Regulators launch two ACT EU advice pilots to promote clinical research in Europe
The European Union's Accelerating Clinical Trials in the EU (ACT EU) launched two advice pilots that regulators hope will improve the quality of clinical trial applications in premarket submissions to increase multi-state clinical trials in the region.ACT EU was launched two years ago as a collaboration between the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA), and the European Commission (EC) to address the lack of multi-state clinical trials in Europe during the COVID-19 pandemic. Policymakers hope the collaboration will make the region more competitive for products coming to market by making the EU a focal point for clinical research. (RELATED: EU launches clinical trials transformation initiative, Regulatory Focus 18 January 2022)
On 10 June, the EU said the two new ACT EU advice pilots were in effect immediately. The first pilot is meant to help medical product developers with scientific advice on conducting clinical trials and requirements for marketing authorization applications (MAA).
"In this pilot program, 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," said the EU. "The SAWP is responsible for advice on marketing authorization applications and the Member States represented at CTCG oversee clinical trial applications (CTA).”
“This pilot consolidates the views of these two groups to minimize avoidable divergences. It is the first time that both entities are providing joint scientific advice on clinical trials,” it added.
According to the EU, the second pilot will be run by CTCG, which will advise premarket application sponsors about technical and regulatory issues regarding the clinical trial application portion of their premarket dossier using its Clinical Trials Information System (CTIS).
"Before this pilot, applicants could only receive technical and regulatory support at the national level from the Member State evaluating the application," said the EU. "The pre-CTA pilot will provide consolidated views of the Member States concerned on pre-submission topics."
Regulators said that the pilots will cover a range of topics, such as how to advise sponsors on regulatory considerations for low interventional clinical trials, and decentralized elements and complex designs used in clinical trials.
“The duration of both pilots will be evaluated over time based on data and feedback collected from applicants,” said the EU. “All this information will inform a possible change of scope and a final decision from the ACT EU steering group on how to optimize clinical trial support in the future.”
“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 authorization,” it added.
EU pilot announcement
