Europe – Two new advice pilots to improve clinical trials in Europe

The Accelerating Clinical Trials in the EU (ACT EU) initiative is today launching two advice pilots aimed at improving the quality of applications for clinical trials, the foundation for the development of safe and effective medicines in Europe.

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). Assessors of clinical trials are not consistently involved in scientific advice procedures for MAAs, and vice versa. In this pilot programme, the Scientific Advice Working Party (SAWP), coordinated by EMA, and the Clinical Trials Coordination Group (CTCG), managed by HMA, will be the bodies assessing 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