European Medicines Agency (EMA) Regulation

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products

Stage: In force, reached 3 Aug 2026
In force: In force since 20 May 2004 · CELEX 32004R0726
Procedure: Regulation
Last activity: 3 Aug 2026

1 entry · record as of 14 Sept 2026

Where it stands

Latest: Delegated act published: Correcting acts, 3 Aug 2026.

3 Aug 2026
- Delegated act published: Correcting acts

3 acts

Delegated and implementing acts beneath it

By status: 3 published.

Act	Kind	Status	Adoption
Commission Delegated Regulation (EU) 2026/863	Delegated · Regulation	Published
Commission Delegated Regulation (EU) 2024/1701	Delegated · Regulation	Published	Q1 2024
Commission Delegated Regulation (EU) 2021/756	Delegated · Regulation	Published	Q1 2021

Titles link to EUR-Lex where the act has been published.

Summary

Generated

Regulation (EC) No 726/2004 establishes the EU centralized procedure for authorizing and supervising medicinal products for human use and creates the European Medicines Agency. It applies from 20 November 2005, with certain annex provisions from 20 May 2008. The regulation affects pharmaceutical companies seeking EU-wide marketing authorizations, national authorities, and the EMA.

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Sources: EUR-Lex. Record as of 14 Sept 2026. Something wrong on this page? Report an error.

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