The Accelerating Clinical Trials in the EU (ACT EU) initiative, jointly run by the European Commission, European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) of the Member States, is publishing new draft guidance on the conduct of clinical trials during public health emergencies. The document presents recommendations designed to streamline and accelerate the authorisation procedure for new clinical trials, as well as modifications to ongoing trials. It will facilitate the rapid generation of clinical evidence during public health emergencies.

This draft guidance document is open for public consultation until 30 April 2026. Comments should be included in the template and sent to: acteu@ema.europa.eu.