Life Sciences weekly highlights—1 May 2025
This week's edition of Life Sciences weekly highlights includes two news analyses on the EU AI Act, its key developments and strategic implications for business as well as the challenges of the EU AI Act-GDPR interplay, and news that the European Commission opened a targeted consultation on guidelines to clarify rules for general-purpose artificial intelligence (GPAI) models under the EU AI Act, the Association of British HealthTech Industries (ABHI) published guidance to help UK policymakers considering international regulatory reform and recognition understand the US Food and Drug Administration (FDA) 510(k) process of pre-market submission for devices deemed substantially equivalent to those already legally marketed, the EFPIA released a research on assessment of the impact of the transferable exclusivity voucher (TEV) system proposed as part of the pharmaceutical legislation reform package, both the EFPIA and MedTech Europe have submitted responses to the Commission’s call for evidence on the EU Life Sciences Strategy. Also included is news that the MHRA issued new guidance on risk minimisation measures to reduce or prevent the risk of an adverse event, the HRA published updated model agreements for research as well as a report on clinical trial registration and a blog on the impact of its 2022–25 strategy, and the EMA and ICH released two new Step 2b guidelines on drug development, among other stories.