Prepared for the Regulatory Compliance Push to Accelerate and Expand EU Clinical Trials?

The EU Clinical Trial Regulation (CTR) transformed the regulatory compliance procedure and assessment of Clinical Trial Applications (CTAs) in the EU. CTAs were centralized through the Clinical Trials Information System (CTIS), and joint review procedures were established across the EU Member States. The joint assessment procedures have greatly impacted how trial sponsors, regulators, and the clinical supplier landscape interact. Notably, Member State authorities and Independent Ethics Committees are now doing their review in parallel in a 45-day assessment window.

With the CTR, the standard end-to-end clinical trial application procedure is 60 days, including the 10-day validation and the 5-day decision steps. For CTAs subject to Request for Information (RFI) from regulatory reviewers, the standard procedure can take up to 106 days. Under the Accelerating Clinical Trials in the European Union (ACT EU) initiative, performance statistics were compiled from September 2023 to March 2025. They demonstrated that the actual average timeline from initial CTA submission to decision is around 120 days for multinational trials. This is roughly two weeks longer than the 106 days targeted for trials subject to RFIs.

ACT EU and FAST EU Accelerate Execution Timelines

The ACT EU and the Facilitating and Accelerating Strategic Trials (FAST EU) (established by the European Commission (EC), the Heads of Medicines Agencies HMAs), and the European Medicines Agency (EMA)) aim to facilitate better, faster, and smarter clinical trials and (thus clinical trial translation). The five-year goals of the ACT EU initiative are:

• 500 more multinational clinical trials authorized by 2030 
• 66% of trials begin recruiting patients within 200 calendar days or less from the CTA. 

The FAST EU initiative, launched in January 2026, seeks to fast-track the assessment and authorization of multinational trials across the EU/EEA. Additionally, FAST EU serves as a pilot for the future implementation of the EU Biotech Act. This regulatory compliance legislation is the European Commission’s December 2025 proposal for a major overhaul of the EU drug regulations.

Accelerating Clinical Trial Translations for Regulatory Compliance

According to the Regulatory Affairs Professionals Society, adapting and innovating clinical trial translation procedures for clinical trial documentation is one of the key challenges posed by the single regulatory translation framework for clinical trials in the EU. Translations play a critical role in CTA timelines and regulatory compliance reviews for multinational clinical trials. During the transition to the CTR from January 2022 to January 2025, sponsors submitted 10,608 initial CTAs via the Clinical Trials Information System. They covered:

• New trials
• Resubmissions
• Mass migration of legacy trials from the repealed Clinical Trials Directive (CTD)

Multinational trials alone represented 42% of all submissions, and commercial sponsors conducted over 71% of these trials across multiple Member States. 

Read our white paper about clinical trial authorization procedures for multinational clinical trials under the CTR. It also covers the challenges related to clinical trial translation requirements in the EU.  

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Want recommendations on centralizing CTAs to accommodate the parallel submissions across EU Member States? Need clinical trial translation services that ensure speed and submission-ready quality? Let’s get in touch.