The European Commission proposed the EU Biotech Act on December 16, 2025. Final adoption is expected in late 2026 or 2027. Until then, the December 2025 proposal text is the working document every life science company should be reading.
The Act does not change one regulation. It amends six simultaneously: EU CTR 536/2014, the ATMP Regulation, the SoHO Regulation, the GMO Directives, the General Pharma Package, and EMA’s AI framework. Each amendment touches documents that need to exist in multiple EU languages.
This blog covers the localization implications only. It does not cover general clinical trial translation; Milestone’s EU CTR 536/2014 translation guide addresses that. This blog picks up where that one ends.
What Is the EU Biotech Act?
The Act is a proposed regulation to strengthen Europe’s health biotechnology sector across ATMPs, biosimilars, clinical trials, and biomanufacturing.
The problem it is trying to solve is measurable. The EU’s share of commercially sponsored clinical trials fell from 22% in 2013 to 12% in 2023, while China’s share rose from 5% to 18% in the same period. China and the US approve validated trial applications within 60 days. The EU averages 113 days for multinational trials.
The Act’s response is speed and simplification. But speed does not reduce the number of languages required. That distinction is what this blog addresses.
Source: European Commission Biotechnology page | COM(2025) 1022 final, EUR-Lex
Under EU CTR 536/2014, Part II of every trial application, informed consent forms, participant information sheets, and all country-specific elements, must be submitted in each member state’s official language. The EU has 24 official languages. That obligation does not change under the Biotech Act.
What changes is the time available to meet it.
Sponsors that begin translation after the dossier is drafted will miss the 47-day window. Translation must run in parallel with drafting, not after it.
Also Read: Post-Market Surveillance Translations: What Documents You Need, and When
Five New Document Types With No Established Translation Process
This is the section that matters most for localization teams. The Act introduces five document types that have never existed before. None has standard multilingual templates. None has established translation workflows.
1. ATMP-GMO Exemption Declaration
Sponsors of clinical trials involving ATMPs that contain or consist of GMOs no longer need to submit a full environmental risk assessment, provided their product falls into one of the defined low-risk categories:
- Replication-deficient viral vectors without antimicrobial resistance genes
- Genetically modified somatic cells that cannot secrete or produce infectious agents
- Genetically modified bacteria without antimicrobial resistance genes
- Genetic material altered using genome editing techniques with negligible adverse effects
Instead, sponsors submit a declaration. That declaration must accompany the trial application for each member state concerned, in that member state’s official language. No standard template exists yet. Companies building this document are starting from scratch and need localized versions in place before their first submission under the new rules.
2. Regulatory Sandbox Application
For novel or atypical products that cannot be accommodated under any existing regulatory framework, the Act establishes a dedicated sandbox. Entering the sandbox requires a formal application. That application carries the same language obligations as all EU regulatory submissions.
The terminology for sandbox applications is still being established at the regulatory level, translation teams working on these documents will need to make active decisions about how new terms are rendered in each target language.3.
3. Combined Clinical Trial Application
The Act introduces a single application for studies combining a clinical trial with a medical device performance study or clinical investigation. These were previously two separate submissions, each with their own translation workflows.
The localization challenge here is terminology consistency. Pharmaceutical regulatory documents and medical device regulatory documents have historically used different translated language for the same underlying concepts. A combined application requires those two vocabularies to align across all target languages. Without a unified termbase, translators working on different sections of the same document will produce inconsistencies that regulators will flag.
4. Health Biotechnology Strategic Project Application
Companies can apply for strategic project status to access accelerated permits, priority funding, and coordinated regulatory support. Applications must demonstrate EU-wide scope, which requires multilingual supporting documentation. This is a new application category. No established format or translation template exists.
5. Biosecurity Declaration for Products of Concern
The Act creates a restricted list of biotechnology products of concern. Placing these products on the EU market requires a formal declaration of legitimate need, submitted to member state authorities.
Legal declarations carry a higher precision standard than scientific documentation. A mistranslation in a regulatory science document may prompt a query. A mistranslation in a legal declaration can constitute non-compliance. The declaration format is still being finalized in the legislative process. Companies in relevant product categories should monitor the Act’s progress and build translation frameworks before the format is confirmed.
Planning your EU Biotech Act translation strategy?
Changes to Existing Documentation
Preparing Existing Regulatory Documentation and Translation Workflows for New EU Biotech Act Requirements.
ATMPs and SoHO
The Act expands the SoHO regulatory sandbox, bringing substances-of-human-origin documentation into a broader regulatory pathway. SoHO documents now interact with clinical trial documentation in ways they previously did not. Localization teams handling ATMP trials need to map these new intersections into their document management workflows and ensure consistent terminology across both document sets.
Biosimilars
The Act tasks the EMA with developing new non-binding guidelines on a tailored regulatory approach for biosimilar development. These guidelines may reduce clinical data requirements where strong analytical evidence supports comparability. They have not been published yet.
When they are published, biosimilar development dossiers will need to reflect the new structure. All translated versions will require updating.
Do not wait. Build a version-controlled translation memory and controlled termbase for your biosimilar dossiers now. When the EMA guidelines change the document structure, those updates become targeted edits rather than full retranslations.
Also Read: Proposed Changes to EU MDR and IVDR: What It Means for Translations
GDPR Harmonization: A Consolidation Opportunity
The Act makes three changes to how clinical trial data is handled under GDPR.
- First, it fixes legal obligation as the single legal basis for clinical trial data processing across all member states, ending country-level divergence on this point.
- Second, it assigns joint controller status to both sponsors and investigators, resolving a long-standing compliance ambiguity.
- Third, it permits secondary use of clinical trial data for scientific research without requiring new GDPR consent from participants.
None of this removes patient-facing language obligations. Data processing notices, consent withdrawal information, and data subject rights notices must still be available in the local language of each participant. That does not change.
What the harmonization does create is a consolidation opportunity. Many companies currently maintain 27 slightly different GDPR notice versions, each adapted to the national GDPR interpretation of a different member state.
The Act’s harmonized legal basis allows a more consistent master document. That master document is simpler and cheaper to translate, and far easier to maintain when updates are needed.
AI Documentation: Prepare Now
The Act requires the EMA to publish guidance on the use of AI across the full medicinal product development lifecycle, from preclinical research through clinical development, manufacturing, and post-authorization monitoring. That guidance does not exist yet.
When it is published, AI systems used in drug development will need to be documented in line with EMA expectations, and that documentation will carry EU language requirements.
Companies using AI in trial design, safety monitoring, or manufacturing should build their AI documentation frameworks in English now. A clean, well-structured source document localizes faster and with fewer errors than one drafted reactively under a submission deadline.
Five Actions to Take Before the Act Is Adopted
Five Practical Localization Actions Companies Should Take Before the EU Biotech Act Takes Effect
1. Audit your translation timeline
Map your current clinical trial translation process against the new 75-day and 47-day authorization timelines. Find where translation sits in the critical path and move it to run alongside dossier drafting.
2. Assess your ATMP-GMO products
Check whether your ATMP products fall into the low-risk GMO exemption categories. If they do, begin drafting the exemption declaration and its multilingual versions before you need them for submission.
3. Update your termbase
Terms like “health biotechnology strategic project,” “biotechnology product of concern,” and “combined clinical trial application” have no established translated equivalents in most EU languages yet. Establish your translations now to prevent inconsistency across submissions.
4. Build translation memory for biosimilar dossiers
Set up version-controlled translation memory before the EMA guidelines are published. When the guidelines change your dossier structure, updates will be tracked and targeted rather than requiring full retranslation.
5. Consolidate your GDPR notices
Use the Act’s legal basis harmonization to reduce from 27 country-specific versions to one consistent master document. It is both a compliance improvement and a cost reduction.
Also Read: MHRA Language Requirements for Clinical Trial Documents
Conclusion
The EU Biotech Act is not yet law, but the December 2025 proposal text is detailed enough to act on now. New document types, compressed timelines, and shifting regulatory intersections all create localization work that cannot be left to the last minute.
Companies that start planning before adoption will be ready when the rules take effect. Contact Milestone to build a localization strategy around your submission timelines.
Need localization support for EU Biotech Act submissions?
FAQs
What is the EU Biotech Act and when does it take effect?
The European Commission proposed the EU Biotech Act on December 16, 2025. Final adoption is expected in late 2026 or 2027. The Act simultaneously amends six existing regulations, including EU CTR 536/2014, the ATMP Regulation, the SoHO Regulation, and EMA’s AI framework.
Do shorter authorization timelines reduce the number of languages required?
No. The Act compresses timelines but does not change language obligations. Part II of every clinical trial application must still be submitted in each member state’s official language. The EU has 24 official languages. What changes is how much time sponsors have to meet that requirement.
What new documents does the Act introduce, and do they need to be translated?
The Act introduces five new document types: the ATMP-GMO Exemption Declaration, the Regulatory Sandbox Application, the Combined Clinical Trial Application, the Health Biotechnology Strategic Project Application, and the Biosecurity Declaration for Products of Concern.
All carry standard EU language obligations. None has established multilingual templates yet.
How does the GDPR harmonization in the Act affect translation workload?
The Act harmonizes the legal basis for clinical trial data processing across all member states. This allows companies to maintain one master GDPR notice document rather than 27 country-specific versions.
It does not remove the obligation to provide patient-facing notices in local languages. The benefit is a simpler, cheaper master document to translate and maintain.
How should companies prepare their translation workflows before the Act is adopted?
The most important steps are: moving translation to run in parallel with dossier drafting, building a version-controlled translation memory for biosimilar dossiers, establishing translated equivalents for new regulatory terms before they appear in submissions, and consolidating GDPR notice versions into a single master document. Companies with ATMP products should also begin drafting the GMO exemption declaration now.
What should companies do about AI documentation requirements?
The EMA’s AI guidance under the Act has not been published yet. Companies should build their AI documentation frameworks in English now. A well-structured English source document localizes faster and with fewer errors than one drafted reactively under a submission deadline.
