Connecting Pharmaceutical Knowledge
Regulatory Resources
Worldwide Regulatory Agencies
- 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)
- 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
- 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
- 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 America
Regional/Harmonization Organizations
- Mercado Comun del Sur (MERCOSUR)
- Pan American Health Organization
- Pan American Network for Drug Regulatory Harmonization (PANDRH)
- 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
- Middle East
- Africa
- 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
