CTIS newsflash - 10 June 2025

10 June 2025 EMA/179146/2025 European Medicines Agency CTIS newsflash – 10 June 2025 Important Update: Changes to the CTIS Newsflash Please be informed that from July 2025, the biweekly CTIS Newsflash will be replaced by the Clinical Trials Highlights Newsletter. The final issue of the CTIS Newsflash will be released on 24 June 2025. For updates on CTIS and other topics related to clinical trials in the EU, we encourage you to subscribe to the Clinical Trials Highlights Newsletter. This newsletter will now be released monthly, offering a more comprehensive overview of clinical trial developments and insights. Subscribe here to stay updated on the evolving clinical trials landscape in the EU. Key updates • Open consultation until 15 September 2025: EMA has released for public consultation a new guideline providing recommendations on how to include or retain pregnant and breastfeeding people in clinical trials. The goal is to ensure developers generate robust clinical data in those populations, so that these individuals and their healthcare providers can make informed, evidence-based decisions when using medicines. More information on how to provide comments is available in the news announcement. • María Lamas and Peter Arlett discussed ‘Strengthening evidence generation in the EU’ in a LinkedIn live event on Tuesday 10 June 2025. The event was inspired by the recent paper: “Clinical evidence 2030” and a recording is available on EMA’s...