EMA Management Board Highlights: October 2025

10th October 2025

EMA Management Board Highlights: October 2025

Summary:

• Mid-Year Report 2025: EMA reported consistent application numbers for new medicines and veterinary products compared to 2024. Notably, the average duration of company-requested clock stop extensions decreased by 18%, from 182 days in 2024 to 150 days in the first half of 2025, reflecting improved efficiency in the approval process.

• International Collaboration: EMA provided an update on its leadership of the International Coalition of Medicines Regulatory Authorities (ICMRA) since 2019. The agency will transition the chairmanship to another member during the upcoming ICMRA summit in Amsterdam from 21–24 October 2025.

• OPEN Framework Expansion: The Board agreed to broaden the scope of EMA’s OPEN Framework to encompass all medicines targeting unmet medical needs and advanced therapy medicinal products (ATMPs). This expansion includes permitting the use of the framework for post-authorisation changes, such as extensions of indication. A detailed Q&A document on this expansion will be published later this year.

• Network Data Strategy: EMA endorsed its first comprehensive data strategy for the European medicines regulatory network. This strategy aims to optimise the management, quality, standardisation, and sharing of data assets, including regulatory submissions, master data, and healthcare data, to enhance regulatory decision-making.

Link: EMA Management Board: Highlights of October 2025 Meeting

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