Potential Impact of the EU Biotech Act Proposal on Clinical Trial Activities
The European Commission’s proposed Biotech Act introduces changes that could reshape how clinical trials are approved and managed across the EU. While the broader package spans multiple areas of the health ecosystem, proposed updates to the EU Clinical Trial Regulation (EU CTR) stand out for their potential to address long-standing operational challenges including lengthy timelines, limited flexibility in submissions, and fragmented processes across member states.
If adopted, these changes would accelerate key steps in the approval process and introduce new mechanisms that could affect how sponsors manage trials at both the study and portfolio level. This post examines the proposed revisions under Article 58 and what they may mean for clinical trial operations.
Key Takeaways
- The proposal directly targets the operational friction that has defined the EU CTR since 2022
- Shorter timelines and parallel review steps could meaningfully accelerate approvals
- Parallel modifications remove a longstanding bottleneck in trial lifecycle management
- A centralized IMP core dossier could shift documentation from trial-level to portfolio-level
- Much will depend on what survives negotiations and how delegated acts define the details
Overview of the EU Clinical Trial Regulation (EU CTR)
The Clinical Trial Regulation (EU) No. 536/2014 (EU CTR) governs interventional clinical trials involving investigational medicinal products conducted across the European Union (EU) and European Economic Area (EEA). It replaced the earlier Clinical Trial Directive.
The regulation passed in 2014 but didn't go live until January 2022, held up by years of delays in building the supporting portal. A three-year transition period ended in January 2025, and all interventional clinical trials in the EU/EEA are now required to comply.
Since implementation, more than 13,000 trials have been submitted through CTIS. Transparency has improved, with features like a dynamic clinical trial map enhancing search capabilities on the Clinical Trial Information System landing page and public portal. But sponsors have reported that the process is still too complex, rigid, and slow, which can be seen in initiatives such as the Act EU. Four years of operational data backs them up.
Current Challenges in the EU Clinical Trial Framework
Four years in, the EU CTR has delivered on transparency, but efficiency is a different story. Member state requirements still diverge in ways that create coordination headaches for multinational trials. This is an issue the EU CTR was intended to address.
Assessment timelines are the most cited frustration. Delays compound when questions are raised mid-review, and misalignment between Part I and Part II (the scientific and national/ethical assessments) routinely holds up overall approvals.
The framework also locks sponsors into one substantial modification under review at a time, per member state. During a long assessment window, that restriction can stall progress, holding up both the amendment under review and any updates that follow.
The cumulative effect is that sponsors increasingly question whether the EU is worth the complexity, a problem the Biotech Act is trying to reverse.
Proposed Changes Under Article 58 of the EU Biotech Act
Article 58 is where the proposal applies in real-world scenarios. The revisions target the specific pain points sponsors have flagged since the EU CTR went live in 2022: long timelines, rigid submission rules, and limited flexibility across the trial lifecycle.
Reduced assessment timelines
The proposal shortens overall timelines for both initial applications and substantial modifications by reducing process steps and allowing certain validation and assessment activities to occur in parallel. It also removes the optional timeline extension previously available for advanced therapies.
Why it matters
Initial applications could move from a maximum of 106 days down to 75 when questions are raised, and to 47 days when they aren’t. Substantial modifications could drop from 95 days to 47 with questions, and to 33 days without. These aren’t hypothetical targets. A pilot program called FAST EU, launched by the Clinical Trial Facilitation Group in January 2026, is already testing similar timelines ahead of any formal adoption.
Parallel submission of substantial modifications
Sponsors would be permitted to submit multiple substantial modifications at the same time, provided they are mutually exclusive. This addresses a current limitation that restricts submissions to one modification under review per member state.
Why it matters
Right now, a single pending amendment can hold up everything else in that country or even for the whole trial (Part I changes). Being able to run parallel modifications removes a bottleneck that sponsors have been complaining about for years.
Accelerated authorization in public health emergencies
The proposal introduces a pathway for faster authorization of multinational clinical trials during public health emergencies.
Why it matters
Specifics such as timelines, qualifying criteria, and dossier structure will follow in delegated acts. The proposal does, however, establish a dedicated pathway.
EU-level investigational medicinal product core dossier (IMP CD)
A centralized core dossier would be established for investigational medicinal products, containing key product data and applicable across multiple clinical trials. A designated member state would oversee its validation and maintenance.
Why it matters
If you’re running multiple trials with the same IMP, right now you’re essentially filing the same product information over and over. A centralized dossier could change that significantly, with one update that’s reflected everywhere.
Expanded risk-based approach
The proposal introduces a new category of “minimal intervention clinical trials,” building on the existing low-intervention framework.
Why it matters
The existing low-intervention category already recognizes that not all trials carry the same risk. This builds on that logic by adding a new “minimal intervention” tier, meaning that the rules, application requirements, and oversight can be scaled to match the actual risk of the study.
Streamlined process for combined studies
Clinical trials involving both medicinal products and in vitro diagnostic devices could be submitted through a single application under the proposed COMBINE initiative, via Clinical Trial Information System (CTIS).
Why it matters
Combined trials involving both a drug and a diagnostic device currently mean two separate applications and two separate processes. One submission through CTIS isn’t glamorous, but it’s a fix that could save real time.
Additional procedural updates
The proposal includes refinements to member state roles, selection procedures, and stakeholder coordination, along with clarifications related to data processing under the General Data Protection Regulation (GDPR).
Why it matters
These are process-level fixes: clearer roles for the Reference Member State, a new option to change the RMS when needed, better coordination between stakeholders. The details will matter, but the direction is toward less ambiguity in who does what.
Implications for Clinical Trial Submissions and Management
The Article 58 revisions don’t address one or two pain points. They target the full list of operational frustrations sponsors have raised since the EU CTR went live.
Shorter timelines will require faster internal alignment
Reduced assessment periods may accelerate trial approvals, but they also place greater pressure on sponsors to prepare complete, high-quality submissions up front and respond quickly to regulatory queries.
Greater flexibility may reduce lifecycle bottlenecks
For sponsors running multinational trials, the ability to submit parallel modifications could meaningfully change how lifecycle management is planned, not just how fast individual amendments move.
Centralized product data could change submission strategy
The IMP core dossier is arguably the most consequential change in the proposal for sponsors managing multiple trials with the same product. If it works as described, it reorients product documentation from a per-trial exercise to a portfolio-level one.
Impact will depend on final implementation details
Several elements, including the accelerated emergency pathway and the minimal intervention classification, won't be fully defined until delegated acts are published after the Biotech Act vote. What those acts say will determine how much of the proposal’s promise is actually realized.
What Happens Next
The proposal now moves to the European Parliament and Council for negotiation. The source material makes clear that the current text will likely change—potentially significantly—before adoption.
If adopted, implementation will not be immediate. The proposal includes a six- to nine-month window for delegated acts to be finalized and CTIS to be updated accordingly.
This timeline gives sponsors room to track the negotiation, flag concerns through stakeholder channels, and start thinking through how the final provisions might affect their portfolios.
Final Considerations
The EU Biotech Act proposal takes direct aim at the operational frustrations that have defined the first four years of the EU CTR. The direction is clear. Whether the final act delivers on that direction depends on what survives negotiation and how the delegated acts fill in the gaps.
The proposal is a starting point, not a finished product. Sponsors who engage with the negotiation process now are better positioned than those who wait for the final text.
For sponsors, the time to pay attention is now—not when the final text lands.
Looking to stay ahead of ongoing changes in the EU clinical trial landscape, including the EU CTR and CTIS? Reach out today to get started.