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ICMRA（International Coalition of Medicines Regulatory Authorities）
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 Structure
https://www.icmra.info/drupal/aboutus/structure
Activities of ICMRA
ICMRA Statements, Reports and Reflection Papers
COVID-19
Statements Related to COVID-19
Workshops
- 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
Global Regulatory Workshop on COVID-19 Vaccine Development
| Date | Event | Keywords |
|---|---|---|
| 22 Jun 2020 | #2 | Vaccine Development, Clinical Trials |
| 18 Mar 2020 | #1 | Vaccine Development, Pre-Clinical Data |
Global Regulatory Workshop on COVID-19 Therapeutic Development
| Date | Event | Keywords |
|---|---|---|
| 20 Jul 2020 | #2 | Therapeutic Development, Clinical Trials |
| 2 Apr 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 Jan 2021 | #5 | RWE, Observational Studies |
| 13 Oct 2020 | #4 | RWE, Observational Studies |
| 22 Jul 2020 | #3 | RWE, Observational Studies |
| 19 May 2020 | #2 | RWE, Observational Studies |
| 6 Apr 2020 | #1 | RWE, Observational Studies |
ICMRA Vaccine Safety Collaboration Workshop
| Date | Event | Keywords |
|---|---|---|
| 13 Jan 2021 | #1 | Vaccines, Global Collaboration |
ICMRA Pregnancy and Lactation Workshop
| Date | Event | Keywords |
|---|---|---|
| 9 Feb 2021 | #1 | Pregnancy, Lactation |
ICMRA COVID-19 Virus Variants Workshop
| Date | Event | Keywords |
|---|---|---|
| 30 June 2022 | #4 | Vaccine Development, Omicron Variant, Booster Doses, Variant-Adapted Vaccines |
| 12 Jan 2022 | #3 | Vaccine Development, Omicron Variant, Booster Doses, Immunogenicity Bridging Studies |
| 24 Jun 2021 | #2 | Vaccine Development, Booster Doses, Immunogenicity Bridging Studies |
| 10 Feb 2021 | #1 | Vaccine Development, Virus Variants |
ICMRA Workshop on Enabling Manufacturing Capacity in the COVID-19 Pandemic
| Date | Event | Keywords |
|---|---|---|
| 7-8 Jul 2021 | #1 | Manufacturing Capacity |