EU to pilot new advice service for clinical research

The Accelerating Clinical Trials in the EU (ACT EU) initiative has launched two advice pilots aimed at improving the quality of applications for clinical trials in Europe. The new initiatives could reduce inconsistency between national regulators, helping to make the system less bureaucratic and more predictable.

ACT EU is a collaboration between the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) in the Member States and the European Commission (EC), which seeks to transform how clinical trials are initiated, designed, and run.

The first pilot offers developers of medicinal products scientific advice on clinical trials and on requirements for marketing authorisation applications (MAA). In this pilot programme, the EMA Scientific Advice Working Party (SAWP and the Clinical Trials Coordination Group (CTCG), managed by national medicines authorities, will assess incoming requests of a scientific nature.

The SAWP is responsible for advice on marketing authorisation applications and the Member States represented at CTCG oversee clinical trial applications (CTA). This pilot consolidates the views of these two groups to minimise avoidable divergences. It is the first time that both entities are providing joint scientific advice on clinical trials.

The second pilot is coordinated by the CTCG and provides technical and regulatory support on the dossier of a CTA prior to its submission through the Clinical Trials Information System. Before this pilot, applicants could only receive technical and regulatory support at national level from the Member State evaluating the application.

The pre-CTA pilot will provide consolidated views of the Member States concerned on pre-submission topics. The scope of this pilot covers several areas such as advice on regulatory aspects of low interventional clinical trial status and submission of trials with decentralised elements or complex designs, to name a few.

‘By strengthening the coordination of the European 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 EMA said.