
Furthermore, the pharmaceutical services is planning to establish a technicalcommittee for traditional medicines, compile a national database of indigenous
medicinal plants as well as promote preservation and protection of medicinal
plants.
b. Introduction of Modern Drugs
Modern medicine came in with the occupation of the continent by missionaries
from Europe and America in the 19th century.
Traditional medicines and modern drugs are still practiced side by side though very little
communication exists between the different practitioners. Progress is being made incollaboration of the two practices through the Traditional Doctors Association and the
Botswana Medical Association.

－8－

c. History of the national plan and legislation on Pharmaceutical Services
As a result of collective efforts from government institutions, internationalorganizations, non-government organizations, professional bodies, academic
institutions and individual professionals, the Botswana National Drug Policy(BNDP) was born as part of the National Development Plan 8 (NDP 8) and the
document was thus published in 2002. The need for the policy was due to anincrease in the health services and as such an increase in the need forpharmaceutical services. The aim of the BNDP was to make drugs of acceptablesafety, efficacy and quality available and affordable to Batswana (nation of
Botswana) who need them and to promote their rational use thorough theestablishment of Botswana Essential Drug Action Programme (BEDAP), a semiautonomous Drugs Regulatory Authority (DRA) which will implement the Drugs
and Related Substances Act (DRSA), National Drugs and Information Center(NDIC) and National Drug Quality Control Laboratory (NDQCL).
To date, BEDAP has been established and has published the Botswana Essential Drugs
List in 2005 and the Botswana Treatment Guidelines which was updated in 2007. The
Drugs and Related Substances Act 18 of 1992 is still under review so that the semiautonomous DRA can be established and also merged with NDQCL. Currently there is
the Drugs Regulatory Unit (DRU) and the NDQCL and both work separately. The NDIC
is still to be established.
d. Pharmaceutical Administration Systems and Services.
The Pharmaceutical Services has evolved over the years as follows:
1970s:• The pharmaceutical services gained prominence in the earlyseventies with the help of the Norwegian government. A training
institution for pharmacy technicians was established in the country
in 1976 with the first graduates of 1979.
• Central Medical Stores (CMS) was established, by then it wascalled Botswana Central Pharmacy and core business was as bulk
storage and distribution.
1980 -2000• Pharmacist started joining the pharmacy technicians in the early
1980s and provided clinical pharmacy activities in hospitals.
• There was an expansion of pharmacy roles with the formulation of
the BNDP and as such there was establishment of a Quality
Assurance unit at CMS, DRU, BEDAP and NDQCL. Pharmacists
have been trained in and outside the country through government
sponsorships and currently there are 260 pharmacists in the
country deployed in hospitals, medicines regulation, drug selection,
medical aids schemes, pharmaceutical wholesaling, andcommunity pharmacy. The services have developed with improved－9－

skills from cooperation with international organizations, though theservices are still hampered by the relatively few numbers.
2000 to date
•
•
•

•

The Drug Management Unit was set up
Pharmaceutical Care concepts introduced by clinical pharmacists
Training in Provision of comprehensive pharmacy services care to
HIV/AIDS patients (Drug adherence counseling, drug availability,
drug side effects ADR Monitoring, involvement in drug selection)
Set up of Pharmacy and Therapeutics Committees at hospitals toprovide guidance on drug issues

4. Pharmaceutical affairs administrationa. The Pharmaceutical Services are housed in the Ministry of Health within the Clinical
Services Department. Clinical Services Department is one of the seven departments andis comprised of medical, nursing, pharmaceutical, diagnostic, dietetic, rehabilitative andbiomedical engineering services.
The head of the pharmaceutical services is the Chief Pharmacist who is responsible forthe different units which are:• Drugs Regulatory Unit – responsible for medicine regulation and control, drug
registration and inspectorate functions.
• Central Medical Stores – responsible for procurement and distribution of drugs togovernment health facilities.
• Botswana Essential Drugs Action Programme – responsible for drug selection andessential drugs list and rational drug use.
• National Drug Quality Control Laboratory – responsible for testing of drugs toensure conformity to the standards of quality recognized internationally.
• Hospital Pharmacies – responsible for providing clinical pharmacy services.
• Drug Management Unit – responsible for supply logistics.
b. List of laws/ regulations covering pharmaceutical affairs• Drugs and Related Substances Act18 of 1992 (DRSA) and Regulations of 1993
• Botswana Health Professions Act 17 of 2001
• Pharmacy Practice Standards• Botswana National Drugs Policy• Botswana Labour Act• Trade Act
c. Medicines regulation encompasses the registration of medicines and inspection offacilities where medicines are stored, distributed from and dispensed for compliance withgood distribution and dispensing practices. This is done under the mandate of the Drugs
and Related Substances Act of 1992. All drugs with medicinal indications have to beregistered including biologicals. There is currently no manufacturer in the country so all
medicines are imported. The Ministry, through DRU, has conducted some GMP
inspections, not all manufacturing facilities whose products are applied for registration－10－

are inspected as we sometimes are dependant on other regulatory authorities for thesekind of information.
Herbal medicines have to be evaluated for exemption from registration. An average of
190 applications are received each year by the unit and it takes about three days toprocess each application. Traditional medicines are also exempted from registration
because as of now they are in crude form and not in dosage formulations.
d. The DRU is still in the process of developing guidelines for Pharmacovigilance as well
as sensitization of the health professionals. Therefore there is not much that is currently
done on post marketing surveillance. There is a need for this office to be set up as it will
be responsible for processing of all information about the medicines on the market,
coordinating the analysis of the samples collected by the inspectorate and processing
reports, this office alos will be responsible for ADR monitoring.
e. The National Quality Control Laboratory [NDQCL] was established in 2005 with theaim of testing pharmaceuticals for quality. The laboratory is currently able to do some
simple tests on most pharmaceuticals including antibiotics and antiretrovirals. There arestill challenges to be faced with biologicals.
5. National Drug Policy
The Botswana National Drugs Policy was published in August 2002 after it was approved
by Parliament. It is aimed at improving the management of drug supplies including
ensuring safety, quality and efficacy. The Policy recommended the establishment of theabove mentioned offices so as to meet its objectives.
6. Drug supply system and drug price mechanism
Supply of medicine is from both the private and public sectors. All drugs are imported as
there is no manufacturer in the country. The public sectors accounts for more thanseventy percent [70%] of the consumptions and the services from the public sector are
funded by government for the most part. Procurement is done through an open tendersystem and there very little price control. There is a growing private sector which was
relatively small several years back and an increase in the number of medical aids schemes
which funds about 30% of the health services.
7. Management of hospital pharmacies in Botswana
Hospital pharmacies are managed by pharmacists who report to the Chief pharmacist in
the Ministry. They provide pharmaceutical care by taking responsibility for thetherapeutic outcome of therapy and by being actively involved in the design,
implementation and monitoring of clinical of pharmacy services.
8. Research and Development of drugs
Research and development of drugs is not done in the country.

－11－9. Pharmacopoeia
The country does not have its own pharmacopoeia, however, international
pharmacopoeias such as the British, United States and European pharmacopoeias are themain references used in Botswana.
10. Donor Coordination
There have been a number of donor agencies in Botswana. Most coordination is throughthe Department of Public Health which sources technical assistance from the different
departments in the ministry depending on the type of donations. Funding activities arecoordinated from Ministry of Finance and Development Planning. The efforts are usuallyin line with the requirements of the donors with memoranda of understating signed
between government and the donor agencies. However all drugs donated must meet thefollowing criteria:• They must be based on Botswana’s expressed need and must be relevant to thedisease pattern in the country.
• They must be of good quality and have a shelve life of more than 12 months at thetime of handing over to the recipient.
• They must be authorized for use in Botswana and must meet the labelingrequirements as stipulated in the DRSA.
• They must all be tested by the NDQCL for conformity to specifications.
11. References
1. Health Statistics Report 2001: Published by Central Statistics Office
2. Health Statistics Report 2003: Published by Central Statistics Office
3. Health Statistics Report 2004: Published by Central Statistics Office
4. 2001 Population and Housing Census, National Statistical Tables report
5. 2001 Population and Housing Census, Dissemination Seminar, September 2003
6. Statistics Update, June 2008, Central Statistics Office
7. List of drugs allowed into Botswana 2007
8. Botswana National Drug Policy 2002
9. Pharmacy Practice Standards 2002
10. Botswana Health Professions Act 17, 2001
11. 2003 Adult Literacy Survey Report－12－The Study Programme
for the Pharmaceutical Affairs Experts

Indonesia

－13－

－14－

COUNTRY REPORTTHE STUDY PROGRAMME FOR PHARMACEUTICAL AFFAIRS EXPERTS(#J0900794)
JAPAN, November 8, 2009 ~ December 9, 2009

WARTA BR GINTING
NATIONAL AGENCY FOR DRUG AND FOOD CONTROLINDONESIA

－15－

1.

COUNTRY PROFILE
Indonesia is the largest archipelago in the world, stretching for more than 5,000
kms across the equator. It lies on crossroads between two oceans, the Pacific andthe Indian, and bridges of two continents, Asia and Australia.
It is an appropriate description of the archipelago as there are estimated to be a
total of 17,508 islands, of which only about 6,000 are inhabited.
Five main islands and about 30 smaller archipelagoes are home to the majority ofthe population. The five main islands are: Sumatra (473,606 sq. km); Java/Madura(132,187 sq. km); Kalimantan, which comprises two-thirds of the island of Borneo(539,460 sq. km); Sulawesi (189,216 sq. km); and Papua (421,981 sq. km) which ispart of the world’s second largest island, New Guinea. The capital city of Indonesia,
Jakarta is located in Java Islands.
Indonesia has tropical climate with two seasons, namely the dry season and therainy season. Indonesia’s populations are almost 220 millions which consist of
hundreds of ethnic groups, languages and cultures. It is about 300 ethnic groups
and cultures, each with its own language (speaking in 583 languages), butpossessing one national language i.e. Bahasa Indonesia. A part of people arefollower of Moslem, beside other religions like Christianity, Catholic, Hinduism, andBuddhism.

2.

STATISTICAL DATA
1) Populationa) Population density per 1 sq km
Data:

42,174,719

Year

:

2007

－16－

b) Number of populationData: 230.873.595

….

Year

: 20072008c) Precentage distribution by three broader age groups (%)
0-14

15-64

65 years and over

Data

:

36,3 %

38,3%

6,1%

Year

:

2007

2007

2007

d) Rate of natural increase of population (% per annum)Data: 1,3%

Year: 20072) Vital statisticsa) Rate of vital statistics (per 1,000 [population)(per 1,000 live births*)
Live birthrate *
Data

:

61,5

Year

:

2007

b) Five main diseases causing morbidity
causesnumberyear

1 Periodental

60

2006

2. Upper respiratory canal infection

30

2006

3. Refraction disorder

25

2006

4. Anemia

20

2006

5. Gastro Intestinal Tract Infection

15

2006

－17－

c) Five leading causes of deathcausesnumber

year
2006

1.

Lower Respiration disease

15,5%

2.

Obstetric & abortion complication

11,8%

2006

3.

Intestine infection disorder

10%

2006

4

Injury and poisoning disease

7,1%

2006

5

Stomach, intestine and peritonea

4,1%

2006

3) Medical carea) Number of hospitals
Government

PublicPrivateClinics

Hospital

hospital

hospital

Data

:

578

273

812

575

Year

:

2007

2007

2007

2007

b) Number of health manpower
Physicians

Dentists

NursesData:

16,1158750

227,560

Year

:

2007

2007

2007

d) Number of Pharmacists
Data

:

7,495

Year

:

2007

c) Number of drug manufacturers/plants
Data

:

204

Year

:

2009

－18－

d) Number of traditional medicine manufacturers/plans
Data

:

1597

Year

:

2007

e) Number of cosmetic products manufacturers/plants
Data

:

6775

Year

:

2007

f) Number of drug importers
Data

:

89

Year

:

2007

g) Number of drug wholesaler
Data

:

2740

Year

:

2007

h) Number of pharmacies
Data

:

4955

Year

:

2007

i) Number of drug stores
Data

:

9412

Year

:

2007

j) Number of registered drug (please specify number of traditional
medicine if possible)
Data

:

2050

Year

:

2007

k) number of registered drugs
Data

:

14196

Year

:

2009

－19－

4. Educational Information for Pharmacista) System of Education
Primary School:

6

years system

Age at enrolment:

6

years old

Secondary school:

3

years system

High school:

3

years systemb) System of university or college education
University or college years

:

4

years

Professional education

:

1

years

Practical training:

18 – 20 weeks

Duration of training each facility:

1 – 7 weeks

Hospital Pharmacy:

8 weeks

Pharmacy:

8 weeks

Pharmaceutical company:

8 weeks

Other (government office):8 weeksc) National examination system for pharmacist
Academic exams

:

6

days

Clinical exams

:

5

days

None
d) Requirement to obtain pharmacist’s licensee)-1

Be a university or college graduatee)-2Pass the national examinatione)-3 Conclude practical training after graduating in drug factory, pharmacy,
hospital, and government officee) Graduates number of pharmaceutical university or college. people per
year (as of 600-800)

－20－

3.

Historical Development of Pharmaceutical Services
A.

History of the Traditional (Herbal) Medicine
Traditional medicine is still widely used by many people. Most of the
traditional medicine raw material can be obtained locally and only a small
amount of the raw material is imported. In the period of the Dutch rule, thetraditional medical plants were collected and written. In the period Japaneserule, to anticipate the lack of the medicine, the Japanese Government
complied the formulas of The Indonesia Traditional Medicine.
In 1974, The Directorate of Traditional Drug Control was established. Since
1976, The Traditional Medicine has been registered gradually. Control has
been taken by sampling from the market and checked by the National andRegional Quality Control Laboratory of The Ministry of Health. The Traditional
Medicines that have curative effects have to pass the pre-clinic/clinic test. The
uses of the traditional medicines has increased. However, the real efficacy ofmost traditional medicine has not yet been scientifically proved. The effort isfocused mostly on the improvement of the safety and quality of the traditional
medicines. The improvement of the production should be accompanied by thepreservation of medical plants and animals.

B

Describe how the pharmaceutical administration system and services in yourcountry have been transformed, improved, strengthened through the various
training programmes for human resources provided by international partners
such as WHO<JICA<JICWELS,ect.
To add knowledge administration system and services and support our dailytasks administration system and services are more effective and efficient－21－

4 . Pharmaceutical Affairs Administration
1)

Organization Charta. Details of the National Agency of Drug and Food Control (see Figure 1.)
b. Details of the Provincial Office of Drug and Food Control (see Figure 2.)2)

The role of national/state and local pharmaceutical administrative
organizations.
The Main Functions of NADFC are:a. Legislation, regulation and standardization;b. Licensing and certification of pharmaceutical industries based on Good
Manufacturing Practices;c. Pre-market evaluation of products;
d. Post-marketing vigilance including product sampling and laboratory testing,inspection of production and distribution facilities, investigation and law
enforcement;f.

Research on drug and food policies implementations;g. Public communication, information and education including public warning.
A Technical implementation unit of the National Agency of Drug and FoodControl is Regional Office of Drug and Food Control.
3) List of regulation covering pharmaceutical affairs
Classification of Regulation3)-1 Product Regulation- Drug, Foog, Cosmetic, D• Head of National Agency of Drug and Food Control Decree on Criteria
and Procedure of Drug Registration No. HK.00.05.3.1950 year 2003－22－• The Ministry of Health Regulation for imported drug registration No.
920 year 1993•

Head of National Agency Drug and Food Control

for Good

Manufacturing Practise No HK 00.05.3.02152 year 2002
• Head of National Agency Drug and Food Control for Good Distribution
Practise No HK 00.05.3.2522 year 2003
• The Ministry of Health Regulation for Wholesaler No 938/Menkes/per/X
year 1993• The Ministry of Health Regulation for Food Registration No. 382 year
1989
• The Ministry of Health Regulation for cosmetic and medical device
production and distribution no. 220 year 1976
• The Ministry of Health Regulation for traditional medicine license andregistration no. 246 year 1991
• The Ministry of Health Regulation for medical device, cosmetic, anddomestic medical device registration no. 140 year 1991
- Counterfeit Drugs
The Ministry of Health Regulation No 1010 year 2008 has regulated thecounterfeit drug is a medicinal product with is manufacturer by illegal
manufacturer or deliberately mislabled with respect to identity－23－

- Genetics
The Government of Indonesia has not made the regulation ofgenetic/genetic modification of drug, genetic/genetic modification offood has regulated by The Law of Food, No. 7, 19963)-2

Profession Regulation
Pharmacist
The Ministry of Health Regulation for Replacing The Ministry of HealthRegulation no. 184 year 1995 for Implementation of serve period andlicense of pharmacist no. 149 year 1998.
The pharmacist before getting the license of pharmacist, they must
work in non government sectors, except in government sector.
There is a standard competency for pharmacist certificated byprofessional organism3)-3Health Promotion and Regulations-

Health Establishment Regulation
The Government of Indonesia has two regulations that support
regulation of health; they are he Law of Health No 23, 1992 andthe Law of Food, No. 7, 1996-

Traditional Medicine
Traditional Medicine are regulated by The Law of Health No. 23,
1992 because traditional medicine is one of pharmaceuticalpreparation. Production of traditional medicine from the small
industry until the large industry, the people of Indonesia like thetraditional medicine for therapy or to keep health.

－24－

-

Health Economics
In Indonesia the cost of therapy are paid by the people
themselves. In Indonesia there is insurance of health that is
managed by the government that gives medical guarantee to thegovernment official by paying premi.
The people who don’t pay the premi, they go to the health centerget diagnosis services and been given generic medicine they pay
cheap cost or consult to private doctor with more expensive
checking cost.

4) Licensing system of factory and registration system of drug
A license of manufacture drugs is given after confirming that the applicant
has an adequate ability or condition to do such business, and whether hecan secure appropriate facilities and personnel for that purpose.
Requirements for approval license applications for drugs are needed.
The license is granted on examination of material conditions such asbuildings and facilities for safe and hygienic manufacture, and of theconditions of personnel such as the manufacturing control managers,
quality control manager accordance to GMP.
Criteria to get approve of marketing authorizator :- NADFC carries out pre-market evaluation on efficacy, safety and qualityof drugs, biological products in Indonesia as well as operates a clinical
trial.
- The Quality of product should complythe specification according to GMP
Implementation specification and testing method- Tabel which consist of complete and objective information to assure theused of drug property rationaly and safetly.

－25－

5) Pharmaceutical inspection including quality control check system
The period of drug inspection is conducted after pharmaceutical manufacture
has it license for drug production and license for distribution and registration
number. The inspector of drug will examine whether the GMP concept is
applied on production infrastructure. The inspection covers all the production
aspect.
List of GMP Inspection and Guidance:o

General ProvisionoPersonneloPremisesoEquipmentoSanitation and HygieneoProductionoQuality ControloSelf InspectionoHandling of product recall; Product Complaint & Return drug productoDocumentation

6) Good Manufacturing Practice (GMP)
The Activities of GMP in Indonesia have been stated since 1986, byimplementation the WHO GMP. By April 1994, all drug manufacturers should
implement GMP. The fisrt edition GMP quideline was establisted on 1988 andsecond edition was revised in 2001 and the Third edition was revised in 2006.
The GMP quideline are complited with operational manual for GMP
implementation on each edition.
Manufacturer should conform GMP requirement, GMP certificate will be given if
the requirement is confirmed and GMP certificate issued for each dosage form

－26－

The implementation of GMP in Pharmaceutical Industries is under control of
National Agency of Drug and Food Control.
7) Post marketing surveillance system (PMS)
One of main functions of NADFC is post marketing vigilance including
Pharmacovigilance(Adverse drug reaction monitoring), product sampling andlaboratory testing, inspection of production and distribution facilities, labelinging and promotion control. NADFC undergoes a multi face dimension and acomplex aspect of consequences. Therefore, a comprehensive control system isneeded from the use in community.
There are three layers of control sub-system:- Producer Control Sub-system
Producer should have an internal control system for complying with therequirements of the Code of Good Manufacturing Practices to enable early
detection of every product deviation of quality standards.
- Consumer Control Sub-system
The control system by consumers is through increased awareness andimproved knowledge on product quality and safety for the intended purpose.
- Government Control Sub-system
The control system conducted by the government includes legislation andregulation, standardization, evaluation of safety, efficacy and quality of
products before marketing, inspection and investigation, product sampling in
the market and laboratory testing, public warning together with law
enforcement.
Recognising that in Indonesia we rely on voluntary spontaneous reporting, byhealth professionals, to increase the reporting by health professionals, toincrease reporting rate we have to create a culture of ADR Reporting.

－27－

To do that, we have to make health professionals aware of and understand thepharmacovigilance programme in Indonesia. NADFC, as National Centre has
responsibilility to communicate with health professionals by conducted
workshops for health professionals especially in some large hospitals.
Alongside workshops or seminars in hospitals, we encourage health bulletin
consists of new information on drug safety, regulatory actions, labeling updates(if any) and also a sample of reported ADRs cases.
8) Sale and distribution of drug
Drug, food, traditional medicine professionals to report by sending them theIndonesian ADR Bulletin twice a year with blank yellow ADR reporting forms in
it. For every report submitted, feedback or an acknowledgement will be sent
back to the reporter. Theand cosmetic product have to be registed NADFC
before distributed. Drug distribution should implementation Good Distribution
Practise (GDP) to assure the quality of the product consisten since release GMP
manufacturing until end user and also to keep the product in the legal
distribution
Flowchart of drug distribution system on figure 3.
9) Additional requirements for biological (vaccines) and antibiotics suchas National test system
Stable Supply of Vaccines
Manufacturing of vaccine production should comply to the recent GMP in
Indonesia. Bio Farma in Bandung West Java has manufactured vaccine
productions.Additional requirements for biological (vaccines) and antibiotics is－28－

clinical test, and there is only the National laboratory of drug and food control
can do the test.

5. Present situation and future plan (ex National plan, introduction of GMP
concept etc) in the National drug policy
Drug control system are comprehensive control system.. There are three layers ofcontrol sub-system :-Producer Control Sub-system : Producer should have an internal control systemfor complying with the requirements Good Manufacturing Practices-

Consumer Control Sub-system, consumers is through increased awareness andimproved knowledge on product quality and safety for the intended purpose.

-

Government Control Sub-system The control system conducted by thegovernment includes legislation and regulation, standardization, inspection andinvestigation, product sampling in the market and laboratory testing, public
warning together with law enforcement.

To achieve public health protection from substandard product, counterfeit drug andproduct that not meet safety, quality and eficacy spesification

6.

Drug supply system and drug price mechanism including local product,
imported and exported drugs- Drug Supply
Imported, exported and local produce drug should be registered according to drug
registration regulation with the same criteria in safety, efficacy and quality.
Registration of imported drug products should be carried out by local pharmaceuticalindustries, pharmaceutical wholesaler that have written agreements from thepharmaceutical industry abroad. This pharmaceutical industry must fulfill criteria of－29－

GMP which are proved by relevant document. If necessary, Inspection to the sites will
be carried out by competent inspectors from NADFC.
Drug Price Mechanism
The expensive drug price is one of the problems for people to get the medication.
The contribution of higher distribution and promotion cost increase the price of drugs.
One of the Government efforts on the expensive drug problem is to introduce thegeneric drug. The government (The Ministry of Health) controls the generic drug
price. Drug price control is only prevailed for generic product (copy product using
International Non-proprietary Names). For branded product, there is no control on
price setting; the producers set the price based on the market mechanism. To
protect public health interest, NADFC implement some strategies on drug pricing
policy. Namely initial price control, price comparison information on drug price inpharmacy, as well as active and passive price monitoring.

7. Information on the management of hospital pharmacies
Pharmacy departement is one of Departement under the hospital organization
structure. A pharmacist is responsible as a head of hospital pharmacies. Hospital also
has “therapeutical comitte” consist of doctor, pharmacies etc. One of its task is tobuilt a drug list as aquide to prescription by the doctor. This drug list are composedby consider type of diseases, drug price etc.
Hospital pharmacies also give information services, that can be acessed by website
The other service is give conselling to certain patient about drug usege

8. Activities of research and development of drug
8.1 Research Development－30－

The drug of health research development is conducted by The Health
Department (NIDH), The National Agency of Food and Drug Control, The
University, Drug Research directs to clinic examination. Dug Research has notdirected yet to a new discovery drug (New chemical structure)
8.2 Industrial development
Industrial development of drug and medical devices continue the old policy andthere is the addition of some new manufacturer. New industrial invest walks
slowly after “Reformation Era”

8.3 Educational Development- Pharmacy Education
Pharmacy Education Development in Indonesia walks fast enough, some
Universities conduct post graduate program. There are Government university
and private university, with length of study are 4 year for bachelor degree and1 year for pharmacist.

8.4 Other
The traditional medicines are developing in Indonesia namely Curcuma
xanthorriza (temulawak),Morinda citrifolia fruit (Mengkudu), it’s an extract or

fermentation which is made in capsule or syrup, it’s useful for some diseases.
Food supplements or health foods have the same development in Indonesia,
either traditional medicines or food supplements have to be registered at NAFDC
before distributed.
9. Pharmacopoeia
Pharmacopoeia Indonesia is the official standard for drugs, which is published by
Ministry of Health. The standard has objectives on guidance of quality control for raw－31－

material and drugs. The latest edition of pharmacopoeia was fourth edition that was
published on 1995.

－32－

－33－

1. Directorate of Drug and Biological
Product Evaluation
2. Directorate of Production Therapeutic
Product and Household Product Control
3. Directorate of Distribution Therapeutic
Product and Household Product Control
4. Directorate of Therapeutic ProductInspection and Certification
5. Directorate of Narcotics psychotropic andAddictive Substance Control

Deputy I
Therapeutic Product, Narcotics,
Psychotropic and Addictive SubstanceControl

INSPECTORATE

4.

3.

2.

1.

Drug and Food Control OfficeDirectorate of Traditional Medicines,
Food Supplement and Cosmetics
Evaluation
Directorate of Traditional Medicines,
Cosmetics, and Complementary ProductStandardization
Directorate of Traditional Medicines,
Cosmetics, and Complementary ProductInspection and Certification
Directorate of Indonesian Traditional
Medicines

Deputy II
Traditional Medicines, Cosmetic andComplementary ProductControl

National
Quality Control
Laboratory

NATIONAL AGENCY OF
DRUG AND FOOD CONTROL

5.

4.

1.
2.
3.

Centre of Drugand Food
Research

Centre of Drugand Food
Information

Bureau of Planning and Financing
Bureau of International Cooperation
Bureau of Legal and Public Relation
Bureau of General Affairs

Directorate of Food Product Evaluation
Directorate of Food Standardization
Directorate of Food Inspection andCertification
Directorate of Hazardous Product andSubstance Control
Directorate of Surveillance and Food
SafetyDeputy III
Food safety and Hazardous SubstanceControl

Centre of Drugand Food
Investigation

1.
2.
3.
4.

PERMANENT SECRETARYORGANIZATION STRUCTURE OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL

Figure 1.

－34－

DIVISION OF
THERAPEUTICPRODUCT,NARCOTICS, ,TRADITIONALMEDICINE,
COSMETICS ANDCOMPLEMENTARYPRODUCT TESTINGDIVISION OF FOOD
AND HAZARDEOUS
SUBSTANCESTESTINGDIVISION OF
MICROBIOLOGYTESTINGREGIONAL
DRUG AND FOOD
CONTROL OFFICESECTION OF
CERTIFICATIONSECTION OF
CONSUMER
INFORMATIONSERVICESSECTION OF
INVESTIGATIONDIVISION OF
CERTIFICATIONAND CONSUMERINFORMATIONSERVICESSECTION OF
INSPECTIONDIVISION OF
INSPECTION ANDINVESTIGATIONSUB UNIT OFADMINISTRATIONORGANIZATION STRUCTURE OF REGIONAL DRUG AND FOOD CONTROL OFFICE

Figure 2.

Figure 3.

DRUG DISTRIBUTION SYSTEMDRUG MANUFACTURER

WHOLESALER

OTHER

PHARMACY(WITH
PARMACIST)

WHOLESALER

Remark :Distribution of prescription
drugDistribution of non prescription
drug

HOSPITAL

CLINIC/HOSPITAL(WITHOUT
PHARMACIST)

Distribution of vaccines－35－

LICENCED
DRUG STORE

－36－

The Study Programme
for the Pharmaceutical Affairs Experts

Iraq

－37－

－38－

－39－

KIMADIA
KIMADIA

MOH
MOH

REPAIRDEPT
DEPT
REPAIR

IMPORTDEPTDEPT
IMPORT

WAREHOUSESDEPT
DEPT
WAREHOUSESLEGALDEPT
DEPT
LEGAL

EQUIPDEPT
DEPT
EQUIP

VACCINE-ANTISERADEPTDEPTVACCINE-ANTISERATECHNICALDEPTDEPTTECHNICALPRINTINGDEPT
DEPT
PRINTING

FINANACEDEPTDEPT
FINANACEDRUGINFOINFODEPT
DEPT
DRUG

MDMINDEPT
DEPT
MDMIN

DRYGDISTIDISTIDEPT
DEPT
DRYG

PLANINGDEPT
DEPT
PLANING

－40－

PHARMACY DEPT IS A PART OF TECHNICAL AFFAIRS DIRECTORATE IN MOH AND
IS CONCERNED WITH THE MANAGEMEN OF TECHNICAL ASPECTS OF THE
PHARMACEUTICAL AFFIARS
WHILE KIMADIA WORK INVOLVES IMPORT/STORAGE AND DISTRIBUTION OF
DRUG AND MEDICAL SUPPLIESTHE KIMADIA SYSTEM IS LOCATED IN FIVE LOCATIONS

2-CHARACTERISTICS OF PAA IN IRAQ

－41－

•ABSENCE OF HEALTH INFORMATION SYSTEM BOTH IN KIMADIA AND PHARMACY DEPT IN
MOH•POOR PRIVATE LOCAL MANUFACTURING PLANTS•AVAILABILITY OF ILLEGAL AND UNREGISTERD DRUG FROM UNKNOWN SOURCES•WEAK QCL•BAD COMUTERIZED SYSTEM•NON QUALIFIED PHARMACISTS IN THE WAREHOUSES•IRRATIONAL DRUG USE•NO TREATMENT GUIDELINES

3-PROBLEMS TO BE SOLVED IN THE CURRENT SYSTEM

－42－•EXPANDING AND ENCOURIGING PRIVATE LOCAL DRUG MANUFACTURING PLANTS•NEED FOR HEALTH INFORMATION SYSTEM IN MOH•AVAILABILITY OF GOOD COMPUTARIZED SYSTEM FOR CARRYING OUT WAREHOSESWORK•AVAILABILITY OF INSURANCE COMPANIES•STRENGTHENING THE QCL CAPACITY•CONTINEOUS TRAINING PROGRAMMS FOR PHARMACISTS AND PHYSICIANS•NEED FOR NEW AND UPDATED RULES AND REGULATIONS FOR PHARMACY DEPT

4-CONTENTS OF THE REFORM TO SOLVE THE PROBLEMS

－43－

UNQUILIFIED ADMINSITRATIONTHE ABSENCE OF IDEAL OR PERFECT HEALTH SYSTEMSOLUTION

THEABSENCE OF SECURITY AND PEACE IN IRAQ EFFECTS CARRYIG OUT ANY POSSIBLE

5-PROBLEMS FOR CARRYING OUT THIS REFORM

－44－

THERE IS NO MENTIONABLE ACHIEVEMENTS HAS BEEN TAKEN PLACE IN THE RECENT
YEARS

6-MAJOR ACHIEVEMENTS IN RECENT YEARS IN PAADEVELOPMENT IN IRAQThe Study Programme
for the Pharmaceutical Affairs Experts

Malaysia

－45－

－46－

STUDY PROGRAMME FOR PHARMACEUTICALAFFAIRS EXPERTS

08 November 2009 – 09 December 2009
Tokyo, Japan

COUNTRY REPORTMINISTRY OF HEALTH, MALAYSIA－47－

1. GEOGRAPHICAL AND POLITICAL FEATURES
Introduction

In 1948, the British-ruled territories on the Malay Peninsula formed theFederationof

Malaya,whichbecameindependent

in

1957.

Malaysia was formed in 1963 when the former British colonies of Singapore andthe East Malaysian states of Sabah and Sarawak on the northern coast of
Borneo joined the Federation. The Federation of Malaya Agreement was signedin August 1957. At the end of the month, Independence was finally achieved with
Tunku Abdul Rahman as the first Prime Minister.

Geographical Background

Malaysia is a country with two distinct parts. Peninsula Malaysia constitutes thelong fringe of land, extending down from Asia, which borders Thailand andSingapore. The South China Sea separates the mainland from the East
Malaysian provinces of Sabah and Sarawak. The dense jungles of Sabah andSarawak support abundant plant and wildlife. It is the Peninsula that seems to
attract the most visitors, probably because of the diversity it offers in the way ofpeople, activities and climates.

－48－

The capital city is Kuala Lumpur, while Putrajaya is the seat of the federal
government. The population stands at over 28 million inhabitants. Malaysia
consists of thirteen states and three Federal Territories (Kuala Lumpur, Putrajaya
and Labuan). The 13 states are Johor, Pahang, Negeri Sembilan, Melaka,
Selangor, Perak, Terengganu, Kelantan, Kedah, Pulau Pinang, Perlis, Sabah andSarawak.

Climate－49－

Malaysia lies near the Equator between latitudes 1o and 7o North and longitudes
100o and 119o East. The year is generally divided into the South-East and theNorth-East Monsoon seasons. The average daily temperature throughout
Malaysia varies from 21oC to 32oC. Humidity is high that is 80%.

Society and Culture

Malays, Chinese, Indians and many other ethnic groups have lived together in
Malaysia for generations. The largest ethnic groups in Malaysia are the Malays,
Chinese and Indians. In Sabah and Sarawak, there are a myriad of indigenous
ethnic groups with their own unique culture and heritage. The Malays, Malaysia'slargest ethnic group, make up more than 50% of the population in Malaysia.

The base of the national culture is Malay culture, which is native to this region.
Islamic values are embedded in Malay Culture. The Malay culture emphasises
values on courtesy, moderation, tolerance, harmony and cordial relations amongfamily members, neighbours and community.

As Malaysian respect each other's beliefs and faiths, cultural and religious
festivals such as Hari Raya, Chinese New Year, Deepavali, Christmas, Gawai
Day and other auspicious occasions are given due importance. One of the uniquefeatures of Malaysia is its multi-racial population which practices various religions－50－

such as Islam, Buddhism, Taoism, Hinduism and Christianity. Each ethnic group
has its own beliefs. Under the Federal Constitution, Islam is the official religion of
Malaysia but there is freedom of worship. The Malay Language (Bahasa Melayu)
is the national language of the country. However, the people are free to use theirmother tongue and other languages. English as the second language is also
widely used especially in business.

Constitution and Separation of Power

Malaysia is a federal constitutional elective monarchy. The federal head of stateof Malaysia is the Yang di-Pertuan Agong, commonly referred to as the King of
Malaysia. The Yang di-Pertuan Agong is elected to a five-year term among thenine hereditary Sultans of the Malay states. The states are Perlis, Kedah, Perak,
Selangor, Negeri Sembilan, Johor, Pahang, Terengganu and Kelantan. In theother states, namely Melaka, Pulau Pinang, Sabah and Sarawak, the Head ofState is the Yang di-Pertua Negeri of Governor of the State. The Yang di-Pertua
Negeri is appointed by the Yang di-Pertuan Agong for a four-year term. The－51－

Federal Constitution of Malaysia clearly divides the authority of the Federation
into its Legislative Authority, Judicial Authority and Executive Authority. The
separation of power occurs both at federal and state levels, as in keeping with theconcept of federalism, which form the basis of the government administration.

Executive Authority

Executive power is vested in the cabinet led by the prime minister; the Malaysianconstitution stipulates that the prime minister must be a member of the lower
house of parliament who, in the opinion of the Yang di-Pertuan Agong,commands a majority in parliament.http://en.wikipedia.org/wiki/Malaysia ‐ cite_note‐46
The cabinet is chosen from among members of both houses of Parliament and is
responsible to that body.

State governments are led by Chief Ministers (Menteri Besar in Malay states or
Ketua Menteri in states without hereditary rulers), who is a state assembly
member from the majority party in the Dewan Undangan Negeri. In each of thestates with a hereditary ruler, the Chief Minister is required to be a Malay Muslim,
although this rule is subject to the rulers' discretions.

－52－

Education System

Education in Malaysia is monitored by the federal government Ministry of
Education. Most Malaysian children start schooling between the ages of three tosix, in kindergarten. Most kindergartens are run privately, but there are a few
government-run kindergartens. Education in Malaysia may be obtained fromgovernment-sponsored schools, private schools, or through homeschooling. The
education system is highly centralised, particularly for primary and secondary
schools. Education in Malaysia broadly consists of a set of stages which are:•••Pre-school
Primary Education (6 years)
Secondary Education (5 years, excluding pre-university education for 2
years)••

Tertiary Education
Postgraduate

Primary and secondary education in government schools is handled by the
Ministry of Education, but policies regarding tertiary education are handled by the
Ministry of Higher Education, created in 2004. In addition to the Malaysian
National Curriculum, Malaysia has many international schools. International
schools offer students the opportunity to study the curriculum of another country.
These schools mainly cater to the growing expatriate population in the country.

－53－

Literacy Rate

The literacy rate among Malaysian citizens aged 10 - 64 years improved from
88.6% in 1991 to 93.5% in 2000, thus representing an increase of about 5
percentage points over the 1991-2000 periods. The percentage of Malaysian

citizens aged 20 years and over with post secondary, college or university
education increased from 8.9% in 1991 to 16.0% in 2000. This pattern was
also observed for all the major ethnic groups.

School Attendance

At Malaysia level, it was observed that 92.7% of the male population aged 6
years and over had ever been to school compared to 87.6% for females in
Census 2000. This represented a narrowing in the gap between the sexes whencompared to Census 1991 where these percentages stood at 88.4% for males
and 79.8% for females.

－54－

2. STATISTICAL DATA

1) Population

According to the 2008 statistic, Malaysia has a population of 27.73 million
consisting of approximately 61% Malays, 30% Chinese, 8% Indians and 1% ofother ethnic groups. Other significant groups are the indigenous racesof Sarawak and Sabah, that is, the Dayaks, Kadazans (Dusuns), Bajaus,
Melanaus and Muruts; and the aborigines of Peninsular Malaysia. There arealso Europeans and Eurasians.

2) Vital Statisticsa) Rate of vital statistics (per 1,000 population) (per 1,000 live births*)
Year : 2008
Live Birth Rate

17.5

Death Rate

4.5

Infant Death Rate

6.3b) Five main diseases causing morbidity

－55－

2002

2004

2006

2008

1

Normal Deliveries(17.70%)Normal Deliveries(15.65%)

Normal Deliveries Normal Deliveries(14.91%)(13.99%)2Complications ofPregnancy,Childbirth and the
Puerpeirum(11.49%)Complications ofPregnancy,Childbirth and the
Puerpeirum(11.75%)Complications ofPregnancy,Childbirth and the
Puerpeirum(12.39%)Complications ofPregnancy,Childbirth and the
Puerpeirum(12.77%)

3

Accident (8.79%)

Accident (8.74%)

Accident (9.11%)

Accident (8.40%)

4Diseases of the
Circulatory System(6.96%)

Diseases of the
Circulatory System(7.11%)

Diseases of the
Respiratory
System (7.30%)

Diseases of the
Respiratory
System (8.05%)

5

Diseases of the
Respiratory
System (6.35%)

Diseases of the
Respiratory
System (6.83%)

Diseases of the
Circulatory
System (7.26%)

Diseases of the
Circulatory
System (6.99%)

2008c) Five leading causes of death
2002

2004

2006

1

Septicaemia(15.44%)

Septicaemia(15.10%)

Septicaemia(14.87%)

Heart Diseases &Diseases ofPulmonary
Circulation(16.54%)

2

Heart Diseases &Diseases ofPulmonary
Circulation(14.51%)

Heart Diseases &Diseases ofPulmonary
Circulation(14.52%)

Heart Diseases &Diseases ofPulmonary
Circulation(15.70%)

Septicaemia(13.18%)

3

Malignant
Neoplasma(9.23%)

Malignant
Neoplasma(9.54%)

Malignant
Neoplasma(10.59%)Malignant
Neoplasma(11.21%)－56－

4

Cerebrovascular
Diseases (8.18%)

Cerebrovascular
Diseases (8.40%)

Cerebrovascular
Pneumonia
Diseases (8.49%) (9.28%)

5

Accident (6.32%)

Accident (6.07%)

Pneumonia(5.81%)d) Life expectancy

Year : 2008
Male

71.70

Female

76.46

Total

74.08

3. MEDICAL CARE POLICY
Year : 2008a)b) Number of hospitals by establishing organ
Government Hospitals

130

Government Clinics

802

Private Hospitals

209

Private Clinics

6,371c) Number of health manpower－57－

Cerebrovascular
Diseases (8.65%)

Physicians

25,102

Dentists

3,640

Auxiliary medical personnel*

100,582d) Number of pharmacists

:

6,397

e) Number of drug manufacturer / plants:

73 (until Sept 2009)f) Number of traditional medicine manufacturers / plants :g) Number of drug importers :373 (until Sept 2009)h) Number of drug wholesalers:(until Sept 2009)

Drug

:

460

Non Poison/Trad./Cos

:

453

－58－

175

4-1. PHARMACEUTICAL AFFAIRS ADMINISTRATIONA) National Pharmaceutical Control Bureau, Ministry of Health
1-1)Administrative Organization

The National Pharmaceutical Control Bureau (NPCB) under the Ministry of Health
Malaysia is an institution that carries out pharmaceutical regulatory control in
Malaysia and ensures the quality, efficacy and safety of pharmaceutical products
as well as the quality and safety of natural products and cosmetics marketed in
the country (Refer organization charts below).

The NPCB was recognized by the World Health Organisation (WHO) as a
Collaborating Centre in the Regulatory Control of Pharmaceuticals and has been
providing training in pharmaceutical quality assurance and regulatory affairs tofellows from other countries.

The NPCB gained accession as the 26th member of the Pharmaceutical
Inspection Cooperation Scheme (PIC/S) from 1st January 2002.

－59－

The NPCB has implemented the ISO 9001:2000 Quality Management System
and acquired certification from SIRIM for the regulatory control ofpharmaceuticals, natural products and cosmetics.

ORGANISATION CHART MINISTRY OF HEALTH MALAYSIAMINISTERPARLIMENTARY
SECRETARYDEPUTY MINISTER
SECRETARY GENERALDIRECTOR GENERAL OF HEALTH
Legal
AdvisorInternal
Audit
Corporate
Policy &Industrial
HealthPublic Relations
Unit

DeputySecretary
General(Management)

Deputy Director
General(Public HealthServices)

Human
Resources
Training
Competency
Information
Technology &Communication
DivisionManagement
Services

IMR

Deputy Director
General(MedicalServices)

Deputy Director
General(Research &Technical support)

Epidemiology
DiseaseControl

MedicalDevelopment

FamilyHealthMedicalPractice

Engineering

Food Quality &Safety Division

TeleHealth

Medical
Device Control

Integrated
HealthTCM

Health
Education

IKPAV

DeputySecretary
General(Finance)

Planning &Development

Nursing
Division

NATIONAL
INSTITUTE
OF HEALTH(NIH)
SECRETARIAT

IPSK

IKU

Director(Dental)SeniorDirector(Pharmacy)

Policy &Development

Pharmaceutical
Care
Management

DentalPractice

Licensing &Enforcement

Finance

Accounts

Procurement& Privatisation

National
PharmaceuticalControl Bureau(NPCB)

IPK

CRC

3

INSTITUTE / STATE MEDICAL HEALTH DIRECTOR－60－

SENIOR DIRECTOR
Pharmaceutical
Services

DIRECTOR(Pharmaceutical
Service andDevelopment)

DIRECTOR(Pharmacy
Enforcement)

DIRECTOR OF NPCB
(Pharmacy
Regulatory)

National Pharmaceutical Control Bureau
MOH Malaysia

Director
Regulatory Pharmacy
Deputy Director
Centre For Product Registration

Deputy Director
Centre for Quality Control

Deputy Director
Centre For Compliance &LicensingSenior Principal Assistant Director
Centre For Organisational
Development

Senior Principal Assistant
Director
Centre For Post-Registration

Executive Officer
Administrative Centre

Total number of staff: 321¾ Pharmacists: 188¾ Pharmacy Assistants: 68¾ Scientific Officers: 15¾ Support Staff: 50
National Pharmaceutical Control Bureau MOH Malaysia－61－

Registration
Education

Pharmacovigilance

Licensing

Surveillance
Analysis

National Pharmaceutical Control Bureau MOH Malaysia

FUNCTIONS OF NPCB•

Evaluation and Registration of Products, Issuance of CPP, CFS•

Sample analysis•

Inspection and Licensing of premises (Manufacturers, Importers, &Wholesalers)•Issuance of Licenses for Clinical Trial•

Post-registration market surveillance•

Adverse drug reaction (ADR) monitoring•

Dissemination of product information•

Training•

International & Regional collaboration

The Drug Control Authority (DCA) - established for the purpose of making
policies as well as the authority in registration of products.

－62－

MEMBERS:

Director-General of Health (chairman);

Director of Pharmaceutical Services (alternate chair);

Director of the NPCB; and

7 other members appointed by the Minister of Health

NPCB functions as the secretariat of the DCA in which NPCB ensure thattherapeutic products are approved for the local market are safe, efficaciousand of quality, and also to ensure that traditional medicines and cosmetics
approved are safe and of quality.

B) Pharmaceutical Service Division, Ministry of Health1-1) Administrative Organization－63－

1-2 ) Pharmaceutical Affairs Administration

The Pharmaceutical Services Division in the Ministry of Health ensures that the
Malaysian public is accessible to quality, safe, efficacious and affordable
pharmaceutical and healthcare products including advice in using themrationally. In this context, the division plays the following 3 major roles :•Contributing directly towards public health through quality assurance
whereby the Pharmaceutical Services Division, through the National
Pharmaceutical Control Bureau, is responsible for regulating thepharmaceutical industry. This is to ensure that pharmaceutical products－64－conform to acceptable standards of quality, safety and efficacy before they
are registered; and that all premises and practices employed to
manufacture, store and distribute these products comply with the required
standards till they are delivered to the end users.
•

Enforcement of related acts and regulations.

•

Provision of pharmaceuticals for hospitals and health clinics under the
Ministry of Health. Ensuring a patient-focused service through the conceptof Pharmaceutical Care. The ultimate aim is to ensure provision of
optimum drug therapy, both by contributing to the preparation/manufacture,supply and control of medicines and associated products, and by providing
information and advice to those who prescribe or use pharmaceuticalproducts.

－65－

Regulatory Pharmacy – National Pharmaceutical Control Bureau
2) List of Laws / Regulation Covering Pharmaceutical Affairs

Pharmacy Legislation in Malaysia

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 and functions of the overall pharmacy services, which contributed
towards development of the healthcare sector. The Pharmaceutical Services
Division currently undertakes 3 component activities namely Quality
Assurance of Pharmaceutical Products, Pharmacy Enforcement andLicensing, and Pharmaceutical Care. The enabling powers that allow the－66－

division to control and regulate the pharmaceutical sector are embodied in thefollowing legislations :•Registration of Pharmacist Act 1951 (revised 1989) which provides theestablishment of the Pharmacy Board and Registration of Pharmacists•

Poisons Act 1952 (revised 1989) which regulates the importation,possession, manufacture, compounding, storage, transport, sale and useof scheduled poisons. Basically this Act determines whether apharmaceutical product is a prescription item, a pharmacy-only item or an
OTC.

•

Sale of Drugs Act 1952 (revised 1989)•

Control of Drugs and Cosmetics Regulations 1984 which regulates thesale of pharmaceuticals through a system of product registration andlicensing of manufacturers, importers and wholesalers.

•Dangerous Drug Act 1952 (revised 1980) which regulates theimportation, exportation, manufacture, sale and use of narcotics.

•

Medicines (Advertisement and Sale) Act (revised 1983) which
regulates advertisement of over-the-counter (OTC) medicines in the lay
media.

－67－

•

Others related – Patent Act 1983, Trade Description Act 1972,
Pesticides Act 1974

The Pharmaceutical Services Division in the Ministry of Health ensures that
the Malaysian public is accessible to quality, safe, efficacious and affordable
pharmaceutical and healthcare products including advice in using themrationally. In this context, the division plays the following 3 major roles :•Contributing directly towards public health through quality assurance
whereby the Pharmaceutical Services Division, through the National
Pharmaceutical Control Bureau, is responsible for regulating thepharmaceutical industry. This is to ensure that pharmaceutical products
conform to acceptable standards of quality, safety and efficacy before they
are registered; and that all premises and practices employed to
manufacture, store and distribute these products comply with the required
standards till they are delivered to the end users.

•

Enforcement of related acts and regulations.

•

Provision of pharmaceuticals for hospitals and health clinics under the
Ministry of Health. Ensuring a patient-focused service through the conceptof Pharmaceutical Care. The ultimate aim is to ensure provision of－68－optimum drug therapy, both by contributing to the preparation/manufacture,supply and control of medicines and associated products, and by providing
information and advice to those who prescribe or use pharmaceuticalproducts.

Drugs and Cosmetics Regulations
The promulgation of the Control of Drugs and Cosmetics Regulations in June
1984 marked the dawn of the regulatory era in Malaysia. This laid thegroundwork necessary towards moulding a systematic pharmaceuticalregulatory system in Malaysia. In January 1985, the Drug Control Authority(DCA) was established under the chairmanship of the Director General of
Health Malaysia, with a mission of ensuring the safety, efficacy and quality ofpharmaceuticals as well as safety and quality of traditional medicines andcosmetics marketed locally. To accomplish this goal, the DCA through its
Secretariat based at the National Pharmaceutical Control Bureau (NPCB)
undertakes several functions which include evaluation and registration of
products; analysis of samples; inspection and licensing of manufacturers,
importers and wholesalers premises; post-marketing surveillance; adverse
drug reaction (ADR) monitoring and dissemination of information.

－69－

Counterfeit Drugs
Sales of counterfeit pharmaceuticals are a growing problem in Malaysia.
Counterfeit medicines include "drugs" with the wrong ingredients, insufficient
active ingredients, and those with fake packaging. The counterfeit medicines
siphon off profits of legitimate manufacturers, and leave companies vulnerable
to lawsuits from patients who may have adverse reactions to the counterfeit
products. Due to that, activities in monitoring of drugs, precursors, essential
chemicals with potential abuse of being diverted and counterfeit medicinesremain the top priority of the Pharmaceutical Enforcement Branch in
Pharmaceutical Services Division, Ministry of Health.

As of 1st May 2005, the Ministry of Health has implemented Phase 1 of thecompulsory ruling requiring manufacturers and importers of pharmaceuticalproducts to fix security hologram labels onto their products or packaging.
When affixed, the hologram labels raise the expectation that these products
have been duly registered with the Drug Control Authority (DCA). This latest
move by the Ministry was motivated by the need to curb counterfeit problems
with pharmaceutical products and augment enforcement efforts against－70－

imitation of such products. The hologram label will have a unique serial
number that can be traced to the licensed manufacturer or importer of the
product, which makes it easier for monitoring purposes.

Food Regulations
Food safety responsibilities throughout Malaysia are executed through asystem of administration including the central, state, district and local authority
levels. Within the Ministry of Health, the Food Safety and Quality Division,
which was established in 1974, is responsible for the overall technicalsupervision of food safety activities; formulation of legislation, codes ofpractice and guidelines; determination of food safety policies; adoption of foodsampling and food premises inspection strategies; and coordination ofactivities at the state and district levels. The Food Act 1983 (Act 281 of theLaws of Malaysia) and its regulations are the primary legislative documents
for food safety activities in Malaysia. The regulations deal with such subjects
as food hygiene, labelling, import and export, advertising and laboratories,
and also contain numerous and detailed food standards.

－71－Medical Device Regulations
In February 2005, a decision was made by the Malaysian Government toregulate medical devices in Malaysia. The Ministry of Health Malaysia is
responsible for developing and implementing a regulatory framework tocontrol medical devices in Malaysia. The aims of the medical devices
regulation are to protect public health and safety; to allow patients for earlier
access to new technology for early detection, diagnosis and treatment; and to
facilitate trade and invigorate the medical devices industry.

3) Licensing System of Factory and Registration System of Drug

The issuance of Manufacturer’s License, Import License and Wholesaler’s
License are under the purview of the NPCB. In the year 2008, there was adecrease in the number of licenses issued due to the fact that the DCA does
not issue those licenses for cosmetic products, in line with the execution of
the cosmetic products notification system effective 1st January 2008. The
NPCB is also responsible for the issuance of Clinical Trial Import Licenses(CTIL), issuance of Registered Product Additional List, issuance of Good－72－

Manufacturing Practice (GMP) Certificate, and revocation of manufacturing
license. The NPCB also carries out pre-certification inspections of veterinary
manufacturers for the purpose of issuing GMP Certificates. GMP Certificatesissued would then confirm compliance to GMP whereby it is required for theregistration of veterinary products overseas.

The Drug Control Authority (DCA) plays an important role in ensuring thequality, safety and efficacy of pharmaceutical products as well as the quality
and safety of natural products in the market. The NPCB in line with its role assecretariat to the DCA is responsible for the registration of new chemical
entities (NCES), biotechnology, prescription, non-prescription, veterinary,
health supplements and natural products (refer chart below). Following theapplication for the registration of a product, the DCA is the body that makes
decisions on approving or rejecting such applications. The aim of the DCA isto review policies and to deliberate upon applications for product registrationand licensing. As for cosmetic products, the registration process is throughnotification process since 1st January 2008. Hence, cosmetic products are nolonger required to be registered by the DCA. The existing registration
numbers for cosmetic products has been changed to notification numbers－73－which begin with NOT instead of MAL. As for new cosmetic products,
companies are only required to submit notification to market their products
and the NPCB will issue notification notes, which are valid for two years.

Registrations of products are conducted via the online system (QUEST2)
which was introduced since the year 2002. The QUEST2 system enables theregistration of products through a readily accessible system and thus reduces
the need of submitting documents manually. This results in faster registrationof products and reduces the bureaucracy involved. The current system of
QUEST2 will be upgraded to QUEST3 and the system is expected to be up
and running by the year end 2009. The new and upgraded system of
QUEST3 will introduce new online modules namely NCE, biotechnology,
veterinary and For-Export-Only products.

The NPCB ensures the quality of pharmaceutical, natural and cosmetic
products through two important procedures of protocol evaluation and data
validation as well as analytical laboratory testing. This allows pre-registrationand post registration sample testing as well as quality testing for complaintcases and adulterated samples from enforcement sources to be carried out.

－74－

Currently, analytical method protocols and validation data replaces the testingof pre-registration samples for pharmaceuticals.

APPROVAL OF DRUGS
Evaluation of application dossier
Verification of GMP status (approval from recognised authorityof the country of origin), CPP and CFS
Protocol Evaluation and Testing
New Chemical Entity (NCE) – sent to panel of experts for comments.

Evaluation Committee(within NPCB)Drug Control Authority(DCA)(decision making body-meets monthly)

Applicant can appeal through Ministerof Health for review of DCA’s decision

Application rejected
Registered

National Pharmaceutical Control Bureau MOH Malaysia

Online Product Registration System (QUEST2)
On-line web based registration system implemented since 2002

Allows for submission of data 24 hrs a day, 365 days a year from any
part of the worldFor all categories of products except for the submission of applications
for New Chemical Entities and Biotech products－75－4) Pharmaceutical Inspection including Quality Control Check System

The NPCB conducts inspections on manufacturers of pharmaceutical, naturaland cosmetic to ensure compliance with GMP. To ensure compliance with
Good Storage Practice (GSP) among the importers and wholesalers, the
NPCB collaborates with the State Pharmacy Enforcement Branch inconducting GSP inspections. Inspections are also carried out to ensure thatclinical research conducted in Malaysia is in accordance to the Good Clinical
Practice (GCP) and Good Laboratory Practice (GLP) guidelines as well as
applicable legislations. As of 1st January 2008, all cosmetic products are notrequired to undergo the registration and licensing processes but GMP
requirements are still required for all cosmetic product manufacturers. Thus,
the NPCB still continues to carry out GMP inspections for cosmetic
manufacturers according to a pre-determined schedule. The NPCB also
carries out inspections of facilities for the preparation of pharmaceuticals(including public and private hospitals) in an effort to ensure that all products
prepared by hospitals and research institutes are safe for patient use, staff are－76－

safe from dangerous emissions and the environmentisprotected

frommedicine contamination.

The Centre for Quality Control has constantly given support and technicalinput to the Centre for Compliance and Licensing in auditing cosmetic andtherapeutic product manufacturers.

The Centre for Quality Control is responsible for ensuring that the quality of all
registered products marketed in Malaysia are compliant to the specifications
claimed by the manufacturer, and to ensure that products are of quality, safeand effective. The quality control on the pharmaceutical, traditional andcosmetic products registration process are based on protocol evaluation anddata validation and analytical testing. The tests conducted follows in-house or
manufacturer’s approved protocol and specification as well as theinternational pharmacopoeias as reference. The centre is actively involve incollaborative research and proficiency testing scheme organised by ASEAN,
WHO and EDQM to ensure continual competency in testing. The centre alsoestablishes a unit called the Reference Standard Unit which prepares and－77－

provides reference standards to all laboratories in the NPCB as well as topharmaceutical companies and other government agencies.

5) Good Manufacturing Practice (GMP)

The promulgation of the Control of Drugs and Cosmetics Regulation in 1984
provided the foundation for development of a systematic pharmaceuticalregulatory system. To maintain standards and safeguard public well-being,measures were undertaken by the National Pharmaceutical Control Bureau(NPCB) to implement a drug and cosmetic registration and licensing scheme
which covered pharmaceutical manufacturers, importers and wholesalers aswell as clinical trials. NPCB also provided technical assistance to local
pharmaceutical manufacturers to upgrade manufacturing standards to levels
equivalent to the requirements of Good Manufacturing Practice (GMP) as
recommended by the World Health Organisation (WHO) and other relevantorganisations.

－78－

With globalisation and trade liberalisation, efforts were made to ensure thecompetitiveness

of

the

pharmaceuticalindustrythrough

continuous

improvement in standards and quality assurance requirements. Effective from
1st January 2002, Malaysia became the 26th member of the Pharmaceutical
Inspection Cooperation Scheme (PICS), a cooperative arrangement between
international pharmaceutical inspection authorities in the field of GMP. The
acceptance of Malaysia into the PICS paved the way for the local
pharmaceutical products to be recognised internationally. The GMP
guidelines that are currently applied are PIC/S Guidelines on GMP for
Pharmaceuticals, Malaysian Guidelines on GMP for Traditional Medicines and
ASEAN Guidelines on GMP for Cosmetics. Being a member of PIC/S, theQuality

Management

Systemofmanufacturers

and

the

qualityofpharmaceutical products produced must be at par with other member
countries. Manufacturers having a tough time to comply with the highstandards, need to spend much to upgrade their facilities and also need totrain the personals involved.

In order for the products to be registered, all manufacturers must comply with
Good Manufacturing Practice (GMP). Poor understanding of GMP and－79－

registration procedures, communication breakdown, used of undeclared
ingredients i.e. premixes in production and increasing number of adulteration
cases were some of the major problems encountered. Nevertheless, several
initiatives have been taken by the Ministry to assist the local industries.
Regulardialogues,

guidanceandadvice,training

programmes

anddissemination of information have led to fruitful outcomes. Ministry is also
proactively making wide surveillance on the products in the market and would
continue to monitor the situation. Should any product found to contain harmful
substances, there would be an immediate recall of these products from the
shelves.

6)Post Marketing Surveillance System (PMS)The NPCB is responsible on regulatory matters pertaining to registered
medicinal products and notified cosmetics that have been placed on the
Malaysian market. It is conducted through a range of activities such as
surveillance and investigation of product complaints to ensure themaintenance

of

the

appropriate

establishedproduct

standards

andcompliance to requirements as set by the DCA. Post-Marketing Surveillance－80－

(PMS) programme was initiated in 1990. The NPCB is also involved inassessment of product variations and change of manufacturing sites. Thus,
once the products are registered, the quality of the products in the market iscontinuously monitored by NPCB through its PMS programme.

7)Sale and Distribution of Drugs

Drug Advertisement
The Medicine (Advertisement and Sale) Act 1956 provides the basis for thecontrol of advertisements of medicines, appliances, remedies, skill andservices that relate to medical and health claims. The Pharmaceutical
Services Division, Ministry of Health as the custodian of this Act has put into
place an enforcement mechanism that is committed to eradicating illegal
advertisements. A total of 81 cases were investigated under Medicine(Advertisement and Sale) Act 1956 and 160 warning letters were issued in
2005.

8)Additional requirements for biological (vaccines) and antibiotics such as
National Test System (if any)－81－

Vaccines used for public sectors are supplied by Pharmaniaga Berhad withstringent control on cold chain requirements.

5.

PRESENT SITUATION AND FUTURE PLAN

The registration online system, QUEST2, which was introduced since theyear 2002 is currently in the process of upgrading to QUEST3. The new
online system, QUEST3, is scheduled to be ready for implementation inyear end of 2009.

A Technical Working Group (TWG) for biotechnology products has been
established to prepare relevant guidelines for biosimilar products.
Representatives from various agencies such as Ministry of Science,
Technology and Innovation (MOSTI), Malaysian Bio-Industry Organisation,
Malaysian Biotechnology Corporation Sdn Bhd, Pharmaceutical
Association of Malaysia (PhAMA), Malaysian Organisation of
Pharmaceutical Industries (MOPI) attended the meeting at the NPCB. In
line with the government’s mission to further develop areas related to－82－biotechnology products in Malaysia, the skills of officers or evaluators of
the products need to be enhanced. Officers in this area need to undergo acomprehensive training within Malaysia and overseas to develop andimprove their skills in this area.

The NPCB continues to play an active role in the harmonisation efforts
through ASEAN Consultative Committee for Standards and Quality(ACCSQ), Pharmaceutical Product Working Group (PPWG), Traditional
Medicines and Health Supplements Product Working Group (TMHS PWG)
as well as ASEAN Cosmetic Committee (ACC). Other international
involvements include Pharmaceutical Inspection Cooperation Scheme(PIC/S) activities.

The NPCB continue to improve GMP and Good Storage Practice (GSP)
standards of manufacturers, importers as well as wholesalers, to strive
towards implementing GMP requirements on veterinary productmanufacturers and to regulate GMP requirements on the manufacture of
biologic/blood products.

Challenges
NPCB Annual Report 2008－83－

Several training programmes have been conducted since theimplementation of cosmetic notification procedure as of 1st January 2008.
The aim of these programmes was to improve the skills and competencyof regulators and the industry to ensure smooth implementation of thenotification procedure as well as compliance to the ASEAN Cosmetic
Directive requirements.

The Cabinet has approved the use of the Good Laboratory Practice (GLP)of the Organisation for Economic Cooperation and Development (OECD)
in Malaysia and the NPCB was appointed as the GLP Compliance
Monitoring Authority (CMA) for the conduct of clinical trial tests forpharmaceutical products.

As for the future plans, NPCB continues to strive towards excellence in theregulatory area by maintaining a high standard in the regulatory practice.
In tandem with the rapid growth of the pharmaceutical industry, NPCB
needs to keep abreast in terms of capacity and capability building so as tostay relevant. Strategies have been identified to further improve services in
NPCB. Among the strategies identified are developing human resource－84－and maintaining staff and expertise, emphasizing on Information
Technology (IT) culture within the organisation, additional emphasis on
training programme, overall development plan for Quality Management
System (QMS) and reinforcing cooperation with other regulatory agencies.
The current system of QUEST2 will be upgraded to QUEST3 in which it
will be in operation by year end 2009. The QUEST3 system is to facilitate
the implementation of online registration for New Chemical Entities (NCE)and Biotechnology products. In addition, the QUEST3 system will facilitate
the integration of different online modules involving product registration,
licensing of premises, analytical testing, surveillance, Adverse Drug
Reaction (ADR) monitoring and dissemination of information.

Efforts are also taken to enhance the Quality Management System (QMS)of the NPCB and to reinforce compliance to the Pharmaceutical Inspection
Cooperation Scheme (PIC/S). In terms of compliance of products to Good
Manufacturing Practice (GMP), the NPCB will improve the processing ofRegistered Product Additional Lists and GMP certificate, introduce theGood Distribution Practice (GDP) guideline to replace the Good Storage
Practice (GSP) guideline, provide training regarding the system of－85－documentation and records to natural product manufacturers, inspect stem
cell based product processing facilities, ensure compliance of clinicalresearch centres to Good Clinical Practice (GCP) as well as ensurelaboratories comply to Good Laboratory Practice (GLP).
i overseas training for our staff.
The NPCB, after attaining the MS ISO 9001:2000 certification, will continue
its efforts towards obtaining MS ISO/IEC 17025:2005 accreditation for heavy
metal tests and microbial contamination for natural products. Efforts are also
intensified in Research & Development (R & D) of i) Lovastatin in herbal
medicines, ii) Development of reference materials for the adulterants and toiii) Perform complete validation on the analytical methods of cadmium
testing in natural products which are determined by graphite furnace atomic
absorption spectrophotometry technique.
In years to come, the NPCB will continuously strive to improve ties and cooperation
National Medicines Policy
The Malaysian National Medicines Policy (MNMP) presents the framework ofstrategies and commitments of the government and all stakeholders in bothpublic and private sectors to a common medium and long term goals for thenational pharmaceutical sector. It comprises of four main components namely,－86－Quality. Safety and Efficacy of Medicines, Availability of Medicine, Affordability of
Medicines and Quality Use of Medicines. Four other supporting components are
Human Resource Development, Research and Development, Technical Cooperation and Management of the National Medicines Policy.

In 2008, the monitoring of MNMP indicators was implemented on 29 backgrounds,
39 structural and 18 process indicators. Background indicators are intended toprovide data on demography, economy, health and pharmaceutical status while
structural indicators provide qualitative information assess the pharmaceuticalsystem’s capacity to achieve the policy objectives. Process indicators impartquantitative information on the processes by which the policy is implemented,
and outcome indicators measure the result achieved and the change that can be
attributed to the implementation of the National Medicines Policy.

－87－

6.

DRUG

SUPPLYSYSTEM

AND

DRUG

PRICE

MECHANISM

INCLUDING LOCAL PRODUCTS, IMPORTED AND EXPORTED DRUGSDrug Distribution System
Pharmaniaga Berhad, a private company, is currently responsible indistributing the medicines to hospitals and health centres.

Drug Supply System
Private company, Pharmaniaga Berhad currently responsible in distributing the
medicines to hospitals and health centres.

Drug Advertisement
The Medicine (Advertisement and Sale) Act 1956 provides the basis for thecontrol of advertisements of medicines, appliances, remedies, skill andservices that relate to medical and health claims. The Pharmaceutical
Services Division, Ministry of Health as the custodian of this Act has put into
place an enforcement mechanism that is committed to eradicating illegal
advertisements. A total of 81 cases were investigated under Medicine－88－

(Advertisement and Sale) Act 1956 and 160 warning letters were issued in
2005.

Drug Price Mechanism
The expensive drug price is one of the problems faced by people to get their
medication but drug price regulation does not exist in Malaysia. The
Government of Malaysia has no control over the prices of medicines. Under
the present practice, market forces are expected to stabilize drug prices. In
Malaysia, medicines are available from many outlets such as private clinics,
hospitals, retail pharmacies and supermarkets (for OTC products only) but
however patient treated in government hospitals will get the medicines almost
free of charge. Ministry of Health Malaysia has set-up a Price Monitoring Unit
(PMU) under the Pharmaceutical Services Division to carry out continuous
price monitoring activity for trending purposes guided by the WHO Consultant.

National Essential Drug List
The National Essential Drugs List was formulated by using the Ministry of
Health’s (MOH) Drugs List as a basis. The MOH Drugs List which wasintroduced in 1983 serves as the essential drugs list for the public healthcare－89－sector. Every drug in this list is classified according to the category of medical
officer or healthcare provider allowed to prescribe it. This list is dynamic and isreviewed every 4 months by a panel consisting of specialists from the main
disciplines and pharmacists.

The Committee for Creating the National Essential Drugs List has decided
that the List shall consist of two parts. The first part called the Essential Drugs
List contains all preparations needed for primary and secondary healthcare
treatment commonly used by Medical Officers and paramedics in primary
healthcare facilities. Several preparations used in tertiary care are included inorder to be consistent with WHO’s Model Essential Drugs List. This partcontains 358 chemical entities and 605 preparations. The second part called
the Supplementary List consists of drugs used by specialists for tertiary level
treatment. This part contains 257 chemical entities and 391 preparations.

－90－

7. PHARMACOPOEIA

Quality control activity is an important element in the evaluation ofpharmaceutical, traditional and cosmetic products. The products tested
include products for registration, post-marketing surveillance of registeredproducts, complaints on registered products and products from enforcement
activities. The tests conducted are based on pharmacopoeias mainly British
Pharmacopoeia (BP) and United States Pharmacopoeia (USP), in-house or
manufacturers’ approved protocols of analysis and specifications.

8.

REFERENCES :1)

Malaysia – Wikipedia, the free encyclopedia

http://en.wikipedia.org/wiki/Malaysia

2)

Department of Statistics, Malaysia

http://www.statistics.gov.my

3)

Ministry of Health Malaysia

http://www.moh.gov.my

5)

Pharmaceutical Services Division, Ministry of Health Malaysia－91－http://www.pharmacy.gov.my

6)

National Pharmaceutical Control Bureau, Ministry of Health Malaysia

http://www.bpfk.gov.my

7)

Security hologram labeling for medicines; Su Siew Ling – Tay &Partners , http://www.asianlegalonline.com/asia/detail_article

8)

Affordability of medicines in Malaysia – Consumer perceptions; Zaheer
Uddin Baba and Mizham M. Ibrahim, 2003.

http://mednet2.who.int/edmonitor/33/EDM33_18-19_Affordability_e.pdf.

－92－

The Study Programme
for the Pharmaceutical Affairs Experts

Papua New Guinea

－93－

－94－

PAPUA NEW GUINEA (PNG) - COUNTRY REPORT

Compiled by: Ms Nancy Swanjo Waffi ; Acting Pharmacist – Drug Registration andLicensing; Medical Supplies Branch, National Department of Health - PNG.

Suggested Guidelines for Country Report

The Study Programme for Pharmaceutical Affairs Experts -2009.

1. Country Profile/ Introduction of Papua New Guinea.
(Includes geographical and political features, and general information suchas language, system of school education, GNP and political system).

With a total landmass of approximately 465,000 km2, Papua New Guinea (PNG) is by far
the largest and most populated of all the Pacific Island Countries (PIC). Topographically,－95－

it is one of the most rugged and diverse countries in the world, with an extraordinary
range of ecosystems.

PNG has vast natural resources, especially mineral, forest and marine resources and it ishome to many rare and endangered species of animals and plants.

PNG’s governance system is a parliamentary democracy based on the Westminster model.
As a member of the Commonwealth, the head of the Independent State of PNG is the
Queen of England, represented by the Governor General who is elected by the National
Parliament for a five-year term.

The current single chamber parliament has 109 members comprising of one
representative from each of the nineteen provinces and the National Capital District, andone representative from each of the 89 open constituencies. Every five years the politicalleaders are elected at the two tiers of government: national and local level government(LLG). Presently, there is only one women representative in the National Parliament.

PNG has a decentralized system of government. At the sub-national level, there are threelevels of administration viz. at the province, district and LLG level.

PNG is a country with an extremely diverse sociocultural profile. More than 800 distinct
languages are spoken, which is a serious impediment for development. In recent times,－96－

development pressures and globalization have had an impact on the social life andtraditional culture of Papua New Guineans.

The current system of education in PNG is a top up system whereby children are enrolled
into elementary schools at the age of 5years and enter primary school at the age of 8.At
the primary level, the children do grades one to eight (1-8) and than move on to thesecondary school to do grades nine to twelve (9-12). After grade 12, the students thanmove on to the tertiary institutions (colleges and universities) after which they are
graduated once excelled than employed.

Ninety Six percent (96 %) of PNG’s population are Christians. The other 4 % are fromthe other religions or religious groups.

2. Statistical Data (Please fill in with the latest data).

1. Population.
The national census usually takes place every 10 years in Papua New Guinea.
According to the country’s National Statistics Office, the last census was taken in
the year 2000 and the next one will be next year (2010). The figures below are
therefore current until next year when a new count on the population is taken.

－97－

Indicator

Year

Data

Area (in 1000sq.km)

2005 estimated462.84 (in 1000sq.km)

Estimated population2005 estimated

5,950.69 million (5,950,690)

Annual population growth

2000

2.7%

Percentage of population-

Less than 15 years old

2004 estimated41.68% (248.25 million)-

Over 65 years old

2004 estimated2.54 % (151.15 million)

Urban population

2003

13.20 % (785.5 million)

Rate of natural increase of population

2000

2.3%

2) Vital Statistics

Indicator

Year

Data

Live birth rate (per 1000 population)

2000

35 %

Death rate (per 1000 population)

2000

12.00 %

Infant death rate (per 1000 live births)

2000

64.00 %a) Rate of vital statistics:b) Five main disease causing morbidity

No. of cases per 100,000 ( allThe data below is only for the year 2004.

ages, male and female)

Currently, no data is available for theyears 2002, 2006 and 2008.

－98－i) Malaria

2004

27, 376ii) Pneumonia

2004

27, 369iii) Other Intestinal Infectious disease 2004

6, 8292004

6, 0852004

6, 008i) Normal deliveries (incl. BBA)

2004

49,461ii) Pneumonia

2004

27,369iii) Other types of Malaria

2004

14,799iv) Cerebral malaria

2004

12,577v) Certain conditions originating in the

2004

8,282

i) Male2000

53.70 yearsii) Female

2000

54.80 yearsiii) Total

2000

54.2

iv) Disease of other parts of thedigestive systemv) Tuberculosisc) Five leading causes of death

perinatal periodd) Life expectancy (from birth; years)

－99－

years

3. Medical care policy

Indicator

Data

Year

Year

Data

2008

23 (includes 20 provinciala) Estimated number of patients who
received medical treatment on
specific date ( not yearly total)i)

Government Hospitalii)

Public Hospitaliii)

Private Hospitaliv)

OthersCurrently, no data is available in relation
to the number of patients who receive
medical treatments at different hospitalsettings as above.
b) Number of hospitals by establishingorganizationi) Government hospital

hospitals and 3 district
hospitals)ii) Public hospital2008

26 (includes 23 government
hospitals, 2 mission
hospitals and 1otherhospital.

－100－iii) Private hospital2008

4 ( all located in Port
Moresby)iv) Others– Health centers

2008

196 ( Govt = 142, Mission= 47. Joint G+M = 5,
Others = 2)-

Health sub centres

2008

436 ( Govt = 153, Mission= 276, others = 7)

2008v) Clinics

72 ( Govt = 43, Mission =14, Others 15c) Number of health manpower
The figures below for number of healthmanpower are current estimated figures
for year 2009.
i) Physicians

20093182 (registered)ii) Dentists

2009

311 (registered)iii) Auxiliary medical personnel-

Medical technologists

2009

331 (registered)-

X-ray technician

2009

124 (registered)-

Registered Nurses (RN)

2009

9, 856 (registered)-Community Health Nurses

2009

19

(CN)

－101－

-

Primary Health Nurses (PHN)d) Number of pharmacist

2009

-

2009

145 (registered, nationals =53 whiles expatriates = 92)e) Number of drug manufacturers/plants

2009

0

f) Number of traditional medicine

2009

0

g) Number of drug importers

2009

37 (registered)h) Number of drug wholesalers2009

30 (registered)manufacturers/plants

Note:a) The total number of Pharmacists registered in 2009 is 145. Of these, only 33 arenationals while the rest (92) are Foreign Pharmacist.
b) Papua New Guinea does not produce/ manufacture drugs and other medicinal products
because there are no manufacturing plants in the country. There are also no traditional
medicine manufacturing plants in the country.

4. Pharmaceutical affairs administration in PNG

1) Administrative organizational chart showing PNG’s pharmaceutical administration at
national and local level (covering licensing, registration, quality control, production sale,
import/export of drugs; and same for biologies and antibiotics)－102－

* The Current Organizational Chart of Medical Standard Branch.

**P’cist:
Pharmacist

Ministry of Health(Minister)

National Department of Health(Secretary)

D/Secretary(National Health standards
Division)

EMS 001 (19)
Executive Manager
Medical Standards
EMS 003 (12)Executive Officer

EMS 002 (10)Personal Assistant

MMS 001 (17)Director Medical
Supplies Standards

MMS 002 (06)Administration
Assistant

MMS 004 (13)TA Pharmaco
Vigil

MMS 003 (15)

MMS 009 (15)PA
Post Regist Prod

PA
Compl & Lic
Officer

MMS 010 (13)TA Reg Pharm InspIR

MMS 005 (12)

MMS 011 (12)TO Drug Information

TO Reg Pharm InspSR

MMS 006 (12)TO Variation

MMS 016 (13)TA Pharm Chem Sc

MMS 017 (09)
AMS Lab Tech

TO Reg Pharm Insp
MR Officer

MMS 013 (12)

MMS 018 (12)TO Quality Stds
GMP GLPTO Pharm Narcotics
Psychotro Subs

PA
Supplies ProdRego

MMS 020 (13)TA Drug Eval Gen
Medicine

MMS 024 (12)TO AMS Compl& Cosm

MMS 021 (13)

MMS 025 (12)TA Drug Eval Gen Medicine

TO AMS Biotech

MMS 022 (13)TA Drug Eval Gen
Medicine

MMS 026 (12)TO AMS Med
Device

MMS 023 (13)

MMS 014 (12)
MMS 004 (13)

MMS 003 (15)

MMS 015 (15)PA
Supplies Quality
Control

MMS 012 (12)

MMS 007 (12)TO Supplies Regu Prod

EMS 004 (06)Driver/ Admin Assistant

TA Drug Eval Gen Medicine

AMS Registrar

TO Promotion & Adv

1) The role of national/ state and local pharmaceutical administrative organizations.

Medical Supplies Branch is responsible for the Procurement, Storage andDistribution of pharmaceuticals, medical supplies and equipments for all healthfacilities in Papua New Guinea.
It is also responsible for the preparation and implementation of legislation
controlling Medicines & Cosmetics Act & Regulation, Poisons and Dangerous
Substances Act and Dangerous Drugs Act; and liaison with international agencies
with respect to matters, which are the responsibilities of Medical Supplies.

－103－2) List of laws/regulation governing the pharmaceutical affairs

The pharmaceutical affairs in Papua New Guinea is governed by a list of laws andregulations (National Drug Policy, Medicine and Cosmetic Act 1999 and it’sregulation 2002).
The National Drug Policy is a guiding document for legislative reforms, staff
development and management improvements used to help control and regulate and theavailability, quality, safety and rational use of drugs in order to improve health of thepeople of Papua New Guinea.
The Medicine and Cosmetic Act 1999 is the governing laws of pharmaceutical affairs
in PNG while the Regulation emphasizes on the enforcement of the act in detail.

Medical Supplies Branch in consultation with the Licensing Authority approves drugs
and medical supplies to be imported for both Government Health Facilities and Private
Importers and Wholesalers of Pharmaceuticals in Papua New Guinea. Papua New Guinea
does not have manufacturing plants or factories therefore all pharmaceuticals and medical
supplies are imported from other countries. Under the provision of the Medicines andCosmetics Act 1999 (Section 9 (1) (a)), the Licensing Authority can authorize or approvedrugs to be manufactured in a particular premise if PNG has manufacturing plants in the
future.
The Medical Supplies Branch under the provision of the Medicines and Cosmetics Act
1999

also

regulates

Pharmacists

andPharmacy－104－

Technicians,

Pharmaceutical

Establishments’ such as: Hospital Pharmacies, Community Pharmacies, Pharmaceutical
Importers and Wholesalers, Pharmaceutical Exporters etc. in Papua New Guinea.
It is also responsible for regulating pharmaceuticals (medicines), cosmetics, devices etc.
in the country. The drugs or medicines are categorized into: Prescription Only, Pharmacy
Only and Over the Counter (OTC) medicines. It is also responsible for regulating
cosmetics and even counterfeit drugs in the country.
The Medical Supplies Branch does not directly control and regulate ‘Traditional
Medicines’ in the country and currently there is also no legislation in place governing
Traditional Medicines in the country. However, a Policy on Traditional Medicine in
PNG has been drafted, approved and printed.

Pharmaceutical Inspection and Guidance.

-

Pharmacy Board of Papua New Guinea0j have appointed inspectors who inspects
pharmacy outlets, pharmaceutical importers & wholesalers, exporters etc. to ensure
they comply with GMP and the PNG Medicines and Cosmetics Act 1999 and its
Regulation of 2002.

-

In Papua New Guinea there are no drug manufacturing plants and therefore no
GMP inspection is carried out. However, there is a Checklist for the inspection ofpremises intended to be used for pharmacy, import and wholesale, export etc.
Companies normally apply for the license to operate for: Pharmacy, Import &Wholesale, and Export License etc. These checklists are used to evaluate the－105－premises intended for the above activities. If they meet all the standard
requirements they are granted the above licenses.

-

In addition, when Tender of Pharmaceuticals and medical supplies are evaluatedfor procurement, suppliers are asked to submit their GMP documents and othernecessary documents from their manufacturers. Pharmacists use these documents
to qualify or disqualify a supplier or manufacturer when they bid in tenders.

vi) Classification of Pharmaceuticals and Medicinal Products.

For example in Japan, pharmaceuticals and medicinal products are classified into
three categories; medicines for ethical use, over –the –counter (OTC) drugs, andquasi-drugs. Almost all ethical medicines are listed on the National Health
Insurance (NHI) price list, and are reimbursed by the NHI system.
OTC drugs are not reimbursed by the medical insurance systems. OTC drugs aredefined as medicines that have a mild action and a high degree of safety if usedcorrectly. They can be purchased directly from pharmacies or other type of
licensed drugstores or outlets and used by consumers at their own discretion. OTC
drugs are further roughly divided into OTC drugs and “HAICHI HANBAI” drugs(Medicines distributed directly to households). They are governed by the
Pharmaceutical Affairs Law.

－106－

Most preparations of vitamins and minerals are classified as OTCs, Quasi-drugs
or foodstuffs like dietary supplements and functional food products such as
FOSHU (foods for specific health use) are governed by the Food Sanitation Law.

In Papua New Guinea, pharmaceuticals and medicinal products are classified into
three categories: Prescription Only, Pharmacy Only and Over-the- Counter (OTC)
medicines. Prescription Only Medicines are medicinal products that can only bedispensed or supplied by a pharmacist on a prescription given by a medical
practitioner, dentist or veterinary surgeon; Pharmacy Only Medicines are medicinal
products that can be sold or supplied without prescription issued by a medical
practitioner, dentist or a veterinary surgeon, but under the supervision of apharmacist; and Over-the-Counter Medicines are medicinal products that cangenerally be sold over the counter without the supervision of a pharmacist.

vii) Licensing system of factory and registration system of drug
Papua New Guinea does not manufacture drugs or any pharmaceuticals because there isno manufacturing plants or factories in the country. For this reason, there is no licensing
system for factories in the country.
However, the National Department of Health has started drug registration in 2006 and has
initially started with the registration of Antibiotics. Here, interested applicants for drug
registration usually obtain application forms for drug registration from the medical
supplies office, fill in the applications, than submit their technical documents and samples
for product registration. The applications are than screened and accepted only when all－107－the requirements are met. Next, the technical documents (dossiers) are evaluated firstinternally by the internal drug registration committee comprising of allthe nine (9)pharmacist within the medical supplies branch. Onced passed by the internal drug
registration committee, the dossiers than move on to be evaluated by the external
committee. This external committee is made up of doctors who are experts in the medical
and pharmaceutical fields both within the department of health as well as the school of
medicine and health sciences. Once the technical documentations as well as samples areevaluated and seen that all the requirements are met, the products are than endorsed forregistration and issuance of license by the pharmacy board..
So far the department has already received 593 antibiotics for registration from different
pharmaceutical manufacturer/suppliers. From these, only 37 antibiotics have fully met all
the requirements for registration and have been registered. The other therapeutic
categories of drugs and cosmetics are yet to be registered. Currently there areapproximately 15,000 medicinal products circulating in the country.

4) Pharmaceutical inspection including quality control check system

5) Good Manufacturing Practice (GMP)In Papua New Guinea there are no manufacturing plants for pharmaceuticals, instruments,
equipments etc. Because of that GMP is not practiced in the country, especially for drugs.
PNG only import drugs and medical supplies from other drug manufacturing countries
such as India, Malaysia, China etc. for its consumption. Maybe in the future when the－108－country has enough expertise, technologies and capital then the country can start thinkingof establishing its drug manufacturing plants or factories. This is when GMP can bepracticed.

6) Post Marketing Surveillance system (PMS)
As stated above, there is no Pharmaceutical Plants in Papua New Guinea therefore no
manufacturing of drugs and no post marketing surveillance is done in PNG.
However, one Post Marketing Surveillance was recently done in PNG on ARCO
(artemisinine 125mg + naphthoquine 50mg) tablets manufactured by Kunming
Pharmaceuticals of China. ARCO was tested for its safety and efficacy, ADR etc. byProfessor Francis Hombanje of the Divine Word University (PNG).
As already mentioned above Papua New Guinea does not manufacture drugs or any
pharmaceuticals because there is no manufacturing plants or factories in the country.
PNG only import from other drug manufacturing countries such as India, Malaysia,
China etc. for its consumption7) Sale and Distribution of drugs (ethical and OTC)

8) Additional requirements for biological (vaccines) and antibiotics such as national test
system (if any)

5. Present situation and future plan (ex. National plan, introduction of GMP concept, etc.)
in the national drug policy including essential drugs and traditional medicine.

－109－

A. History of the Traditional (Herbal) Medicines in Papua New Guinea (PNG).

Traditional Medicine includes medicaments prepared from plants, animals and minerals.
Traditional Medicine is the total combination of knowledge and practice, whether
explicable or not, used in diagnosing, preventing or eliminating a physical, mental orsocial disease and is based mainly on past experience and observations handed downfrom generation to generation, either verbally or in writing (WHO definition).

Traditional (Herbal) Medicines existed even before ‘Modern Medicine’ was introduced in
PNG. That is, our ancestors have been practicing or using traditional medicines even
before modern medicine was introduced. PNG has a lot of traditional medicinal plants,
which was used by our ancestors, and some are still being used today in our rural villages
and even urban areas. Currently there is no proper record of traditional medicines and thedates our ancestors invented and began using them.

Traditional or Herbal Medicine forms an important and integral part of medicinalpractices in PNG. However, there is little recognition of and documentation on thecommonalities, identities and uses of these plants. The national health services would
benefit if this field of medicine was further explored and incorporated into the formal
health care system.

－110－Traditional medicine also includes non-medical practices, such as bone setting,spiritualism, incantations, divinations, mental therapy and baths. However, witchcraft,
sorcery or related dangerous practices must not be recognized as part of traditional
medicine and not incorporated into the formal health care system.

Traditional Medicine in PNG is non-codified i.e. there is no formal recognition or written
text; sources of information are inaccessible and scattered; they are utilized by bothVillagers and Urban dwellers. Therefore, the National Health Plan recognized thattraditional healers have a role to play in the delivery of health care in PNG.

A Policy on Traditional Medicine in PNG has been drafted and is currently in the processof being printed.

B. History of the National Plan on Pharmaceutical Services in PNG.

The PNG Department of Health has for many years provided a comprehensive low cost
medical service to the people of the country, particularly those in the rural area. By low
cost we mean that at the time of the service the recipient pays very little, if anything, forconsultation and treatment. The health system including the cost of administration, staff
and medical supplies is funded under the annual budget from consolidated revenue.
The Medical Supply Branch of the National Department of Health was established afterWorld War II to provide a comprehensive medical supply service to the entire country. In－111－

its very early years, medical supply service based its operation on a catalogue derived
from military. Through time, the catalogue grew to include a comprehensive range ofgeneric drugs, most of which these days would be called “Essential Drugs”. PNG
Department of Health is pioneer in this field as well as other areas such as Treatment
Guidelines.

As early as the 1960’s, Medical Supply Branch was purchasing generic drugs on theinternational market, which is common place now, but revolution then. This activity
elicits considerable comment from the multinational drug companies strongly opposed tothe idea, and international agencies who watched the development with interest. It cameto be generally regarded that PNG has, in principle, one of the most cost effective, andefficient, medical procurement and distribution system in the world.
It should be noted that not only does Medical Supply Branch now handles drugs, but also
vaccines, dressings, hospital furniture and equipment, pathology and laboratory requisites,
x-ray equipment and consumable and dental requirements.

However, with the growth of urbanization most of the business in the private practitioners
and pharmacies now comes from Papua New Guinea nationals, not expatriate.
The demands and expectations of the general population on the health system haveincreased. The

populationisbettereducated, which

increases

expectations.

Communications and roads have improved. Demands for health services have therefore
increased because people have a greater awareness of the impact of health care, and theinfrastructure allows easier access. Together with these factors, the population has been－112－

increasing very rapidly since independence in September 1975, outstripping budgetary
growth, adding more pressure.

There are other pressures on the health system. After independence, there was an exodusof health professionals and administrative standards. There were too few qualified people
in Papua New Guinea to take over, and those could often receive poor handovers, andlittle experience in these position.

Political and social changes after independence were almost far reaching, and included
such dramatic events as almost complete and rapid decentralization of the health system,
which went hand in hand with formation of provinces had control of their own
Department of Health, with the National Department providing consultancy and advisory
services. Fortunately, the medical supply remained under the National Department of
Health which supplies were held in check. Economies of scale were maintained, even if
the administrative functions suffered.

In recent times, political events have served to further undermine the operation of
Medical Supplies Services, attracting bad publicity and calls for reform. Frequentchanges of Government, financial constraints and staff shortages are the main
contributing factors.

It is, then fair to say that factors outside the control of Medical Supply Branch haveseverely impacted upon the ability of the Service to fulfill its chapter.

－113－

6. Drug supply system and drug price mechanism including local products, imported andexported drugs

Drug Distribution System.

-

All drugs and medical supplies are procured from other countries such as China,
India, Thailand, Malaysia etc. When the supplies arrive, they are stored in the
Government’s six (6) Area Medical Stores and then they are distributed to hospitals
and health centres in the country. Medical supplies are also delivered to theProvincial Transit Stores and then they are further distributed to their healthfacilities. The Health Department has engaged a freighting company to distribute
drugs and medical supplies on a timely manner to hospitals and health centres in
Papua New Guinea to avoid shortage of drugs and medical supplies.

Drug Price Mechanism.

- All drugs are imported from other countries. PNG has a free market and Government
does not control price of drugs.

－114－

7. Pharmacopoeia- Does your country have its own pharmacopoeia?
- If not, what kind of pharmacopoeia do you refer to as an official pharmacopoeia?
-

Papua New Guinea does not have a Pharmacopoeia of its own. PNG uses the
British Pharmacopoeia (BP), British Pharmaceutical Codex (BPC), Martindale etc.
for reference purposes only.

8. List of reference
List report, materials and publications that were quoted or used as references in theinformation of this country report. This list of reports/materials/publications should
include titles, writers, years published, publishers, and places of publication.

5. Essential Drug List.

-

Papua New Guinea has the Medical and Dental Catalogue as the country’s
Essential Drug List. All items listed in the Medical and Dental Catalogue arepurchased or procured by the National Department of Health for all Government
and Mission Hospitals, Health Centres and Aid Posts in the country.

-

The Medical and Dental Catalogue (MDC) contains approximately 2, 654 items.
The MDC is divided into the following sections:－115－

Section 1- Drugs and Medicinal Preparations: 420 items
Section 2- Dangerous Drugs: 12 items
Section 3- Serological Products: 40 items
Section 4- Dressings: 42 items
Section 5- Hospital Sundries: 490 items
Section 6- X-Ray Supplies and Equipments: 61 items
Section 7- Laboratory Supplies and Equipment: 569 items
Section 8- Minor Instruments and Equipments: 321 items
Section 9- Dental Items: 699 items.

6. Difficulties and constrains in Manufacturing Control of Essential Drugs (e.g.
GMP, etc.) that you have been facing these days and clear directions in the future.

7. Current situation concerning Counterfeit and Substandard Drugs and its
Countermeasures.

Currently Papua New Guinea does not have a big problem with counterfeit andsubstandard drugs and no counterfeit or substandard drugs have been detected yet.
However, some antimalarial drugs were reported to be counterfeit or substandard sosamples of all antimalarial drugs used in the country were collected from selected Area
Medical Stores, hospitals and health centres in the country. These samples were sent to－116－

Therapeutic Goods Administration (TGA) in Australia and we are still waiting for the
results.

8. Overview of relationship with Overseas Assistance Organization.

The relationship with Overseas Assistance Organizations such as JICA, JICWELS, WHO
etc. have helped greatly in many areas such as; human resource development, provisionof equipments, provision of experts and volunteers, provision of aid, grants etc. This has
also helped greatly in the financial, economic, social, health and human resource
development of Papua New Guinea and other developing countries.

9. Overview of Technical Assistance Programmes in the fields of Pharmaceuticals,
GMP, Quality Control organized by International Organizations, NGOs etc.
including details of programmes; Programme Name/ Duration/ Organizer/ Aims/
Outline.

WHO, JICA and other International Organizations have been sponsoring and organizing
workshops and training programmes in the fields of Pharmaceuticals, GMP, Quality
Control etc. for developing countries and this has greatly improved their human resource－117－

development. For example, in October 2006, I attended a training workshop organized by
WHO in Manila, Philippines. The workshop was on Consultation on Financing ofEssential Medicines. The workshop was organized by WHO Regional Office for theWestern Pacific Region. The workshop was held from the 4th – 6th October 2006. My
other colleagues also have attended similar workshops on Pharmaceuticals, Rational
Drug Use, Quality Control etc., which were organized by WHO and other International
Organizations. Some of the Training Programs or Workshops they attended were:i) Training Program on Counterfeit Medicine Control and Law Enforcement.
Organized by: Therapeutic Goods Administration (TGA) in Australia.
Duration of training: 17th – 28th October 2005.

ii) Workshop on Implementation of the Regional Strategy for improving access toEssential Medicine in the Western Pacific Region held in Manila- Philippines.
Organized by: World Health Organization (WHO) Regional Office in Manila.
Duration of Workshop: 17th – 19th November 2004.

iii) Pacific Regional Workshop on Intellectual Property and access to medicines.
“Appropriate National Responses”. Held in Nadi, Fiji.
Organized by: Third World Network in Malaysia, WHO, UNDP and Commonwealth
Secretariat.
Duration of Workshop: 19th – 21st June 2006.

－118－

10. REFERENCES

1. PNG National Department of Health- Monitoring, Research and Evaluation
Branch.

2. World Health Organization.

3. Nursing Council of Papua New Guinea.

4. Medical Board of Papua New Guinea.

5. University of Papua New Guinea- School of Medicine and Health Sciences.

6. PNG National Department of Health- Medical Supplies Branch.

－119－

－120－

The Study Programme
for the Pharmaceutical Affairs Experts

Philippines－121－

－122－

COUNTRY REPORTSTUDY PROGRAMMEFORPHARMACEUTICAL AFFAIRS EXPERTSSUBMITTED:SHARON ROSE P. GARCIA, MSc
Food Drug Regulation Officer III

DEPARTMENT OF HEALTH
Center for Health Development - Zamboanga Peninsula
Upper Calarian, Zamboanga CityPHILIPPINES－123－

THE PHILIPPINES
1. Geographical and political featuresI
The Philippines is a tropical country of 7,100 islands lying in the Pacific Ocean off thecoast of Southeast Asia. The islands have a total land area of 300,000 square kilometers. The
two largest islands are Luzon in the north and Mindanao in the south. Between these islands
lies a group of small to medium-sized islands called the Visayas. Manila is the capital city.
Metropolitan Manila, which is made up of 12 cities and five municipalities, is the biggest urban
center in the country.
The country is mountainous with narrow strips of lowland along the coast and somebroad inland plains. Tropical forests used to cover most of the Philippines, but very large
areas are now devoid of forest leading to soil erosion and flash floods. The country has anextensive coastline and many fine bays and harbors. A wide variety of tropical plants andanimals can be found in its mountains, rivers and lakes and along its coastal areas. Except
for a few plants, the medicinal values of this flora remain to be fully tapped.
Philippines, due to its population as of 2004 of 82,636,689, make one of the world’s mostpopulous countries. The population density is 249 people per square kilometer, but this isunevenly distributed throughout the islands.
The Philippines is the only predominantly Christian country in Asia. The majority ofFilipinos are Roman Catholics. There are at least 110 ethno linguistic groups. The
indigenous peoples account for about 18 percent (13 million) of the population. Most
Filipinos are bilingual, speaking both English and Filipino or any of the other local
languages. The presence of a well-established educational system accounts for the highfunctional literacy rate of 83.3 percent. In urban areas, where the people have easieraccess to educational facilities, including mass media, the functional literacy rate ishigher compared to in rural areas.
Although the functional literacy rate is high, folk beliefs, misconceptions and practices
detrimental to health are still rampant. Socio-cultural barriers to health are prevalent andmore apparent in indigenous communities.
The family is the basic unit of the Filipino society. It is usual to find extended families
where the members include not just the husband, wife and their children but also
grandparents, parents, siblings and other relatives. Families are close knit, strongly
influenced by tradition and have a sense of loyalty to family and the community. Special
events like the births of a certain child and deaths as well and religious affairs like fiestas
bring families together. The family support systems are very strong, especially in times ofneed.
Under the Constitution, the Philippines are a democratic and republican state with threebranches of government (executive, legislative and judicial). The executive power isvested in the President who is elected directly by the people. The President is also thehead of the state and commander-in-chief of the armed forces. The Cabinet members
assist the President in executing laws, policies and programs of the government.

－124－

The local government units (LGUs) comprise the political subdivision of the Philippines.
These are made up of 78 provinces headed by governors, 82 cities and 1,525
municipalities headed by mayors and 41,939 barangays or villages headed by barangay
chairmen. LGUs are granted local autonomy under the Constitution. Legislative power inthese LGUs is vested in their respective local councils. The country is also divided into
16 administrative regions. One is the Autonomous Region for Muslim Mindanao(ARMM) headed by a governor. In other regions, offices of national agencies are under
the respective regional directors. The Bureau of Food and Drugs in Alabang, Muntinlupa,
represents the main office where overall management, direction, supervision, and control
over the Bureau stands. On the other hand, the regional offices also have BFAD section
headed by the regional health directors. Although all the licenses underwent final
evaluation in terms of documentary requirements still it has to be indorsed by the regional
health directors.
The economy traditionally depends on agriculture, forestry, mining and fishing. One of thethrusts of the administration is to strengthen agricultural production to attain food security.
This will positively affect the health and nutrition of the Filipinos.
The economic growth is partly due to the deployment in other countries of Filipino
workers. This sector, the overseas Filipino workers, has greatly helped the Philippine
economy. Their health as well as that of their families needs to be addressed. The leading
imports include machinery, equipment, petroleum, chemicals and raw and semiprocessed materials. The major trading partners of the Philippines are United States,
Japan, the European community and the ASEAN neighbors. The country still depends onimported health care products like drugs, vaccines, equipment and medical supplies.

DEPARTMENT OF HEALTH
REPUBLIC OF THE PHILIPPINES
Vision: The leader of health for all in the Philippines.
Mission: Guarantee equitable, sustainable and quality health for all Filipinos, especially the poor, and to leadthe quest for excellence in health.

The Bureau of Food and Drugs
VISION: The Bureau of Food and Drugs is an internationally recognized center of regulatory
excellence safeguarding the health of Filipinos. .
MISSION: To protect public health and ensure the safety, efficacy, purity, and quality of all the
products it regulates through the effective and efficient implementation of national policies
consistent with international best practices.

－125－

HISTORICAL BACKGROUND
The origin of the Food and Drug Administration ((FDA), Now the Bureau of Food andDrugs (BFAD) can be traced to the year 1947, the following year after the Philippine
Independence.
By virtue of Executive Order No. 94 s. 1974, the Drug Inspection Division and theDivision of Laboratories of the Department of Health (DOH) were created.
The division of Laboratories was later transformed into an Office of Public HealthResearch Laboratories (PHRL) by virtue of Executive Order No. 392 s. 1950.
PHRL was composed of various divisions dealing with national disease problems likemalaria, venereal diseases and schistosomiasis and Central (manila) and Regional Health
Laboratories for food and Drug, water and soft drinks.
In 1958, after a series of reorganization, PHRL was abolished and its place was created the
Bureau of Food and Drug Testing.
In 1961-1962, in the light of the tremendous progress in the food and pharmaceuticalindustry, the late Department of Health (DOH) Secretary Francisco Duque, Sr. created a
Subcommittee on Food and Drugs to initiate an administration bill to Congress to enact a lawthat would ensure the safety, purity and quality of foods, drugs and cosmetics being madeavailable to the public. The Subcommittee was chaired by the then Undersecretary for special
Health Services, Dr Rodolfo Canos. Thus, on June 22, 1963, Republic Act No. 3720 was
passed into law known as the “food, Drug and Cosmetic Act.” To carry out the provision of
R.A. 3720, the food and Drug Administration (FDA) was created and offices and laboratories
were constructed in the DOH San Lazaro Compound, Sta. Cruz, Manila. The Food and Drug
Administration became operational with the President of its first FDA Administrator, Ms.
Luzonica M. Pesigan and Deputy Administrator, Mr. Emilio Espinosa . By the virtue of R.A
3720, the powers, functions and duties of the Division of Food and Drug Testing of the
Bureau of Research and Laboratories (BRL) engaged in food and Drug control together
with all their equipment, supplies, records, files, and balance of appropriations weretransferred to the FDA.
With the Integrated Reorganization Plan of 1973, the Narcotics Division of the Bureau ofInternal Revenue, Department of Finance, was transferred to the FDA, Department of
Health as one of its Divisions.
In 1982, Executive Order No. 851 abolished the FDA and created the Bureau of Food andDrugs (BFAD). Ms. Catalina C. Sanchez was appointed the first Director of the BFAD.
In 1987, the Bureau moved to its new site in Alabang, Muntinlupa City and acquired new
facilities including state-of-the-art analytical instruments and a modern experimental
animal laboratory with the $12M grant from the Government of Japan International
Cooperation Agency (JICA). This new BFAD in Alabang became operational on April 30,
1987. In 1987, RA 3720 was amended by Executive Order 175 to the new title “Foods, Drugs
and Devices and Cosmetics Act.”－126－

On the retirement of Mrs. Sanches, Dr. Cecile P. Gonzales (February 01, 1989-January 31,
1991) took over, followed by Dr. Quintin l. Kintanar (March 13, 1991-January 4, 1999);
Dr. William D. Torres (January 5, 1999-August 31, 2002), with the Deputy Director for
Drugs, Dr. Kenneth Hartigan-Go (June 1, 1999-June 10, 2001) and the lateral transfer of Mrs.
Adelisa C. Ramos, Director III of the DOH Nutrition Service as Deputy Director for Food
(November 6, 2000- present). On September 1, 2002, Professor Leticia Barbara B.
Gutierrez was appointed Director of the Bureau until 15 June 2009. Currently BFAD isheaded by Acting Director NAZARITA T. TACANDONG. BFAD is now renamed as FOOD
AND DRUG ADMINISTRATION by virtue of Republic Act 9711. The crafting of theimplementing rules and regulations is in progress.
2. STATISTICAL DATAHEALTH INDICATOR
Indicator
1. Area (in 1000 sq. Km)
2. Estimated Population*Male: 42,401,391
Female: 41,839950
Both Sexes : 84,241,341
3. Annual Population Growth Rate
4. Percentage of Population- less than 15 years old- over 65 years old
5. Urban Population
6. Rate of Natural Increase of population (%)
7. Crude birth rate (per 1000 population)*
8. Crude Death rate (per 1000 population)*
9. Life expectancy at birth (years)*- Total- Male- Female
10. Infant mortality rate (per 1000 live births)
11. Maternal mortality rate (per 1000 live births)
12. Child mortality rate under 5 years old
13. Percentage- Urban area
- Rural area

Year
2005
2005

Data
300,00sq. Km

2000-2005

2.32%

2004
2004
2001
2000-2005
1995
1995
1995

38%
3.5%
44,734,419.72
4.3%
24.09
5.66

2000
2000
2000
2002

Sources:N. 2, 7-9
10-11

: 1995 Census-Based National and Regional Population Projection*: 2005 Philippine Health Statistics－127－

67.83 years
73.08 years
15.7
1.0
15.7
94%
83.2%

Indicators

Data

14. Five main diseases causing morbidity

No. of cases (2003)

Rate/100,00• Acute Lower Respiratory
Tract Infection & Pneumonia• Diarrhea• Bronchitis/Bronchiolitis• Influenza• Hypertension

674,386

861.2

615,692
604,107431,216
325,390

786.2
771.4
550.6
415.5

No. of cases (2002)

Rate/100,00

60,417
48,271
36,414
32,63732,355

79.1
63.2
47.7
42.7
42.4

15. Five leading causes of morbidity
•
•
•
•
•

Diseases of the Heart
Diseases of the Vascular System
Malignant Neoplasm
Pneumonia
Accidents

B. Medical Care
1. Number of Hospitals (in 2003 or the year in which the latest data is available)
Number- Number of Government Hospitals(2004)
694- Number of Public Hospitals(2004)
421- Number of Private Hospitals(2004)
1450- Clinics(2004)
483- Health Centre(2004)
RHU: 41,458

2. Number of Health Manpower (With 3- year interval towards the year in which
the latest data is available)- Physician (year)

Number

1997

1876

2000

2174

2004

2983

－128－

- Pharmacist (year)

Number

1997

1447

2000
2004

1622
1769

- Dentists (year)
1997
2000
2004

Number
1571
1052
1235

- Nurses (years)

Number

1997

11,693

2000

5784

2004

9471

- Midwives (year)
1997
2000
2004

Number
4018
1738
1258

- (Licensed) Pharmaceutical Manufacturers (years)

Number

1997

249

2000

225

2004

238

- (Licensed) Traditional Medicine Manufacturers (year)
1997

NumberNo data available

2000

10

2004

17

- (Licensed) Drug Importer (year)
1997

Number
291

2000

392

2004

402

- (Licensed) Wholesalers (year)

Number

1997

1127

2000
2004

1773
2562

－129－

- Pharmacy/ies (year)

Number

1997
2000

1345
1670

2004

1053

- Drugs Stores (other than pharmacies )1997(year)

Number9545

2000

12,3292004

17,402- Prescription Items Registered
1997(year)

NumberNo data available

2000

8035

2004

15629

- OTC Products Registered
1997(year)

NumberNo data available

2000

8035

2004

3674

- Traditional Medicines Registered
1997(year)

Number
No available data

2000

12

2004

30

- Cosmetics Registered
1997(year)

NumberNo data available

2000

6094

2004

7951

－130－

C. Educational Information for Pharmacist in your countrya) System of Education
Primary School:

4 years system

Age at enrollment:

7 years old

Secondary School:

2 years system

High School:

4 years systemb) System of university or college education (Age at graduation: 21 years old)
University or college years

: 4-5

years

Professional education

: 4

years

Practical Training

: 30

weeks

Duration of Training by each facility : 5

weeks

Hospital Pharmacy

: 5

weeks

Pharmacy

: 5

weeks

Pharmaceutical Company

: 5

weeks

Others

:

weeks

-

c) National examination system for pharmacist in your country
Academic Exams: 2 days
Clinical Exams: N/A days

Noned) Requirement to obtain pharmacist’s Licensed) - 1 must be a graduate of Bachelor of Science major in pharmacyd) - 2 passed the examination given by the Professional Regulation
Commissiond) - 3 must be 21 years of agee) Graduates number of Pharmaceutical university or college: Average of
1,500/year－131－f) Percentage of the alumni’s progressive (as of: 2002)
HospitalCommunity Pharmacy
Government Organization
Enterprise
Others (Academe)

25%
55%
10%
5%
5%

3. HISTORICAL DEVELOPMENT OF PHARMACEUTICAL SERVICES

A. HISTORY OF THE TRADITIONAL (HERBAL) MEDICINES IN THE PHILIPPINES
For the DOH-BFAD, regulations as to the registration of Herbal and/0r Traditional drugs
both local and imported are strictly implemented. All these herbal and/or traditional drugs
are presently recognized in the Philippine National Drug Formulary. Moreover, theregistration of herbal and/or traditional drugs is required to be supported by pharmaceuticaldata’s, pharmacologic documentation, and quality control specifications as determined by
BFAD.
The Philippine government through the Department of Health has created thePhilippine Institute of Traditional and Alternative Health Care, an institution
which will promote the development traditional alternative system of medicine
which can offer safe, effective health care that is accessible, affordable andacceptable to the majority of the Filipinos. At present, BFAD has recognized theten Medicinal Plants since November 14, 1992 during the leadership of Dr. Juan
M. Flavier. The ten medicinal plants Lagundi (5 leave Chaste tree), Yerba Buena(Peppermint), Sambong Blumea Camphor), Tsaang Gubat (A shrub), Ulasimang
Bato (Peperomia pellucida-a wild fruit in the Philippines), Bawang (Garlic), Niyugniyogan (Burma creeper), Bayabas (Guava), Akapulko (Ringworm bush of shrub), andAmpalaya (Bitter Gourd).

B. HISTORY OF THE NATIONAL PLAN ON PHARMACEUTICAL SERVICES
The formulation of National drug Policy (NDP) was the product of a long processof consultations and deliberations that came out in response to a felt need which
was conveyed to the government by people from various sectors of society.
On April 30, 1987, during the inauguration of the Bureau of Food and drugs in
Alabang, muntinlupa, the former President Corazon C. Aquino announced the birthof the NDP and the government’s commitment to its implementation of Philippine
national drug policy (PNDP).
It was on September 13, 1988 when the Republic Act 6675, otherwise known as theGenerics Act of 1988, was passed in congress and enacted into law. When the Philippine
National Drug policy (PNDP) Program, was formulated in 1987, the Generics Law served
as its legislative framework for implementation.

－132－

It was in 1993 that the Philippine-Australian National Drug Policy Cooperation project wasformerly launched.
The people’s need to have essential drugs that are safe, efficacious and of good quality atreasonable and affordable cost with emphasis on rational drug use is the core of the PNDP.
At present, the PNDP Program is set on five pillars with its main concern is tobring about the availability and affordability of safe, effective and good quality
drugs for all sectors of the country especially for the poor who need them the most,
but who can least afford them. These five pillars with an acronym, P Q R S T,
form an integral unit, mutually complimentary and supportive of each other.
The first pillar is people empowerment. The main goal is to assist people exercise an informed
choice in the market place concerning purchase of cost-effective medicine. Today, many
public hospitals run out of drugs. People buy medicine in their own pockets.
The second pillar emphasizes on quality assurance. This involves the assuranceof drug quality, safety and efficacy. Since then, Philippines have in battle to theproliferation of sub-standard products and drugs of unknown quality and dubious
quality.
The third is the rational drug use. To provide accurate and objective information on healthpromotion and disease prevention and management that will guide health providers andconsumers on the proper use of medicines.

Fourth pillar is the strengthening of self reliance wherein it aims to promote self reliance inlocal production of certain strategic essential products and drugs. There is continued
domination of foreign drug companies.
The last pillar tackled on tailored procurement. To assure cost-effective drug procurement
and supply for DOH and other government agencies. Philippines aim on the efficiency of
government procurement as well as compliance of the national and local government
with the NDP.
Executive Order No. 851 was superseded by Executive Order No. 119, s. 1987 that again
reorganized the Bureau of Food and Drugs (BFAD) on the basis of Administrative
Order(A.O.) No. 30
1987, Provisions to Implement the Reorganization of the
Department of Health.”
The functions and operations of the Department of Health. BFAD was expandedwith an added Division, the Policy, Planning, and Advocacy Division. He joiningof the National Drug Policy workforce with that of BFAD further strengthened
the Bureau to meet new challenges in serving the interest of the Filipino people
consistent with the Philippine National Drug Policy and the National Health
Policy.

－133－

In the joint effort also of the regional BFAD offices, DOH believes that
the NDP can help our people. Its main concern now is to concentrate on theinternal strengths to overcome difficulties and realize the DOH main goal-toserve the people.

C. History of GMP
As defined by WHO, Good Manufacturing Practice is the part of quality assurance which
ensures that products are consistently produced and controlled to the quality assurance
standards appropriate to their intended use and as required by marketing authorization or
product specification. With the development of the quality control technology, it has beenencouraged that the quality be incorporated during the manufacturing process. In thisregard, the WHO has recommended to its entire member that GMP be implemented inevery country since 1969.
In 1974, the Philippines have formulated its own version of good Manufacturing
Practice with an Administrative Order No. 220 s. 1974. This order prescribes theconditions and requirements for good manufacturing practice, which applied tobuildings and facilities, equipment, personnel and documentation.
In 1999, pursuant to the provisions of RA 3720 otherwise known as foods, Drugs,
Devices and Cosmetics Act, as amended and in consonance with the developmentin science, Technology, industry and public health interest, Administrative OrderNo. 220 s. 1974, Current Good Manufacturing Practice was amended with the
adoption and implementation of Administrative Order No. 43-A s. 1999 otherwise
known as Current Good Manufacturing Practice Guidelines for Drugs.
In 2002, Administrative Order No. s. 2002 otherwise known as Current Good
Manufacturing Practice Guidelines for Cosmetics Products was also adopted for
implementation.
The Bureau of Food and Drugs (BFAD) is the regulatory agency responsible for
ensuring licensed pharmaceutical and cosmetic establishment meet the GMP
requirement to assure good quality. For the bureau to continue implementing
GMP guidelines several trainings abroad has been an opportunity for our
regulatory chiefs. Regional meeting of GMP experts in the pharmaceutical sector
was conducted in Hanoi last December 2004. The main concern is on thelegislative framework. Assessing the said legislative framework and why there is a needto assess has been given emphasis.
The past months, BFAD regulatory chiefs and other food and drug regulatory
officers have attended PIC/S Training in other countries in the interest of the
Bureau to join the Pharmaceutical Inspection Convention (PIC). PIC/S is theabbreviation and logo used to describe both the Pharmaceutical Inspection
Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC
Scheme) operating together in parallel. The need to form the PIC Scheme became
necessary when it was realised that an incompatibility between PIC and European law
did not permit individual EU countries that were members of PIC to sign－134－

agreements with other countries seeking to join PIC. Only the European
Commission was permitted to sign agreements with countries outside Europe, and theCommission itself was not a member of PIC.

PIC and the PIC Scheme, operating together as PIC/S, provide an active andconstructive co-operation in the field of GMP (Good Manufacturing Practice).
The purpose of PIC/S is to facilitate the networking between participating
authorities and the maintenance of mutual confidence, the exchange of
information and experience in the field of GMP and related areas, and the mutual
training of GMP inspectors. Fortunately, Philippines are among the eight
countries that shows interest in joining. As to date, the BFAD is currently on theprocess of formulating, drafting and soon to final Quality of System Manual for
GMP inspectorates not only for the BFAD main but also that of the regional
BFAD offices.
The food and drug regulation officers in the region have taken part in acquiring
the necessary expertise to monitor the covered establishments being licensed by
BFAD. Joint inspection from the main and regional level is on-going.
Comprehensive audit inspection within the regional FDROs is likewise being
strengthened thru full involvement of the entire regional health office. Additional
FDRO’s is also one of the thrusts of the regional directors to be able to assess andmonitor GMP compliance to all drugs manufacturing and the like.

－135－

4. PHARMACEUTICAL AFFAIRS ADMINISTRATION
1) A. Flow of Authority from the DOH to the Lowest Level of Health Units
DEPARTMENT OFHEALTH
Office of the Secretary

Office for External
Affairs
Center for Health
Development-BFAD
Regulation & Licensing
SectionHealth Human
Resource Unit

Health Operation
Division

Provincial
Government

Administrative
Support Unit

Regulatory
Division

DOH Team in the Province
DOH Team Leader in theProvince or Provincial
DOH Representative

Component
City
City
HealthOfficeDistrict
Hospital

Provincial
Health Board

Chartered City

City DOH
Representative

City
HealthBoard

Community
Hospital
Municipal
Government

Rural
Health UnitManagement
Division

Local Health
AssistanceDivision-

Provincial Health
OfficeBureau of Local
Health Development

Municipal
Health Board

Barangay
Health Station－136－

Municipal DOH
Representative

City
HealthOfficeCity
HealthBoard

DEPARTMENT OFHEALTHCENTER FOR HEALTH
DEVELOPMENT

Office of the
REGIONAL DIRECTOR

Office of the
ASSISTANT REGIONALADMINISTRATIVEADMINISTRATIVESUPPORTSUPPORTDIVISIONDIVISIONREGULATORY, LICENSING
and ENFORCEMENTDIVISIONLOCAL HEALTHSUPPORT DIVISIONHOSPITAL LICENSINGSERVICE SECTION

FOOD AND DRUGSERVICE SECTION－137－

B. BFAD ORGANIZATIONAL CHART

DIRECTORADMINISTRATIVEDIVISIONREGULATIONDIVISION I•

DEPUTY DIRECTORREGULATIONDIVISION IIPRODUCTSERVICESDIVISION

POLICYPLANNING
ADVOCACYDIVISIONLABORATORYSERVICESDIVISION

RA 9711 (Food and Drug Administration Act of 2009) approved on
18 August 2009 strengthens BFAD.

－138－

LEGAL BASES FOR REGULATIONS:
1987 Philippine constitution, Section 12, Article XIII:“The State shall establish and maintain an effective food and drug regulatory system”
Republic Acts
R.A. 3720 (1963) -Food , Drug and Cosmetic Act later amended by
EO175 otherwise known as Foods, Drugs, Devices and Cosmetic Act
R.A.6675 (1988) - Generics Act
R.A.7394 (1992) - Consumer Act
R.A. 9165 (2002)- Comprehensive Dangerous Drugs Act which
superseded R.A. 6425 Dangerous Drugs Act of 1972
R.A. 8203 (1996) - Special Law on Counterfeit Drugs
R.A. 5921 (1951) - Pharmacy Act as amended by E.O. 174 s. 1987
P.D. 881 (1976) - Household Hazardous Substances Decree
R.A. 7581 (1992) - An Act Promoting Salt Iodization Nationwide and for
Related Purposes (ASIN Law)
R.A. 8976 (2000) - An Act establishing Food Fortification Program andfor other Purposes (Food Fortification Law)

R.A. 7432 (1993) - Senior Citizens Act
E.O. 51 (1986)- Philippine Milk Code of Marketing of Breast Milk

Substitute (milk Code)
E.O. 302 (2004) - Declaring and Adopting the Philippine Pharmacopoeia
as the Official Book of Standards and Reference for Pharmaceutical products
and Crude Plant Drugs in the Philippines.
AO 153 s. 2004 cGMP on Food - Guidelines on the operation of Food
Manufacturers
AO 152 s. 2004 Prescribing Regulations for Irradiated Food
AO -Guidelines on the Registration of Herbal Food Products &Herbal Dietary Supplements (B0 142-A s.2005)－139－2) The Role of National / State and Local Pharmaceutical
Administrative Organizations.
Develops plans, programs, and strategies for regulating processed foods, drugs,
medical devises, cosmetics, in vitro diagnostic reagents and householdhazardous substances.
Formulates rules, regulation and standards for licensing and accreditation ofprocessed foods, drugs, medical devices, cosmetics, in vitro diagnostic
reagents and household hazardous substances.
Conduct licensing and accreditation of processed food, drugs and other related
products.
Provides technical, consultation and advisory services and develops capabilityof field offices on licensing and enforcement of laws, rules and regulations
pertaining to processed foods, drugs and other related products.
Monitors, evaluates and ensures compliance of manufacturer, distributors,
advertisers and retailer of processed foods, drugs and other related productswith health rules and regulations and standards of quality.
Advises the Secretary and the Undersecretary of Health on matters pertaining
to regulation of processed foods, drugs and other related products.
The regional health offices shall be responsible for the field operations of thedepartment and for providing efficient and effective health and medical
services through its supervision and control of all Department agencies
located in the region.

The Provincial Health Office, located in each of the province of the country,
shall exercise supervision and control over district health offices, municipal
hospitals, medicare hospitals, and other Department agencies in the province
except those otherwise placed under the Department proper or directly under
the Regional Health Office which is now known as the Center For Health
Development.

－140－3) CLASSIFICATION OF REGULATIONS
3.1 PRODUCT REGULATIONS
Republic Act No. 3720: Food, Drug and Cosmetic Act later amended by
EO 175 otherwise known as Foods, Drugs and Devices and Cosmetics Act- an act ensure the safety, and purity foods and cosmetics and the purity,
safety, efficacy and quality of drugs and devices being made available tothe public vesting the bureau of Food and Drugs with authority toadminister and enforce the laws pertaining thereto, and for other purposes.
Republic Act No. 8203: The Special Law Counterfeit Drugs- it is thepolicy of the state to protect and promote the right to health of the people
and still health consciousness among them. It further declared the policy ofthe state that in order to safeguard the health of the people, the State shallprovide for their protection against counterfeit drugs.
Republic act No. 6675: Generics Act of 1988- it is an act to promote,require and ensure the production of an adequate supply, distribution, use
and acceptance of drugs and medicines identified by their generics names.
3.2 PROFESSIONAL REGULATION
Republic Act No. 5921: Pharmacy Law- an act regulating the practice ofpharmacy and setting standard of pharmaceutical education in thePhilippines and other purposes.
3.3 HEALTH PROMOTIONS AND REGULATIONS- Health Establishments and Regulations
Republic act 4426- an act requiring the licensure of all hospitals in thePhilippines and authorizing the Bureau of Licensing and Regulations.
Administrative Order 55-(for laboratory clinics) - revised rules andregulation in the licensing of laboratory performing HIV testing. The
licensure of laboratory clinic is done by the bureau of Research andLaboratory.
Administrative Order 56 s. 1989- Licensing requirements for securing
BFAD license to operate.
Administrative Order No. 43-A s. 1999- and amendment of A.O. 220 s.
1974, Current Good Manufacturing Practice. With the development in thescience and technology, industry and public health interest, the current
Good Manufacturing Practice Guidelines for Drugs was adopted andimplemented.

－141－

Administrative Order No. 90 s. 2002: Current Good Manufacturing
Practice Guidelines for Cosmetics Products- lenient guidelines forcosmetics as compared with A.O. 43-A s. 1999.
- TRADITIONAL MEDICINES
Republic Act 8423 - an act creating the Philippine Institute of
Traditional Medicine and Alternative Health Care to accelerate thedevelopments of traditional and alternative health care in thePhilippines.
Administrative Order 12 s. 1993- Traditional Medicine Program for
Promotion and development of traditional medicines that has beenfound safe and effective.
- HEALTH ECONOMICS
Section 2.3 BFAD Regulation No. 5 s. 1987 and A.O 65 s. 1989 - No
Pharmaceutical product classified by BFAD as a Prescription or
Ethical Drug shall be advertised or promoted in any form of mass
media except through medical journals, publications and/or literaturesolely intended for medical and allied professions.
Article 116 of Republic Act No. 7394 or the Consumer Act of thePhilippines - xxx. That any sales promotion campaign using medicalprescriptions in any part thereof or attachment thereto for raffles or apromise of reward shall not be allowed, nor permit be issued thereof.
Section 4 of BFAD Regulation No. 5 s. 1989 - Press releases,
editorials, health columns and features and public service
announcements on health and medicines shall not specify brand/trade
names. Generic names are, however, permissible. For prescriptios
drugs, it should be clearly stated that this product can be bought onlywith a prescription and a doctor’s advise shall be sought.
A.O 119 of s. 2000 (item no.1) - Consistent with the rational drug use
policy, the promotion of OTC drug to the public will only be allowed
if its known adverse effects are also cited. Moreover, it is the intentionof RA 6675 or the Generic Acts of 1988, to promote drug safety byminimizing duplication medications and/or use of drugs withpotentially adverse drug interactions.

－142－

3.4

RESEARCH AND INDUSTRIAL DEVELOPMENTThe DOH work hand in hand with the academe, pharmaceutical industries,
private sectors and other government agency as PCHRD (Philippine Council for
Health Research and Development) for the research and development of drugs
such as herbal medicines. PCHRD will recommend to the Department of Budget
deserving health research and development proposal for government funding.
3.5

EDUCATIONAL DEVELOPMENT
Pharmacy Education

The practice of pharmacy in the Philippines began only after the arrival of the
Spaniards in 1521. The official pharmacy started in 1871 at the University ofSanto Tomas with a five-year curriculum. In 1899, the course had ceased and in
1901it has resumed and the curriculum was reduced to four years. In 1954, thecurriculum was developed to five years and finally in 1984 the degree in science inPharmacy was reduced again to fours years due to the integration of somesubjects. To date, there are about 24 colleges offering this course.

4) MANUFACTURING (IMPORT) APPROVAL OF DRUGS, ETC.
The manufacturing (import) approval of drugs is one of the responsibilities of the
Bureau Of Food and drugs. Establishments engaged in the manufacture anddistribution of drugs shall first secure a license to operate (LTO) from the
Bureau’s Regulation Division I for importer/distributor and Regulation Division II for
Manufacturers. Food Drug Regulation Officers will conduct inspection on
establishment applying for a license. If the establishment complies withthe licensing requirements, a license to operate will be issued.
Since unregistered products are not allowed in the Philippine market, this must be
registered first with the Bureau’s Product Service Division. Applicants are advice tosubmit an application for registration and other supporting documents forpreliminary evaluation and representatives samples for laboratory analysis. (Note:
Routine/random sampling is also conducted by GMP Auditors during their visit to the
manufacturing facilities aside from the samples summated by the applicants). Aftercollation of results, if it passes the analysis, BFAD will issue a Certificate of ProductRegistration (CPR).
Last 2001, President Gloria Macapagal Arroyo pledge to reduce the cost of
essential drugs by at least 50%. The Department of Health has organized theGMA-50 Project to spearhead the achievement of this objective. In partnershipwith the Department of Trade and Industry (DTI) procured essential drugs
through the Parallel drug importation program. The said imported drugs wereregistered with BFAD.

－143－

5) PHARMACEUTICAL INSPECTION AND GUIDANCEIn the Philippines, there are about 119 drug inspectors stationed all over thecountry. There are 40 inspectors (particularly on drugs) from the National Capital
Region (main office) and 128 inspectors detailed in the different regions. In the
National Capital Region, drug inspectors are divided into two (2) divisions:
Regulation Division I- drug inspectors are responsible for the inspection ofdrugstores, nonprescription drug outlets, Chinese drugstores, hospital pharmacies anddistributors (importer/exporter, wholesaler) of food, drug, cosmetics, medical device
and household hazardous substances.
Regulation Division II- drug inspector are responsible for the inspection of
establishments that deals with the manufacture and repacking of drug, cosmetic,
medical device and household hazardous substance, moreover, traders are also
under the jurisdiction of the Regulation Division II.
The regional health offices have their own regulation, licensing andenforcement division where the Food and Drug Services Section belongs,
implementing BFAD rules and regulation.
The Food and Drug Services Section of the DOH Regional Offices is technicallyunder the supervision of the BFAD Central Office. The regional offices then haveextension offices in the provinces. The regional offices and extensions offices
are handled by Food Drug Regulation Officers (FDROs). The provincial
FDROs conduct
inspection/licensing of regulated establishments (drugmanufacturers, drug distributors, retail drugstores, hospital pharmacies and food
manufacturers) and monitoring of health products to ensure quality, efficacy
and safety.
Inspectors under the Bureau of Food and Drugs are all government officials and aremostly pharmacists except for the food inspectors.
FDROs conduct an on the spot inspection on all licensed establishments and forestablishments applying for a license. Based on the actual inspection, if theestablishment is non-compliant to BFAD rules and regulations, the establishments are
not recommended for the issuance of BFAD license to operate and not to distributethe products in the market. The company are required to submit a commitment
letter with time frame for their compliance to the deficiencies noted. Once
deficiencies are complied, follow-up inspection is made and a license can then be
issued (for opening) or renewed (for old applicants).

－144－6) PHARMACEUTICAL INSPECTION AND GMP
The Bureau of Food and Drugs is the regulatory agency under the Department of
Health responsible for ensuring that the products distributed in the market bylicensed establishments met the basic GMP requirements based on A.O. 43 S. 1999,
Current Good Manufacturing Practice Guidelines for Drugs.

6.1 List of GMP Inspection and Guidance:
Administrative Order No. 43 s. 1999 - Current Good Manufacturing
Practice Guidelines for Drugs
Administrative Order No.

90 s. 2002 - Current Good

Manufacturing Practice Guidelines for Cosmetics
Administrative Order No. 153 s. 2004 - Revised Guidelines for Current
Good Manufacturing Practice in Manufacturing, Packing, Repacking,or Holding Food.

7) POST MARKETING SURVEILLANCE (PMS)
One of the functions of the Bureau of Food and Drugs is Post Marketing
Surveillance (PMS). PMS is a close observation of drug effects, whether
beneficial or adverse, following the marketing of a drug. The Bureau ensures thatall product marketed are regulated by the agency and conforms to its standards
and specification. One way of surveillance is by routine sampling of products inthe market and during the actual manufacture or at the company’s finished goods
warehouse. This is done during the inspection. Samples are taken to the laboratory
for testing; appropriate action is advised by the Legal Division depending on the
result of analysis.

－145－

QUALITY CONTORL SYSTEM OF DRUGS AND COSMETICS“QUALITY ASSURANCE LOOP”
Safety, Efficacy, Qualit

PRODUCT REGISTRATIONLABORATORYANALYSIS

LISENSING OFESTABLISHMENT
Product Quality, Label Information,
Advertisement

Physicochemical,
Microbial, Toxicological
GMP, GLP, GSP

POST MARKETING/QUALITY
MONITORING

Assuring the quality of drugs and cosmetics is a continuous process and is not limited
to one (1) division of the Bureau of Food and Drugs.
The Licensing Division assures of the establishment to GMP, GLP and GSP.
The Product Services Division assures that the product meet the criteria for safety, efficacy,and quality.
The Laboratory Services Division (LSD) verifies compliance of the product with thepsychochemical, microbiological and toxicological tests.
Samples tested by LSD include products randomly collected from the market or from the
manufacturers as well as traders. The Inspection Section of Regulations Divisions I
and II conduct the post marketing monitoring through random sampling of products inthe market and in the manufacturers as well as traders.
The Legal Information and Division monitors through sales promotion andadvertisements the product’s labeling information.

－146－8) EFFORT FOR DRUG SAFETY
Collection and Evaluation of ADR Data
Collection and evaluation of adverse drug reaction data is one of the
responsibilities of the Bureau of Food and Drugs. Food-Drugs Regulation Officers
from the Regulation Division I - assigned to monitor Adverse Drug Reaction. The
group collects data from sources such as report from hospitals or drug
manufacturers. Reports are evaluated. Products found to have adverse reaction areendorsed to Product Services Division for further evaluation and revision of drug
literature.

ADR MONITORING SYSTEM
Reports
Reports
Report
from
from
from
Participating Private
Drug Mfr.
Hospitals Practitioners Traders /Outlets

Reports
Reports
Reports
on
from
from
ClinicalInt ’lRegulatory
Investiga- Authorities
ADR
tions
Centers

BFAD ADR UNIT
WHO Collaborating Center

Director- BFAD
Secretary of
Health - DOH

REPORTING SCHEME
CASE
Reporter Fills Out a Form
Hospital
Therapeutic Committees

ADR Monitoring(Central Database)

－147－

WHO

9) PHARMACOPOEIAThe Philippine Pharmacopoeia Project
The Bureau of Food and Drugs, embarked on a project to prepare and publish thePhilippine Pharmacopoeia which will be utilized on the national official reference
book for standards of purity and quality of pharmaceutical substances and product.
The Philippine Pharmacopoeia will consist of two parts: part I will contain the
General Considerations and the Official Monographs of Chemical/Pharmaceutical
Substances and Products, while Part II will contain the Official Monographs of
selected Philippine Medicinal Plants and Products. A Philippine Pharmacopoeia
Committee, composed of representative from different fields of pharmacy,
chemistry and medicine was created to ensure the success of the project.
To provide preliminary guidance and direction to the project, technical assistance has
been requested from the Government of Japan through the Japan International
Cooperation Agency. (JICA)
To date, under Executive Order No. 302 dated 29 March 2004, the Philippine
Pharmacopoeia (PP) 1st edition 2004 and any supplement thereto, has been
declared and adopted as the official book of standards and references for thedetermination of the identity, purity, and quality of pharmaceutical products andcrude plants drugs in the Philippines.
10) PRODUCTION AND TRADE OF DRUGS AND OTHER PRODUCTS
All establishments in the Philippines that are engaged in the manufacture of drug
products are registered with the Bureau of Food and Drugs. These manufacturers
distribute their products locally or to be exported in foreign country. These
importers are licensed with the Bureau.
11) DRUG DISTRIBUTION SYSTEM
Drug distribution is done by a licensed Drug Distributor (importer, exporter, andwholesaler) and by a licensed Drug Manufacturer and Drug Trader. Usually, thedrugs Distributors are authorized by Drug Manufacturers and Traders to distribute theirproducts. Distribution Agreement between each client is provided. (Note:
Antibiotic products must first be batch certified aside from being registered prior to
distribution in the market).

－148－

Documentation System such as records of delivery receipts and invoices are
required between the distributor and the supplier (Drug Manufacturer or Drug
Trader). Each distribution records must indicate the necessary data such as thename of the product, description of the product as its dosage form and strength,
expiry date, date of manufacture and the lot or batch number. Storage conditionand handling must also be specified, such record is needed for easy traceability incase of a product recall.
For the drug distribution of drugs in all government hospital, the regional healthoffices thru the DOH has certain list of accredited suppliers allowed in to join in
the bidding. All manufacturers/suppliers are all BFAD licensed holders. The local
government units have their own system of procuring essential drugs. Provincial
health hospital has their own therapeutic committee to check on the procurementof drugs and medicines following the Philippine National Formulary as mandatedby E.O 49 s. 2003-directs the mandatory use of Philippine National drug
Formulary (PNDF) as the basis for procurement of drug products by thegovernment.
12) DRUG PRICE MECHANISM
In the Philippines, high prices of drugs and other products do not only alarm thepublic but also the government. High prices are usually based by manufacturers
on the cost of imported raw materials, taxes, labor fee, etc. For this, thegovernment has created Republic Act 7581 on June 7, 1992, otherwise known as
the “Price Act.” The Act provides protection to consumers by stabilizing the priceand supply of the basic necessities and prime commodities and by prescribing
measure against undue price increase especially during the emergency situation.
The Bureau of Food and Drugs and the National Drug Policy conducts monthly
monitoring of prices of drugs, especially essential drugs.
In answer to the high cost of drugs, the Republic Act 9502 “Cheaper Medicine Act”
was enacted in 2008.

13) STABLE SUPPLY OF VACCINES
The Philippines has only one manufacturer of vaccines - the Biological and
Vaccine Production Division which is directly under the Department of Health.
Currently the agency has produced the BCG vaccine. The vaccines are alreadyimported to supplement the needs of the people.
14) Re - examination of Drugs (if any) - No available Data

－149－15) Classification of Pharmaceuticals and Medicinal Products
In the Philippine setting, drugs are categorized as;
Prescription / Ethical Drugs
Over-The-Counter
Household Remedies
Vaccines and Biologicals
HerbalVeterinary
Medical Devices
In vitro Diagnostic Reagents
Cosmetics
Household Hazardous Substances

An essential drugs list which is a concept promoted by the WHO and refers to
those drugs which cure the vast majority of illnesses and should be available toall persons are the ones listed in the National Drug Formulary of the Philippines(NDF). The NDF is a list of medicines officially recognized and approved by the
Department of Health (DOH). This formulary is being prepared by the National
Drug Committee and when completed will be regularly revised and updated. All
drugs listed in the NDF shall be reimbursed by the Philippine Health Insurance(PHILHEALTH). On the other hand, those OTC are not reimbursed by
PHILHEALTH.
OTC drug in the Philippines is also referred to as Non-Prescription drugs. This isdefined as any Pharmaceutical product that can be dispensed without the written
order of a duly-licensed physician, dentist or veterinarian, for the use of theconsumers for the prevention or symtomatic relief of minor or self-limiting
ailments.
Food supplements are not allowed to have therapeutic claims and also being
registered to BFAD.
5. ESSENTIAL DRUGSThe Philippine National Drug Formulary (NDF) contains the essential list of
drugs, which are the most needed for the health care of the majority of the
population. It enumerates the kind of drugs that can cure most common ailments
or diseases and the most needed health care that should be made available andaffordable to all people. The essential drug list of the Philippines is in its 5thedition which contains 557 drugs: 365 in the core list and 307 in thecomplimentary list.
CORE OR MAIN LIST - A list of drug for the health care needs of the majority ofthe population: the listed drugs should therefore be made available at all items inadequate amounts and in appropriate dosage forms at the lowest possible cost. They
are of utmost importance and are basic, indispensable and necessary for the healthneeds for the population－150－

COMPLIMENTARY LIST- a list of drugs for treating rare disorders or in
exceptional circumstances: alternative drugs when drugs in the main list are
known to be ineffective or inappropriate for a given individual: alternative drugs
when drugs in the main list cannot be made available: drugs with special
pharmacological properties.

CRITERIA FOR INCLUSION OF
NATIONAL DRUG FORMULARY

DRUGS

IN

THE

PHILIPPINEa.) the drug is needed for the prevention and treatment of conditions notalready covered in the existing list:b.) the drug is more effective and/or less toxic than a drug listed for the same
indication:c.) the drug’s at least as effective and safe and of lower cost than the drug
listed for the same indication: andd.) The drug is seemed essential for a specific DOH health program/project.

CRITERIA FOR DELETION OF DRUGS FORM THE PHILIPPINENATIONAL DRUG FORMULARYa) A more effective or equally effective but less toxic drug becomes
available:b) In the light of further knowledge, the therapeutic efficacy of the drug isfound to be unsatisfactory or questionable:c) Toxicity/suspected toxicity or potential for abuse and dangerous
interaction prove to out weight its therapeutic value:d) The drug has fallen into disuse and is no longer available:e) The drug is no longer deemed cost-effective to other therapies; andf) The drug is a fixed- dose combination which does not satisfy therequirements of A.O. 96 s. 1990.

－151－

6. DIFFICULTIES & CONSTRAINTS IN MANUFACTURING CONTROLOF ESSENTIAL DRUGS (e.g. GMP, etc.) that you have been facing thesedays & clear directions in the future.
From the continuous implementation of the GMP in the Philippines, BFAD stillfinds Drug Company not in compliance to the guidelines. Due to the economiccrisis arising from the country, more drug company has opted to just have theirproduct toll manufactured. The issue of the local pharmaceutical lab cannot easily
cope up with the advanced technology of the multinationals. The knowledge,
skills and capability of the personnel in every manufacturing facility can be
pirated by other laboratories or the opportunity to go other countries. Other,
manufacturing companies still has not improved or established quality
management system. The proliferation of the counterfeit drugs by unknown fly by night
manufacturers still exists.
On the part of the implementing agency both in the BFAD main and BFAD
regional health offices, the main problem is the insufficient number of Food
Drug Regulation Officers particularly in the regions. The expertise is not
fully acquired due to the limited budget of the BFAD main to conduct seminars
to re-echo the latest updates on the GMP inspections. Insufficient numbers ofvehicles to locate and reach some drug manufacturing facilities.
The Bureau is very strict not to issue license to operate to drug manufacturers notcomplying GMP. The continuous coordination of BFAD main to the BFAD
regional has been done using the zonal approach and continuous training of
FDROs. Thus, making it sure that all the FDROs fully understand the latest
updates GMP. The latest PIC/S seminar done by the main is an added solution.
This will provide harmonized guidelines in the country.
Other solutions, being considered by the Bureau are the additional plantilla,
technical training and technical competency enhancement, and competitive salarystandards. With the approval of Republic Act 9711, there will improved andstrengthened Food and Drug Regulatory Agency.
7. CURRENT SITUATION CONCERNING COUNTERFEIT AND
SUBSTANDARD DRUGS AND ITS COUNTERMEASURES
While Philippines are on the verge of increasing technology, BFAD has difficulty
in recognizing genuine from counterfeit products. Many of the fast moving drugs
especially those from multi-nationals are being counterfeited. This problem is not
only happening in the national capital regions but also in the provinces. The project of
the government to allow the imported drugs coming from Pakistan to be sold in
the existing licensed drug retail outlets has been one of the problems. This is sodue to the fact that some would take advantage by incorporating those imported
drugs and medicines not registered in BFAD and has not passed PITC.

－152－

PITC is the responsible agency allowed to import these drugs and medicines.
This imported drugs and medicines are previously available at all government hospital.
It has been expanded due to the government’s program to provide affordable,
accessible and quality medicines in all communities.
BFAD on the other hand, has on-going activities that include collaboration with thepharmaceutical sector thru the conduct of monthly meetings of the Technical
Working Group on Counterfeit Drugs, saturation drive, product monitoring,regional audit inspection, random collection and purchases of pharmaceuticalproducts for laboratory testing, investigation and validation of phone-incomplaints received thru hot line and call center.
The strategy on saturation drive involves all Food and Drug regulation Officers in
the inspection of licensed and unlicensed drugstores, sari-sari stores, in an
identified vicinity of locality. This is done simultaneously within one-day toprevent the spread of information on the presence of the FDROs.
Monitoring of counterfeit drugs in various places nationwide giving priority to areas
where information of prevalent counterfeiting from confidential sources is the mainpriority thrust of BFAD.
8. OVERVIEW OF RELATIONSHIP WITH OVERSEAS ASSISTANCE
ORGANIZATION
The financial grant given by the World Health Organization (WHO) to the Bureau ofFood and Drugs in the Agreement for Performance of Work (APW) has boost BFAD
commitment to the cause of ensuring the availability of safe, quality and efficacious
drugs. The support allowed the FDROs to conduct intensified surveillance on
counterfeit drugs nationwide.
The coordination of PIC/S secretariat Geneva will enable BFAD to facilitate the
networking between participating authorities and the maintenance of mutual
confidence, the exchange of information and experience in the field of GMP and
related areas, and the mutual training of GMP inspectors. This will also provide theframework for all necessary exchange of information and experience and help us
achieve coordination on mutual training for inspectors and for other technical experts
in related fields. BFAD effort to continue common efforts for thedevelopment, harmonization and maintenance of GMP, and to extend the cooperation to other competent authorities having the national arrangements necessary
to apply equivalent standards and procedures with a view to contributing to global
harmonization.

－153－9. OVERVIEW OF TECHNICAL ASSISTANCEPROGRAMMES IN THE
FIELD OF PHARMACEUTICALS, GMP,QUALITY CONTROLORGANIZED BY INTERNATIONALORGANIZATIONS, NGOs, etc
WHO - How to monitor counterfeit drug in themarket. The support allowed the FDROs to conduct
intensified surveillance on counterfeit drugs
nationwide.
PIC/S Secretariat Geneva - To
leadtheinternational
development Implementation andmaintenance of harmonized GMP standards and quality
systems of inspectorates in the field of medicinal products.
JICA - the yearly training being offered by the
JICA is a major step in BFAD strengthening
process especially on the Good Manufacturing
Practice (GMP) and Pharmaceutical Affairs
Experts.
10. LIST OF REFERENCES
National Objectives for Health Philippines 1999 - 2004, Department
of Health Philippines.
National Health Plan 1995 - 2020, Department of Health Philippines
National Health Statistics 2002 - 2004, Department of Health Philippines.
List of accredited Government Hospitals and Privateand Other Health Facilities for the calendar Year 2004 Department of Health Philippines.
Compilation of Administrative Orders andMemorandum Circulars with Summaries andAnnotations 1992 Edition.

－154－

Reportontheintensified

surveillanceonCounterfeit drugs: A Philippine Approach 2005 Bureau of Food Drug Regulation Division I (Miss
Theresa Guiterrez - Supervisor) Philippines.
List of licensed and their classification under
Regulation Division I 2004 , BFAD Philippines.
List of Licensed Drug manufacturers 2004- Bureau of Food andDrugs, Regulation Division II Philippines.
List of Registered Prescription Drugs and OTC in
soft copy 2004 - Policy,
Planning and Advocacy Division Bureau of Food andDrugs Philippines.

－155－

－156－

The Study Programme
for the Pharmaceutical Affairs Experts

Thailand－157－

－158－

Country Report
ThailandStudy Programme for Pharmaceutical Affairs Experts(No. J09-00794)

Ms. Daranee Pencharoen
Head of New Drug Section
Drug Control Division
Food and Drug Administration of Thailand－159－

Name: Ms. Daranee Pencharoen
Position and Name of Organization: Head of New Drug Section, Drug Control Division, Food andDrug Administration of Thailand.
Name of Country: Thailand

1.Geographical and political features
1.1 Location, Territory and Boundary
The Kingdom of Thailand is situated in the continental Southeast Asia, just north of the equatorand is part of the Indochina Peninsula.
Thailand covers an area of about 514,000 square kilometers. It is the third largest country
among the Southeast Asian nations, after Indonesia and Myanmar.
In the North, bordered by Myanmar and the Lao People’s Democratic Republic.
In the South, bordered by Malaysia and the Gulf of Thailand.
In the East, bordered by the Lao People’s Democratic Republic and Cambodia.
In the West, bordered by Myanmar, the Andaman Sea, and the Strait of Malacca.

1.2 Topography and Climate
Thailand can be topographically divided into three different areas: the plain areas are mostly in
the Central Region of the country, the highland areas are mostly in the Northeast, and the mountainareas are mostly in the North and the Southeast.
Thailand has three types of climate as follows:-

Tropical rain climate in the coastal areas in the East and the South, with heavy rainfall all year
round and tropical rain forests.

-

Tropical monsoon climate in the Southwestern and Southeastern coasts with monsoons anda very high average annual rainfall.

－160－

-

Seasonal tropical grassland or savannah climate with a lot of heavy rains in the Southwest
monsoon season and dryness in the cold season covering most regions of the country,
particularly the Central Region, the North and the Northeast.
Prevailing winds include the southwesterly monsoon from about mid- May through October
and the northeasterly monsoon from November through February.

1.3 Population, Language and Religions
The population of Thailand is 66.9 million (October 2009); almost all residents (98.1%) are ofThai nationality and the rest are of other nationalities such as Chinese, Myanmar and Lao.
For communication purposes, the Thai language is officially and commonly used for speaking
and writing, while English tends to play a greater role particularly in the business sector.
Most of Thai people are Buddhists (94.5%), followed by Muslims (4.5%) Christians (0.7%) andothers.

1.4 Education
Education in Thailand is provided mainly by the Thai government through the Ministry of
Education from pre-school to senior high school. A free basic education of twelve years is guaranteedby the constitution, and a minimum of nine years’ school attendance is mandatory.
Formal education consists of at least twelve years of basic education and higher education.
Basic education is divided into six years of primary education and six years of secondary education,
the latter being further divided into three years of lower and upper secondary levels. Kindergarten
levels of pre-primary education, also part of the basic education level, span 2-3 years depending on
the locale, and are variably provided.

Non-formal education is also supported by the state.

Independent schools contribute significantly to the general education infrastructure.
Administration and control of public and private universities are carried out by the Ministry of
University Affairs.

1.5 Political system
The politics of Thailand are currently conducted within the framework of a constitutional
democratic monarchy, whereby the Prime Minister is the head of government and a hereditary
monarch is head of state. The judiciary is independent of the executive and the legislative branches.

－161－

According to the constitution, the three major independent authorities holding the balance ofpower are executive, legislative and judicial. The King has little direct power under the constitution
but is a symbol of national identity and unity. The head of government is the Prime Minister. Under
the present constitution, the Prime Minister must be a Member of Parliament. Cabinet members do
not have to be Members of Parliament. The legislature can hold a vote of no-confidence against thePremier and members of his Cabinet if it has sufficient votes.

1.6 Literacy rate and GNP
The literacy rate among Thai population aged 15 and over rose from 78.6% in 1970 to 93.5 %in 2005. It is estimated that the literacy rate will be as high as 97% in 2010. The Gross National
Product (GNP) per capita at current market prices of Thailand in the year 2007 was 124,831.6 baht.

－162－

2. Statistical data
1) Population
66.9 million (Male 32.9 million, Female 34.0 million) (data on October 2009)2) Vital statisticsa) Rate of vital statistics (per 1,000 population) (per 1,000 live births*)
Live birth rate

Death rate

Infant death rate*

Data

12.4

6.3

7.3

Year

2008

2008

2008

b) Five main diseases causing morbidity
2003

2004

percentage

percentage

1 Respiratory tract diseases

40.2

44.8

45.0

44.3

2 Musculoskeletal disease

14.9

11.8

12.2

11.4

3 Gastrointestinal diseases

10.3

9.1

9.3

9.4

4 Cardiovascular disease

6.3

5.2

5.9

6.3

5 Endocrine system diseases

4.4

3.1

4.4

4.1

2002

2004

2006

2008

Causesnumbernumbernumbernumber

1 Malignant neoplasm, all forms

45,83450,81852,06255,4032 Accident and poisonings

34,56836,85537,43334,851

5,361

16,766

17,775

18,820Group of diseases

2005

2006

percentage percentagec) Five leading causes of death

3 Disease of the heart－163－

4 Hypertension and cerebrovascular disease

16,64021,756

15,284

15,596

5 Pneumonia and other diseases of lung

13,185

16,462

13,766

14,542

6 Human immunodeficiency virus (HIV) disease

15,597

11,473

6,551

4,683

d) Life expectancy
Male

Female

Total

Data

70.59

77.54

74.06

Year

2005-20102005-20102005-2010

3.Medical care policya) Estimated number of patients who received medical treatment on the specified date (notyearly total)
Government hospital

Public hospital

Private hospital

Others hospital

Data

N/A

N/A

N/A

N/A

Year

N/A

N/A

N/A

N/A

b) Number of hospitals by establishing organ
Government hospital

Public hospital

Private hospital

Clinics

Data

999

1

317

16,800

Year

2007

2007

2007

2006

c) Number of health manpower
Physicians

Dentists

Auxiliary medical personnel*

Nurses (RN, CN, PHN)

Data

22,651

4,653

13,146105,398

Year

2007

2007

2007

2007

*: as lab. Technician, X-ray technician, et al.

－164－d) Number of Pharmacists
Data

6,288

7,413

7,940

8,565

Year

2002

2004

2006

2007

e) Number of drug manufacturers/ plants
Data

174

171

165

168

167

Year

2002

2004

2006

2008

2009

f) Number of traditional medicine manufacturers/ plants
Data

883

912

881

1,002

1,013

Year

2002

2004

2006

2008

2009

g) Number of drug importersData

641 (modern drugs)

177 (traditional drugs)

Year

2009

2009

h) Number of drug wholesalersData

15,939 (modern drugs)

Year

2009

1,986 (traditional drugs)
2009

－165－

4. Pharmaceutical affairs administration
1) Administrative organization
The Food and Drug Administration is a department under the Ministry of Public Health (seeFigure 1). It is divided into ten divisions and three units as shown in Figure 2. There are about 663
workforces (data in 2006). Most of them (60%) are pharmacists and food technologists. The rest ofthem are nutritionists, lawyers, public- relation officers, etc. The top administrators are SecretaryGeneral and three deputies Secretary General.
The Drug Control Division is responsible for all kinds of control activities involving licensing to
manufacture, import, export and sell pharmaceutical products and granting registration certificates forpharmaceutical products to ensure their quality and legality. The division conducts research anddetermines principles, regulations, and measures regarding the safety, efficacy and quality of drugs.
It promotes and supports the manufacture, import, and sale of quality drugs. The division carries out
the inspection and surveillance on drugs and drug advertising to ensure their legality. It also provides
information and technical advice and develops data resources for drug information service.
The organizational structure of the Drug Control Division is shown in Figure 3.
The functions of the division can be divided into 3 major parts: pre-marketing control, postmarketing control and development of the work system and national drug policy.
1. Pre-marketing Control
1.1 Consideration of authorization to operate a modern or traditional drug manufacturing,
importing or selling facility
1.2 Consideration of registration of modern and traditional drugs
1.3 Consideration of authorization of drug media advertising to the public or healthcare
professionals.
1.4 Consideration of the notification of pharmaceutical chemicals which are active ingredients.
1.5 Consideration of the other approvals regarding medicines, e.g. authorization to
manufacture or import sample drugs for registration, issue of certificates ofpharmaceutical products/ certificates of free sales (CFS/CPP), certificates of veterinary－166－

biological product lot release and approval of import according to the Ministry ofCommerce’s announcements.
2. Post-marketing Control
Inspection and surveillance of drugs and of facilities and drug advertising are necessary toensure the quality, efficacy, safety and legality of drug products in the market.
3. Development of the Work System and National Drug Policy
The Drug Control Division acts as coordinator in the making of national policy regarding drugs
in order to determine the direction of drug development as a whole and the translational ofpolicy into practice.

2) List of laws/regulation covering pharmaceutical affairs
After several years of endeavoring, the Drug Act 1967 (B.E. 2510) was promulgated tosupersede the 1950 Drug Act. The Drug Act 1967 has been employed for almost three decades.
This brought in quite substantial improvement in all aspects of pharmaceutical control in the country.
Up to now, there were four more revisions subsequently emerged in order to cope with the overchanging situation of pharmaceutical industry and the globalization of international pharmaceuticaltrade.
The current laws and regulations for pharmaceutical control are as follows:
1. Drug Act 1967 (B.E. 2510)
2. Drug Act (2nd revision) 1975 (B.E.2518)
3. Drug Act (3rd revision) 1979 (B.E.2522)
4. Drug Act (4th revision) 1984 (B.E.2527)
5. Drug Act (5th revision) 1987 (B.E.2530)
These Acts contain provisions on definitions, authorities of the designated officers, role andresponsibilities of business operators and personnel, registration and licensing, enforcement, offenses
and penalties.
The activities under the above Acts are conducted under the supervision of Drug Committee
which will give consent, advice and make recommendation to the Minister of Public Health regarding
control and enforcement measures, issuances of notifications, licensing and registration, or other－167－

related issues concerning pharmaceutical products. The Drug Committee has been appointed every
two years. The committee is also authorized to approve pharmaceutical registration and to withdraw
or suspend the licenses. There are 23 regular members in the committee;14 of them are positional
appointed from related organizations; the other nine members are drug experts. The committee canthen appoint subcommittees to assist them in the technical viewpoint. Presently, twenty
subcommittees have been appointed; these are:1. Subcommittee on review and approval for registration of modern medicines(new drugs) for
human use
2. Subcommittee on review and approval for registration of modern medicines(new genericdrugs) for human use
3. Subcommittee on review and approval for registration of modern medicines(generic drugs) for
human use
4. Subcommittee on review and approval for registration of modern medicines(biologicalproducts) for human use
5. Subcommittee on review and approval for registration of traditional and herbal medicines
6. Subcommittee on review and approval for registration of modern medicines for use
7. Subcommittee on re-evaluation of registered medicines for human use
8. Subcommittee on surveillance of safety of drug utilization
9. Subcommittee on review and approval of drug advertisement
10. Subcommittee on establishment of good manufacturing practices(GMP) requirements
11. Subcommittee on approval of manufacturing or importing medicines for clinical studies
12. Subcommittee on establishment of requirements for bioequivalence studies
13. Subcommittee on GCP inspection of clinical studies
14. Subcommittee on establishment of guidelines on problem-solving of pharmaceutical raw
materials and products for veterinary use
15. Subcommittee on evaluation and approval of pharmaceutical quality and testing forcompliance with quality standards
16. Subcommittee on licensing approval of manufacturers, importers, distributors and drugstores
17. Subcommittee on policy development and promotional of biological products
18. Subcommittee on establishment of requirements for biological products－168－19. Subcommittee on the exemption of certificates of free sale in the registration of certain
products
20. Subcommittee on approval for registration of growth hormone products

3) Licensing system of factory and registration system of drug
Licensing system
The Drug Act requires that any persons, who wish to sell, manufacture or import
pharmaceutical products into the kingdom must obtain licenses from the licensing authorities. The
Drug Control Division is the licensing authorities. The Drug Control Division is the licensing authority
for manufacture, import and selling of pharmaceutical products in Bangkok metropolitan and its
territories.

Provincial Health Offices are the licensing authorities for manufacture and import of

traditional drugs and sale of pharmaceutical products in other provinces.
Application for a license must be submitted to the licensing authority. Buildings and facilities
will then be inspected. A license will be given after the inspection has confirmed that the applicant
has adequate capabilities of conducting such business, and he/she can secure appropriate facilities
and personnel for that purpose. There are different categories of licenses as the following:-

License to manufacture modern drugs-

License to sell modern drugs-

License as a wholesaler of modern drugs-

License to sell ready-packed modern drugs which are neither in the categories of dangerous
nor specially-controlled drugs-

License to sell ready-packed modern veterinary drugs-

License to import modern drugs-

License to manufacture traditional drugs-

License to sell traditional drugs-

License to import traditional drugs

Drug Registration System－169－

The registration process is necessary to ensure efficacy, safety and effectiveness of thepharmaceutical products freely sold in Thailand. Only the authorized licensees are qualified to apply
for pharmaceutical product registration certificates.

The manufacturing plant, in which a

pharmaceutical product is manufactured, is subject to inspection for compliance GMP (GoodManufacturing Practices). According to the Drug Act, the granted certificate is valid to the validity of
its authorized licensee.
The process of drug registration is carried out through two channels, which differ in degree ofcontrol and dossier submission: modern drugs and traditional drugs.
Modern drugs include chemical and biological entities. Modern drugs are classified according
to the purpose of regulatory assessment into 3 categories, differing in the type of dossiers required ofthem. These are new drugs, new generic drugs and generic drugs.
There are 5 sections of the Drug Control Division responsible for drug registration as thefollowing:
1. New Drug Section is responsible for the registration of new drugs and new generic drugs
for human use.
2. Generic Drug Section is responsible for the registration of generic drugs for human use.
3. Biological Product Section is responsible for the registration of biological products forhuman and veterinary use.
4. Veterinary and Pharmaceutical chemical Section is responsible for the registration ofveterinary drugs (not include biological products and traditional and herbal drugs)
5. Traditional and Herbal Medicine Section is responsible for the registration of traditional andherbal drugs for human and veterinary use.
New Drugs include products with new chemical entities, new indication, new combination,
new delivery system, new route of administration, new dosage form (of new drugs) and new strength(of new drugs)
New Generic Drugs are medicines with the same active ingredients, dosage forms andstrengths as those of new drugs registered after 1991.
Generic Drugs include products with the same active ingredients and dosage forms as thoseof new drugs registered before 1991.

－170－

Biological Products mean any products of biological origin, prepared with biologicalprocesses, derived from human blood and plasma, or manufactured by biotechnology, consisting of
substances of higher molecular whose purity, potency and composition cannot readily and reliably be
determined by chemical or physicochemical analysis. (e.g. Vaccines, blood products, modified animal
tissues, high-molecular weight hormones, allergens, products of genetic engineering or other newer
biotechnological techniques.)
Veterinary Drugs mean drugs intended for use in the diagnosis, treatment, relief, cure or
prevention of animal disease or illness.
Traditional Drugs mean drugs intended for use in the practice of the traditional medicine (thepractice of medicine by dependence on the knowledge acquired from a textbook or through learningwhich is not on a scientific basis)
Drug Registration Process
The registration process of all categories of drugs involves 2 steps:
1. Application for permission to manufacture or import of drug samples.
2. Application for product registration approval
The diagram showing the registration process is shown in Figure 4.
There are two registration tracks for new drug and new generic drug registration.
Track 1: Standard Review: This track applied to all drugs other than those allowed under
Track 2.
Track 2: Accelerated or Priority Review: This is a fast track registration. This track has beencreated for-

Drugs for public health problems/life threatening e.g. Anti-HIV, Anti-cancer.

-

Drugs which are manufactured for export.

Application for permission to manufacture or import of drug samples
The applications have to be submitted at one stop service center of Thai FDA.
Documents to be submitted:－171－

1. Application

form:

Manufacturer/Importer

Name

and

Address,

Licensetomanufacture/import number, Product Name and Description, Drug Formula(active
ingredient(s) only), Packaging, Quantity of drug sample to manufacture/import
2. Labels
3. Leaflets
Application for product registration approval
The applications have to be submitted at the specific sections of the Drug Control Divisionaccording to the drug category.
Documents to be submitted:
In Thailand, the ASEAN Common Technical Requirements (ACTR) and ASEAN Common
Technical Dossier (ACTD) has been fully implemented for the registration of new drugs, new genericdrugs, generic drugs and biological products since 1 January 2009 (B.E. 2552). Thai FDA created 5
books for the industry as follows:
1. Manual/Guidance on New Drug Registration (ASEAN Harmonization)
2. Requirements and Documents to be submitted for New Drug Registration (ASEAN
Harmonization)
3. Manual/Guidance on New Generic Drug Registration (ASEAN Harmonization)
4. Manual/Guidance on Generic Drug Registration (ASEAN Harmonization)
5. Manual/Guidance on Biological Product Registration (ASEAN Harmonization)
New Drugs
The dossier requirements for this type of registration are the most demanding compared toother types.
There are 4 parts of documents to be submitted (ACTD).
Part 1: Administrative Data and Product Information
Part 2: Quality Document
Part 3: Nonclinical Document
Part 4: Clinical Document
The ASEAN Common Technical Requirements (ACTR) of the Quality Part is as follows:
1. Drug Substance－172－

2. General Information, Manufacture, Characterization, Control of drug substance,
Reference Standards, Container Closure System, Stability
3. Drug Product
Description/Composition, Pharmaceutical development, Manufacture, Control of
excipients, Control of Finished Product, Reference Standards, Container Closure
System, Stability, Interchangeability
The ASEAN Common Technical Requirements (ACTR) of the Nonclinical Part is as follows:
1. Pharmacology
Primary Pharmacodynamics, Secondary Pharmacodynamics, Safety Pharmacology,
Pharmacodynamics Drug Interactions
2. Pharmacokinetics
Absorption, Distribution, Metabolism, Excretion, Pharmacokinetics Drug Interactions,
Other Pharmacokinetic studies
3. Toxicology
Single dose toxicity, Repeat dose toxicity, Genotoxicity, Carcinogenicity, Reproductive
and developmental toxicity, Local tolerance, Other toxicity studies, if available
The ASEAN Common Technical Requirements (ACTR) of the Clinical Part is as follows:
1. Bioavailability (BA) and Bioequivalence (BE) Studies
2. Studies Pertinent to Pharmacokinetics using Human Biomaterials
3. Human Pharmacokinetic (PK) Studies
4. Human Pharmacokinetic (PD) Studies
5. Efficacy and Safety
6. Post Marketing Data (if available)
7. References
The requirements of each parts are classified by types of new drugs.
Once a new drug passes the product assessment process and market authorization is granted,
it is registered as “conditional approval”. This means that the drug can be sold only in hospitals andother medical service institutes (both government and private sector) under supervision of physicians
and at the same time the safety monitoring program (SMP) has to be conducted by the drug company.
The SMP will be run for at least 2 years period. After the monitoring period, the company will have to－173－submit all safety data (both local and foreign drug experience information) to FDA to review with theexpert and if satisfactorily would get an “unconditional approval”. Then, the drug can be distributed
through normal market channels.

Afterward, post marketing surveillance will be continued byvoluntary spontaneous adverse drug reaction monitoring system.
New Generic Drugs
There are 2 parts of documents to be submitted (ACTD).
Part 1: Administrative Data and Product Information
Part 2: Quality Document plus bioequivalence study report (or therapeutic equivalence
study) to provide evidence of equivalency with the original product.
Generic Drugs
The dossier requirements for this type of registration are the least complex among all
modern drugs. There are 2 parts of documents to be submitted (ACTD).
Part 1: Administrative Data and Product Information
Part 2: Quality Document
Bioequivalence study reports are required for some generic drugs (antiretroviral drugs,
postcoital contraceptives and sustained release dosage form)
Biological Products
For the purpose of assessment and registration, biological products are classified into new
drugs, new generics and generic drugs, in parallel to the scheme used for registration of chemical
entities.
Traditional Drugs
The registration of drugs for this group is much simpler than that of the modern drugs. The
dossier requirements are as follows: application form, drug sample, drug formular and manufacturing
process, labeling and packaging, certificate of analysis of microbial contamination.
Veterinary Drugs
The following documents are required: application form, drug sample, pharmacological andtoxicological study (if any), clinical trials, safety and efficacy study (if any), complete drug formula,drug literature, labeling and packaging.

－174－

Table 1 Number of pharmaceutical products registered in Thailand (data on April 2009)
Human use

Types of drugs

Veterinary use

total

manufacture

importmanufacture

importModern drugs

19,462

5,544

2,040

1,714

28,760

Traditional

11,407

856

116

6

12,025drugs
Source: Drug Control Division, Food and Drug Administration of Thailand.

4) Pharmaceutical inspection including quality control check system
There are 3 main offices responsible for pharmaceutical inspection.
1. Thai FDA
1.1 Post-Marketing Inspection Section- inspect all modern pharmaceutical manufacturers.
- inspect traditional pharmaceutical manufacturers in Bangkok area.
- inspect pharmaceutical importers/pharmacies in Bangkok area.
1.2 Import and Export Inspection Division- monitor and surveillance the health products at the custom and ports (seaports/airports).
1.3 Rural and Local Consumer Health Products Promotion Protection Division- collaboration and supervision the Provincial Health Offices to monitor andsurveillance the health products in the province.
2. Provincial Health Offices (local monitoring and surveillance agency)-

monitorandsurveillancethepharmacy/importer/

traditional

pharmaceuticalmanufacturer located in the province.
3. Department of Medical Science- perform the analysis/test for the health products which is sampling by the Thai FDA.
Thai FDA monitors the quality as assurance program of pharmaceutical products in themarket by collaboration with Department of Medical Sciences (DMS). The results of analysis from－175－

DMS would be complied and the recommendation would be made for the authorities to take oversome actions in order to correct the existed efficiencies. There are 5 types of inspection program:
regular inspection (planned), follow-up inspection, suspected or petition inspection, establishedinspection and GMP evaluation inspection.

5) Good Manufacturing Practice (GMP)
Quality assurance of pharmaceutical product safety and efficacy before marketing canundoubtedly be achieved through Good Manufacturing Practice.

Inspection of pharmaceuticalmanufacturers and sampling of pharmaceutical samples from manufacturers, importers or retailpharmacies for analyses by the regulatory authorities cannot effectively solve the cause of tha
encountering problems.

Pharmaceutical manufacturers, importers and distributors must establish

their quality system according to the GMP guidelines to ensure that the pharmaceutical products haveand always maintain the quality as claimed.
Thai FDA has started campaigning on GMP compliances since 1984.

A project on

development of local manufacturing standards in pharmaceutical industry is therefore stipulated in the
Sixth (1987-1991) and also in the Seventh (1992-1996) 0f the National Economic and Social
Development Plan. The aim of the project is to promote and support pharmaceutical manufacturers
on implementing Good Manufacturing Practice. A current code of Thai Good Manufacturing Practice
was published in 1987 as the FDA recommended guideline.
Activities that have been carried out towards accomplishment of the goal are as follows:
1. Organizing a national seminar on GMP once a year and periodically training programs forboth government and private personnel.
2. Production and dissemination of technical documents, slides and videos on upgrading andtraining technical skills of personnel in pharmaceutical industry.
3. Conducting regular GMP monitoring and auditing with recommendations to pharmaceuticalmanufacturers if violation to Good Manufacturing Practice is found.
4. Revision of ministerial regulations to make GMP compulsory in pharmaceutical industry.
5. Audit and evaluation of pharmaceutical manufacturers according to GMP compliances.
Since 1992, it has been compulsory that drugs purchased under the allocated government
budget must be from GMP certified manufacturers. In addition, the FDA has requested collaboration－176－

from retail pharmacy stores to do the same. In 2003, GMP for modern pharmaceutical product has
become to the law for the first time on March 2003. As the result, every modern pharmaceuticalmanufacturer must comply with GMP. GMP code is developed in accordance with the WHO GMP
guideline.
GMP for traditional pharmaceutical manufacturers has adopted from ASEAN guideline 1993
(GMP Guidelines for the Manufacture of Herbal Medicinal Products). At present, there are 14 of 987
traditional pharmaceutical manufacturers received GMP Certificate.
PIC/S Regulatory Up date for Thailand
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation
Scheme (jointly referred to as PIC/S) are two international instruments between countries andpharmaceutical inspection authorities, which provide together an active and constructive co-operationin the field of GMP. ASEAN member countries has been already signed ASEAN Sectoral MRA for
GMP Inspection of manufacturers of medicinal products on 10 April 2009, which in its principal, theASEAN member state have to adopt PIC/S GMP guide or equivalent GMP code and the inspection
service has adopted PIC/S quality system requirements. Thai FDA has submitted application to PIC/S
since 2006. At present, Thai FDA is under the process of PIC/S assessment and the Thai GMP’sregulation has been revising, adopted the PIC/S Guide, which will be finished within the end of 2009.

6) Post Marketing Surveillance system (PMS)
Inspection and surveillance of drugs and of facilities and drug advertising are necessary toensure the quality, efficacy, safety and legality of drug products on the market.

Inspection of

manufacturing sites for GMP compliance, monitor advertisement and products in the market for
substandard, adulteration, counterfeiting, misleading, exaggerating and hazard to the public areroutinely carried out. Medicines that are unregistered will be recalled and those that may present
hazards to consumers will be destroyed. In addition, the registered drug products are periodically reevaluated.
The monitoring about side effects or adverse drug reactions from drug users has been
performed by center namely the National Adverse Drug Reactions Monitoring Center (NADRM),
established by FDA, collecting, analyzing and compiling all evidences related to adverse drug
reactions, by applying the principal and knowledge of epidemiology and statistics. The main purpose－177－

is to find out the degree and causes of problems on drugs and report these events, make comments
and solutions to the drug committee and FDA to determine.

7) Sale and distribution of drugs (ethical and OTC)
The drug distributors could be divided to 3 levels as follows:
Level 1 (National level): The drug manufacturers , importers and the Government
Pharmaceutical Organization distribute drug to government and private hospitals, health centers anddrug stores. Thai FDA who is responsible for distribution of narcotic drug and some psychotropic
substances are also included in this level.
Level 2 (District level): Wholesalers including drugstores situated in each province distribute
drug to drug stores and clinics.
Level 3 (Consumer level): The drug products are distributed to consumer via distributors
such as government and private hospitals, drug stores, clinics etc.
Ethical drugs
1. Psychotropic substance schedule 2: The sale restricted to psychotropic substanceschedule 2. Only hospitals can purchase directly from FDA – Ministry of Public Health.
2. Psychotropic substance schedule 3 and 4: The sale restricted to psychotropic substanceschedule 3 and 4 license holder.

A first grade pharmacist should be on duty.

Psychotropic substance schedule 3 and 4 supplies to the public that is on prescription
only. Monthly and yearly purchase and sale report should be submitted to FDA - Ministryof Public Health.
3. Narcotic drug scheduled 3: The sale restricted to Narcotic drug scheduled 3 license
holders. A first grade pharmacist should be on duty. Narcotic drug scheduled 3 supplies
to the public, which is on prescription only. Monthly and yearly purchase and sale report
should be submitted to FDA - Ministry of Public Health.
4. Special controlled drug: A first grade pharmacist shall be on duty at the premises sellingmodern drugs. Sale to public is on prescription only. Daily purchase and sale record
required.

－178－

5. Dangerous drug: A first grade pharmacist should be on duty at the premises sellingmodern drugs, at all time, while the premises are open for operation. Daily purchase andsale record required.
6. Non dangerous drug: A first grade pharmacist, second grade pharmacist, a person
engaging in the medical profession, a person engaging in the modern medical practice,in the branches of dentistry, obstetrics and nursing should be on duty at the premises
selling modern non dangerous drugs.
OTC drugs
At present, drugs for household remedies can be purchased in the stores without
prescription and pharmacist suggestion.

8) Additional requirements for biological (vaccines) and antibiotics such as
National Test System (if any)Special restriction imposed on biological products is the control at lot level. A certificate of lot
release for biological products issued by the Thai Department of Medical Science (in case of locallymanufactured and imported products) or by relevant agency in the manufacturing country (in case ofimported products) is required before the sale of each batch of biological.

－179－5)Present situation and future plan (ex. National plan, introductionof GMP concept etc.) in the National drug policy including essential
drugs and traditional medicine.
The National Policy on Drugs intends to assure standard quality of local productivity, availability,
accessibility (or effective distribution) and rational utilization of quality drugs, in terms of therapeutic
efficacy and safety of drugs. The policy can succeed by collaborative interactions government andprivate sectors.
The national policy is aimed at many aspects as follows:
1. Availability and accessibility of quality drugs, in terms of therapeutic efficacy and safety to
all at reasonable prices.
2. Encouragement on rational use of drugs in such a way that waste and over-consumption ofdrugs are minimized.
3. Upgrading and promotion of domestic pharmaceutical industry, leading toward self reliancewith emphasis on research and development as well as production for export.
4. Advocating on local manufacturing of raw materials from locally available resources fordomestic supply and for export.
5. Support particular studies, for example, research and development activities on disease
prevention, general health care and potential therapeutic efficacies, safety and efficientutilization of herbs, herbal medicines and traditional medicines.
6. Campaign on recognition and adoption of the National Essential Drug List in bothgovernment and private sectors.
7. Improvement of efficiency in legislative administration, strengthening the enforcement oflaws, rules and regulations on drugs in favor of consumer protection.
The Drug Control Division acts as coordinator in the making of national policy regarding drugs
in order to determine the direction of drug development as a whole and the translation of policy into
practice. Important tasks are as follows:-

Development of the national list of essential drugs-

Promotion of rational drug use-

Amendment of legislation, regulation and notification regarding drugs

－180－

-

Research and analysis-

Improvement of the strength, capacity and sustainability of the domestic drug industry
The division also works on important projects such as the drug quality assurance project, thepromotion of quality system in pharmacy dispensaries project, the support for ASEAN Harmonization
on registration of pharmaceutical products.

Development of the national essential drug list (NEDL)
Updating the national essential drug list (NEDL) is a continuous process for the public benefitson accessibility to essential drugs when needed. The national drug committee, chaired by the Ministerof Public Health, has appointed a subcommittee, chaired by the Minister’s Advisor on Public Health
Economics, on March 29, 2007, to revise and update the NEDL 2004 coping up with the current
medical and public health situations. The subcommittee has appointed 16 working groups, consistingof over 200 experts, physicians and pharmacists covering the entire areas if medicine profession.
The current NEDL 2008, which has become effective since January 23, 2008, contains threekinds of list: a list to be used in public hospitals and health care units, a list for herbal medicines and alist for hospital formulary.

Promotion of rational drug use
The FDA has adopted a pilot project to promote rational use of drugs, starting with the“Antibiotics Smart Use Project” since August 2006, with some of the budget provided by the World
Health Organization. The project is intended to reduce the problems arising from bacterial resistanceas well as risks from the use of antibiotics. The project was first implemented in Saraburi to create amodel of appropriate prescribing and use of antibiotics in community hospitals and public healthcenters. Significant strategies in changing the use of antibiotics are as follows:-

Educational measures, which involve training courses in operational areas with media andequipment, consisting of a manual on rational antibiotic use, DVD, technical lectures, posters ,pamphlets, VCD, and a newsletter-

Management measures, which involve support of media and equipment-

Social measures, which involves reward, praise and trend setting-

Policy measures : Saraburi Public Health Office’s approval and support of the project－181－

The pilot project ended in August 2007. However, the Antibiotics Smart Use has been adapted
as practice in other provinces with the collaboration between FDA and other related organizations.

Support for ASEAN Harmonization on registration of pharmaceutical products
The most important thing that has just been emerged in the drug registration process is theASEAN harmonized registration scheme. The ASEAN working group on this matter established since1999 has adopted the common technical requirements as well as a dossier used for market approval
application.

It is mandatory for ASEAN members to implement the ASEAN Common TechnicalRequirements (ACTR) and ASEAN Common Technical Dossier (ACTD) by the end of the year 2008.
Thai FDA issued a notification on the full implementation of the ASEAN Harmonization of
Pharmaceutical Product Registration on December 26, 2008. According to the notification, the FDA
would accept applications in the full format of ASEAN Harmonization from January 1, 2009.

Development and standardization of drug manufacturer
This is intended as preparation for membership of PIC/S (please see the topic “PIC/S
Regulatory Up date for Thailand”).

－182－6)Drug supply system and drug price mechanism including local
products, imported and exported drugs
Drug supply system
The quality of domestically produced drugs has much imported as a result, in part, of thepromotion of Good Manufacturing Practices (GMP). In 2003, the Ministry of Public Health issued arule requiring that all pharmaceutical manufacturers have a GMP certification.
During the economic booming period 1988-1996, with the monopolies of new drugs, theproportion of imported drugs had a rising trend. Even after the economic crisis, since 2002, theimport trend had been rising steadily, up to 56.3% in 2005. When considering the values of local
production and drug imports, the trends rose steadily, except for a slightly downward trend for
production in 2005, while the import values rose and surpassed the production values for the same
year, the difference being approximately nine billion baht.
In addition to production and dispensing of drugs for domestic consumption, some drugs areexported to other countries, the export values rising from 480.8 million baht in 1989 to 6958.3 million
baht in 2006.
In 2005, drug consumption of Thai people accounted for approximately 103,517 million baht inwholesale prices or 186,331 million baht in retail prices, or 42.8 % of the overall national healthexpenditure. According to the market survey data by IMS company Thailand (in 2006), drugs are
distributed through the following channels: drugstores 24%, public and private hospitals 66%, private
clinic and Government Pharmaceutical Organization (GPO) 8 % and others 2 %.

Drug price mechanism
The drug pricing in Thailand is controlled through the following mechanisms:
1. Market mechanism allowing free competition among generics, and competition among
drugs under the same category.
2. Direct price control under the Price fixing and Antitrust Act, enforce by the Ministry ofCommerce.
3. Medium pricing designated for the sale of essential drugs in public facilities. The
medium price list is a price control mechanism established by the government foressential drug. The medium price list has been effective from 1986 and guides the－183－purchasing committees in price negotiations. The government has also establishedthe new policy for procurement of drugs, whereby the hospitals have to use not lessthan 80 % of the government allocated money to buy the essentials drugs.
4. Patented drug pricing control designed by the Committee on Patented Drug appointed
under the 1992 Patent Act.

－184－7)Pharmacopoeia
In the previous day, the official standards for pharmaceutical products are as set forth in theforeign pharmacopoeia only e.g. British Pharmacopoeia, United States Pharmacopoeia.

Someproblems have been encountered due to the discrepancies between the standards of thepharmacopoeia. Some methods or standards do not fit in with the real situation in Thailand. The Thai
Pharmacopoeia Committee has been therefore appointed by the Ministerial Cabinet to establish theThai Pharmacopoeia (TP) which defines national standards to assure the quality of pharmaceuticalproducts.

TP comprises the recommenced methods and specifications that aim primarily ataccommodation the needs of the country. TP also provides information of drug safety and stability i.e.
information on dose, contraindication, warning etc. for the benefit of dispensing drugs and important
information for drugs which tend to decompose in hot humid weather.
According to the Notification of the Ministry of Public Health 2006, the official Pharmacopoeia
for modern drugs is as follows:
1. Thai Pharmacopoeia Volume I Part 1, Part 2 and Supplements
2. Thai Pharmacopoeia Volume II Part 1, Part 2, Part 3 and Supplements
3. Thai Herbal Pharmacopoeia Volume I and Supplements
4. Thai Herbal Pharmacopoeia Volume II and Supplements
5. International Pharmacopoeia 3rd edition and Supplements
6. United States Pharmacopoeia 22nd Revision 2004 and Supplements
7. British Pharmacopoeia 2004 Volume 1-4 and Addenda
8. British Pharmacopoeia (Veterinary) 1998 and Supplements－185－8)List of References
1. FDA Thailand, Third Edition 2001, Technical Division. The Office of Food and Drug
Administration. Ministry of Public Health, Thailand.
2. FDA Thailand, Third Edition (revised in 2004), Technical Development & Foreign Affairs
Division. The Office of Food and Drug Administration. Ministry of Public Health, Thailand.
3. The website of Food and Drug Administration Thailand (www. fda. moph.go.th)
4. Thailand Health Profile 2005-2007, Bureau of Policy and Strategy, Ministry of Public Health,Thailand.

－186－

－187－

Office of the Permanent
Secretary
Provincial Administration

Accreditation(Act required)

Institute of Hospital Quality Improvement and

•

•
•

•

Department of Health Service
SupportDepartment of Medical Sciences
Food and Drug Administration

Office of the National HealthCommission•

Health facilities (Royal Decree enacted for Ban Phaeo Hospital)

Public organization (Royal Decrees required)Department of Disease Control
Department of Health

Government Pharmaceutical Organization••

Source: Thailand Health Profile 2005-2007, Bureau of Policy andStrategy, MOPH.

•

State Enterprise:

Department of Medical Services
Department for Development of Thai
Traditional and Alternative Medicine
Department of Mental Health

Health system Research InstituteNational Health Security Office
Praboromarajchanok Institute of Health Workforce
Development (Act required)
National Institute of Health (Act required)
Institute of Emergency Medical Services (Actrequired)

•

•
•

•
•
•
•
•
•

Agencies under the supervision of MOPH:••

Professional Councils

Figure 1 Organization of Ministry of Public Health－188－

Figure 2 Organization of Food and Drug Administration (Source: Technical and Planning Division, FDA)

－189－

Source: Drug Control Division, Food and Drug Administration.

Figure 3 Organization of Drug Control Division

－190－

Source: Drug Control Division, Food and Drug Administration.

Figure 4 Drug Registration Process

－191－