European Commission published new proposal for the Biotech Act

On 16 December 2025, the European Commission published a proposal for the Biotech Act, which defines future rules for the development and application of biotechnology in the European Union. The aim is to create a clear and predictable regulatory framework that supports innovation and strengthens the EU’s competitiveness. Regulation also ensures safety and ethics in the areas covered by the regulation.

The current regulation on biotechnology is based on fragmented directives and regulations that have not sufficiently responded to the rapid development of the sector. The Commission proposal seeks to address these shortcomings and is based on extensive dialogue with stakeholders.

What does the proposed Biotech Act mean in practice?

The processing of the proposal will start in early 2026, and it is expected to bring:

• A single regulatory framework for biotechnology innovation in the EU.
• Clearer and faster approval processes that support research and commercialisation.
• Stronger ethical principles and safety principles, especially in gene technology and synthetic biology.

The Biotech Act is an important step towards the EU’s biotechnology strategy and is expected to have a broad impact on research institutes, companies and authorities. Fimea recommends that you learn more about the proposal and assess its impact on your own operations. 

Fimea will provide more information on the topic to operators later. If necessary, we will organise webinars and other information events on the topic. 

More information:

European Commission biotechnology web page