With the draft of an EU Biotech Act presented on 16 December 2025, the European Commission has sent a clear political signal to strengthen Europe as a location for biotechnology and biomanufacturing. The COM-proposal for a new (amending) Regulation aims to create innovation-friendly, science-based, and at the same time predictable regulatory and financial framework conditions, thereby improving the EU’s competitiveness in the global landscape.
For clinical trials with medicinal products, the COM-proposal provides for the following changes:
- Reduction of approval timelines for multinational clinical trials: The authorisation period is to be shortened from 106 to 75 days. Where competent authorities raise no requests for information, a decision must be adopted within 47 days. In addition, the current 50-day extension option for ATMP studies (e.g. gene and cell therapies) is to be removed.
- Acceleration of review timelines for “substantial modifications”: The assessment period will be reduced from 96 to 47 days. If no additional information is requested, a decision must be taken within 33 days (currently 64 days).
- Strengthening of the role of the Reporting Member State: The Reporting Member State will act as the lead authority for the scientific, regulatory, and coordinated ethical assessment (Part I). Objections from other Member States will be more narrowly defined. In addition, EU-harmonised templates are to be introduced to reduce divergences in Part II assessments.
- Simplification of so-called “combined studies”: Procedures for clinical studies involving both medicinal products and medical devices/IVDs will be streamlined.
- Harmonisation of the data protection framework: The processing of personal data will be based on the public interest in the field of public health as a “legal basis”, with the aim of ensuring a more uniform application of the GDPR and reducing national deviations (such as the current practice in Germany requiring explicit data protection consent from trial participants).
Key Takeaways | What’s next?
The COM-proposal represents a European Commission draft at an early stage of the legislative process. Based on legislative practice, substantial amendments can be expected during the further course of the procedure, in particular during the trilogue negotiations between the Commission, the European Parliament, and the Council. Adoption of the Regulation is therefore not expected before the end of 2026 at the earliest.
Furthermore, European Commission has already announced a second regulatory package (“Biotech Act II”), which is intended to go beyond the primarily health-related focus of the first legislative proposal and address additional areas of biotechnology. Against this background, it is recommended to closely monitor the legislative process and to consider concrete implementation measures only once the final version of the Biotech Act has been adopted.
