The European Commission has opened a feedback period on the forthcoming European Biotech Act, allowing all stakeholders to express their views in the legislative debate.
The European Biotech Act Ion establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health. It was presented by the European Commission in December 2025 as part of a broader package of measures aimed to strengthen competitiveness, innovation, and strategic autonomy in the field of biotechnology. On 19 March 2026, the proposal was presented during the joint meeting of the Public Health committee and Industry, Research and Energy committees of the European Parliament.
The Biotech Act proposes to several EU pieces of legislation in the human health sector, including
Clinical Trials Regulation (EC Regulation No 536/2014)[2]
Regulation on Advanced Therapy Medicinal Products (ATMPs, EC Regulation No 1397/2007)[3]
Regulation on standards of quality and safety for substances of human origin intended for human application (SoHO, 2024/1938) [4]
Strategic Technologies for Europe Platform Regulation (EC Regulation No 295/2024)[5].
The proposal is also aligned with other ongoing EU legislative initiatives, including the proposed Critical Medicines Act, the revision of EU pharmaceutical legislation, and the revision of the regulations on medical devices and in vitro diagnostic medical devices, with the aim of creating synergies and ensuring coherence within the broader EU regulatory system. The Biotech Act also addresses issues related to the management and sharing of health data, the governance of SoHO, and the need to ensure high standards of safety, quality, and traceability in the use of biological materials for research and therapeutic purposes.
The Biotech Act is complemented by a Directive to update and clarify EU rules on the placing on the market of genetically modified organisms (GMOs) and on the processing of human organs[6]. Moreover, it has been planned the release of the Biotech Act II, focused on industrial biotechnology and biomanufacturing in the European Union.
The feedback period on the Biotech Act will remain open until July 2026[7] This consultation phase allows citizens, researchers, institutions, associations, and sector stakeholders to submit observations and contributions that will be taken into consideration during the European legislative debate.
Further information is available on the European Commission website.
[1] European Commission. Proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act). COM(2025) 1022 final, 2025/0406 (COD). Strasbourg: European Commission; 16 Dec 2025. Available from: EUR-Lex – COM(2025) 1022 final
[2] European Parliament and Council of the European Union. Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Clinical Trials Regulation). Official Journal of the European Union. 2014;L158:1–76. Available from: Regulation – 536/2014 – EN – EUR-Lex
[3] European Parliament and Council of the European Union. Regulation (EC) No 1394/2007 of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. Official Journal of the European Union. 2007;L324:121–137. Available from: Regulation – 1394/2007 – EN – EUR-Lex
[4] European Parliament and Council of the European Union. Regulation (EU) 2024/1938 of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (SoHO Regulation). Official Journal of the European Union. 2024;L:1–79. Available from: Regulation – 2024/1938 – EN – EUR-Lex
[5] European Parliament and Council of the European Union. Regulation (EU) 2024/795 of 29 February 2024 establishing the Strategic Technologies for Europe Platform (STEP), and amending Directive 2003/87/EC and Regulations (EU) 2021/1058, (EU) 2021/1056, (EU) 2021/1057, (EU) No 1303/2013, (EU) No 223/2014, (EU) 2021/1060, (EU) 2021/523, (EU) 2021/695, (EU) 2021/697 and (EU) 2021/241. Official Journal of the European Union. 2024;L:1–40. Available from: https://eur-lex.europa.eu/eli/reg/2024/795/oj
[6] European Commission Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs
[7] The feedback period is being extended every day until this adopted proposal is available in all EU languages