International Coalition of Medicines Regulatory Authorities
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.
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.
T he “connecting the dots” document also includes analysis of some of the mappings.
Stakeholders can send suggestions on the published mappings to firstname.lastname@example.org. REMA will take these into consideration for future revision.