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International Council for Harmonization
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)
Founding Regulatory Members
European Commission (EC) and European Medicines Agency (EMA) | U.S. Food and Drug Administration (FDA) | Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) of Japan |
Founding Industry Members
Standing Regulatory Members
Regulatory Members
Industry Members
Observers
Standing Observers
Legislative or Administrative Authorities
Analytical Expertise Center of Azerbaijan | Administración Nacional de Medicamentos, Alimentos y Tecnología Médica of Argentina (ANMAT) | Central Drugs Standard Control Organisation of India (CDSCO) |
Control Estatal de Medicamentos, Equipos y Dispositivos Médicos of Cuba | This section is incomplete. |
International Pharmaceutical Industry Organisations
International Organisations regulated or affected by ICH Guideline(s)
1)
Members & Observers. (2019). International Coalition for Harmonisation. https://archive.ph/JNNaY