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European Union: 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 Regulation

Updated on : 23-02-2026

European Union: 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 Regulation

The proposal consists of measures targeted to strengthen the competitiveness of the biotechnology, structured in the following chapters:Chapter I – Subject Matter, Scope and Definitions,sets out the subject matter of this proposal, which consists of measures that articulate its overall objective to improve the functioning of the internal market by establishing a framework to strengthen the competitiveness of the biotechnology sector and specifies the scope of the proposal, which applies to health biotechnology products and services during their entire lifecycle,Chapter II – Union health biotechnology and biomanufacturing,introduces the concepts of health biotechnology strategic projects and high impact health biotechnology strategic projects and establishes a framework for the recognition and the support of such projects aimed at strengthening the EU’s industrial biomanufacturing capacity and value chains.Chapter III – Access to funding,establishes an EU health biotechnology investment pilot in partnership with the European Investment Bank Group and other implementing partners.Chapter IV – Extension of the supplementary protection certificate,introduces an extension of 12 months of the Supplementary Protection Certificate (SPC) for medicinal products developed by means of biotechnology processes and for Advanced Therapy Medicinal Products.Chapter V - Enhancing competitiveness in biosimilars,supports EU competitiveness in the field of biosimilars by encouraging the development of EMA guidelines on facilitating the authorisation of biosimilar medicinal productsChapter VI – Artificial intelligence and data as biotechnology enablers,encourages the adoption and integration of AI in actions supporting biotechnology, to foster innovation, efficiency and technological sovereignty in biotechnology and biomanufacturing.Chapter VII – Regulatory tools for novel health biotechnology products,sets out a flexible, collaborative and anticipatory approach to regulate novel health biotechnology products by reinforcing and complementing existing mechanisms in Union law, Chapter VIII – Biodefence and preventing biotechnology misuse, establishes a framework for preventing the misuse of biotechnology products of concern. Chapter IX –  Amendments to Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938, introduces amendments to EU legislative frameworks in the areas of health and food and feed safety with the aim of simplifying procedures and accelerating time to market that are necessary to ensure the effectiveness of the substantive provisions established in this proposal by creating legislative frameworks conducive to innovation. Further, it establishes amendments to Regulation (EU) 2024/795 (STEP Regulation) regarding the status of health biotechnology strategic projects and of high impact health biotechnology strategic projects under that Regulation. Chapter X – Final provisions, contains provisions on (i) monitoring; (ii) delegation of power; (iii) committee procedure, (iv) an obligation for the Commission to prepare regular reports to the European Parliament and to the Council for the evaluation of this Regulation; (v) handling of confidential information, and entry into force and application. Annexes to the proposal:Annex I- Biotechnology Products of ConcernAnnex II- Amendments to Regulation (EU) 536/2014 Annex III- Amendments to Regulation (EU) 2019/6

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