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Home
Initiatives
Regulatory
Regulatory Resources
Regulatory Resources
International Regulatory, Standards, and Harmonization Organizations
ANDEAN Community
International Coalition of Medicines Regulatory Authorities
International Conference on Harmonisation (ICH)
IPEC Federation
International Generic Drug Regulators Programme
International Medical Device Regulators Forum
International Organization for Standardization (ISO)
International Pharmaceutical Regulators Forum (IPRF)
Organisation for Economic Co-operation and Development (OECD): Good Laboratory Practice (GLP)
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)
United Nations - Global Health
World Health Organization (WHO)
World Intellectual Property Organization (WIPO)
Regional & National Regulatory Authorities
Africa
Algeria: Directorate of Pharmacy and Medicine
Botswana: Ministry of Health
Egypt: Egyptian Drug Authority
Ghana: Food and Drugs Authority
Kenya: Pharmacy & Poisons Board
Morocco: Ministry of Health (French)
Namibia: Namibia Medicines Regulatory Council
South Africa: Medicines Control Council
Sudan: National Medicines and Poisons Board
Tanzania Food and Drugs Authority
Tunisia: Directorate of Pharmacy and Medicine
Uganda: National Drug Authority
Zimbabwe: Medicines Control Authority of Zimbabwe
Asia - Pacific
Regional/Harmonization Organizations
ASIAN Harmonization Working Party (AHWP)
Asia Pacific Economic Cooperation (APEC)
Association of Southeast Asian Nations (ASEAN)
National Authorities
Bangladesh: Directorate General of Drug Administration (DGDA)
Brunei Darussalam: Ministry of Health
China: China Food and Drug Administration
Hong Kong: Drug Office, Department of Health
India: Central Drugs Standard Control Organization (CDSCO)
Indonesia: The National Agency of Drug and Food Control
Republic of Korea: Ministry of Food and Drug Safety, Korea Food and Drug Administration
Malaysia: National Pharmaceutical Control Bureau
Mongolia: Ministry of Health
Nepal: Department of Drug Administration
Philippines: Department of Health, Philippine Food and Drug Administration
Singapore: Health Sciences Authority (HSA), Health Products Regulation Group (HPRG)
Sri Lanka: Ministry of Health
Taiwan Food and Drug Administration (TDFA)
Thailand: Food and Drug Administration
Vietnam: Drug Administration of Vietnam
Australia - New Zealand
Regional/Harmonization Organization
Australia New Zealand Therapeutic Product Agency (ANZTPA)
Australia
Australia: Therapeutic Goods Administration (TGA)
Australian Department of Health: Expert Review of Medicines and Medical Devices Regulation
New Zealand
New Zealand: Medicines and Medical Devices Safety Authority
Europe
Regional/Harmonization Organizations
European Medicines Agency (EMA)
European Heads of Medicines Agencies
European Directorate for the Quality of Medicines& Healthcare
European Commission: Medicinal products for human use
National Authorities
Armenia: Scientific Centre of drug and medical technology expertise
Austria: Austrian Agency for Health and Food Safety
Azerbaijan: Azerbaijan Ministry of Health
Belarus: Center for Examinations and Tests in Health Service
Belgium: Federal Agency for Medicines and Health Products (FAMHP)
Bulgaria: Bulgarian Drug Agency
Croatia: Agency for Medicinal Products and Medical Devices of Croatia
Czech Republic - State Institute for Drug Control
Denmark: Danish Medicines Authority
Estonia - State Agency of Medicines
Finland - Finnish Medicines Agency
France - French National Agency for the Safety of Medicine Health Products (ANSM)
Germany: Federal Institute for Drugs and Medical Devices (BfArM)
Greece: National Organization for Medicines
Hungary: National Institute of Pharmacy and Nutrition
Iceland: Icelandic Medicines Agency
Ireland: Health Products Regulatory Authority (HPRA)
Italy: Italian Medicines Agency
Kazakhstan: National Center for Drug Expertise, Medical Devices and Medical Equipment
Latvia: State Agency of Medicines
Liechtenstein: Office of Health/Department of Pharmaceuticals
Lithuania: State Medicines Control Agency
Luxembourg: Ministry of Health
Malta: Medicines Authority
Netherlands: Healthcare Inspectorate
Netherlands: Medicines Evaluation Board
Norway - The Norwegian Medicines Agency
Poland: Chief Pharmaceutical Inspectorate
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Authority of Medicines and Health Products, IP (INFARMED)
Romania: National Agency for Medicines Agency
Russian Federation: Ministry of Public Health
Slovakia: State Institute for Drug Control (SIDC)
Slovenia: Agency for Medicinal Products and Medical Devices (ARSZMP)
Spain: Spanish Agency of Medicines and Medical Devices (AEMPS)
Sweden: Medical Products Agency (MPA)
Tajikistan: Ministry of Health of the Republic of Tajikistan
United Kingdom: Medicines and Healthcare Products Regulatory Agency (MHRA)
North and South America
Regional/Harmonization Organizations
Mercado Comun del Sur (MERCOSUR)
Pan American Health Organization
Pan American Network for Drug Regulatory Harmonization (PANDRH)
Central and South America Regulatory Authorities
Argentina: National Administration of Drugs, Food & Medical Technology
Brazil: Health Surveillance Agency (ANVISA)
Chile: Ministry of Health
Colombia: National Institute of Food and Drug Monitoring (INVIMA)
Costa Rica: Ministry of Health
Cuba: Center for State Control of Drugs, Medical Devices
Dominican Republic: Directorate General of Drugs and Pharmacies
Honduras: Directorate General of Health Regulation
Panama: Ministry of Health
Peru: Ministry of Health
Uruguay: Ministerio de Salud
Venezuela: National Institute of Hygiene
North America Regulatory Authorities
Canada: Health Canada
Mexico: Federal Commission for the Protection against Sanitary Risk (COFEPRIS)
United States: Food and Drug Administration (FDA)
Middle East
Jordan: Jordan Food and Drug Administration
Israel: Ministry of Health
Saudi Arabia: Saudi Food and Drug Authority
United Arab Emirates: Ministry of Health
Yemen: Supreme Commission for Drugs and Medical Appliances
GMPs
European Commission EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines
Health Canada Good Manufacturing Practices
International Conference on Harmonization (ICH): Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (APIs)
MHRA Good Manufacturing Guide
Pharmaceutical Inspection Cooperation Scheme (PIC/S): GMP Guides
TGA Good Manufacturing Practices
USFDA Good Manufacturing Practices
World Health Organization (WHO) GMP Guidelines
Pharmacopeias
World Health Organization (WHO) International Pharmacopeia
European Pharmacopoeia
Argentina: Farmacopea Argentina
Brazil: Farmacopeia Brasileira
India: Indian Pharmacopoeia Commission
Japan: Japanese Pharmacopoeia
United Kingdom: British Pharmacopeia
United States: United States Pharmacopeial Convention
Initiatives & Programs A to Z
Drug Shortages
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