This is one in a series of Inside European Life Sciences blogs on the proposal for an EU Biotech Act in the form of a regulation that the European Commission released on 16 December 2025. This blog focuses on the proposals to amend the EU’s clinical trial rules and establish a new regime for combined clinical studies involving both investigational medicinal products and investigational medical devices and/or in vitro diagnostic medical devices (“IVDs”).
Slow approval timelines and fragmented processes have meant that the EU’s share of clinical trial research has declined globally – from 22% in 2013 to 12% in 2023, while China’s share has increased from 5% to 18% and the US share has remained stable. This is, in part, because of the faster approval times for clinical trial applications in those jurisdictions – within 60 days – whereas this takes on average 113 days for multijurisdictional trials in the EU. The Commission hopes that increasing the EU’s share of clinical trials may potentially contribute to more manufacturing in the Union; more and earlier marketing authorization applications; and an increased proportion of EU clinical data in those applications.
Key Amendments to Clinical Trial Rules
The Biotech Act proposes targeted amendments to streamline procedures and reduce regulatory burdens under the EU Clinical Trials Regulation 536/2014 (“CTR”) and related frameworks. Amendments include accelerated review times, reducing the regulatory burden on applicants for clinical trial authorizations (“CTAs”) and increasing the coordination and harmonization of review.
Accelerated Timelines
The timeline for review of CTA applications for multinational trials would be from 106 to 75 days and as low as 47 days when there is no information request to the applicant. The 50-day additional period for review of clinical trials involving advanced therapy medicinal products (“ATMPs”, i.e., gene and cell therapy medicinal products and tissue engineered products) under the CTR would be removed.
The timeline for review and approval of substantial modifications to ongoing trials is reduced from 96 to 47 days and 33 days if there is no request for additional information.
Reductions in Regulatory Burdens
Rather than having to submit complete free-standing dossiers for each clinical trial, applicants could cross-refer to reviewed and approved data in dossiers for related trials.
The proposal would also allow for the parallel submission of substantial modifications to a clinical trial, rather than requiring sequential submissions and approvals.
The Biotech Act would also introduce the concept of a “minimal-intervention clinical trial” involving on-label use of authorized investigational products where additional diagnostic or monitoring procedures pose only minimal additional risks to the safety of the subjects or procedural burdens on participants. Such studies would only require ethics committee approval, not a CTA.
Increased Coordination and Harmonization
To improve coordination and help harmonize the outcome of CTA reviews, a reporting Member State (“RMS”) will take the lead in the scientific, ethical and regulatory assessment of CTA applications. Other Member States are expected to rely on the RMS assessment and only raise additional considerations when necessary (e.g., due to nuances in national law or standard of care).
One of the challenges under the CTR was that the requirements for Part II of the CTA dossier containing materials for ethics committee review varies significantly between Member States. The Biotech Act proposes mandatory EU harmonized templates for Part II submissions.
The proposal also envisages Member State freedom to maintain or introduce further conditions governing the processing of clinical trial data, including genetic data or health data.
Support for Innovation
Finally, the proposal envisages so-called regulatory sandboxes for testing novel approaches to, and innovations in, clinical trials that cannot fully comply with existing requirements. Examples might include AI-driven trial design, decentralized trials, and novel data collection methods.
New Combined Study Rules
A focus of the proposed revisions to both the Biotech Act and to the EU’s medical device and IVDrules is addressing significant issues arising in the context of combined studies. A combined study is one in which a clinical trial is combined with a performance study of an IVDunder the EU IVD Regulation 2017/746 (“IVDR”) and/or with a clinical investigation of a medical device under the EU Medical Device Regulation 2017/745 (“MDR”). As the law currently stands, the sponsor must seek authorization of each of these studies independently under each regime. Delays in establishing the infrastructure necessary to support the coordinated review of clinical investigations under the MDR and performance studies under the IVDR have meant that sponsors must currently submit separate national applications. Variations in national procedures, and also the resources to review such applications, have resulted in significant delays, and the sponsor cannot start its combined study until all approvals are in place.
The new combined study rules are designed to address this regulatory friction by removing the requirement for separate regulatory submissions under the CTR and MDR/IVDR. Instead, the sponsor would submit a single integrated application covering both the investigational medicine and the device/IVD. There would be a single assessment led and coordinated by an RMS and ultimately coordinated approvals.
Please note that this blog is based on the wording of the EU’s proposal published on 16 December 2025. This wording may significantly change during the legislative process. Our European Life Sciences team will continue to monitor developments. Please feel free to reach out to the team with any questions.