A transformative overhaul of European Union clinical trial regulations promises to accelerate drug development and strengthen resilience against medication shortages through streamlined approval processes and enhanced international coordination.
Andreas Schwinn, senior qualified person (QP) for investigational medicinal products (IMPs) at Roche, characterized the regulatory reform as "probably the most important regulatory development within the past decades for clinical trials" during his presentation at the 2025 Clinical Trial Supply Europe conference in Barcelona.
Streamlined Application Process
The cornerstone of the new framework is a unified submission system that allows sponsors to file applications through a single portal for all EU member states. This represents a dramatic simplification from previous requirements, reducing documentation from an average of seven sets to just one comprehensive package.
Under the new system, trials can receive EU-wide approval through a standardized process with a 106-day timeline. Notably, individual nations retain the ability to process single-country trials more rapidly when necessary.
Enhanced Flexibility for Drug Supply Management
A key innovation in the updated regulations addresses the persistent challenge of drug shortages in clinical trials. Sponsors can now submit commercial products by active substance and active therapeutic chemical (ACT) code, rather than specific marketing authorization numbers. "This would allow that you change, for instance, between several generic comparators – without any submission," Schwinn explained, highlighting the potential to maintain trial continuity despite supply chain disruptions.
Terminology and Transparency Updates
The regulatory overhaul introduces important clarifications in trial terminology, distinguishing between interventional trials and noninterventional studies. It also establishes Article 81.9 of the CTR, enabling communications with regulatory authorities without documentation modifications.
Transparency receives significant attention through the implementation of a universally accessible clinical trials information system (CTIS), ensuring broader access to trial information across the EU.
Implementation Challenges and Resolution
During the transition period, Roche and other organizations encountered various challenges, including conflicts between data privacy laws and QP declarations. The EU has worked to resolve these issues, though some concerns remain, such as the potential for member states to contest approvals, which could lead to nationally divergent documentation requirements.
Despite these challenges, industry experts remain optimistic about the new framework's potential to create a more efficient, comprehensible, and coordinated approach to clinical trial regulation across the European Union.
