Global Regulatory Agencies

Effective regulation of medicines requires a variety of functions, including evaluating the safety and efficacy data from clinical trials and licensing and inspecting manufacturing facilities and distribution channels. Other main tasks include monitoring adverse drug reactions for investigational and marketed drugs, and controlling drug promotion and advertising.

In some countries all functions related to drug regulation are handled by a single agency, while in others, state or provincial governments have some regulatory authority.

Regulatory Agencies around the World

Here is a list of some regulatory agencies around the world.

Africa

Benin
Ministry of Health (in French)

Botswana
Ministry of Health

Egypt
Ministry of Health

Ghana
Ministry of Health

Kenya
Ministry of Health

Maldives
Ministry of Health

Mauritius
Ministry of Health and Quality of Life

Morocco
Ministry of Public Health (in French)

Namibia
Ministry of Health and Social Services

Senegal
Ministry of Health and Prevention (in French)

South Africa
Department of Health
Medicines Control Council

Tanzania
Ministry of Health and Social Welfare

Tunisia
Ministry of Public Health (in French)
Office of Pharmacy and Medicines (in French)

Uganda
Ministry of Health

Zimbabwe
Ministry of Health and Child Welfare

Americas

Argentina
Ministry of Health (in Spanish)
ANMAT (in Spanish)

Belize
Ministry of Health

Bolivia
Ministry of Health and Social Welfare (in Spanish)

Brazil
Ministry of Health (in Portuguese)
National Health Surveillance Agency (in Portuguese)

Canada
Health Canada

Chile
Health Ministry (in Spanish)
Institute of Public Health (in Spanish)

Columbia
Ministry of Social Affairs (in Spanish)
INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos (in Spanish)

Costa Rica
Ministry of Health (in Spanish)

Ecuador
Ministry of Public Health (in Spanish)

El Salvador
Ministry of Public Health and Social Assistance (in Spanish)

Guatemala
Ministry of Health (in Spanish)

Guyana
Ministry of Health

Jamaica
Ministry of Health

Mexico
Ministry of Health (in Spanish)
Federal Commission for Protection against Health Risks
(in Spanish)

Netherlands Antilles
Department of Public Health and Environmental Protection

Nicaragua
Ministry of Health (in Spanish)

Panama
Ministry of Health (in Spanish)

Paraguay
Ministry of Public Health

Peru
Ministry of Health (in Spanish)
National Institute of Health

Trinidad and Tobago
Ministry of Health
Bureau of Standards

United States
Food and Drug Administration
National Institutes of Health

Uruguay
Ministry of Public Health (in Spanish)

Venezuela
Ministry of Health and Social Development (in Spanish)

Asia Pacific

Australia
Department of Health
Therapeutic Goods Administration
National Health and Medical Research Council

Brunei
Ministry of Health

China
Ministry of Health (in Chinese)
National Institute for the Control of Pharmaceutical and Biological Products (in Chinese)

Fiji
Ministry of Health

Hong Kong
Department of Health

India
Ministry of Health and Family Welfare
Central Drug Standards Control Organisation
Indian Council of Medical Research

Indonesia
Ministry of Health

Japan
Ministry of Health, Labour and Welfare
NIHS Division of Drugs

Malaysia
National Pharmaceutical Control Bureau
Ministry of Health – Pharmaceutical Services Division

New Zealand
Ministry of Health
Medicines and Medical Devices Safety Authority

Papua New Guinea
Department of Health

Philippines
Department of Health

Singapore
Health Sciences Authority
Ministry of Health

South Korea
Food and Drug Administration

Europe, including Armenia, Georgia, Russia and Turkey

European Union
European Agency for the Evaluation of Medicinal Products
Health-EU

Andorra
Ministry of Health and Welfare (in Catalan)

Armenia
Ministry of Health
Drug and Medical Technology Agency

Austria
Secretariat of Health (in German)

Belgium
Federal Public Service (FPS) Health, Food Chain Safety and Environment

Bulgaria
Ministry of Health (in Bulgarian)
Drug Agency

Croatia
Ministry of Health (in Croatian)

Czech Republic
Ministry of Health (in Czech)
State Institute for Drug Control

Denmark
Ministry of Health and Prevention

Estonia
State Agency of Medicines

Finland
Ministry of Social Affairs and Health
National Agency for Medicines

France
Agence Francaise de Securite Sanitaire des Produits de Sante
(in French)
Agence Francaise de Securite Sanitaire des Aliments
Ministry of Health and Sports (in French)

Georgia
Ministry of Labor, Health and Social Protection

Germany
Ministry of Health
Federal Institute for Drugs and Medical Devices
Robert Koch Institute (mostly in German)
Paul Ehrlich Institute (mostly in German)

Greece
National Organization for Medicines

Hungary
Ministry of Health, Social and Family Affairs
National Institute of Pharmacy

Iceland
Ministry of Health
Medicines Control Agency

Ireland
Department of Health and Children
Medicines Board

Italy
Ministry of Health (in Italian)
Istituto Superiore di Sanità (ISS)

Latvia
State Agency of Medicines

Lithuania
Ministry of Health
State Medicines Control Agency

Luxembourg
Ministry of Health (in French)

Malta
Ministry for Social Policy, Health, the Elderly and Community Care

Netherlands
Ministry of Health, Welfare and Sport
Medicines Evaluation Board

Norway
Ministry of Health and Care Services
Norwegian Board of Health Supervision
Norwegian Medicines Agency (in Norwegian)

Poland
Ministry of Health and Social Security (in Polish)
National Medicines Institute

Portugal
Ministry of Health (in Portuguese)
National Institute of Pharmacy and Medicines (in Portuguese)

Romania
Ministry of Health and the Family (in Romanian)

Russia
Ministry of Health

San Marino
Ministry of Health and Social Security (in Italian)

Serbia
Agency for Medicinal Products

Slovak Republic
Ministry of Health (in Slovak)
State Institute of Drug Control

Slovenia
Ministry of Health (in Slovenian)

Spain
Ministry of Health and Consumption (in Spanish)

Sweden
Medical Products Agency
National Board of Health and Welfare

Switzerland
Federal Office of Public Health
Agency for Therapeutic Products

Turkey
Ministry of Health (in Turkish)

Ukraine
Ministry of Health

United Kingdom
Department of Health
Health Protection Agency
Medicines and Healthcare Products Regulatory Agency
National Institute for Biological Standards and Control

Middle East

Bahrain
Ministry of Health

Israel
Ministry of Health

Jordan
Ministry of Health

Lebanon
Ministry of Public Health

Palestinian Authority
Ministry of Health

Saudi Arabia
Ministry of Health

United Arab Emirates
Ministry of Health

Yemen
Ministry of Public Health & Population