The Commission is expected to present, on 16 December 2025, a legislative proposal for a regulation dedicated to Biotechnology (“Biotechnology Regulation I”), with a particular focus on health. The proposal will consolidate provisions relating to clinical trials, in vitro diagnostics and medical devices, as well as foodstuffs and animal feed.
The European Commission’s initiative will address the fields of agriculture, energy, sustainability, economic resilience, national security and biosecurity. This constitutes the first phase of a new omnibus regulation – that is, a legislative reform that reviews and amends multiple legal acts within the same area, in an effort to simplify the overall legislative framework.
By the third quarter of 2026, the Commission is expected to adopt a proposal for a “Biotechnology Regulation II”, focusing on industrial policy and the creation of a research and development ecosystem.
The introduction of a regulation on biotechnology is one of the flagship initiatives of the European Strategy for Life Sciences, adopted on 2 July 2025, aimed at fostering a world-leading innovation and scientific discovery ecosystem in health, food and sustainability by the end of the decade.
The key measures proposed under the Strategy include regulatory simplification, improved access to finance, expansion of manufacturing capacity, integration of data and artificial intelligence, and the streamlining of market access for biotechnological products, particularly for start-ups.
In 2021, the global biotechnology market amounted to EUR 720 billion, with an annual growth rate exceeding 18%. The United States dominates this market, accounting for 60% of global value, followed by the EU (12%) and China (11%). Productivity in the biotechnology sector is significantly higher than the EU average, with employment growing at a pace six times faster than the wider European economy.
The EU ranks second (with an 18.3% share) in the creation of high-value patents in the biotechnology sector, behind the United States (39.6%) and ahead of China (10.4%, rapidly increasing). According to the Commission’s report, many research outcomes are still insufficiently translated into market applications.
The new proposal for a Regulation will be closely linked to other initiatives, such as the European Bioeconomy Strategy, scheduled for adoption on 25 November, and the EU Biotech Hub, established in January 2025 to support start-ups and SMEs in bringing innovative biotechnological products to the European market.
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