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.”

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