Fast-track clinical trial procedures in the EU: turning complexity into opportunity

The EU has taken important steps to make Europe a more attractive place for conducting clinical trials. One of the most significant steps was introducing the Clinical Trials Regulation (CTR) and the Clinical Trials Information System (CTIS). These measures harmonized many requirements across Member States, introduced common templates and enabled sponsors to submit applications to multiple countries simultaneously.

Nevertheless, conducting a clinical trial in Europe requires careful planning. Sponsors must navigate national requirements, language obligations and local procedural differences. The encouraging news is that the EU and individual countries are working to reduce these barriers by creating a faster, more predictable research pathways, with the introduction of fast-track procedures.

Currently, at least seven EU countries have national fast-track procedures designed to boost clinical trial activity within their borders. While these pathways differ in scope and timing, they share a common goal of helping innovative studies reach patients sooner.

For example, Denmark, Estonia and Sweden, have created fast-track procedures for mononational Phase 1 and integrated Phase 1/2 clinical trials. In Sweden ^[1], eligible studies involving chemical investigational medicinal products (IMPs) are assessed and approved within 26 to 30 days. Denmark ^[2] goes further by completing the full evaluation process – including validation, assessment, requests for information (RFIs), conclusions and approval – within 36 days for mononational Phase I and integrated Phase I-II trials. Multinational trials may also benefit from shorter timelines if the other participating Member States agree. In Estonia, the assessment of mononational trials in these phases takes 30 to 40 days.

Spain and France have taken a more targeted approach, focusing their fast-track pathways on specific types of trials or diseases. In France ^[3], sponsors conducting Phase 1 or integrated Phase 1/2 trials for rare or debilitating diseases without treatment options, or first-in-class medicines, may apply for the Fast Track program. The timeline is up to 49 days for chemical and biological IMPs and up to 63 days for advanced therapy medicinal products (ATMPs), from submission to conclusion and decision.

In Spain ^[4], the fast track applies to mononational Phase 1 trials involving biological or biotechnological medicinal products in oncology or rare diseases, as well as bioequivalence trials. In these cases, validation is expedited and the assessment period is 26 days, provided no RFIs are issued.

Germany and Belgium have broader fast-track options. In Germany ^[5], mononational trials across all phases, including those involving GMOs, can be assessed within 26 days of validation being issued. If no RFIs are issued, approval can be granted in as little as 31 days.

In Belgium, initial applications for mononational Phase 1, Phase 1/2 and Phase 2 clinical trials will be assessed within 20 days of submission at most. If requests for additional information are made during the assessment period, the maximum time limit is 59 days. Applications for mononational phase 2/3, phase 3, phase 3/4, and phase 4 clinical trials will be assessed within 35 days or within 79 days if additional information is requested. These deadlines can be extended by 10 days, for advanced therapy medicinal products (ATMPs) and certain biotechnological medicinal products

Belgium ^[6] also offers accelerated assessments for multinational Phase 1, Phase 1/2 and Phase 2 trials where Belgium acts as the reporting Member State (RMS). These timelines apply with the sponsor’s request and the agreement of the Member States concerned (MSC). Initial applications can be assessed within 35 days of submission, in this case, or within 79 days if additional information is requested. There is a possible 10-day extension for ATMPs and certain biotechnological medicinal products.

These national initiatives demonstrate the competition among European countries to create a more efficient and attractive environment for clinical research.

At the EU level, the Fast EU-Pilot project ^[7] takes this ambition further. Twenty-six EU countries are participating in the initiative, which aims to expedite the evaluation of multinational clinical trials. To date, 103 fast-track applications have been submitted, and 23 have been approved ^[8]. The goal is to complete the full evaluation – including validation and assessment of Parts I and II, as well as RFIs – within 70 days.

This evolving landscape creates both opportunity and complexity for sponsors. Selecting the right pathway, understanding each country’s requirements and aligning timelines across Member States can significantly impact the start of a study.

Fast-track pathways are most beneficial for early-phase and innovative trials, as a rapid start-up is critical for these types of trials. Fast Track pathways help shorten approval timelines and accelerate patient access. However, these pathways require careful planning, because eligibility criteria are often restrictive. These pathways are most effective when supported by high-quality, submission-ready documentation and integrated early into a clear regulatory strategy.

Sponsors that proactively incorporate fast-track opportunities into their regulatory strategy can significantly improve study start-up timelines and accelerate patient access to innovative therapies.

At Pivotal, we closely monitor developments across the EU and help sponsors navigate different scenarios. Our goal is to support sponsors in taking full advantage of the accelerated pathways and advancing patient access to innovative treatments.

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