Skip to content
OPINION (COM(2025)0102 – C100048/2025 – 2025/0102(COD))

On the proposal for a regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795

ITRE-AD-774586

Committee on Industry, Research and Energy · Rapporteur: Oliver Schenk

Official HTML ↗ PDF DOCX
✦ In shortFull textProcedure & committee votes
✦ In short · AI summary of this text, generated 4 Sept 2026

Written by a language model from the full text only; every figure comes from the text. The paragraph links open the paragraph a statement rests on — check the text itself before relying on it.

The committee opinion proposes amendments to the Critical Medicines Act regulation to strengthen supply security, competitiveness, and innovation in the EU pharmaceutical sector. It emphasizes inclusive governance, strategic projects, financial support, use of existing data, confidentiality, international partnerships, and support for SMEs and SMCs.

Committee position. The committee proposes amendments to enhance effectiveness, clarity, and implementation, focusing on governance, strategic projects, funding, and international cooperation.

Key points

  1. Adds Articles 114 and 173 TFEU as legal basis, linking health protection with industrial competitiveness.
  2. Expands objectives to include strengthening manufacturing capacities, resilience, competitiveness, strategic autonomy, and innovation.
  3. Broadens definition of key inputs and strategic projects to include cross-border joint projects and those reserving capacity or contributing to supply security.
  4. Requires Member States to designate a single authority within 90 days, provide guidance, and ensure adequate resources for permit processes.
  5. Strategic projects are deemed in the public interest; permit processes must be rapid, without prejudice to other projects.
  6. Calls for regulatory support, including fast-tracked reviews and reimbursement processes, and encourages financial support for strategic projects.
  7. Extends STEP to cover biomanufacturing and considers Union funding post-2027.
  8. Requires Member States to avoid negative impacts on other Member States, notify the Critical Medicines Group of stock measures, and adopt guidelines.
  9. Enhances the Critical Medicines Group's role with stakeholder involvement, working groups, and tasks on cross-border projects, crisis measures, and financing.
  10. Promotes international partnerships to diversify supply, harmonize standards, and ensure fair competition.
  11. Protects confidential information and trade secrets, with exceptions for essential security interests.

Who is affected

  • Pharmaceutical manufacturers and marketing authorisation holders: face new requirements for information sharing and supply prioritisation.
  • SMEs and small mid-caps: receive particular attention for administrative support and funding access.
  • Member States: must designate authorities, notify measures, and provide resources.
  • Third-country manufacturers: may face equivalent standards for exports to the EU.

Figures and deadlines

  • 90 days from entry into force for designating a single authority.
  • Multiannual Financial Framework 2021-2027 for Union funding.

Legal basis: Articles 114 and 173 of the Treaty on the Functioning of the European Union.