Expert comment: European Biotech Act to strengthen biotechnology and manufacturing sectors

On 16 December 2025 the European Commission published a proposal for a framework of measures to strengthen the Union’s biotechnology and biomanufacturing sectors particularly in the area of health; the so-called Biotech Act.

Background

EU has a strong scientific research base in biotechnology but is facing issues with taking the early-stage research of these products into further development, manufacturing and commercialization within EU. The Biotech Act’s overarching ambition is to reverse Europe’s declining competitiveness relative to leading biotech hubs, particularly the major regional ecosystems found in the United States and China.

The Act introduces frameworks for recognizing “high‑impact health biotechnology strategic projects”, which would gain priority access to funding, administrative support, and network collaboration opportunities. Alongside these funding measures and guidance initiatives, several changes to the regulatory legislation are proposed.

Key regulatory legislation affected

The present proposal will amend, among others, the Clinical Trial Regulation No 536/2014 (CTR) and the Regulation No 1394/2007 on Advanced Therapy Medicinal Products (ATMPs). It also considers other legislation that is being revised, like the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR).

Clinical Trials

The proposal has a strong focus on clinical trials. Strengthening EU’s role in clinical trials will increase investment, production and patient access in the region. The proposal aims at reducing costs and administrative burden for biotech companies by simplifying regulatory frameworks and shortening procedural timelines.

Amendments include:

• FAST EU – a voluntary initiative with national Medical Agencies and Ethics Committees, to coordinate a fast-track approach for multinational clinical trial evaluations.
• Introducing regulatory sandboxes to facilitate atypical clinical trials. These controlled environments will support innovative trial designs and use of AI tools.
• Introducing a single authorization process for combined studies (biopharmaceutics plus medical devices).
• Strengthening reliance on the reporting Member State’s assessment to reduce duplication of work and allow Member States and sponsors to allocate resources more effectively.
• Shortening the assessment timelines from 75 to 47 days when there is no need for complementary information, and from 106 to 76 days if there is such a need. The additional 50 days for assessment of an ATMP will be removed. Assessment of substantial amendments will be shortened from 96 to 47 days, or from 64 to 33 days if there is no request for information. More than one substantial amendment will be allowed in parallel as long as the changes concern distinct and independent aspects of the dossier.
• Introduction of a single core dossier for investigational medicinal products that can be referenced across several studies with one member state being responsible for the assessment of its completeness and suitability.
• A new “minimal-intervention” category of clinical trials will be introduced for products already authorized. These studies would only need an ethical review before starting.

Extension of the SPC

The Biotech Act proposes a 12‑month extension to the existing Supplementary Protection Certificate (SPC) for biotech medicinal products and advanced therapy medicinal products (ATMPs) that fulfills certain conditions.

Key expected impact for developers

• Faster and more streamlined approval of clinical trials
• An extra year of patent protection
• Increased financial and administrative support to SMEs

Next steps

Once the Commission proposal is negotiated and agreed with the European Parliament and the Council, it will be published in the EU’s Official Journal and will enter into force 20 days after publication. The Clinical Trial Regulation amendments will apply 6-9 months after the Act enters into force.