International Council for Harmonisation

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.¹⁾

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)

¹⁾

Members & Observers. (2019). International Coalition for Harmonisation. https://archive.ph/JNNaY

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International Council for Harmonisation

Affiliations

Members

Observers