International Coalition of Medicines Regulatory Authorities (ICMRA)
The European Medicines Agency (EMA) is a member of the International Coalition of Medicines Regulatory Authorities (ICMRA). ICMRA is a voluntary, executive-level entity of worldwide medicines regulatory authorities set up to provide strategic coordination, advocacy and leadership.
ICMRA acts as a forum to support international cooperation among medicines regulatory authorities. The coalition aims to:
- identify ways to better use existing initiatives and resources;
- develop strategies to address current and emerging challenges in global human medicine regulation, such as the growing complexity of globalised supply chains;
- provide direction for common activities and areas of work.
To achieve these aims, ICMRA supports enhanced communication, information sharing and a greater leveraging of resources.
Membership of ICMRA is voluntary and is open to all medicines regulatory authorities. It includes EMA, the European Commission and a number of European national competent authorities and global medicines regulatory authorities.
For a full list of participating authorities, see ICMRA: Participating regulatory authorities.
ICMRA members meet at least once a year in person.
As of 1 October 2019, EMA’s Executive Director Guido Rasi is the chair of ICMRA.
EMA has led the ICMRA project of mapping ongoing international collaborative regulatory initiatives to help the coalition to make informed decisions on the need for involvement or strategic coordination.
The project also aims at raising awareness of ongoing international regulatory activities in the area of human medicines regulation and provides for the first time comprehensive overview of international projects in which medicines regulators are involved.
EMA published a report in October 2016, describing activities between February 2014 to December 2015. This report includes a summary of the different mapping exercises performed, the steps taken to analyse them and how the outcomes informed ICMRA's strategic priorities.
- Connecting the dots - Towards global knowledge of the international medicine regulatory landscape: mapping of international initiatives
EMA also published a set of sector-specific mapping documents in December 2016. These set out the international initiatives in different areas of medicines regulation:
- ICMRA - Mapping of IT initiatives as a support to global medicines regulation
- ICMRA - Mapping of crisis management initiatives
- ICMRA - Mapping of generic initiatives
- ICMRA - Mapping of GMP inspection initiatives
- ICMRA - Mapping of multinational project initiatives
- ICMRA - Mapping of pharmacovigilance initiatives
- ICMRA - Mapping of supply chain anticounterfeiting initiatives
- ICMRA - Mapping of the bilateral arrangements between the ICMRA members
The sector-specific mapping documents are 'living documents' and may be amended to reflect new initiatives or changes to existing ones.
The 'connecting the dots' document also includes analysis of some of the mappings.
Stakeholders can send suggestions on the published mappings to email@example.com. REMA will take these into consideration for future revision.
Medicine regulatory authorities worldwide are cooperating under the umbrella of ICMRA with the aim of expediting and streamlining the development of COVID-19 vaccines and treatments.
On 28 April 2020, ICMRA members committed to strengthening global collaborative efforts in order to facilitate the rapid development, approval and global roll-out of safe and effective medicines to prevent and treat COVID-19. The efforts focus in particular on increasing the efficiency of regulatory processes and decision-making:
The ICMRA members also recommend that:
- governments and the international research community should prioritise large, well-designed, controlled clinical trials. Such trials are most likely to generate the conclusive evidence that developers and regulators need to enable the rapid development and approval of potential COVID-19 treatments;
- a global approach should be developed to achieve equitable access around the world to treatments and vaccines against COVID-19;
- pharmaceutical industry should work cooperatively in addressing medicine supply issues, shortages and decreased manufacturing capacities.
COVID-19-related policy approaches and regulatory flexibility
ICMRA is holding bi-weekly meetings to allow medicine regulatory authorities worldwide to discuss COVID-19-related policy approaches and regulatory flexibility, with the aim of expediting COVID-19 medicine and vaccine development and approval and avoiding medicine shortages.
EMA and the FDA are taking turns in chairing the meetings.
For more information on the meetings, see the news items published by EMA and ICMRA:
- Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3 (28/05/2020)
- Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #2 (18/05/2020)
- Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 (05/05/2020)
- ICMRA aims for international alignment on policy approaches and regulatory flexibility during COVID-19 pandemic (21/04/2020)
COVID-19 medicine and vaccine development
ICMRA is holding virtual globally regulatory workshops on COVID-19 medicine and vaccine development to enable an exchange of views and experience between medicine regulatory authorities and delegates from many countries worldwide, as well as experts from the World Health Organization and the European Commission.
For more information on the workshops, including summary reports, see:
To mark World Antibiotic Awareness Week in 2019, EMA wishes to highlight ICMRA's statement committing its support to the fight against antimicrobial resistance:
The statement emphasises the:
- need for cross-sectoral, global cooperation to fight the spread of antimicrobial resistance;
- role of medicines regulators in efficiently bringing to the market safe, effective and high-quality products that can help combat antimicrobial resistance, as well as ensuring that no undue regulatory barriers prevent access to critical antimicrobials;
- responsibilities of various stakeholders to increase investment in research and development, incentivise innovation, improve prescribing principles for antibiotics and ensure adequate media coverage to maintain public awareness.