Building on positive momentum, it’s time to implement centralisation and deliver shorter approval times.

The past year has seen renewed political and industry alignment on how to strengthen Europe’s clinical research ecosystem.

Whisper it: cautious optimism is in the air. 

By deepening mutual understanding and highlighting concrete ways to drive innovation, the Accelerating Clinical Trials in the EU (ACT EU), which holds its annual meeting at the European Medicines Agency in Amsterdam this week, is providing a foundation on which to build. We are beginning to see a growing consensus on how Europe can implement practical, targeted updates to existing legislation, allowing faster progress. Policy discussions have emphasised simplification, digital integration, and support for innovation, signalling that EU institutions recognise the urgency of reform. This resonates with EFPIA’s firm view that more can be done on centralisation and harmonisation, and to reduce the timelines for key regulatory decisions.

Opportunities for progress

This shared sense of urgency can be the beginning of a new and lasting way of working. There are further opportunities to modernise and streamline regulatory frameworks across life sciences, notably the EU Biotech Act now anticipated in two parts, with a first act focusing on aspects related to health anticipated by the end of 2025.

We also welcome the European Commission’s work to gather evidence and feedback on how the EU Clinical Trials Regulation (CTR) is functioning in practice. Through a survey conducted independently by Deloitte, the Commission is seeking to inform promising future policy proposals and potential legislative amendments under the Biotech Act by engaging with sponsors, regulators and patients.

Ending fragmentation – for good

For research-driven life sciences companies, two of the biggest outstanding challenges are the need to implement centralisation and to address slow approval times. The EU CTR was designed to create one harmonised system for trial assessment and authorisation, replacing fragmented national procedures. There has been some progress, but there is more to do. Centralisation of assessment and decision-making remains the most effective way to restore Europe’s competitiveness in global clinical research. A more centralised model would foster predictability and enable better coordination of ethics reviews, reducing administrative complexity and delays.

The EU must also achieve its stated goal of delivering globally competitive approval times. Despite harmonised timelines being set under the CTR, average EU approval times still exceed 100 days, compared with 30–60 days in other global regions. Faster, coordinated approvals mean earlier access for patients and stronger investment incentives for research in Europe.

Reducing approval timelines to 30 days for initial reviews and 60-days for final decision, would make Europe significantly more attractive for trials, especially for innovative or time-critical trials with competitive recruitment schemes. We acknowledge that this is no easy task. However, in dialogue with other stakeholders, we have advocated for several specific steps that could deliver efficiency gains:

• Limiting Requests for Information (RFIs) to major grounds for non-acceptance and safety issues;
• Central coordination of Part I (scientific) and more harmonised Part II (ethical) reviews;
• Allowing parallel submission of substantial modifications and reducing unnecessary timeline extensions;
• Enhancing CTIS flexibility and interoperability with other EU systems;
• Implementing a core dossier concept that enables cross referencing to previously approved data rather than requiring re-submission.

Making 2026 a turning point

The momentum achieved this year has put Europe in a position to enact the ambitious policies required to keep European patients at the forefront of global medical innovation. If proposed reforms are enacted swiftly, 2026 could mark a turning point for clinical research.

Let’s take this opportunity to match ambition with action.