International Coalition of Medicines Regulatory Authorities (ICMRA)

The International Coalition of Medicines Regulatory Authorities (ICMRA) is a global, multilateral network involving the heads of various medicinal product regulatory authorities. It aims to promote international cooperation between therapeutic products agencies on current and emerging regulatory challenges in human medicine. Its priorities also extend to coordinated responses to crisis situations.

The ICMRA was founded as an international, non-political organisation in 2013 at the initiative of the heads of the regulatory authorities, the Heads of Agencies (HoA). It currently comprises 24 members, 15 associated authorities and the WHO as an observer. Swissmedic is a member of the ICMRA and supports the initiative in working groups such as the Communication Working Group.

The Executive Committee of the ICMRA comprises six to eight HoA and is chaired by the European Medicines Agency (EMA), which also acts as the secretariat. Membership of the ICMRA is voluntary and is open to all medicinal product regulatory authorities.

Cooperation and sharing

The ICMRA wants to expand the sharing of reliable information and international cooperation between the participating medicinal product regulatory authorities. This includes joint use of data, sharing of regulatory best practices and coordinating responses to health crises.

Regulatory harmonisation

The ICMRA is working to harmonise regulatory processes and standards, and to make medicinal product development, assessment and authorisation more efficient and more consistent. This contributes to improving access to safe and effective medications worldwide.

Crisis response

One key focus of the ICMRA is addressing global health threats, such as pandemics. It plays an important role in coordinating regulatory responses to these types of crises, including accelerating the authorisation procedure for urgently needed medications and vaccines.

Regulatory science

The ICMRA promotes the further development of regulatory science to improve medicinal product assessment and surveillance. This includes supporting research and innovation in areas such as personalised medicine, biotechnology products and digital healthcare technologies.

Supplementary information

Last modification 06.06.2024

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