The initiative is focused on enabling multinational clinical trials in the European Union (EU) to promptly tackle public health emergencies (PHE).
Different aspects of the process of clinical trial approval are being tackled, including strengthening collaboration across national competent authorities and medical research ethics committees, and the role of the European Medicines Agency's Emergency Task Force in fostering alignment and discussion across Member States. The possible benefits of a central ethics committee during PHE are also being analysed.
The initiative is also defining a simplified package for submission of applications for clinical trials in PHE and expedited assessments, to facilitate the rapid approval of clinical trials.
ACT EU is also working on enabling regulatory flexibilities in the assessment and conduct of clinical trials, based on the experience gained during the COVID-19 pandemic.
Joint ETF - ACT EU workshop
In November 2024, EMA's Emergency Task Force (ETF), ACT EU and the ACT EU public health emergencies ethics advisory group held a joint workshop.
The discussions focused on improving preparedness and cooperation during public health emergencies, and on exploring policy options to accelerate clinical trials in the EU.
The workshop report is now available.
