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
Awaiting committee decision
Key players
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European Parliament
Joint committee responsible Rapporteur Appointed SANTANDRIUKAITIS Vytenis Povilas (S&D)
12/02/2026
BEKE Wouter (EPP)
12/02/2026
TER LAAK Ingeborg (EPP) NARDELLA Dario (S&D) DE LA PISA CARRIÓN Margarita (PfE) BORCHIA Paolo (PfE) STORM Kristoffer (ECR) CICCIOLI Carlo (ECR) BOSSE Stine (Renew) KULMUNI Katri (Renew) TOUSSAINT Marie (Greens/EFA) NIINISTÖ Ville (Greens/EFA) HAZEKAMP Anja (The Left) SMITH Anthony (The Left) ANDERSON Christine (ESN)Committee for opinion Rapporteur for opinion Appointed The committee decided not to give an opinion. GONZÁLEZ CASARES Nicolás (S&D)
09/03/2026
The committee decided not to give an opinion. JURIWÖLKEN Tiemo (S&D)
05/03/2026
The committee decided not to give an opinion. Committee for budgetary assessment Rapporteur for budgetary assessment Appointed BUDGThe committee decided not to give an opinion. -
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 | |
| 18/05/2026 | Committee referral announced in Parliament, 1st reading |
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 168-p4 Treaty on the Functioning of the European Union TFEU 173-p3 Treaty on the Functioning of the European Union TFEU 114 |
| Mandatory consultation of other institutions | European Economic and Social Committee European Committee of the Regions |
| Stage reached in procedure | Awaiting committee decision |
| Committee dossier |
CJ53/10/04842
|
Documentation gateway
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Document type Committee Reference Date Summary Committee draft report PE789.987 16/06/2026 Amendments tabled in committee PE790.005 13/07/2026 Amendments tabled in committee PE790.932 13/07/2026 Amendments tabled in committee PE790.933 13/07/2026 Amendments tabled in committee PE790.934 13/07/2026 Amendments tabled in committee PE790.935 13/07/2026 Amendments tabled in committee PE790.936 13/07/2026 Amendments tabled in committee PE790.937 13/07/2026 Amendments tabled in committee PE790.938 13/07/2026 Amendments tabled in committee PE790.939 13/07/2026 Amendments tabled in committee PE790.953 13/07/2026 -
Document type Reference Date Summary Legislative proposal COM(2025)1022 16/12/2025 Document attached to the procedure SWD(2025)1055 17/12/2025 Document attached to the procedure SWD(2026)0450 28/05/2026 -
Document type Parliament/Chamber Reference Date Summary Contribution IT_CHAMBER COM(2025)1022 24/06/2026 Contribution RO_SENATE COM(2025)1022 02/07/2026 Contribution PT_PARLIAMENT COM(2025)1022 02/07/2026 Reasoned opinion FR_SENATE PE790.871 07/07/2026 -
Institution/body Document type Reference Date Summary EESC Economic and Social Committee: opinion, report CES0031/2026 18/03/2026
Additional information
Transparency
Meetings with interest representatives published in line with the Rules of Procedure
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Name Role Committee Date Interest representatives MANDL Lukas Shadow rapporteur for opinion JURI 23/07/2026 PHARMIG - Verband der pharmazeutischen Industrie Österreichs MANDL Lukas Shadow rapporteur for opinion JURI 15/07/2026 Sandoz International GmbH BEKE Wouter Rapporteur ITRE 13/07/2026 Sandoz International GmbH MANDL Lukas Shadow rapporteur for opinion JURI 08/07/2026 Novartis International AG FURORE Mario Shadow rapporteur for opinion JURI 07/07/2026 A. Menarini Industrie Farmaceutiche Riunite s.r.l. BEKE Wouter Rapporteur ITRE 06/07/2026 EuropaBio
Vaccines Europe
LSAAWÖLKEN Tiemo Rapporteur for opinion JURI 03/07/2026 MEDICINES FOR EUROPE WÖLKEN Tiemo Rapporteur for opinion JURI 03/07/2026 PGEU GONZÁLEZ CASARES Nicolás Rapporteur for opinion ENVI 03/07/2026 MEDICINES FOR EUROPE SMITH Anthony Shadow rapporteur ITRE 02/07/2026 Confédération Générale du Travail
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Name Date Interest representatives CHASTEL Olivier 15/07/2026 ZOETIS CHASTEL Olivier 03/07/2026 UCB KELLEHER Billy 03/07/2026 Novartis International AG FERENC Viktória 01/07/2026 MEDICINES FOR EUROPE KELLEHER Billy 01/07/2026 Takeda Pharmaceuticals International AG HADJIPANTELA Michalis 24/06/2026 Genmab A/S RADEV Emil 24/06/2026 MEDICINES FOR EUROPE PIETIKÄINEN Sirpa 24/06/2026 Humane Society International/Europe KELLEHER Billy 24/06/2026 Merck Sharp & Dohme Europe Belgium SRL KELLEHER Billy 18/06/2026 MEDICINES FOR EUROPE