Recent EU Life Sciences Regulatory Changes – What You Need to Know

At the end of 2025, the European Union advanced significant initiatives aimed at modernising and strengthening the regulatory framework for the life sciences sector. From the political agreement on the pharmaceutical package that will make wholesale changes to the regulatory framework for medicinal products, making practical changes to the medical devices legislation, and efforts to increase Europe’s competitive edge in biotech, these developments signal a busy period of regulatory reform and will have important implications for companies in the sector.

This LawFlash includes a brief summary of these key developments, with links to our prior in-depth analyses for more detailed information.

Morgan Lewis is tuned into these developments and the importance for the industry, having recently expanded our European life sciences regulatory team to respond to clients’ needs. Our team of seasoned regulatory lawyers, based in London, Brussels, and Munich, are skilled in providing regulatory advice to life sciences companies, both in-house and in private practice, and are well suited to answer any questions. Contact the team at LifeScienceRegulatoryTeam-EU@morganlewis.com.

AGREEMENT ON THE OVERHAUL OF THE EU PHARMACEUTICAL FRAMEWORK

At the beginning of December 2025, the EU institutions reached political agreement on the EU Pharma Package, a long-anticipated set of revisions to the pharmaceutical legislation intended to improve the affordability, accessibility, and availability of medicines in the European Union. The most highly contested elements of the reforms relate to changes to the regulatory data protection and market protection for innovative medicinal products.

Under the agreement, the baseline period of protection will be eight years of data protection plus one year of market protection, with extensions to the market protection period of up to 11 years if certain conditions are met. A key question will be how these provisions operate, including what steps should be met and how companies can evidence each of the criteria. This adds complexity and uncertainty to the regime, and it is unclear how many products will benefit from the extensions available.

There are also obligations to ensure authorised medicines are made available across all member states; under the agreement, EU countries “have the power” to “require” companies to supply medicines benefiting from regulatory protection in sufficient quantities to meet patient needs, and if this does not take place, companies may lose market protection in the relevant member state. How this process operates and how this is implemented and enforced by the member states will be important for the industry.

While the political agreement marks an important milestone, questions and uncertainties remain. For more information on what is known so far regarding the Pharma Package, refer to our previous blog post; stakeholders are awaiting the final text to understand the detail of the agreement—which is expected in the coming weeks. The European regulatory team will be hosting a webinar once the details are available.

PROPOSAL TO SIMPLIFY THE MEDICAL DEVICES REGULATIONS

Also in December 2025, the EU Commission unveiled a targeted proposal to simplify the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR). The implementation of these new regulations has been criticised due to administrative burden, delays, and complexity. The changes aim to reduce this complexity, enhance predictability in conformity assessment, and reduce costs for manufacturers. To meet these aims, the proposals include simplified conformity assessment procedures to reduce the burden on notified bodies and manufacturers, and reflect a more risk-based approach to the conformity assessment procedure. A more practical relationship with notified bodies, and reduced administrative burden, such as reduced reporting timelines, are also proposed.

There are also proposals relating to specific devices, such as breakthrough and orphan devices and amendments to the in-house hospital exemption.

The proposal will now enter the legislative process and be considered by the European Parliament and Council before agreement and adoption, although the details are likely to be amended during this process. Recent comments from stakeholders suggest agreement may not be as quick as industry had hoped, and the amendments may not be in force for a couple of years. More details on the proposals are discussed in our prior blog post.

PROPOSAL TO BOOST EU BIOTECHNOLOGY COMPETITIVENESS

At the same time as the proposed amendments to the medical devices regime, the European Commission proposed a comprehensive EU Biotech Act designed to reposition Europe as a global hub for biotechnology and biomanufacturing. The proposal seeks to streamline regulatory processes, expand access to funding, and introduce incentives that could accelerate innovation and commercialisation of biotech products within the EU market.

However, many of the proposals go beyond “health biotechnology,” and there are reforms proposed to the Clinical Trials Regulation to streamline and speed up approval of all trials. There are also amendments proposed in relation to food and feed safety, substances of human origin (SoHO), and genetically modified organisms (GMOs), acknowledging the difficulties for companies having to meet these overlapping regulatory requirements.

The proposal will now be discussed by the European Parliament and Council, which will both introduce amendments to the text proposed by the EU Commission. There is also a proposal for a second Biotech Act due to be released later this year, so it is far from certain what form the final legislation will take. For more information, read our full post on the EU Biotech Act.

WHAT DOES THIS MEAN FOR THE INDUSTRY?

Across biotech, devices, and medicines, the EU’s agenda reflects two overarching trends:

• The core aim of the EU Commission is to enhance competitiveness and innovation by streamlining and modernising the regulatory pathways and remove unnecessary blocks in the system.
• The balance of increasing and speeding up access to innovation while ensuring safety as a key priority is clear in the text, with the proposals aiming to take a risk-proportionate approach to regulation.

It will be important that industry’s voice is heard throughout the legislative processes so that these aims are met and patients receive timely access to products.