2025/0406(COD)
European Biotech Act
Basic information
2025/0406(COD)
COD - Ordinary legislative procedure (ex-codecision procedure)
Regulation
Amending Regulation 2002/178
2000/0286(COD)
Amending Regulation 2007/1394
2005/0227(COD)
Amending Regulation 2014/536
2012/0192(COD)
Amending Regulation 2019/6
2014/0257(COD)
Amending Regulation 2024/1938
2022/0216(COD)
Amending Regulation 2024/795
2023/0199(COD)
Subject
3.50.08 New technologies; biotechnology
4.20 Public health
Status
Preparatory phase in Parliament
Key players
-
European Parliament
Joint committee responsible Rapporteur Appointed Pending final decision on the referral Committee for opinion Rapporteur for opinion Appointed Pending final decision on the referral Committee for budgetary assessment Rapporteur for budgetary assessment Appointed Pending final decision on the referral -
European Commission
Commission DG Commissioner Health and Food Safety VÁRHELYI Olivér
Key events
| Date | Event | Reference | Summary |
|---|---|---|---|
| 16/12/2025 | Legislative proposal published | COM(2025)1022 |
Technical information
| Procedure reference | 2025/0406(COD) |
|---|---|
| Procedure type | COD - Ordinary legislative procedure (ex-codecision procedure) |
| Procedure subtype | Legislation |
| Legislative instrument | Regulation |
| Amendments and repeals |
Amending Regulation 2002/178
2000/0286(COD)
Amending Regulation 2007/1394 2005/0227(COD) Amending Regulation 2014/536 2012/0192(COD) Amending Regulation 2019/6 2014/0257(COD) Amending Regulation 2024/1938 2022/0216(COD) Amending Regulation 2024/795 2023/0199(COD) |
| Legal basis | Rules of Procedure EP 58 Treaty on the Functioning of the European Union TFEU 114 Treaty on the Functioning of the European Union TFEU 168-p4 Treaty on the Functioning of the European Union TFEU 173-p3 |
| Mandatory consultation of other institutions | European Economic and Social Committee European Committee of the Regions |
| Stage reached in procedure | Preparatory phase in Parliament |
Documentation gateway
-
Document type Reference Date Summary Legislative proposal COM(2025)1022 16/12/2025 Document attached to the procedure SWD(2025)1055 17/12/2025
Additional information
| Source | Document | Date |
|---|---|---|
| European Commission | EUR-Lex |
Transparency
Meetings with interest representatives published in line with the Rules of Procedure
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Name Role Committee Date Interest representatives WÖLKEN Tiemo Shadow rapporteur SANT 16/04/2026 European Federation of Pharmaceutical Industries and Associations WÖLKEN Tiemo Shadow rapporteur SANT 16/04/2026 Médecins Sans Frontières International WÖLKEN Tiemo Rapporteur SANT 14/04/2026 Merck Sharp & Dohme Europe Belgium SRL ANDRIUKAITIS Vytenis Povilas Rapporteur SANT 09/04/2026 MEDICINES FOR EUROPE WÖLKEN Tiemo Rapporteur SANT 09/04/2026 Pandemic Action Network ANDRIUKAITIS Vytenis Povilas Rapporteur SANT 08/04/2026 European Patients' Forum (EPF) TER LAAK Ingeborg Shadow rapporteur SANT 08/04/2026 European Patient Organisation for Dysimmune and Inflammatory Neuropathies TER LAAK Ingeborg Shadow rapporteur SANT 07/04/2026 SANOFI ANDRIUKAITIS Vytenis Povilas Rapporteur SANT 02/04/2026 Eurogroup for Animals ANDRIUKAITIS Vytenis Povilas Rapporteur SANT 02/04/2026 CropLife Europe
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Name Date Interest representatives GYÜRK András 12/03/2026 MEDICINES FOR EUROPE SOKOL Tomislav 04/03/2026 Bayer AG LØKKEGAARD Morten 27/02/2026 AstraZeneca PLC LØKKEGAARD Morten 16/02/2026 Novo Nordisk Foundation GONZÁLEZ CASARES Nicolás 10/02/2026 Gilead Sciences GONZÁLEZ CASARES Nicolás 04/02/2026 Juvenile Diabetes Research Foundation GONZÁLEZ CASARES Nicolás 04/02/2026 ASOCIACION ESPAÑOLA DE BIOEMPRESAS ANDREWS Barry 27/01/2026 Ibec
Biopharmachem Ireland