Content
- About ICMRA
- Activities of ICMRA
- Activities related to COVID-19
- Statements related to COVID-19
- Workshops 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.
Activities of ICMRA
ICMRA Statements, Reports and Reflection Papers
Workshops
| Date | Title | Deliverables | Keywords |
|---|---|---|---|
| 19 September 2025 | ICMRA-Industry virtual workshop: Strengthening regulatory convergence and reliance through Pharmaceutical Quality Knowledge Management | Workshop report [494KB] Agenda [158KB] Presentation [1.89MB] Recording |
Manufacturing Capacity, Quality management, Collaborative assessment, Collaborative inspection |
| 3 December 2024 | Decentralised or Distributed Manufacturing including point of care (PoC) manufacturing | Workshop report | Innovation, Manufacturing technology |
| 2 October 2024 | Mpox workshop | Workshop report | Infectious Diseases, Vaccine |
| 16 to 17 September 2024 | Rare Disease Workshop | Workshop report [268KB] | Rare Diseases |
| 20 to 21 July 2023 | ICMRA-industry virtual workshop on Development of a Pharmaceutical Quality Knowledge Management System | Workshop report [1.1MB] Agenda [202KB] Presentation [2.2MB] Recording |
Manufacturing Capacity, Quality management, Collaborative assessment, Collaborative inspection |
| 29 to 30 June 2022 | Real World Evidence Workshop | ICMRA statement on Real World Evidence [183KB] | RWE |
ICMRA Summit
Annual ICMRA Summit is an opportunity for Heads of Medicines Regulatory Authorities from around the world to come together and discuss current and emerging issues facing medicines regulators and common global strategies to address them.
Past ICMRA Summit meetings
Working Group / Regulators Network
There are currently several ICMRA Working Group / Regulators Network (WG/RN) where ICMRA members collaborate on specific projects.
List of WG/RN on ICMRA official website
COVID-19
Statements related to 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
Workshops related to COVID-19
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 |