The European Biotech Act represents a major strategic initiative designed to strengthen Europe’s competitiveness in life sciences and health innovation.
The biotechnology sector is one of the fastest-growing sectors in the European Union. It currently represents more than 900,000 jobs, 75% of which are in healthcare, and contributes nearly €40 billion to the European economy.
At the end of 2025, the European Union unveiled the main pillars of its European Biotech Act, an initiative led by the European Commission in response to a widely acknowledged challenge: despite recognized scientific excellence, Europe struggles to transform innovation into accessible health products for patients, particularly in comparison with the United States and China.
The European Biotech Act aims to simplify, accelerate and secure innovation pathways—from research to market access—while maintaining high standards of safety and quality. It directly concerns medicinal products and, in a more indirect but strategic way, medical devices.
The initiative is based on a regulatory proposal published by the European Commission in 2025, defining strategic orientations and regulatory levers to strengthen European competitiveness in biotechnology and health innovation.
Official text: https://health.ec.europa.eu/document/download/ec1475b7-e3f9-409e-b927-fc7e69306a8c_en?filename=biotech_reg-com2025-1022_act_en.pdf
European Biotech Act: what exactly does it cover?
The European Biotech Act seeks to create a more favourable environment for biotechnology development in Europe by addressing structural barriers identified by industry, start-ups and research stakeholders.
According to the European Commission, the key objectives include:
- strengthening Europe’s biopharmaceutical innovation and manufacturing capacity;
- reducing regulatory fragmentation between Member States;
- improving clarity and predictability of regulatory frameworks applicable to innovative health products;
- accelerating development, assessment and market access timelines.
Source: https://ec.europa.eu/commission/presscorner/detail/fr/ip_25_3077
In practical terms, the European Biotech Act is not limited to a single regulatory amendment but constitutes a broader strategic repositioning of Europe’s life sciences ecosystem.
European Biotech Act: accelerating innovation without compromising scientific rigour
A context of declining European competitiveness
The European Commission explicitly acknowledges that the EU has lost market share in clinical trials and innovative drug development.
Lengthy authorisation timelines, procedural complexity and multiple interlocutors are regularly cited as factors discouraging sponsors from conducting clinical research in Europe.
The European Biotech Act builds on recent initiatives such as:
- the implementation of Regulation (EU) No 536/2014 on clinical trials;
- the deployment of the CTIS portal (Clinical Trials Information System);
- and more recently, the launch of the FAST-EU pilot for multinational clinical trials.
Together, these reforms aim to restore Europe’s attractiveness as a hub for clinical research and biopharmaceutical production.
What the European Biotech Act changes for medicines
For medicinal products, the European Biotech Act introduces several key orientations:
- simplification of regulatory pathways for innovative products, particularly those derived from biotechnologies;
- reinforced coordination between European competent authorities;
- improved articulation between clinical development, regulatory assessment and industrial manufacturing;
- measures aimed at reducing evaluation timelines while maintaining scientific and ethical standards.
The strategic objective is clear: enable sponsors of innovative medicines to develop and test their products more efficiently within the European Union, without being incentivised to relocate clinical trials or production activities outside the EU.
Source: https://ec.europa.eu/commission/presscorner/detail/fr/ip_25_3077
This approach reflects a political will to combine competitiveness and regulatory excellence, rather than opposing them.
For medical devices: a more indirect but strategic impact
No FAST-EU equivalent for medical devices, but strong policy signals
Unlike medicines, the European Biotech Act does not introduce a dedicated accelerated procedure for clinical investigations of medical devices.
Medical devices remain governed by:
- Regulation (EU) 2017/745 (MDR);
- Regulation (EU) 2017/746 (IVDR).
However, the European Biotech Act sends several important signals to the medical device sector:
- explicit recognition of difficulties faced by manufacturers, particularly SMEs and start-ups;
- stated intention to reduce administrative burdens affecting innovation;
- articulation with ongoing discussions on the targeted revision of the MDR/IVDR framework.
What medical device manufacturers should anticipate
For medical devices, the European Biotech Act may lead, in the medium term, to:
- improved coordination between competent authorities at European level;
- more proportionate approaches to the evaluation of certain innovative devices;
- stronger digitalisation of regulatory processes;
- reflection on assessment timelines and notified body capacity in relation to overall ecosystem competitiveness.
Even without immediate amendments to MDR/IVDR texts, the European Biotech Act establishes a favourable political and strategic framework for future regulatory adjustments.
Source: https://ec.europa.eu/commission/presscorner/detail/fr/qanda_25_3078
Conclusion
The European Biotech Act marks a key step in the transformation of the European life sciences ecosystem. By addressing structural barriers that hinder innovation, it aims to reposition the European Union as a leading global actor in the development of innovative medicines and medical devices.
While the initiative introduces more direct operational measures for medicinal products, its impact on medical devices is likely to be more progressive yet structurally significant, particularly in connection with forthcoming revisions of the MDR/IVDR framework.
In this evolving context, anticipating regulatory developments becomes a strategic priority for all stakeholders involved in clinical research and health product development.
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Complementary article: FAST-EU pilot for multinational clinical trials: accelerating clinical trial authorisation in the European Union
