What are the Pharmaceutical regulatory authorities
Pharmaceutical regulatory authorities are established by the various countries with the objective, to ensure the quality, safety and efficacy of the pharmaceutical product, these products includes medicines and medical devices both.These Pharmaceutical regulatory bodies are working on certain set of the rules and regulation those are needs to be followed by the pharmaceutical manufacturer. These rules and regulation are related to the drug product registration, manufacturing, distribution, price control, marketing, research and development, and intellectual property protection.
- World Health Organization (WHO)
- World Trade Organization (WTO)
- International Conference on Harmonization (ICH)
- World Intellectual Property Organization (WIPO)
Every
country has its own Pharmaceutical
regulatory authority, which is responsible to enforce the rules and
regulations and issue the guidelines to regulate drug development process, licensing,
registration, manufacturing, marketing and labeling
of pharmaceutical products in their own regions.
For understanding on Pharmaceutical regulatory authorities of various counties let’s regionally categorize the globe;
|
Asia Pacific
|
1
|
Australia
|
Therapeutic goods administration (TGA)
|
|
2
|
Bangladesh
|
Directorate General of Drug Administration (DGDA)
|
|
|
3
|
Bhutan
|
Drug Regulatory Authorities
|
|
|
4
|
China
|
State Food and Drug Administration (SFDA)
|
|
|
5
|
India
|
Central Drug Standards Control Organization (CDSCO)
|
|
|
6
|
Indonesia
|
||
|
7
|
Japan
|
Ministry of Health, Labour and Welfare (MHLW)
|
|
|
8
|
Korea (South)
|
Ministry of Food and Drug Safety (MFDA)
|
|
|
9
|
Laos
|
Food and Drug Department
|
|
|
10
|
Malaysia
|
Ministry of Health (MOH)
|
|
|
11
|
Maldives
|
Maldives Food and Drug Authority
|
|
|
12
|
Nepal
|
Department of Drug Administration
|
|
|
13
|
New Zealand
|
New Zealand Medicine and Medical Devices Safety Authority
(MEDSAFE)
|
|
|
14
|
Philippines
|
Department of Health (DOH)
|
|
|
15
|
Singapore
|
Health Science Authorities (HSA)
|
|
|
16
|
Sri Lanka
|
Ministry of Health (MOH)
|
|
|
17
|
Taiwan
|
Taiwan Food and Drug Administration (TFDA)
|
|
|
18
|
Thailand
|
Food and drug Administration of Thailand
|
|
|
19
|
Vietnam
|
Drug administration
|
|
Africa
|
1
|
Algeria
|
Directorate of Pharmacy and Medicine
|
|
2
|
Botswana
|
Ministry of Health (MOH)
|
|
|
3
|
Burkina Faso
|
Le Ministère de la Santé
|
|
|
4
|
Ghana
|
Food and Drugs Authority
|
|
|
5
|
Kenya
|
Pharmacy and Poisons Board
|
|
|
6
|
Mauritius
|
Ministry of Health and Quality of Life
|
|
|
7
|
Morocco
|
Ministry of Health (French)
|
|
|
8
|
Namibia
|
Namibia Medicines Regulatory Council
|
|
|
9
|
Nigeria
|
National Agency for Food and Drug Administration and Control
|
|
|
10
|
Rwanda
|
Ministry of Health
|
|
|
11
|
Senegal
|
Ministère de la Santé et de l’Action Sociale
|
|
|
12
|
South Africa
|
Medicines Control Council (MCC)
|
|
|
13
|
Sudan
|
National Medicines and Poisons Board
|
|
|
14
|
Swaziland
|
Ministry of Health
|
|
|
15
|
Tanzania
|
Tanzania Food and Drug Authority (TFDA)
|
|
|
16
|
Tunisia
|
Directorate of Pharmacy and Medicine
|
|
|
17
|
Uganda
|
National Drug Authority
|
|
|
18
|
Zambia
|
Ministry of Health
|
|
|
19
|
Zimbabwe
|
Medicines Control Authority of Zimbabwe
|
|
Europe
|
1
|
Armenia
|
Scientific Centre of Drug and Medical
Technology Expertise
|
|
2
|
Austria
|
Agency for Health and Food Safety
(AGES)
|
|
|
3
|
Belgium
|
Federal Agency for Medicines and Health
Products
|
|
|
4
|
Bulgaria
|
Bulgarian Drug Agency
|
|
|
5
|
Croatia
|
Agency for Medicinal Products and Medical
Devices of Croatia
|
|
|
6
|
Cyprus
|
Ministry of Health
|
|
|
7
|
Czech Republic
|
State Institute for Drug
Control
|
|
|
8
|
Denmark
|
Danish Medicines Agency
|
|
|
9
|
Estonia
|
State Agency of Medicines
|
|
|
10
|
Finland
|
Finish Medicines Agency
|
|
|
11
|
France
|
Agence Nationale de Sécurité du
Medicament et des Produits de Santé
|
|
|
12
|
Germany
|
Federal Institute for Drugs and Medical
Devices
|
|
|
13
|
Greece
|
National Organisation for Medicines
|
|
|
14
|
Hungary
|
National Institute of Pharmacy
|
|
|
15
|
Iceland
|
Icelandic Medicines Agency
|
|
|
16
|
Ireland
|
Irish Medicines Board
|
|
|
17
|
Italy
|
National Institute of Health
|
|
|
18
|
Lithuania
|
State Medicines Control Agency
|
|
Middle East
|
1
|
Bahrain
|
National Health Information System
[I-SEHA]
|
|
2
|
Egypt
|
Ministry of Health
|
|
|
3
|
Iran
|
Ministry of Health
|
|
|
4
|
Israel
|
Ministry of Health
|
|
|
5
|
Jordan
|
Jordan Food and Drug Administration
|
|
|
6
|
Lebanon
|
Ministry of Public Health
|
|
|
7
|
Saudi Arabia
|
Saudi Food and Drug Authority
|
|
|
8
|
United Arab Emirates
|
Ministry of Health
|
|
Central / South
America
|
1
|
Argentina
|
Administración Nacional de Medicamentos,
Alimentos y TecnologÃa (ANMAT )
|
|
2
|
Brazil
|
Agencia Nacional de Vigilancia Sanitaria
(ANVISA)
|
|
|
3
|
Chile
|
Instituto de Salud Publico (ISP)
|
|
|
4
|
Columbia
|
Instituto Nacional de Vigilancia
Medicamentos y Alimentos (INVIMA)
|
|
|
5
|
Costa Rica
|
Ministerio de Salud
|
|
|
6
|
Cuba
|
CECMED [Centro para el Control Estatal de
Medicamentos, Equipos y Dispositivos Médicos]
|
|
|
7
|
Dominican Republic
|
Dirección General de Drogas y Farmacias
|
|
|
8
|
Jamaica
|
Ministry of Health
|
|
|
9
|
Mexico
|
Comisión Federal para la Protección contra
Riesgos Sanitarios (COFEPRIS)
|
|
|
10
|
Paraguay
|
Ministro de Salud Pública y Bienestar Social
|
|
|
11
|
Peru
|
Ministerio de Salud
|
|
|
12
|
Uruguay
|
Ministerio de Salud Publica
|
|
North America
|
1
|
Canada
|
Health Canada
|
|
2
|
United states of America
|
Food and Drug Administration (FDA)
|
|
|
3
|
Luxembourg
|
Ministry of Health
|
|
|
4
|
Malta
|
Maltese Medicines Authority
|
|
|
5
|
Moldova
|
Medicines Agency
|
|
|
6
|
Netherlands
|
Medicines Evaluation Board
|
|
|
7
|
Norway
|
Norwegian Medicines Agency
|
|
|
8
|
Poland
|
The Office for Registration of
Medicinal Products, Medical Devices and Biocidal Products
|
|
|
9
|
Portugal
|
National Authority of Medicines and Health
Products
|
|
|
10
|
Romania
|
National Medicines Agency
|
|
|
11
|
Russia
|
Ministry of Health of the Russian Federation
|
|
|
12
|
Serbia
|
Medicines and Medical Devices Agency of
Serbia
|
|
|
13
|
Slovakia
|
State Institute for Drug Control
|
|
|
14
|
Slovenia
|
Ministry of Health
|
|
|
15
|
Spain
|
Spanish Medicines Agency
|
|
|
16
|
Sweden
|
Medical Products Agency
|
|
|
17
|
Switzerland
|
Swiss Agency for Therapeutic Products
|
|
|
18
|
Ukraine
|
Ministry of Health
|
|
|
19
|
United Kingdom
|
Medicines and Healthcare Regulatory Agency
(MHRA)
|
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