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ICMRA(International Coalition of Medicines Regulatory Authorities)



Introduction of ICMRA

The ICMRA is a voluntary, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities that work together to

  • address current and emerging human medicine regulatory and safety challenges globally, strategically and in an on-going, transparent,    authoritative and institutional manner
  • provide direction for areas and activities common to many regulatory authorities’ missions
  • identify areas for potential synergies
  • wherever possible, leverage existing initiatives/enablers and resources

ICMRA Members

Therapeutic Goods Administration (TGA), Australia; National Health Surveillance (ANVISA), Brazil; Health Products and Food Branch, Health Canada (HPFB-HC), Canada; National Medical Products Administration (NMPA), China; European Medicines Agency (EMA) and European Commission - Directorate General for Health and Food Safety (DG - SANTE), European Union; French National Agency for Medicines and Health Products Safety (ANSM), France; Paul-Ehrlich-Institute (PEI), Germany; Health Product Regulatory Authority (HPRA), Ireland; Italian Medicines Agency (AIFA), Italy; Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan; Ministry of Food and Drug Safety (MFDS), Korea; Federal Commission for the Protection against Sanitary Risks (COFEPRIS), Mexico; Medicines Evaluation Board (MEB), Netherlands; Medsafe, Clinical Leadership, Protection & Regulation, Ministry of Health, New Zealand; National Agency for Food Drug Administration and Control (NAFDAC), Nigeria; Health Sciences Authority (HSA), Singapore; Medicines Control Council (MCC), South Africa; Medical Products Agency, Sweden; Swissmedic, Switzerland; Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom; Food and Drug Administration (FDA), United States, etc.

ICMRA Public Website

Activity of ICMRA



ICMRA statement on COVID-19

ICMRA statement on clinical trials

Date Event ICMRA website
Global regulatory workshop on COVID-19 vaccine development
22 June 2020 #2 Summary repory #2
18 March 2020 #1 Summary report #1
Date Event ICMRA website
Global regulatory workshop on COVID-19 therapeutic development
20 July 2020 #2 Summary report #2
2 April 2020 #1 Summary report #1
Date Event ICMRA website
Global regulatory workshop on COVID-19 real-world evidence and observational studies
22 July 2020 #3 Summary report #3
19 May 2020 #2 Summary report #2
6 April 2020 #1 Summary report #1


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ICMRA(International Coalition of Medicines Regulatory Authorities)