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2025/0406(COD)COM(2025)1022ITRE

European Biotech Act

Establishing a framework of measures for strengthening Union's biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)

Stage
Committee report adopted, reached 16 Jun 2026
Procedure
Regulation · Ordinary legislative procedure
Rapporteurs
Wouter Beke (EPP), Vytenis Povilas Andriukaitis (S&D)
Lead DG
DG SANTE
Commissioner
Olivér Várhelyi
Last activity
7 Sept 2026
Legal basis
TFEU Art. 114; TFEU Art. 168; TFEU Art. 173; TFEU Art. 294
29 entries · record as of 14 Sept 2026

Where it stands

Latest: Adoption of draft report, 10 Sept 2026. Next: Adoption of draft report, 1 Dec 2026 (provisional).

Show the earlier record: 15 dates, 11 Jun 2025 to 10 Jul 2026
  1. 11 Jun 2025
    • Call for evidence closed: Biotech Act, 225 responses · Commission
  2. 10 Nov 2025
    • Public consultation closed: Biotech Act, 464 responses · Commission
  3. 17 Dec 2025
    • Adoption of legislative proposal by the Commission
  4. 11 Feb 2026
    • Decision on procedure
  5. 9 Mar 2026
    • Appointment of rapporteur
  6. 19 Mar 2026
    • Consideration / exchange of views
  7. 18 May 2026
    • Referral of the legislative proposal to the EP committee responsible (announced in plenary) · Parliament
    • Referred to committee
  8. 3 Jun 2026
    • Deliberations in Coreper · Council
  9. 5 Jun 2026
    • Deliberations in Coreper
  10. 8 Jun 2026
    • Deliberations in Council working party
  11. 16 Jun 2026
    • Committee report tabled
    • Deliberations in Council · Council
    • EP committee draft report · Parliament committee
  12. 25 Jun 2026
    • Deadline for tabling amendments
  13. 29 Jun 2026
    • Consideration / exchange of views
  14. 9 Jul 2026
    • Deliberations in Council working party · Council
  15. 10 Jul 2026
    • Deliberations in Council working party · Council
  1. 13 Jul 2026
    • Committee amendments tabled
    • Tabling of amendments in the EP committee responsible · Parliament committee
  2. 22 Jul 2026
    • Deliberations in Council working party · Council
  3. 23 Jul 2026
    • Deliberations in Council working party · Council
  4. 5 Aug 2026
    • Feedback on adopted proposal closed: Biotech Act, 30 responses · Commission
  5. 3 Sept 2026
    • Deliberations in Council working party · Council
  6. 4 Sept 2026
    • Deliberations in Council working party · Council
  7. 7 Sept 2026
    • Adoption of an opinion by the EP opinion-giving committee · Parliament committee
    • Committee opinion adopted
  8. 10 Sept 2026
    • Adoption of draft report · provisional
  1. 1 Dec 2026Scheduled
    • Adoption of draft report · provisional
22 people

Who is on it

The Parliament's rapporteurs, shadow rapporteurs and opinion rapporteurs currently on this file.

RoleNameGroupCountryCommittee
Co-rapporteurWouter BekeEPPBEITRE
Co-rapporteurVytenis Povilas AndriukaitisS&DLTSANT
Shadow rapporteurAnja HazekampThe LeftNL
Shadow rapporteurAnthony SmithThe LeftFR
Shadow rapporteurCarlo CiccioliECRIT
Shadow rapporteurChristine AndersonESNDE
Shadow rapporteurDario NardellaS&DIT
Shadow rapporteurIngeborg ter LaakEPPNL
Shadow rapporteurKatri KulmuniRenewFI
Shadow rapporteurKristoffer StormECRDK
Shadow rapporteurMargarita de la Pisa CarriónPfEES
Shadow rapporteurMarie ToussaintGreens/EFAFR
Shadow rapporteurPaolo BorchiaPfEIT
Shadow rapporteurStine BosseRenewDK
Shadow rapporteurVille NiinistöGreens/EFAFI
Rapporteur for opinionNicolás González CasaresS&DESENVI
Rapporteur for opinionTiemo WölkenS&DDEJURI
Shadow rapporteur for opinionAnja HazekampThe LeftNLENVI
Shadow rapporteur for opinionMarc JongenESNDEENVI
Shadow rapporteur for opinionMartin HäuslingGreens/EFADEENVI
Shadow rapporteur for opinionLukas MandlEPPATJURI
Shadow rapporteur for opinionTobiasz BocheńskiECRPLJURI
212 amendments

Amendments

Tabled on 29 Jun 2026. The texts are in the amendment documents below.

By committee

  • JURI212

By author

  • Sergey Lagodinsky65
  • Daniel Buda35
  • Jörgen Warborn34
  • Lukas Mandl28
  • Mario Mantovani28
  • Mario Furore20
  • Victor Negrescu11
  • Kosma Złotowski10
  • Tobiasz Bocheński10
  • Dainius Žalimas8
  • Emil Radev1

Amendments each member tabled or co-signed.

By article

  • Article 59 – paragraph 1 – point 610
  • Article 58 – paragraph 1 – point 245
  • Recital 1665
  • Article 27 – paragraph 1 – introductory part4
  • Article 19 – paragraph 3 – point f3
  • Article 27 – paragraph 1 – point c3
  • Chapter IV3
  • Recital 203
  • Recital 573
  • Article 17 – paragraph 2 – point b2
Show 20 more provisions
  • Article 17 – paragraph 2 – point e2
  • Article 31 – paragraph 1 – subparagraph 12
  • Article 4 – paragraph 1 – point e a (new)2
  • Article 52 – paragraph 3 – point b2
  • Article 56 – paragraph 1 – point 72
  • Article 61 a (new)2
  • Recital 1132
  • Recital 1492
  • Recital 57 a (new)2
  • Recital 612
  • Recital 642
  • Recital 652
  • Recital 662
  • Article 1 – paragraph 2 – point b1
  • Article 1 – paragraph 2 – point c1
  • Article 1 – paragraph 2 – point f1
  • Article 1 – paragraph 5 a (new)1
  • Article 10 – paragraph 21
  • Article 10 – paragraph 3 – subparagraph 11
  • Article 11 – paragraph 11

Covers 74 of the 212 amendments.

13 documents

Documents

Newest first. Each opens at its source.

1 consultation

Consultations on it

The Commission's Have Your Say consultations linked to this file. Where we publish the positions filed, the title opens them here.

ConsultationFeedback deadlineFeedback received
5 Aug 2026847

Summary

Generated

The European Biotech Act establishes a framework to strengthen the EU's biotechnology and biomanufacturing sectors, focusing on health applications. It amends regulations on food safety, advanced therapies, and clinical trials to harmonize single market rules. The Act aims to boost competitiveness and public health outcomes by reducing regulatory fragmentation.

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Sources: EP Legislative Observatory · EU Law Tracker. Record as of 14 Sept 2026. Something wrong on this page? Report an error.

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