The European Medicines Agency (EMA), in collaboration with the Heads of Medicines Agencies (HMA) and the European Commission (EC), has announced that the Accelerating Clinical Trials in the EU (ACT EU) initiative has launched two advisory pilots to improve clinical trials in the EU.
The pilots aim to improve the quality of applications for clinical trials and lay the foundation for the development of safe and effective medicines in Europe.
First launched in January 2022, the ACT EU initiative seeks to transform how clinical trials are initiated, designed and run.
The first pilot will offer medicinal product developers scientific advice on clinical trials and requirements for marketing authorisation applications (MAA) and will be assessed by the Scientist Advice Working Party and the Clinical Trials Coordination Group (CTCG).
Covering a variety of areas, including advice on regulatory aspects of low intervention clinical trial status and submission of trials with decentralised elements or complex designs, the second pilot, coordinated by the CTCG, will provide technical and regulatory support on the dossier of clinical trial applications (CTA) prior to submissions through the Clinical Trials Information System and will provide consolidated views of the member states concerned on pre-submission topics.
Both pilots will be evaluated over time based on data and feedback collected from applications, which will inform a possible change of scope and a final decision from the ACT EU steering group when determining how to best optimise clinical trial support in the future.
All developers of medicinal products that wish to receive advice on the MAA or CTA requirements will now be able to apply for these pilots to enhance the quality of their applications.
“Before this pilot, applicants could only receive technical and regulatory support at the national level from the member state evaluating the application,” said the EMA. “The pre-CTA pilot will provide consolidated views of the member states concerned on pre-submission topics.”
“By strengthening the coordination of the EU medicines regulatory network, these advice pilots offer applicants additional support to enhance the quality of their applications for marketing and/or clinical trial authorisation,” the regulator added.