Proposal for an EU Regulation introducing measures to strengthen the biotechnology sector (“European Biotech Act”)

On 16 December 2025, the European Commission presented the proposal for a Regulation on Biotechnology and Biomanufacturing, a legislative initiative aimed at positioning the EU as a global leader in health biotechnology.

The EU has an excellent global scientific base but continues to face structural barriers that hinder the translation of research into commercially viable industrial products. Between 2013 and 2023, participation in commercial clinical trials fell from 22% to 12%, while China increased its share from 5% to 18%. Likewise, US biopharmaceutical start‑ups receive approximately nine times more late‑stage funding than their European counterparts.

The main obstacles identified include fragmented and complex regulatory frameworks, limited access to venture capital, shortages in specialised skills and excessively slow authorisation procedures for clinical trials, with an average of 113 days for multinational trials compared with the usual 60 days in other regions.

The proposed Regulation is structured around seven interconnected pillars:

a) Strategic Projects

It establishes a framework for recognising strategic health biotechnology projects and high‑impact projects, which may receive priority financial, technical and administrative support, as well as accelerated authorisation procedures.

b) Access to Finance

It creates a pilot investment programme for health biotechnology to support companies at all development stages — from start‑ups to more established firms — through direct and indirect financing instruments.

c) Biosimilars

It reinforces manufacturing capacity in the field of biosimilars and introduces mechanisms for international cooperation.

d) AI

It facilitates the adoption of AI within biotechnology ecosystems, in line with the AI Regulation, while establishing systems to monitor and mitigate biological risks associated with its use.

e) Novel Biotechnological Products

It introduces specific provisions for innovative biotechnological health products, including the creation of regulatory sandboxes to test new technological approaches.

f) Biosecurity and Biodefence

It incorporates measures to prevent the misuse of biotechnologies and to strengthen biodefence capabilities, including obligations to verify legitimate need for access to biotechnological products deemed sensitive.

g) Regulatory Simplification

It amends key legislation (clinical trials, advanced therapies, etc.) in order to accelerate the transition from development to commercialisation.

In the area of clinical trials, authorisation timelines for multinational studies will be reduced from 106 to 75 days, and from 75 to 47 days where no additional information is required. The role of the reporting Member State is strengthened, and new categories of “low‑intervention” trials are introduced, with simplified requirements.

Additionally, an EU Health Biotechnology Support Network will be established to assist project sponsors — particularly SMEs, start‑ups and non‑profit developers — in navigating regulatory procedures and identifying funding opportunities.

Pharmaceutical and biotechnology companies can also expect more predictable and agile regulatory processes, targeted support for strategic projects, enhanced access to finance and a regulatory framework aligned with scientific and technological progress. The Regulation will enter into force gradually and will be directly applicable in all Member States.