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EU Biotech Act: Clear Rules, Support, and Safety for Innovation
Published December 16, 2025
Goal: Boost EU biotech innovation
The European Biotech Act is a law that simplifies rules for biotech, helps companies get money and skills, and keeps products safe, so the EU can grow its biotech industry faster and more securely.
Main objective of the European Biotech Act
The Act is designed to strengthen the competitiveness of the EU’s biotechnology and biomanufacturing sectors by:
- Creating a clear, simplified, and predictable regulatory framework that covers the entire life‑cycle of health‑biotechnology products – from research and development to manufacturing and market placement.
- Facilitating access to funding, capital, skills and data for innovators, especially SMEs and start‑ups, so that new biotechnological solutions can reach the market faster.
- Ensuring that all health‑biotechnology products meet the highest standards of safety, quality, ethics, food/feed safety and bio‑security while protecting human and animal health and the environment.
In short, the Act aims to unlock the EU’s full potential in biotechnology, making the single market more efficient, innovative and secure for patients, users and the environment.
Licensing: The summaries on this page are available under Creative Commons Attribution 4.0 (CC BY 4.0).
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