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ICMRA (International Coalition of Medicines Regulatory Authorities)

ICMRA

Content

  1. About ICMRA
  2. Activities of ICMRA
  3. Activities related to COVID-19

About ICMRA

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; South African Health Products Regulatory Authority (SAHPRA), 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
 

ICMRA Structure

ICMRA Structure

 

https://www.icmra.info/drupal/aboutus/structure

Activities of ICMRA 

ICMRA Statements, Reports and Reflection Papers

Date Title Keywords
26 June 2023 ICMRA statement on the safety of COVID-19 vaccines Vaccines, 
COVID-19, 
Safety
21 October 2022 International Coalition of Medicines Regulatory Authorities COVID-19 Working Group - Summary of Achievements Global Collaboration, 
COVID-19
13 October 2022 Framework for the Involvement of Health Regulatory Authorities in the Management of Global Health Crises Global Collaboration, 
Pandemic
19 August 2022 A Regulatory Pharmaceutical Quality Knowledge Management System (PQ KMS) to Enhance the Availability of Quality Medicines ICMRA-ICH-PIC/S-IPRP Joint Reflection Paper Quality Management
22 July 2022 ICMRA statement on international collaboration to enable real-world evidence (RWE) for regulatory decision-making RWE,
Global Collaboration
17 May 2022 Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised 17 May 2022) - Joint Statement from the International Coalition of Medicines Regulatory Authorities and World Health Organization Vaccines,
Health Care Professionals,
Variants,
Booster Doses,
Children,
Pregnancy,

COVID-19
10 December 2021 Reflections on the regulatory experience of remote approaches to GCP and GMP regulatory oversight during the COVID-19 pandemic Remote Inspections, COVID-19
10 December 2021 ICMRA statement on need for continued focus on COVID-19 therapeutics Therapeutics,
COVID-19
10 December 2021 Emergency Use Approval deep dive report on the review of provisions and procedures for emergency authorisation of medical products for COVID-19 among ICMRA members Regulatory Flexibilities, Emergency Use, COVID-19
3 December 2021 Report on regulatory flexibilities implemented by national regulatory authorities during the pandemic Regulatory Flexibilities, COVID-19
11 June 2021 Global Pharmaceutical Quality Knowledge Management: Enhancing Regulatory Reliance and Agility Quality Management
11 June 2021 Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised 11 June 2021) - Joint Statement from the International Coalition of Medicines Regulatory Authorities and World Health Organization Vaccines,
Health Care Professionals,
COVID-19
7 May 2021 Joint Statement on transparency and data integrity - International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) Improving Transparency, COVID-19
19 January 2021 ICMRA statement for healthcare professionals: How COVID-19 vaccines will be regulated for safety and effectiveness Vaccines, Health Care Professionals, COVID-19
27 November 2020 Statement from Global Medicines Regulators on the Value of Regulatory Reliance Reliance
27 November 2020 Statement on continuation of vaccine trials Vaccines, COVID-19
6 November 2020 WHO-ICMRA joint statement on the need for improved global regulatory alignment on COVID-19 medicines and vaccines Vaccines, Therapeutics, COVID-19
24 June 2020 ICMRA statement on clinical trials Clinical Trials, COVID-19
17 June 2020 ICMRA statement about confidence in vaccine safety and effectiveness (for healthcare professionals) Vaccines, Health Care Professionals
17 June 2020 ICMRA statement about confidence in vaccines (for the general public) Vaccines
28 April 2020 ICMRA statement on COVID-19 Global Collaboration, COVID-19
31 July 2019 Antimicrobial Resistance Statement AMR
2 September 2016 Zika Virus Disease Press Release Infectious Diseases
August 2014 Consolidated Joint ICMRA statement Ebola Infectious Diseases

 

COVID-19

Statements Related to COVID-19
Workshops

Statements Related to COVID-19

Date Title Keywords
26 June 2023 ICMRA statement on the safety of COVID-19 vaccines Vaccines,
Safety
21 October 2022 International Coalition of Medicines Regulatory Authorities COVID-19 Working Group - Summary of Achievements Global Collaboration
17 May 2022 Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised 17 May 2022) - Joint Statement from the International Coalition of Medicines Regulatory Authorities and World Health Organization Vaccines,
Health Care Professionals,
Variants,
Booster Doses,
Children,
Pregnancy
10 December 2021 Reflections on the regulatory experience of remote approaches to GCP and GMP regulatory oversight during the COVID-19 pandemic Remote Inspections
10 December 2021 ICMRA statement on need for continued focus on COVID-19 therapeutics Therapeutics
10 December 2021 Emergency Use Approval deep dive report on the review of provisions and procedures for emergency authorisation of medical products for COVID-19 among ICMRA members Regulatory Flexibilities, Emergency Use
3 December 2021 Report on regulatory flexibilities implemented by national regulatory authorities during the pandemic Regulatory Flexibilities
11 June 2021 Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised 11 June 2021) - Joint Statement from the International Coalition of Medicines Regulatory Authorities and World Health Organization Vaccines, Health Care Professionals
7 May 2021 Joint Statement on transparency and data integrity - International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) Improving Transparency
19 January 2021 ICMRA statement for healthcare professionals: How COVID-19 vaccines will be regulated for safety and effectiveness Vaccines, Health Care Professionals
27 November 2020 Statement on continuation of vaccine trials Vaccines
6 November 2020 WHO-ICMRA joint statement on the need for improved global regulatory alignment on COVID-19 medicines and vaccines Vaccines, Therapeutics
24 June 2020 ICMRA statement on clinical trials Clinical Trials
28 April 2020 ICMRA statement on COVID-19 Global Collaboration

 

Global Regulatory Workshop on COVID-19 Vaccine Development

 

Date Event Keywords
22 June 2020 #2 Vaccine Development, Clinical Trials
18 March 2020 #1 Vaccine Development, Pre-Clinical Data

 

Global Regulatory Workshop on COVID-19 Therapeutic Development

 

Date Event Keywords
20 July 2020 #2 Therapeutic Development, Clinical Trials
2 April 2020 #1 Therapeutic Development, Clinical Trials

 

Global Regulatory Workshop on COVID-19 Real-World Evidence and Observational Studies

 

Date Event Keywords
20 May 2022 #7 RWE, Observational Studies
10 May 2021 #6 RWE, Observational Studies
25 January 2021 #5 RWE, Observational Studies
13 October 2020 #4 RWE, Observational Studies
22 July 2020 #3 RWE, Observational Studies
19 May 2020 #2 RWE, Observational Studies
6 April 2020 #1 RWE, Observational Studies

 

ICMRA Vaccine Safety Collaboration Workshop

 

Date Event Keywords
13 January 2021 #1 Vaccines, Global Collaboration

 

ICMRA Pregnancy and Lactation Workshop

 

Date Event Keywords
9 February 2021 #1 Pregnancy, Lactation

 

ICMRA COVID-19 Virus Variants Workshop

 

Date Event Keywords
8 May 2023 #5 Vaccine Development, Omicron Variant, Booster Doses, Variant-Adapted Vaccines
30 June 2022 #4 Vaccine Development, Omicron Variant, Booster Doses, Variant-Adapted Vaccines
12 January 2022 #3 Vaccine Development, Omicron Variant, Booster Doses, Immunogenicity Bridging Studies
24 June 2021 #2 Vaccine Development, Booster Doses, Immunogenicity Bridging Studies
10 February 2021 #1 Vaccine Development, Virus Variants

 

ICMRA Workshop on Enabling Manufacturing Capacity in the COVID-19 Pandemic

 

Date Event Keywords
7 to 8 July 2021 #1 Manufacturing Capacity

 

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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