The Working Party on Pharmaceuticals and Medical Devices of the Council of the European Union is scheduled to meet on 22 and 23 July 2026 in Brussels to exchange views on the proposed European Biotech Act, according to a notice of meeting and provisional agenda published on 10 July 2026. The meeting, which will take place at the Council's LEX Building, will focus on the Proposal for a Regulation establishing a framework to strengthen EU biotechnology and biomanufacturing sectors, particularly in health, and amending several existing regulations including those on novel foods, advanced therapy medicinal products, clinical trials, veterinary medicinal products, and the Strategic Technologies for Europe Platform. The agenda item is listed under reference document ST 16945/25.
The Working Party's exchange of views marks the first formal discussion of the European Biotech Act at the Council level. The proposal, introduced by the European Commission, aims to boost the EU's biotechnology and biomanufacturing capacity by streamlining regulatory processes, fostering innovation, and ensuring competitiveness in health-related biotech sectors. The amendments target regulations that govern areas such as clinical trials (Regulation (EU) No 536/2014), advanced therapy medicinal products (Regulation (EC) No 1394/2007), and veterinary medicinal products (Regulation (EU) 2019/6), among others.
No prior coverage of this specific meeting or the European Biotech Act proposal exists in recent records. The meeting format is listed as "2+2," indicating that each delegation may have two representatives plus two advisers. Any other business will follow the main agenda item. The meeting is open to Council delegates and relevant stakeholders, with contact details provided for the Council's Health unit.
The European Biotech Act is part of a broader EU push to strengthen strategic autonomy in health and biotechnology, aligning with the European Health Union and the EU's industrial strategy. The Working Party's discussion will feed into the legislative process, with the proposal expected to be examined by other Council preparatory bodies and the European Parliament in due course.