ICMRA (International Coalition of Medicines Regulatory Authorities)

ICMRA

Content

About ICMRA
- Introduction of ICMRA
- ICMRA Members
Activities of ICMRA
- ICMRA Statements
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

COVID-19 Vaccine Development
COVID-19 Therapeutic Development
COVID-19 Real-World Evidence and Observational Studies
Vaccine Safety Collaboration
Pregnancy and Lactation
COVID-19 Virus Variants（including Booster Doses）
Enabling Manufacturing Capacity

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