Regulatory Authorities in Pharmacovigilance you need to know

GlobalVigiPub provides you the free online pharmacovigilance training via the posts page on our website. This Guidance on drug safety is good enough to understand the Pharmacovigilance basics and get the roots of pharmacovigilance in detailed too. Just browse the posts and read to get the knowledge on Pharmacovigilance course

World wide Drug Regulatory Authorities in Pharmacovigilance and Interview Questions

European (EMEA), USA (FDA), UK (MHRA), Australia (TGA), India (CDSCO) are the well known Regulatories in Pharmacovigilance

International

 International Conference on Harmonisation (ICH)

 World Health Organization (WHO)

 World Trade Organization (WTO

Argentina

National Administration of Drugs, Food & Medical Technology (ANMAT)

Australia

Australia’s Department of Health and Aged Care

Therapeutic Goods Administration (TGA)

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Austria

Austrian Federal Office for Safety in Healthcare BASG https://www.basg.gv.at/en/about-us  https://www.ages.at/startseite/

Bahrain

National Health Regulatory Authority Bahrain  

Bangladesh

Directorate General of Drug Administration (DGDA)

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Belgium

The Federal Agency for Medicines and Health Products (FAMHP)

Botswana

Botswana Medicines Regulatory Authority (BoMRA)

Brazil

Brazilian Health Surveillance Agency   commonly known as ANVISA

Brunei

Ministry of Health

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Bulgaria

Bulgarian Drug Agency (BDA)

Canada

Health Canada

Chile

Ministry of Health

The Ministry of Health is the main health authority in Chile, while the Public Health Institute (ISP) is the regulatory authority responsible for enforcing the regulatory framework for pharmaceutical products.

China

National Medical Products Administration

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Colombia

National Institute of Drug and Food Surveillance (INVIMA)

Costa Rica

Ministry of Health

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Croatia

HALMED – Agency for Medicinal Products and Medical Devices

Cuba

Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)

Czech Republic

State Institute for Drug Control

Denmark

Danish Medicines Agency (DKMA)

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Egypt

Egyptian Drug Authority (EDA)

Estonia

State Agency of Medicines

Europe

European Medicines Agency (EMEA)

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 Fiji

Ministry of Health

Finland

Finnish Medicines Agency (Fimea)

France

Agence Française de Sécurité Sanitaire des Produits de Santé (ANSM)

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Georgia

Ministry of Labour Health and Social Affairs of Georgia

Germany

Federal Institute for Drugs and Medical Devices (BfArM)

Greece

National Organization for Medicines (EOF)

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Guam

Department of Public Health and Social Services

Guatemala

Ministry of Health and Welfare

Guyana

Ministry of Health

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Hong Kong

Department of Health

Hungary

National Institute of Pharmacy and Nutrition (OGYÉI)

Iceland

Icelandic Medicines Agency

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India

Central Drug Standard Control Organization (CDSCO)

Indonesia

National Agency for Drug and Food Control of Indonesia (NADFC)

Ireland

Formerly known as Irish Medicines Board which has been changed as HPRA since 2014 July

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Israel

Ministry of Health (MOH) Pharmaceutical Administration

Italy

Italian Medicines Agency

Japan

PMDA (Pharmaceuticals and Medical Devices Agency)

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Jamaica

Ministry of Health

Jordan

Jordan Food and Drug Administration (JFDA)

Kenya

The Pharmacy and Poisons Board

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Latvia

State Agency of Medicines of the Republic of Latvia

Lebanon

Republic of Lebanon Ministry of Public Health

Lithuania

State Medicines Control Agency of Lithuania

Luxembourg

Ministry of Health

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Malaysia

The National Pharmaceutical Regulatory Division (NPRA)

Maldives

Maldives Food and Drug Authority

Malta

Medicines Authority

Mauritius

Medicines Regulatory Authority (MRA)  

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Mexico

COFEPRIS stands for Comisión Federal para la Protección contra Riesgos Sanitarios

Morocco

Ministry of Health

Nepal

Department of Drug Administration (DDA)

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Netherlands

Medicines Evaluation Board Agency (MEB)

New Zealand

New Zealand Medicine and Medical Devices Safety Authority (MEDSAFE)

Nicaragua

Dirección General de Regulación Sanitaria

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Nigeria

National Agency for Food and Drug Administration and Control (NAFDAC)

Norway

Norwegian Medicines Agency

Pakistan

Drug Regulatory Authority of Pakistan

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Palestine

Medicines Regulatory Authority (MRA)

Panama

Ministry of Health

Papua New Guinea

Pharmaceutical Services Standards Branch (PSSB)

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Paraguay

Ministry of Health

Peru

Dirección General de Medicamentos, Insumos y Drogas (DIGEMID)

Phillipines

Phillippines Food and Drug Administration

Poland

Chief Pharmaceutical Inspectorate

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Portugal

The National Institute of Pharmacy and Medicines (Infarmed)

Romania

National Agency for Medicines and Medical Devices of Romania (NAMMDR)

Russia

Ministry of Health of the Russian Federation

Saudi Arabia

The Saudi Food & Drug Authority (SFDA)

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Senegal

Ministry of Health and Prevention

Serbia

Medicines and Medical Devices Agency (ALIMS)

Singapore

Health Sciences Authority (HSA)

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Slovak Republic

State Institute for Drug Control (SIDC)

Slovenia

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)

Sri Lanka

National Medicines Regulatory Authority (NMRA)

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South Africa

South African Health Products Regulatory Authority (SAHPRA) [formerly known as MCC]

South Korea

The Ministry of Food and Drug Safety (MFDS) which was formerly known as the Korea Food & Drug Administration or KFDA

Spain

Spanish Agency for Medicines and Health Products

Sweden

Medical Products Agency (MPA)

Switzerland

Swissmedic

Taiwain

Taiwan Food and Drug Administration (TFDA)

Thailand

Thai Food and Drug Administration (Thai FDA)

Trinidad and Tobago

Ministry of Public Health  

Tunisia

Ministry of Health

Turkey

Ministry of Health

Uganda

National Drug Authority

Ukraine

Ministry of Health

United Arab Emirates

Ministry of Health

UK

Medicines and Healthcare Products Regulatory Agency (MHRA)

Uruguary

Ministry of Public Health

USA

The Food and Drug Administration (FDA)

Vietnam

Ministry of Health

Yemen

Yemen Supreme Board of Drugs (SBD)

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