On 16 December 2025, the European Commission proposed a package of measures to improve resilience, competitiveness, and safety of the EU health sector. One of these measures is the proposal for the new EU Biotech Act (the “Act”). Despite the Union's strong scientific foundations, barriers like limited access to capital and regulatory complexity have left the EU lagging in biotech innovation, reflected in low venture capital investment, a decline in clinical trial activity, and a growing trend of start-ups relocating outside the EU. With the Act, the EU aims to dismantle these barriers and establish Europe as a global leader in biotechnology innovation.
The Act is designed in the legal form of an EU Regulation, and will amend existing EU health, food, and biotech legislation, such as the Clinical Trials Regulation and the Food Safety Regulation. To enhance the EU’s attractiveness for biotech investments and innovation, the proposal includes:
- mechanisms to improve access to funding—particularly for Small- and Medium-sized Enterprises (“SMEs”) and start-ups—including an EU health biotechnology investment pilot in cooperation with the European Investment Bank Group, designed to support scale-up stages of biotech development.
- rewards for innovation, such as an additional 12-month extension to supplementary protection certificates (extending patent protection) for eligible biotech medicinal products developed and manufactured (at least partially) in the EU. Such additional SPC protection does, however, require that innovation is taking place in Europe, as the pivotal clinical trials for an eligible product must be carried out in more than two EU Member States and at least one manufacturing step other than packaging, quality testing and certification must be performed place in the Union.
- measures that require the European Medicines Agency (“EMA”) to develop and update guidance on a tailored regulatory approach for the development of biosimilars, in which the EMA shall consider a potential reduction of the clinical data required for the development and approval of biosimilars
Implications for clinical trial sponsors
One of the most important aims of the Act is to make Europe a faster and more attractive place to run clinical trials. If enacted, the Act would streamline the regulatory landscape by introducing a suite of measures designed to enhance Europe's competitiveness in clinical development, among which are the following:
Accelerated approvals
One of the most significant changes for sponsors in the EU would be the acceleration of clinical trial approval timelines. The Act proposes to reduce the maximum authorization period for initial multinational clinical trial authorizations from 106 to 75 days. Timelines for the assessment of substantial modifications will be shortened as well. Importantly, the timelines for clinical trials investigating ATMPs would be the same as for any other products, i.e. the current additional 50-day review period would be removed.
Harmonized assessment and submission documents
Further, assessment procedures would be harmonized and streamlined by a stronger role of the reporting Member States (“RMS”) leading the scientific, ethical and regulatory assessment, with other Member States concerned being expected to generally rely on the RMS' assessment (while sharing additional considerations e.g. based on national law or standard of care considerations remain possible). Also, sponsors would be expected to use harmonized template documents to create the submission documents for Part II of the application dossier. To date, submissions for Part II are not harmonized, resulting in administrative burden for both sponsors and Member.
Introduction of single core dossier
The Act introduces the concept of a single core dossier for an investigational medicinal product (“IMP”). This provides the opportunity for sponsors to create a single dossier which can be used as a basis for multiple clinical trials testing the same IMP. Subsequent applications for corresponding clinical trials can then refer to this core dossier, resulting in much simpler and more streamlined creation of submission documents for such subsequent applications.
Combination studies for IMPs and IVD/medical devices
Combined studies involving an IMP and medical devices/in vitro diagnostics would benefit from a newly introduced unified assessment process. As of today, clinical trials for IMPs used in combination with medical devices (e.g. a companion diagnostic device (“CDx”)) often face the challenge that no CE-marked devices are available at the time of the clinical trial. The current regulatory framework acknowledges that a combined study of an IMP with a CDx performance study is in principle possible to address this issue. However, it does not provide for a harmonized procedure for such combination studies and thus each Member State concerned applies different standards and procedures when assessing a respective application.
Reception of the Act
Industry associations overall welcome the Act as a positive and necessary step towards strengthening the EU's biotech position. The measures to simplify and harmonize regulatory framework on clinical trials and to shorten timelines are supported industry wide. While Medicines for Europe supports the Act and the prioritising of health biotechnology, it is particularly sceptical about the SPC extensions as proposed under the Act, which in their view would undermine competition. EFPIA and EUCOPE on the other hand call the extension of the SPC regime an important lever to enhance Europe's attractiveness for pharmaceutical R&D, and call for expansion of the scope of the products that could profit from this extension.
Conclusion and timeline
It is promising that the European Commission recognizes both the importance of clinical trials for delivering innovative treatments and the obstacles currently created by EU law. By cutting timelines, reducing fragmentation, and simplifying complex study designs, the Act addresses long-standing pain points.
The proposal for the Act will be submitted to the European Parliament and the Council for amendments and adoption. The final text of the Act is likely to be adopted towards the end of 2026 or later, with entry into application expected to be around 2027-2028.
This article is the 8th in our thought leadership series, “Trends in Cell, Tissue, and Gene Therapies,” which aims to help you stay informed about the broad array of legal and regulatory issues affecting companies operating in the regenerative medicine space. From clinical studies, to obtaining patents, to scaling up manufacturing, our global team will discuss novel issues arising in all parts of the world, including unique deal-making, litigation, and inspections concerns for CTGT companies.
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