A major overhaul and consolidation of EU clinical trial regulations is paving the way to faster approvals, greater international coordination, and resilience to drug shortages, according to Andreas Schwinn, senior qualified person (QP) for investigational medicinal products (IMPs) at Roche.
Speaking on 26 February at the 2025 Clinical Trial Supply Europe conference in Barcelona, Schwinn noted challenges experienced by trial sponsors during this time while emphasising that the resultant benefits would streamline and consolidate trial coordination among EU member states.
“It’s probably the most important regulatory development within the past decades for clinical trials,” Schwinn stated. Applications for trials conducted within EU nations will now be submitted via a single portal, with a single set of documents reviewed to cover approval across the entire EU. “We will, for the first time, with close to 30 EU member states, [have] one consistent rule set on clinical trials,” said Schwinn.
The restructuring of Europe’s clinical trial infrastructure is accompanied by key changes in terminology. These include distinguishing interventional trials from noninterventional studies, raising points with regulatory authorities without altering documentation through Article 81.9 of the CTR, and greater transparency in a universally accessible clinical trials information system (CTIS).
Foremost among the improvements to trial regulation brought with the new CTR is a simplification of multinational approval and documentation. Schwinn praised the single document set now required for trial approval in Europe, down from a previous average of seven, for which a default timeline of 106 days could be expected. Also, notably, quicker approval timelines for single nation trials are still possible.
Importantly, Schwinn noted that for an interventional therapeutic used in trials, a sponsor can submit commercial products only by active substance and active therapeutic chemical (ACT) code rather than by a drug’s marketing authorisation number. “This would allow that you change, for instance, between several generic comparators – without any submission,” which should buttress trials against generic compound shortages prevalent in Europe over the past few years, said Schwinn.
Much of Schwinn’s presentation focussed on the challenges seen at Roche as the Swiss pharma navigated the regulatory transition period. He noted the EU’s resolution of conflicts between data privacy laws and QP declarations as well as issues in cross referencing with pre-transition trials via the new Mother-Daughter trial system. While he recognised some unresolved conflict, such as the potential for EU member states to contest approvals and thereby reintroduce nationally divergent documentation, Schwinn maintained confidence in the new framework as a route towards a quick, efficient, and comprehensible paradigm for clinical trial regulation.
