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 the latest list of authorities participating in ICMRA, see ICMRA: Participating regulatory authorities.
The EMA Executive Director has been the chair of ICMRA since 1 October 2019.
EMA led ICMRA's project to map ongoing international collaborative regulatory initiatives to help the coalition to make informed decisions on the need for involvement or strategic coordination.
This project aimed to:
- help the coalition make informed decisions on the need for involvement or strategic coordination;
- raise awareness of ongoing international activities in the area of human medicines regulation;
- provide the first comprehensive overview of international projects that medicines regulators are involved in.
The findings are available in this report, published in October 2016:
- Connecting the dots - Towards global knowledge of the international medicine regulatory landscape: mapping of international initiatives
These sector-specific mapping documents set out the international initiatives in various 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
These documents were published in December 2016, but may be amended to reflect new initiatives or changes to existing ones.
Stakeholders can send suggestions on the published mappings to email@example.com. EMA will take these into consideration for future revision.
Medicine regulatory authorities worldwide are working together under the umbrella of ICMRA with the aim of expediting and streamlining the development and approval of COVID-19 vaccines and treatments worldwide. ICMRA members are also working towards increasing the efficiency and effectiveness of regulatory processes and decision-making.
Pledges and recommendations
Strategic meetings and regulatory workshops
ICMRA members discuss international alignment on COVID-19 policies in strategic meetings beingheld every two weeks.
ICMRA is also holding international regulatory workshops on important COVID-19-related topics to allow for in-depth discussions between medicine regulatory authorities and delegates from countries worldwide, as well as with experts from the World Health Organization and the European Commission.
Click on the meeting types below to find out more, including summary reports and related news.
Global regulators cooperate under the umbrella of ICMRA in a range of areas related to the regulation of human medicines that are common to many of the participating regulatory authorities’ missions. More information on these cooperation initiatives is available under 'Strategic initiatives' and 'News' on ICMRA's website.