EU Regulators Streamlined Clinical Trial Processes
New initiatives aim to accelerate medical product development by harmonizing international regulatory review timelines.
Updated on Sept. 29, 2026 in Biotech
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European Medicines Agency (EMA) officials have presented new initiatives designed to expedite clinical trial submissions and improve coordination between global regulators. The agency is currently testing these accelerated evaluation timelines through its FAST-EU pilot program.
Why it matters
These programs are intended to assist drug developers in navigating complex regulatory environments and bringing medical products to market more predictably. The effort seeks to address long-standing technical barriers that previously hampered concurrent trial modifications.
The EMA scientific advice process currently takes an average of 70 days to complete. The initiative relies on a network of over 5,000 experts to provide technical guidance on advanced therapy medicinal products.
The players
European Medicines Agency
The decentralized EU body responsible for the scientific evaluation and monitoring of medicines across European member states.
Food and Drug Administration
The U.S. federal agency responsible for protecting public health through the regulation of food, pharmaceuticals, and medical devices.
The details
The FAST-EU pilot allows sponsors to submit parallel review requests to the EMA and the FDA simultaneously, triggering active agency liaison. This process relies on a coordinated set of timetables facilitated through the Clinical Trials Information System — the centralized digital portal used for submitting trial applications in the European Union. These programs aim to resolve technical friction points that prevented researchers from executing multiple concurrent modifications in ongoing clinical trials.
Timeline
2022: Clinical Trials Regulation adopted to harmonize trial submissions.
January 2026: FAST-EU pilot program launched.
September 2026: Initiatives discussed at RAPS Convergence in Charlotte, NC.
2028: Targeted date for the proposed replacement of the Committee for Advanced Therapies.
The Tech Race
This initiative follows the framework established by the Biotech Act to shorten clinical trial evaluation timelines. It represents a shift from independent regional reviews toward a globally synchronized approval process for advanced therapeutics.
Researchers and drug developers can currently participate in the FAST-EU pilot to request parallel reviews between U.S. and European regulators. Future updates to the Clinical Trials Information System will likely simplify the process for managing multiple modifications in ongoing trials.
The takeaway
The EMA is moving toward an integrated global review structure to reduce the time-to-market for complex therapies. Stakeholders should track the official 2028 timeline for the replacement of the Committee for Advanced Therapies as a key indicator of continued regulatory evolution.
What happens next
A new group of experts is expected to replace the current Committee for Advanced Therapies by 2028.
Further reading
For broader context on current shifts in the industry, explore our Biotech section.
Source note: This article includes information reported by Raps.
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