The Accelerating Clinical Trials in the EU (ACT EU) initiative has published a draft guidance document outlining how clinical trials should be conducted during public health emergencies (PHEs). The guidance, now open for stakeholder consultation, is intended for sponsors and all parties involved in the design and conduct of clinical trials in the EU.

This is the first guidance on PHEs to reflect the EU’s current legislative framework as well as the guidelines from the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed following the COVID‑19 pandemic. It recommends a harmonised approach to ensure that clinical trials can be initiated, adapted and continued efficiently and safely when public health emergencies arise.

The guidance proposes regulatory mechanisms aiming to accelerate the authorisation of new clinical trials and the approval of modifications to ongoing trials during a PHE. Sponsors…