European Biotech Act
01020304050607
With the European Parliament, which is preparing its first-reading position.
Last active 16 Jun 2026
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What this bill does
In plain terms: what it changes and who it affects.
This proposal supports EU health biotechnology by speeding approvals, backing strategic projects, improving funding, encouraging AI use, and adding safeguards against misuse.
Who it affects
It affects biotechnology and biomanufacturing companies, researchers, clinical-trial sponsors, patients, healthcare systems, food and feed innovators, veterinary medicine developers, and users of biotech products.
Core of the proposal
- Creates recognised health biotechnology strategic projects with faster permitting, support contacts, and possible funding priority.
- Shortens and simplifies EU clinical-trial procedures, including multinational trials, substantial modifications, and combined medicine-device studies.
- Introduces biotech investment support, biosimilar competitiveness measures, AI testing environments, and regulatory sandboxes.
- Requires screening and reporting for biotechnology products of concern to reduce biosecurity and misuse risks.
Articles changed · 8 across 6 laws
- Regulation (EC) No 178/2002 (32002R0178)
- entire act: broadens pre-submission advice, shortens study-notification delay, changes EFSA panel chairing, and adds regulatory sandboxes
- Regulation (EC) No 1394/2007 (32007R1394)
- entire act: adds GMO-related exemptions for certain advanced investigational therapy medicinal products and enables definition updates
- Regulation (EU) No 536/2014 (32014R0536)
- entire act: streamlines clinical trial authorisation, assessment, modifications, templates, combined studies, emergencies, AI and sandboxes
- art. Annex I: aligns Annex I with GMO exemptions for certain advanced investigational therapy medicinal products
- Regulation (EU) 2019/6 (32019R0006)
- entire act: optimises variations, changes GMO assessment, adds sandboxes and SPC extension for certain veterinary medicines
- art. Annex II: empowers adaptation of technical requirements to scientific and technical progress
- Regulation (EU) 2024/795 (32024R0795)
- art. 2(1): deems recognised health biotechnology strategic projects to contribute to STEP objectives
- Regulation (EU) 2024/1938 (32024R1938)
- entire act: introduces a regulatory sandbox in the substances of human origin framework
Latest update
09 Jun 2026The most recent development in this bill's progress.
1st reading – European Parliament → 1st reading – European Parliament
1st reading – European Parliament → 1st reading – European Parliament
Documents
1 recentSourcesOEILEUR-LexEU Law Tracker