====== International Council for Harmonisation ====== {{ ::ich-logo.png?200|}} The **International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use** (ICH) is a supra-national non-government organization "brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration." ===== Affiliations ===== ==== Members ==== ICH's membership consists of national regulatory bodies, non-governmental organizations and pharmaceutical industry interests. They are categorized into Members and Observers.((//Members & Observers.// (2019). International Coalition for Harmonisation. https://archive.ph/JNNaY)) Members include: * [[Agência Nacional de Vigilância Sanitária]] (ANVISA) * [[Biotechnology Innovation Organization]] (BIO) * [[Comisión Federal para la Protección contra Riesgos Sanitarios]] (COFEPRIS) * [[European Commission]] * [[European Federation of Pharmaceutical Industries and Associations]] (EFPIA) * [[European Medicines Agency]] (EMA) * [[Food and Drug Administration]] (FDA) * [[Global Self-Care Federation]] (GSCF) * [[Health Canada]] * [[Health Sciences Authority]] (HSA) * [[International Generic and Biosimilar Medicines Association]] (IGBA) * [[Japan Pharmaceutical Manufacturers Association]] (JPMA) * [[Ministry of Food and Drug Safety of the Republic of Korea]] (MFDS) * [[Ministry of Health, Labour and Welfare of Japan]] (MHLW) * [[National Medical Products Administration]] (NMPA) * [[Pharmaceutical Research and Manufacturers of America]] (PhRMA) * [[Pharmaceuticals and Medical Devices Agency]] (PMDA) * [[Saudi Food & Drug Authority]] (SFDA) * [[Swissmedic]] * [[Taiwan Food and Drug Administration]] (TFDA) * [[Turkish Medicines and Medical Devices Agency]] ==== Observers ==== Observers include: * [[Active Pharmaceutical Ingredients Committee]] (APIC) * [[Administración Nacional de Medicamentos, Alimentos y Tecnología Médica]] (ANMAT) * [[Asia-Pacific Economic Cooperation]] (APEC) * [[Association of Southeast Asian Nations]] (ASEAN) * [[Bill & Melinda Gates Foundation]] (BMGF) * [[Center for Analytical Expertise]] * [[Central Drugs Standard Control Organisation]] (CDSCO) * [[Control Estatal de Medicamentos, Equipos y Dispositivos Médicos]] (CECMED) * [[Council for International Organizations of Medical Sciences]] (CIOMS) * [[Directorate of Medical Technologies, Informatics & Research]] * [[East African Community]] (EAC) * [[Egyptian Drug Authority]] (EDA) * [[European Directorate for the Quality of Medicines & HealthCare]] (EDQM) * [[Federal Service for Surveillance of Healthcare]] * [[Gulf Health Council]] (GHC) * [[Indonesian Food and Drug Authority]] * [[Instituto Nacional de Vigilancia de Medicamentos y Alimentos]] (INVIMA) * [[International Federation of Pharmaceutical Manufacturers & Associations]] (IFPMA) * [[International Pharmaceutical Excipients Council Federation]] * [[Iran Food and Drug Administration]] (IDFA) * [[Jordan Food and Drug Administration]] (JFDA) * [[Medicines and Healthcare Products Regulatory Agency]] (MHRA) * [[Medicines and Medical Devices Agency]] (MMDA) * [[Ministry of Public Health of Lebanon]] * [[National Center for Expertise of Medicines and Medical Devices]] (NDDA) * [[National Pharmaceutical Regulatory Agency]] (NPRA) * [[Pan American Network for Drug Regulatory Harmonization]] (PANDRH) * [[Pharmaceutical Inspection Co-operation Scheme]] (PIC/S) * [[Scientific Centre of Drug and Medical Technology Expertise]] * [[South African Health Products Regulatory Authority]] (SAHPRA) * [[Southern African Development Community]] (SADC) * [[State Expert Center of the Ministry of Health of Ukraine]] (SECMOH) * [[Therapeutics Goods Administration]] (TGA) * [[United States Pharmacopeia]] (USP) * [[World Health Organization]] (WHO)