Current Members and Observers

As of November 2016, the ICH Association comprises the following Members and Observers:

Founding Regulatory Members

  • The European Commission (EC)
  • The US Food and Drug Administration (FDA)
  • The Ministry of Health, Labour and Welfare of Japan (MHLW) also represented by the Pharmaceuticals and Medical Devices Agency (PMDA)

Founding Industry Members

  • The European Federation of Pharmaceutical Industries and Associations (EFPIA)
  • The Japan Pharmaceutical Manufacturers Association (JPMA)
  • The Pharmaceutical Research and Manufacturers of America (PhRMA)


Standing Regulatory Members

  • The Health Canada
  • The Swissmedic


Regulatory Members

  • The Agência Nacional de Vigilância Sanitária (ANVISA, Brazil)
  • The Ministry of Food and Drug Safety (MFDS, Republic of Korea)


Industry Members

  • The Biotechnology Innovation Organisation (BIO)
  • The International Generic and Biosimilar Medicines Association (IGBA)
  • The World Self-Medication Industry (WSMI)


Standing Observers

  • The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
  • The World Health Organisation (WHO)



Legislative or Administrative Authorities

  • The Central Drugs Standard Control Organization (CDSCO, India)
  • The Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED, Cuba)
  • The Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS, Mexico)
  • The Health Sciences Authority (HSA, Singapore)
  • The Medicines Control Council (MCC, South Africa)
  • The National Center for the Expertise of Drugs, Medical Devices and Equipment (National Center, Kazakhstan)
  • The Roszdravnadzor (Russia)
  • The Food and Drug Administration (TFDA, Chinese Taipei)
  • The Therapeutic Goods Administration (TGA, Australia)

Regional Harmonisation Initiatives (RHIs)

  • The Asia-Pacific Economic Cooperation (APEC)
  • The Association of Southeast Asian Nations (ASEAN)
  • The East African Community (EAC)
  • The Gulf Health Council (GHC)
  • The Pan American Network for Drug Regulatory Harmonization (PANDRH)
  • The Southern African Development Community (SADC)

International Pharmaceutical Industry Organisation

  • The Active Pharmaceutical Ingredients Committee (APIC)

International Organisations with an Interest in Pharmaceuticals

  • The Council for International Organizations of Medical Sciences (CIOMS)
  • The European Directorate for the Quality of Medicines & HealthCare (EDQM)
  • The International Pharmaceutical Excipient Council (IPEC)
  • The United States Pharmacopeia (USP)


Apply for Membership and Observership

Any party eligible as a Member or an Observer in accordance with the ICH Articles of Association can apply for ICH Membership or Observership. Application forms for Regulatory and Industry Membership, as well as for Observership are available on the ICH website for download.

If you wish to apply for Membership or Observership in the ICH Association, you are invited to fill the appropriate application form and return it to the ICH Secretariat at All parts of the application form should be fully filled and any necessary documentation provided.

The ICH Management Committee will process all completed applications received and make a recommendation to the ICH Assembly which will be invited to take a decision on Membership / Observersip admission.

As per the ICH Articles of Association, the Assembly should take a decision on the membership admission as soon as possible in any of its subsequent meetings.

As per the Assembly Rules of Procedure (point 1.3.3.), it would be optimal for membership applications to be submitted sufficiently in advance and should preferably be submitted at least two months before the Assembly meeting. It is suggested that applications for observership are preferably also submitted in this timeframe. 

If you have any questions concerning the application process please do not hesitate to contact us.