Proposal for a Regulation on establishing a framework of measures for strengthening the Union's biotechnology and biomanufacturing sectors (European Biotech Act) (European Biotech Act)
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Summary
This is a Commission proposal (COM(2025) 1022 final, published 16 December 2025) for a Regulation establishing a framework of measures to strengthen the EU’s biotechnology and biomanufacturing sectors, with a focus on health biotechnology. It aims to accelerate scale-up, improve access to finance, and streamline navigation of relevant regulatory pathways while maintaining high standards for safety, ethics and biosecurity. The proposal also foresees coordination mechanisms (e.g., support networks and single points of contact) and targeted simplification/amendments across related EU frameworks.
Who is affected?
Biotechnology and biomanufacturing companies (including SMEs, start-ups and scale-ups), research organisations and technology transfer actors, investors and financial intermediaries, and Member State/EU authorities involved in authorisation, supervision and support of health biotech activities (e.g., clinical trials, medicines/ATMPs, substances of human origin, veterinary medicines, and relevant food/feed processes).
Scope
EU-wide measures to support and accelerate the development, scale-up and manufacturing of biotechnology and biomanufacturing—particularly in health biotechnology—covering support structures, investment facilitation and regulatory coordination/simplification across relevant EU rules.
Key Points
- Creates an EU framework to identify and support strategic biotechnology/biomanufacturing projects to speed up scale-up and time-to-market.
- Sets up an EU health biotechnology support network and national single points of contact to help innovators navigate regulatory pathways and access support.
- Introduces an EU health biotechnology investment pilot to improve access to capital for biotech companies and projects.
- Includes measures aimed at strengthening EU biosimilars manufacturing capacity and expertise, including through international cooperation.
- Encourages use of data and AI in biotech and biomanufacturing ecosystems, in alignment with applicable EU digital rules (including the AI Act).
- Foresees targeted simplification and/or amendments across related EU frameworks (e.g., clinical trials, ATMPs, substances of human origin, veterinary medicines, and general food law) and may enable regulatory sandboxes in specific contexts.
Key Deadlines
- — Call for evidence opened
- — Call for evidence closed
- — Commission proposal published (COM(2025) 1022 final)
Related Regulations
Frequently Asked Questions
Who must comply with the European Biotech Act?
Biotechnology and biomanufacturing companies, including SMEs, start-ups, and scale-ups, as well as research organisations, technology transfer actors, investors, financial intermediaries, and relevant Member State/EU authorities involved in health biotech activities must comply with the Act.
What is the main objective of the European Biotech Act?
The Act aims to strengthen and accelerate the EU’s biotechnology and biomanufacturing sectors, particularly in health biotechnology, by improving access to finance, streamlining regulatory pathways, and supporting scale-up and innovation while maintaining high safety and ethical standards.
What types of biotechnology activities are covered by the Act?
The Act covers a broad range of biotechnology and biomanufacturing activities, with a focus on health biotechnology, including clinical trials, advanced therapy medicinal products (ATMPs), substances of human origin, veterinary medicines, and relevant food and feed processes.
What are the key obligations for companies under this proposal?
Companies may need to engage with new support networks, utilize single points of contact for regulatory guidance, participate in investment pilots, and comply with any streamlined or amended regulatory requirements introduced by the Act.
How does the Act facilitate access to finance for biotech companies?
The Act introduces an EU health biotechnology investment pilot, designed to improve access to capital for biotech companies and projects, particularly those identified as strategic for the EU.
What penalties apply for non-compliance with the Act?
As this is a proposal, specific penalties are not yet defined; however, once adopted, penalties will likely be determined in accordance with the final Regulation and relevant national enforcement mechanisms.
How does the Act interact with other EU regulations?
The Act foresees targeted simplification and possible amendments to related EU frameworks, such as those governing clinical trials, ATMPs, substances of human origin, veterinary medicines, and food law, and is designed to align with digital rules like the AI Act.
What practical steps should companies take to prepare for compliance?
Companies should monitor the progress of the proposal, assess their current regulatory pathways, identify potential opportunities for support or investment, and prepare to engage with new coordination mechanisms such as support networks and single points of contact.
Are there specific measures for biosimilars manufacturing?
Yes, the Act includes measures to strengthen EU biosimilars manufacturing capacity and expertise, including through international cooperation.
When will the European Biotech Act become applicable?
As of now, the Act is still a proposal. It will become applicable after adoption by the EU co-legislators and subsequent publication in the Official Journal, with specific timelines to be set in the final text.
Key Terms
- Health Biotechnology Support Network
- A coordinated EU-level structure intended to assist innovators in navigating regulatory pathways and accessing support for health biotechnology projects.
- Single Point of Contact (SPOC)
- A designated national or EU-level entity that provides guidance and support to biotech companies and researchers on regulatory and administrative matters.
- Strategic Biotechnology Project
- A project identified by the EU as critical for strengthening the biotechnology and biomanufacturing sectors, eligible for targeted support and accelerated regulatory processes.
- Biomanufacturing
- The use of biological systems or organisms to produce commercial products, particularly in the health, food, and feed sectors.
- Investment Pilot
- A targeted EU initiative to facilitate access to capital for biotechnology companies and projects, especially those considered strategic.
- Regulatory Sandbox
- A controlled environment where innovative biotech solutions can be tested under regulatory supervision, allowing for temporary exemptions or adaptations of standard rules.
- Biosimilars
- Biological medicinal products that are highly similar to an already approved reference product, with no clinically meaningful differences in safety or efficacy.
- Advanced Therapy Medicinal Products (ATMPs)
- Medicines for human use based on genes, cells, or tissue engineering, subject to specific EU regulatory frameworks.
- Substances of Human Origin (SoHO)
- Materials such as blood, tissues, and cells derived from humans, used in medical treatments and subject to specific regulatory controls.
- Technology Transfer Actor
- Entities or individuals involved in transferring scientific discoveries and innovations from research settings to commercial or clinical applications within the biotech sector.