Just published a draft guidance detailing how clinical trials should be designed and conducted when public health emergencies arise. The document is aimed at sponsors and all parties involved in clinical research across the EU.
The document provides practical direction on key aspects, including:
🔸 Regulatory flexibilities to enable faster authorisation of new trials.
🔸 Operational measures to keep trials going during disruptions.
🔸 Scientific advice to ensure trials are well designed.
The Accelerating Clinical Trials in the EU (ACT EU) initiative has published a draft guidance document outlining how clinical trials should be conducted during public health emergencies (PHEs).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 are encouraged to seek scientific advice from EMA’s Emergency Task Force (ETF) to ensure trials are well designed, efficient and capable of delivering meaningful data for regulatory assessment.
The draft also provides guidance for situations in which trial participants can be transferred across investigational sites. Adapted procedures or alternative approaches may be required due to the specific challenges posed by public health emergencies. The rights, safety and well-being of trial participants and the generation of scientifically robust evidence remain central to regulatory decisions on clinical trials during such emergencies.
This draft guidance document is open for public consultation until 30 April 2026. Comments should be included in the template available below and sent to: acteu@ema.europa.eu.
A public consultation is open until 30 April 2026.