Authorisation and supervision of medicinal products for human use and governing rules for the European Medicines Agency
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Provisional agreement reached, awaiting formal adoption by Parliament and Council.
Last active 18 Mar 2026
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What this bill does
In plain terms: what it changes and who it affects.
This proposal overhauls EU rules for approving, monitoring and supplying human medicines and reorganises the European Medicines Agency’s role.
Who it affects
It affects patients, pharmaceutical companies, medicine developers, generic and biosimilar manufacturers, healthcare systems, and people needing rare-disease, paediatric or antimicrobial treatments.
Core of the proposal
- Requires central EU authorisation for more medicine categories, including priority antimicrobials and orphan medicines.
- Creates variable orphan-medicine market exclusivity and extra rewards for access and new indications.
- Introduces transferable data-exclusivity vouchers to encourage priority antimicrobial development.
- Strengthens shortage reporting, supply monitoring, inspections, environmental assessment and EMA scientific support.
Articles changed · 6 across 5 laws
- Regulation (EC) No 1394/2007 (32007R1394)
- entire act: amends regulation; specific targeted provisions not supplied
- Regulation (EU) No 536/2014 (32014R0536)
- art. 61(2)(a): extends manufacturing and import authorisation requirement to GMO investigational medicinal products
- art. 91: adjusts relationship with Directives 2001/18/EC and 2009/41/EC for GMO clinical trials
- Regulation (EC) No 726/2004 (32004R0726)
- entire act: repeals the entire regulation
- Regulation (EC) No 141/2000 (32000R0141)
- entire act: repeals the entire regulation
- Regulation (EC) No 1901/2006 (32006R1901)
- entire act: repeals the entire regulation
Latest update
05 Jun 2026The most recent development in this bill's progress.
Adopted → Trilogues (interinstitutional negotiations)
Adopted → Trilogues (interinstitutional negotiations)
Documents
1 recentSourcesOEILEUR-LexEU Law Tracker