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 medicines regulatory authorities worldwide providing strategic coordination, advocacy and leadership.
ICMRA acts as a forum to support international cooperation among medicines regulatory authorities. It aims to avoid duplication and promote informed, risk-based allocation of resources in order to:
- strengthen dialogue;
- facilitate the wider exchange of reliable and comparable information;
- encourage greater leveraging of resources and work products of its members.
ICMRA was established to respond to several trends in the global regulatory environment:
- Medicines that are distributed and used in domestic markets are increasingly global commodities. The manufacturing and distribution supply chains are complex, globally integrated and may at times be unclear. The ability of a regulator to assure the safety, quality and efficacy of a medicinal product domestically requires knowledge of and confidence in these supply chains and regulatory oversight at all stages.
- There is growing complexity in medicines and their ingredients, and managing the risks and benefits requires international collaboration among regulators to provide access to collective resources and the best available scientific and technical expertise.
- The range and diversity of existing international initiatives, usually conducted at the technical/operational level, also call for increased efficiency in managing international collaboration and the collective expertise and resources invested in these initiatives.
Membership of ICMRA is voluntary and is open to all medicines regulatory authorities.
It currently includes a number of European national competent authorities as well as medicines regulatory authorities in Australia, Brazil, Canada, China, India, Japan, Korea, Mexico, New Zealand, Nigeria, Russia, South Africa and the United States. The European Commission is also a member and the World Health Organisation (WHO) is an observer.
Mapping of international initiatives (new)
EMA has led the ICMRA project of mapping ongoing worldwide collaborative regulatory initiatives to help enable the coalition to make informed decisions on the need for involvement or strategic coordination.
The project also aims at raising awareness of ongoing regulatory international 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 were used to inform ICMRA’s strategic priorities. It also includes two examples of the actual 'mappings':
- Connecting the dots - Towards global knowledge of the international medicine regulatory landscape: mapping of international initiatives
Individual mappings documents
- 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 mappings are 'living documents' and may be amended to reflect new initiatives or changes to existing ones. Suggestions on the published mappings can be submitted electronically via email@example.com and will be taken into consideration for future revision.
Analysis of some of the mappings are included in the “connecting the dots” document.
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