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2025/0102(COD)ETrilogues (interinstitutional negotiations)

Critical Medicines Act

Provisional agreement reached, awaiting formal adoption by Parliament and Council.

Last active 14 Jul 2026

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What this bill does

In plain terms: what it changes and who it affects.

This proposal aims to reduce medicine shortages by supporting EU production, coordinated purchasing, and stronger supply chains for critical and hard-to-access medicines.

Who it affects

It affects patients who rely on essential or hard-to-access medicines, pharmaceutical manufacturers, medicine suppliers, and public health systems buying medicines.

Core of the proposal
  • Creates “strategic projects” for EU manufacturing of critical medicines, active substances, and key inputs.
  • Fast-tracks permits, support, and possible funding for qualifying strategic manufacturing projects.
  • Requires public buyers to consider supply resilience, not only price, when buying critical medicines.
  • Allows Commission-supported cross-border, joint, or central purchasing for eligible medicines.
Key provisions
Takes effect
It enters into force on the twentieth day after publication in the Official Journal; the application date is left blank in the proposal.
Articles changed · 5 across 1 law
  • Regulation (EU) 2024/795 (32024R0795)
    • art. 2(1)(a)(iii): replaces subparagraph (iii) on biotechnologies and technologies relevant for critical medicines manufacturing
    • art. 2(3): adds subparagraph on value chains for critical medicinal products
    • art. 2(8): adds paragraph deeming certain Critical Medicines Act strategic projects to contribute to STEP objectives
    • art. 4(7): replaces paragraph to include Critical Medicines Act strategic projects in cumulative Union funding rules
    • art. 6(1)(c): replaces point to include Critical Medicines Act strategic projects in Sovereignty Portal details

Latest update

14 Jul 2026

The most recent development in this bill's progress.

EP committee approves provisional agreement on critical medicinal products regulation

Trilogues (interinstitutional negotiations) → Trilogues (interinstitutional negotiations)

The file moved forward in trilogue as the responsible EP committee backed the provisional deal, signaling agreement on supply and access safeguards.

  • Why now: The responsible EP committee approved the provisional agreement reached with the Council.
  • Committee approval supports the provisional agreement with Council.
  • The proposal concerns critical medicinal products and medicines of common interest.
  • No new text is provided, so specific wording changes are not identifiable.
Evidence
Event · 2026-07-14 Approval of the provisional agreement with the Council by the EP committee responsible

Documents

1 recent

SourcesOEILEUR-LexEU Law Tracker