Introduction
On 16 December 2025, the European Commission (“Commission”) published its Proposal for a Regulation on establishing a framework of measures for strengthening the Union’s biotechnology and biomanufacturing sectors particularly in the area of health (“Biotech Act”) (see here). The Proposal follows a public consultation held between August 2025 and November 2025 (see here) and forms part of the Commission’s broader life sciences strategy for the 2024-2029 mandate (see here).
Health biotechnology accounts for most of the sector’s value and employment in Europe and is playing an increasingly central role in the development of innovative medicines, including advanced therapy medicinal products (“ATMPs”), personalised therapies, and biological medicinal products. These technologies have also contributed to recent medical breakthroughs, including CAR-T cell therapies and the expanding use of mRNA therapies.
As noted in the Proposal’s Explanatory Memorandum, the EU has a strong scientific research base with established expertise in specific areas of biotechnology, such as biosimilars. However, it has faced challenges in turning early-stage research into large-scale development, manufacturing, and commercialisation of innovative health biotechnology products within the EU. In practice, this has led companies to seek investments, carry out late-stage development, locate manufacturing, or place products outside the EU.
The Biotech Act aims to address these gaps by improving access to funding, rewarding key innovations, simplifying and accelerating regulatory pathways, simulating alternative approaches through regulatory sandboxes, and strengthening industrial and manufacturing capacity, while maintaining high standards for the protection of human health, animal health, patients and consumers, the environment, ethics, quality, food and feed safety, and biosecurity.
What this means for industry
Below, we highlight some of the main regulatory developments in the Proposal that are particularly relevant for life sciences companies. We will provide further detail on specific aspects of the Biotech Act in future blogs.
- SPC extension for best-in-class biotechnology medicines developed in the EU. Medicinal products developed through biotechnology processes (as defined in Annex I to the new Medicines Regulation) or ATMPs may qualify for a 12-month SPC extension. The eligibility is strict and requires (i) a new active substance “distinctly different” from that of any authorised medicinal product; (ii) a “distinctly different” mechanism of action with safety and efficacy at least equivalent to authorised medicinal products for the same disease; (iii) clinical trials evaluating the efficacy and supporting the marketing authorisation (“MA”) conducted in more than two Member States; and (iv) at least one manufacturing step – excluding packaging, testing, and certification – performed within the EU.
- Boosting competitiveness in biosimilars. To accelerate biosimilar development, the EMA will develop and update guidelines on a tailored regulatory approach for the development of biosimilars, which will consider “reduction of the clinical data required for the development and approval of biosimilars”. The Biotech Act also includes measures supporting strategic health biotechnology projects focused on biosimilar R&D, manufacturing, and authorisation.
- Regulatory tools for novel health biotechnology products. The Biotech Act establishes the EU Health Biotechnology Support Network to help developers – especially SMEs, start-ups and scale-ups – navigate regulatory pathways. It also establishes a Foresight Panel for Emerging Health Innovation that will provide the Commission, the EMA, the Union-level advisory bodies or national competent authorities with regulatory scientific and technical expertise on emerging science and technology.
- Regulatory sandboxes for novel health biotechnology products. The Biotech Act creates a dedicated regulatory sandbox for products that cannot be appropriately accommodated by the regulatory sandboxes available under other legal frameworks (e.g., under the MDR or the new Medicines Regulation) and for whose development it is challenging to identify a suitable regulatory procedure.
- Simplification and acceleration of clinical trials. For multinational trials, authorisation timelines will be shortened from 106 days to 75 days, including validation and ethical review. When there is no request for information to the sponsor, timelines for initial clinical trial authorisations will be reduced from 75 days to 47 days from submission to decision. The additional 50 days for assessing applications for trials involving ATMPs will be eliminated. The assessment period for substantial modifications will be reduced from 96 days to 47 days. If there is no request for information to the sponsor, the timelines for the assessment of substantial modifications will be reduced from 64 days to 33 days from submission to decision.
Other key changes include:
- Accelerated procedures for the authorisation of multinational clinical trials during public health emergencies;
- Strengthening the role of the reporting Member State;
- A new category for “minimal-intervention clinical trials”;
- Parallel submission of substantial modifications;
- A core dossier for investigational medicinal products;
- Regulatory sandboxes.
- Combined clinical trials. The Biotech Act introduces a single application for combined studies, i.e., studies in which a clinical trial is combined with a performance study of an in vitro diagnostic medical device or with a clinical investigation of a medical device.
- Clinical trials with ATMPs that consist of or contain GMOs which present no or negligible risks to human health and the environment. Sponsors of clinical trials with ATMPs consisting of or containing GMOs will not be required to submit an environmental risk assessment if the product belongs to one of the following categories: (a) non-viable or replication deficient viral vector that is used to deliver a genetic sequence of human origin, and the vector does not carry an antimicrobial resistance gene; (b) genetically modified somatic cells, that cannot secrete or produce infectious agents due to the genetic modification; (c) genetically modified bacteria that do not carry an antimicrobial resistance gene; (d) genetic material altered using genome editing techniques (ex vivo or in vivo), provided that it has generally negligible adverse effects on human health and the environment. For those types of ATMPs, the sponsors are also exempted from complying with the GMO-related requirements regarding the authorisation of manufacturing and import of advanced investigational therapy medicinal products.In addition to the Biotech Act, the Commission published a Proposal for a Directive amending Directive 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs (see here), which, among other changes, introduces a new concept of low-risk genetically modified micro-organisms.
- Data protection in clinical trials. The Biotech Act proposes to harmonise the legal basis for the processing of clinical trial data (i.e., legal obligation) and to prevent Member States from diverging from that. In addition, the Biotech Act attempts to settle the allocation of GDPR responsibility between sponsors and investigators (both controllers) in an attempt to resolve this chronic compliance concerns. Finally, the Biotech Act allows for secondary use of clinical trial data for scientific research purposes without a new or additional GDPR consent.
- Artificial intelligence. The EMA will publish guidance on using advanced technologies, including AI, in the lifecycle of medicinal product development – preclinical research, clinical development and trials, manufacturing, post-authorisation monitoring and authorisation procedures. The Biotech Act also aims to create trusted AI testing environments and data-quality accelerators.
- Health biotechnology strategic projects. To foster innovation, the Biotech Act introduces health biotechnology strategic projects and high impact biotechnology strategic projects (i.e., projects with a strong systemic and catalytical potential within the EU’s biotechnology ecosystem to accelerate innovation and enhance the translation of research into market application). These projects will benefit from fast-track permits, coordinated through a single national contact point, and receive administrative, technical, and financial support.
- Access to funding. To mobilise private investment, the Biotech Act establishes an EU health biotechnology investment pilot in partnership with the European Investment Bank Group and other implementing partners.
- Biodefence and biosecurity. The Biotech Act aims to support high-impact strategic health biotechnology projects contributing to the EU Biothreat Radar for the detection, characterisation, identification, analysis and assessment of biological threats, including novel, unknown and engineered pathogens to ensure pathogen-agnostic cross-border surveillance and early threat detection. It also aims to support initiatives to strengthen the EU’s biodefence capabilities.
- Prevention of Biotechnology Misuse. To safeguard against misuse, the Biotech Act establishes a list of “biotechnology products of concern”, whose placing on the market, introduction and use will only be allowed for a “legitimate need”. In addition, benchtop nucleic acid synthesis devices made available in the EU must contain a built-in screening mechanism to detect “sequences of concern”, as defined by the Biotech Act.
This blog is based on the wording of the EU’s proposal published on 16 December 2025. This wording could significantly change during the legislative process. Our Brussels, Dublin, Frankfurt and London teams will continue to monitor this legislation.