On 2 July, 2025, the European Commission published its EU Life Sciences Strategy (the 'Strategy'), setting out a roadmap to position the European Union (EU) as a global leader in life sciences by 2030.
For pharmaceutical, MedTech, and biotech companies, the Strategy may, at least in theory, represent a positive shift towards a more innovation-driven environment for research and development (R&D) and market access in life sciences. This will, however, depend, to a great extent, on the practical impact and implementation of the other policy and legislative initiatives in the EU (e.g., the reform of the EU pharmaceutical legislation (see our latest blog), Biotech Act, Critical Medicines Act (see our blog)).
The Strategy presents concrete EU level actions to address long-standing challenges in life sciences in the EU, such as regulatory fragmentation across EU Member States, as well as the barriers to multi-country clinical trials and to the market access of advanced therapies and novel technologies.
A new Life Science Coordination Group within the European Commission will oversee the implementation of the Strategy and ensure that EU policies are consistent and supportive of innovation.
This blog highlights key elements of the Strategy of relevance to pharmaceutical, MedTech, and biotech companies.
Clinical Trials
The Strategy prioritises multi-country-clinical trials, aligned with the Draghi and Letta reports, with the presented actions focused on reducing national regulatory fragmentation and improving funding.
Key actions include:
- A new Clinical Research Investment Plan, expected in 2026, to strengthen EU research infrastructure and facilitate access to funding for multi-national clinical trials
- Supporting the implementation of the Clinical Trials Regulation, particularly for multi-country clinical trials
The Strategy also foresees that the European Commission will pilot a new approach to funding multi-country clinical trials through European partnerships. This includes further actions by the European Commission seeking to improve the funding landscape. Additionally, the European Commission will continue supporting existing EU initiatives, such as:
- Accelerating Clinical Trials in the EU (ACT EU), to simplify and align national clinical trial requirements;
- MedEthicsEU, a forum of national Ethics Committees representatives tasked to align Ethics Committee requirements across EU Member States; and
- COMBINE programme, which intends to address the challenges encountered by sponsors of combined studies involving medicinal products and medical devices or in vitro diagnostic medical devices (IVDs), see our blog), including to streamline the regulatory interface of combined studies
Further proposal by the European Commission to simplify the EU rules for medical devices and IVDs is also in preparation according to the Strategy.
Advanced Therapy Medicinal Products (ATMPs), Biotechnology and New Approach Methodologies (NAMs)
The Strategy places strong emphasis on Advanced Therapy Medicinal Products (ATMPs), biotechnology, and new approach methodologies (NAMs) (i.e., innovative experimental methods not involving live animals), as central to the EU's biomedical innovation landscape. The suggested actions focus on removing regulatory barriers to help their access to the EU market, and funding to support R&D.
Key actions include:
- Adopting the European Biotech Act, expected for 2026 at the latest, to create a more innovation friendly regulatory environment for biotech products and ATMPs
- Establishing a network of European Centres of Excellence for ATMPs by 2026, to coordinate R&D, with EUR 4 million in dedicated funding
- Launching a pilot on a phased collaborative research funding for the development of health technologies through 2027
- Launching a pilot EU biotech cluster collaboration in 2026 to drive innovation and collaboration between different biotech actors (i.e., companies, research institutions and organisations)
- Prioritising advanced health technologies in public procurement
- Supporting the adoption of NAMs using modern technologies such as advanced computer models or virtual human twins (i.e., digital representation of cells, tissues or organs). EUR 50 million will be dedicated to NAMs that de-risk and accelerate development of medicinal products and medical devices
- EUR 8 million will be dedicated to a Virtual Human Twins Incubator through 2027 to support uptake of virtual human twin solutions in the European market and their use in clinical research
- Supporting cross-sector life sciences technologies driving industrial innovation, sustainability (e.g., developing novel molecules and advanced materials (i.e., materials engineered with new or enhanced properties or structural features to deliver specific functional performance)), with EUR 200 million allocated through 2027
Data and Artificial Intelligence (AI)
Access to high quality data and Artificial Intelligence (AI) integration are identified in the Strategy as cornerstones of life sciences competitiveness in the EU. The suggested actions focus on promoting research integrating data and AI.
Key actions include:
- Establishing a European Life Sciences Research and Innovation (R&I) Data Assembly, expected for 2026, to align legal data frameworks and improve regulatory coordination between the EU and Member States
- Supporting the development of strategic biodata resources, including non-human biodata, enabling access to non-EU users
- Developing an AI-powered regulatory navigation tool to guide innovators through the EU regulatory pathways and on the use of EU data repositories
- EUR 50 million will be dedicated to multi-modal generative AI technologies in biomedical research
- EUR 25 million will be dedicated to strengthen the European genomic data infrastructure. Additionally, the Strategy mentions that the European Commission is already supporting the establishment of a comprehensive European genomic reference database to support advancements in personalised medicine
In addition to these actions, the Strategy mentions different EU plans that had already been presented, including the Data Union Strategy, and the Apply AI Strategy, both expected to be published soon. Additionally, it mentions the implementation of the AI Continent Action Plan, proposed in April 2025, which includes the creation of AI Factories, 10 of which are focused on life sciences applications(e.g., medicine discovery and genome analysis), and up to five AI Gigafactories to develop and train next-generation AI models.
Next steps
Pharmaceutical, MedTech, and biotech companies are advised to:
- Closely monitor the implementation of the Strategy, particularly upcoming regulatory changes to prepare ahead, or possible new regulatory pathways for ATMPs or biotech products
- Explore possible participation in pilot initiatives (e.g., COMBINE, biotech clusters)
- Identify relevant funding opportunities at both EU and national levels
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
