Content
- About ICMRA
- Activities of ICMRA
- 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
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 [130.31KB] |
Global Collaboration,
COVID-19 |
| 13 October 2022 |
Framework for the Involvement of Health Regulatory Authorities in the Management of Global Health Crises [284.44KB] |
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 [183.19KB] |
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 [281.18KB] |
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 [1.02MB] |
Regulatory Flexibilities, Emergency Use, COVID-19 |
| 3 December 2021 |
Report on regulatory flexibilities implemented by national regulatory authorities during the pandemic [455.59KB] |
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 |
| 9 February 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 [130.31KB] |
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 [281.18KB] |
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 [1.02MB] |
Regulatory Flexibilities, Emergency Use |
| 3 December 2021 |
Report on regulatory flexibilities implemented by national regulatory authorities during the pandemic [455.59KB] |
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 |
| 26 to 27 February 2024 |
#6 |
Vaccine Development, Omicron Variant, Booster Doses, Variant-Adapted Vaccines |
| 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 [407.74KB] |
Manufacturing Capacity |
