The European Medicines Agency (EMA) is permanently putting its Accelerating Clinical Trials in the EU (ACT EU) pilot into practice.
The programme, which helps sponsors prepare clinical trial applications, will become a permanent initiative from January 2027.
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The scheme is coordinated by the Heads of Medicines Agencies (HMA) through its Clinical Trials Coordination Group (CTCG) and provides sponsors with technical and regulatory support before they submit a clinical trial application through the Clinical Trials Information System (CTIS).
Launched in 2024, the pilot provides consolidated feedback from the Member States concerned on key pre-submission topics. Previously, sponsors could only receive technical and regulatory support at a national level from the Member State responsible for evaluating their application, meaning this makes it much quicker and easier for sponsors to set up studies in multiple regions.
ACT EU will continue to manage applications already submitted under the pilot until the end of 2026. From the pilot, the EMA will release a summary of lessons learned from certain pilot applications before the end of 2026. Based on these and changes made during the pilot, the EMA will publish updated guidance documents and templates on the CTCG website in January 2027.
The transition to a permanent initiative supports the objectives of the European Biotech Act by helping clinical trial sponsors navigate the EU clinical trials framework more effectively.
It comes after the EU moved all of its systems into the CTIS to create a single unified portal, moderated by the EU body, for sponsors, clinical research organisations and patients across the EU. The legislative ruling, dubbed the Clinical Trials Regulation (CTR), puts an end to the three-year transition period under the Clinical Trials Directive (CTD).
The transition comes nearly four years after the body announced that the CTIS system was fully functional following long delays.
Whilst the EMA is responsible for maintaining the CTIS, it falls to each European member state to enforce the CTR and ensure trials comply. Overall, implementation has been met relatively positively, but some concerns have been raised that inconsistencies between member states and how they enforce the ruling may cause trial sponsors to drop out of the continent altogether.
GlobalData, parent company of Clinical Trials Arena, analysis shows that while the US remains the dominant region for clinical trials, there has recently been an uptick in Asia, especially China. European companies, including AstraZeneca, Boehringer Ingelheim, Chiesi, Ipsen, GSK, Novo Nordisk, Novartis, Roche and Sanofi, pressed the point that Europe has fallen behind the US and China.
