Pharmaceutical Regulatory Agencies and Organizations

This article covers both drugs and device regulatory agencies/organizations across the globe. This article is last updated on 8^th March 2020.

International/Global Regulatory Organizations for Pharmaceuticals
WHO	World Health Organization	The World Health Organization is a specialised agency of the United Nations that is concerned with world public health. It was established on 7 April 1948.
ICH	The International Council for Harmonisation (formerly the International Conference on Harmonisation)	ICH plays major role in bringing together the medicines regulatory authorities and pharmaceutical industry around the world. ICH aims to achieve greater harmonisation worldwide for the development and approval of safe, effective, and high quality medicines in the most resource-efficient manner. It was founded in 1990.
PICS	The Pharmaceutical Inspection Co-operation Scheme	The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established in 1995 as an extension to the Pharmaceutical Inspection Convention (PIC) of 1970. PIC/S aims at harmonising inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to Inspectors. It also aims at facilitating co-operation and networking between competent authorities, regional and international organisations, thus increasing mutual confidence.
EMA	European Medicines Agency	The European Medicines Agency (EMA) is an agency of the European Union (EU 27) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).
EDQM	European directorate for the quality of medicines & healthcare	EDQM is a Directorate of the Council of Europe that is responsible for publishing and updatinggranting certificate of suitability,
APIC	Active Pharmaceutical Ingredient Committee	APIC has played and continues to play an important role in improving the regulatory environment for the API manufacturing industry and increasing patient safety.
IPEC	International Pharmaceutical Excipients Council	IPEC Federation is a global organisation that promotes quality and safety in pharmaceutical excipients.

Regulatory Authorities in Europe
Country	Drug Regulatory Authority	Medical Devices Regulatory Authority	Ministry of Health
European Union (EU 27)
Austria	Federal Office for Safety in Health Care (BASG)	Federal Office for Safety in Health Care (BASG)	Federal Ministry of Labour, Social Affairs, Health and Consumer Protection
Belgium	Federal Agency for Medicines and Health Products (FAMHP)	Federal Agency for Medicines and Health Products (FAMHP)	Federal Public Service (FPS) Health, Food Chain Safety and Environment
Bulgaria	Bulgarian Drug Agency (BDA)	Bulgarian Drug Agency (BDA)	Ministry of Health
Croatia	Agency for medicinal products and medical devices of Croatia (HALMED)	Agency for medicinal products and medical devices of Croatia (HALMED)	Ministry of Health
Cyprus	Ministry of Health – Pharmaceutical Services	Ministry of Health – Medical & Public Health Services, Cyprus Medical Devices Competent Authority	Ministry of Health
Czech Republic	State Institute for Drug Control (SUKL)	State Institute for Drug Control (SUKL)	Ministry of Health of the Czech Republic
Denmark	Danish Medicines Agency	Danish Medicines Agency	Ministry of Health
Estonia	Agency of Medicines	Health Board, Medical Devices	Ministry of Social Affairs
Finland	Finnish Medicines Agency (FIMEA)	Finnish Medicines Agency (FIMEA)	Ministry of Social Affairs and Health
France	National Agency for Medicines and Health Products Safety (ANSM)	National Agency for Medicines and Health Products Safety (ANSM)	Ministry for Solidarity and Health
Germany	Federal Institute for Drugs and Medical Devices (BfArM), Paul-Ehrlich-Institut (PEI)	Federal Institute for Drugs and Medical Devices (BfArM)	Federal Ministry of Health
Greece	National Organization for Medicines	National Organization for Medicines	Ministry of Health
Hungary	National Institute of Pharmacy and Nutrition	Department for Medical Devices, National Institute of Pharmacy	Ministry of Human Capacities
Ireland	Health Products Regulatory Authority (HPRA)	Health Products Regulatory Authority (HPRA)	Department of Health
Italy	Italian Medicines Agency (AIFA)	Directorate-General for Medical Devices and Pharmaceutical Service	Ministry of Health
Latvia	State Agency of Medicines	State Agency of Medicines	Ministry of Health of the Republic of Latvia
Lithuania	State Medicines Control Agency	State Health Care Accreditation Agency	Ministry of Health of the Republic of Lithuana
Luxembourg	Ministry of Health	Ministry of Health	Ministry of Health
Malta	Medicines Authority	Malta Competition and Consumer Affairs Authority	Ministry for Health
Netherlands	Medicines Evaluation Board, Farmatec	Farmatec	Ministry of Health, Welfare and Sport
Poland	Office for Registration of Medicinal Products, Medical Devices and Biocidal Products	Office for Registration of Medicinal Products, Medical Devices and Biocidal Products	Ministry of Health
Portugal	Infarmed	Infarmed	Ministry of Health
Romania	The National Agency for Medicines and Medical Devices (NAMMD)	The National Agency for Medicines and Medical Devices (NAMMD)	Ministry of Health
Slovakia	State Institute for Drug Control (SUKL)	State Institute for Drug Control (SUKL)	Ministry of Health of the Slovak Republic
Slovenia	Agency for Medicines and Medical Devices (JAZMP)	Agency for Medicines and Medical Devices (JAZMP)	Ministry of Health
Spain	Spanish Agency of Medicines and Medical Products (AEMPS)	Spanish Agency of Medicines and Medical Products (AEMPS)	Ministry of Health, Consumer Affairs and Social Welfare
Sweden	Medical Products Agency	Medical Products Agency	Ministry of Health and Social Affairs
European Free Trade Association (EFTA)
Iceland	Icelandic Medicines Agency	Icelandic Medicines Agency	Ministry of Health
Liechtenstein	Office of Health	Office of Health	Office of Health
Norway	Norwegian Medicines Agency	Norwegian Medicines Agency	Ministry of Health and Care Services
Switzerland	Swissmedic	Swissmedic	Federal Office of Public Health (FOPH)
Other Countries
United Kingdom	Medicines and Healthcare products Regulatory Agency (MHRA)	Medicines and Healthcare products Regulatory Agency (MHRA)	Department of Health and Social Care
Albania			Ministry of Health
Andorra			Ministry of Health
Belarus	Center for Expertise and Testing in Healthcare	Center for Expertise and Testing in Healthcare	Ministry of Health
Bosnia and Herzegovina	The Agency for Medicinal Product and Medical Devices	The Agency for Medicinal Product and Medical Devices	Federal Ministry of Health
Macedonia	Agency for Medicinal Products and Medical Devices	Agency for Medicinal Products and Medical Devices	Ministry of Health
Moldova	Medicines and Medical Devices Agency	Medicines and Medical Devices Agency	Ministry of Health, Labour and Social Protection
Montenegro	Agency for Medicines and Medical Devices of Montenegro	Agency for Medicines and Medical Devices of Montenegro	Ministry of Health
San Marino			Ministry of Health and Social Security
Serbia	Medicines and Medical Devices Agency of Serbia	Medicines and Medical Devices Agency of Serbia	Ministry of Health
Ukraine	State Service of Ukraine on Medicines and Drug Control	State Service of Ukraine on Medicines and Drug Control	Ministry of Health

Regulatory Authorities in Asia
Country	Drug Regulatory Authority	Medical Devices Regulatory Authority	Ministry of Health
East Asia
China	National Medical Products Administration (NMPA)	National Medical Products Administration (NMPA)	National Health Commission of the People’s Republic of China
Hong Kong	Drug Office - Department of Health	Medical Device Division – Department of Health	Department of Health
Japan	Pharmaceuticals and Medical Devices Agency (PMDA)	Pharmaceuticals and Medical Devices Agency (PMDA)	Ministry of Health Labor and Welfare (MHLW)
Mongolia			Ministry of Health and Sports
North Korea			Ministry of Public Health
South Korea	Ministry of Food and Drug Safety (MFDS)	Ministry of Food and Drug Safety (MFDS)	Ministry of Health and Welfare
Taiwan (ROC)	Food and Drug Administration (FDA)	Food and Drug Administration (FDA)	Ministry of Health and Welfare
South Asia
Afghanistan	General Directorate of Pharmaceutical Affairs, Ministry of Public Health	General Directorate of Pharmaceutical Affairs, Ministry of Public Health	Ministry of Public Health
Bangladesh	Directorate General of Drug Administration (DGDA)	Directorate General of Drug Administration (DGDA)	Ministry of Health and Family Welfare
Bhutan	Drug Regulatory Authority		Ministry of Health
India	Central Drugs Standard Control Organization (CDSCO)	Central Drugs Standard Control Organization (CDSCO)	Ministry of Health and Family Welfare
Maldives	Maldives Food and Drug Authority	Maldives Food and Drug Authority	Ministry of Health
Nepal	Department of Drug Administration (DDA)		Ministry of Health and Population
Pakistan	Drug Regulatory Authority of Pakistan (DRAP)	Drug Regulatory Authority of Pakistan (DRAP)	Ministry of National Health Services, Regulations and Coordination
Sri Lanka	National Medicines Regulatory Authority (NMRA)	National Medicines Regulatory Authority (NMRA)	Ministry of Health
Southeast Asia
Brunei			Ministry of Health
Cambodia	Department of Drugs and Food	Department of Drugs and Food	Ministry of Health
East Timor			Ministry of Health
Indonesia	National Agency of Drug and Food Control	Ministry of Health	Ministry of Health
Laos	Food and Drug Department	Food and Drug Department	Ministry of Health
Malaysia	National Pharmaceutical Regulatory Agency (NPRA)	Medical Device Authority (MDA)	Ministry of Health
Myanmar	Food and Drug Administration	Food and Drug Administration	Ministry of Health and Sports
Philippines	Food and Drug Administration	Food and Drug Administration	Department of Health
Singapore	Health Sciences Authority	Health Sciences Authority	Ministry of Health
Thailand	Food and Drug Administration	Food and Drug Administration	Ministry of Public Health
Vietnam	Drug Administration of Vietnam	Department of Medical Equipment and Health Works (DMEHW)	Ministry of Health
Western Asia/Middle East
Armenia	Scientific Centre of Drug and Medical Technology Expertise	Ministry of Health	Ministry of Health
Azerbaijan	Center for Analytical Examination		Ministry of Health
Bahrain	National Health Regulatory Authority (NHRA)	National Health Regulatory Authority (NHRA)	Ministry of Health
Cyprus	Pharmaceutical Services – Ministry of Health	Department of Medical and Public Health Services – Ministry of Health	Ministry of Health
Egypt	Egyptian Drug Authority	Egyptian Drug Authority	Ministry of Health and Population
Georgia			Ministry of Health, Labour and Social Affairs
Iran	Iran Food and Drug Administration	National Medical Device Directorate	Ministry of Health and Medical Education
Iraq	State Company for Provision of Medicines and Medical Appliances (KIMADIA)	State Company for Provision of Medicines and Medical Appliances (KIMADIA)	Ministry of Health
Israel	Ministry of Health – Pharmaceutical Division	Ministry of Health – Medical Device Division	Ministry of Health
Jordan	Jordan Food and Drug Administration	Jordan Food and Drug Administration	Ministry of Health
Kuwait	Kuwait Drug and Food Control Administration	Kuwait Drug and Food Control Administration	Ministry of Health
Lebanon	Ministry of Public Health	Ministry of Public Health	Ministry of Public Health
Oman	Directorate General of Pharmaceutical Affairs and Drug Control	Directorate General of Pharmaceutical Affairs and Drug Control	Ministry of Health
Palestine	General Directorate of Pharmacy	General Directorate of Pharmacy	Ministry of Health
Qatar	Pharmacy and Drug Control		Ministry of Public Health
Saudi Arabia	Saudi Food and Drug Authority	Saudi Food and Drug Authority	Ministry of Health
Syria	Directorate of Drug Control		Ministry of Health
Turkey	Turkish Medicines and Medical Devices Agency	Turkish Medicines and Medical Devices Agency	Ministry of Health
United Arab Emirates			Ministry of Health and Prevention
Yemen	Supreme Board for Medicine and Medical Appliances	Supreme Board for Medicine and Medical Appliances	Ministry of Public Health
North/Central Asia
Kazakhstan	National Center for Expertise of Medicines and Medical Devices	National Center for Expertise of Medicines and Medical Devices	Ministry of Healthcare
Kyrgyzstan	State Department of Medicine Provision and Medical Equipment	State Department of Medicine Provision and Medical Equipment	Ministry of Health
Russia	Federal Service for Surveillance in Healthcare (Roszdravnadzor)	Federal Service for Surveillance in Healthcare (Roszdravnadzor)	Ministry of Health
Tajikistan			Ministry of Health
Turkmenistan			Ministry of Health and Medical Industry
Uzbekistan	National Information and Analytical Center on Drugs Control		Ministry of Health
Oceania
Australia	Therapeutic Goods Administration (TGA)	Therapeutic Goods Administration (TGA)	Department of Health
New Zealand	Medicines and Medical Devices Safety Authority (MEDSAFE)	Medicines and Medical Devices Safety Authority (MEDSAFE)	Ministry of Health
Papua New Guinea	Pharmaceutical Services Standards Branch - National Department of Health	Pharmaceutical Services Standards Branch - National Department of Health	National Department of Health

Regulatory Authorities in Americas
Country	Drug Regulatory Authority	Medical Devices Regulatory Authority	Ministry of Health
Argentina	National Administration of Drugs,Foods and Medical Devices (ANMAT)	National Administration of Drugs,Foods and Medical Devices (ANMAT)
Brazil	Agencia Nacional de Vigilancia Sanitaria (ANVISA)	Agencia Nacional de Vigilancia Sanitaria (ANVISA)	Ministry of Health
Canada	Health Canada	Health Canada
Latin America	Panamerican health organization	Panamerican health organization
US	United States Food & Drug Administration (USFDA)	USFDA

Regulatory Authorities in Africa
Country	Drug Regulatory Authority	Medical Devices Regulatory Authority	Ministry of Health
South Africa	South African Health Products Regulatory Authority (SAHPRA)	South African Health Products Regulatory Authority  (SAHPRA)

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