European regulators have released new draft guidance designed to speed up the launch and management of clinical trials during public health emergencies, aiming to ensure critical research can continue even in times of crisis.

 

The document, published under the Accelerating Clinical Trials in the EU (ACT EU) initiative, sets out how trials should be conducted when health emergencies disrupt normal research operations. The guidance is now open for consultation and is aimed at sponsors and all parties involved in designing and running clinical trials across the European Union.

 

The draft marks the first guidance on public health emergencies aligned with the EU’s current legislative framework and updated international standards from the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed in the wake of the COVID-19 pandemic. It calls for a harmonised approach to ensure clinical trials can be launched, adapted and continued efficiently and safely when emergencies strike.

 

Under the proposals, regulators would deploy mechanisms to accelerate authorisation for new clinical trials and speed approval of changes to ongoing studies during a crisis. Sponsors are encouraged to seek scientific advice from the European Medicines Agency’s Emergency Task Force (ETF) to ensure trials are well designed, efficient and capable of producing meaningful data for regulatory review.

 

The guidance also outlines how trial participants could be transferred between investigational sites if necessary—an option that may be required when emergencies disrupt trial locations. While adapted procedures may be needed in such scenarios, regulators stress that the rights, safety and well-being of participants—and the generation of scientifically robust evidence—must remain central to decisions on clinical trials during public health emergencies.