ARTICLE
14 August 2025

EC Begins Public Consultation On Biotech Act

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Bergeson & Campbell

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Bergeson & Campbell, P.C. is a Washington D.C. law firm focusing on chemical product approval and regulation, product defense, and associated business issues. The Acta Group, B&C's scientific and regulatory consulting affiliate provides strategic, comprehensive support for global chemical registration, regulation, and sustained compliance. Together, we help companies that make and use chemicals commercialize their products, maintain compliance, and gain competitive advantage as they market their products globally.
The European Commission (EC) began a public consultation on August 4, 2025, on the European Biotech Act in the form of an online questionnaire. According to the EC, the aim is to gather evidence...
United States Food, Drugs, Healthcare, Life Sciences

The European Commission (EC) began a public consultation on August 4, 2025, on the European Biotech Act in the form of an online questionnaire. According to the EC, the aim is to gather evidence and views from stakeholders across all relevant sectors of biotechnology and biomanufacturing, including the medical and pharmaceutical, agricultural, food and feed, industrial, environmental, and marine sectors. The EC states that stakeholder feedback is crucial for identifying the most important challenges and barriers that could be addressed by the Act and for shaping targeted policy actions. The questions address general view on biotechnology; the regulatory environment in the European Union (EU); access to capital; biotechnology clusters and/or cluster organizations; biotechnology manufacturing; availability, upskilling and reskilling the biotechnology workforce; data and artificial intelligence (AI); and defense and security. Comments are due November 10, 2025. As reported in our June 6, 2025, blog item, the EC began a call for evidence on May 14, 2025, and submissions were due June 11, 2025. The EC plans to adopt final legislation in the third quarter of 2026.

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