ACT EU: Three Years On

The EU’s ambition is clear: to rival the world leaders in clinical research. For years, the region’s fragmented national regulatory landscape was viewed as an impediment, with more streamlined jurisdictions present in other regions contributing to their success in life-saving drug development. To counter this, the EU launched the multi-year initiative Accelerating Clinical Trials in the EU (ACT EU).

Launched in January 2022, ACT EU was less a new law and more a strategic mandate, a transformation program designed to build upon a new regulatory foundation. Now, roughly three years into its existence, with key operational targets looming for 2030, the question emerges: Is the EU becoming the competitive trials hub it set out to be?

The evidence is mixed. While the framework for harmonization is robust, and early signs of engagement are positive, the lingering complexity of national implementation and persistent operational hurdles suggest the goal is within sight, but far from secured. The EU is undeniably moving in the right direction, but there remain challenges and setbacks that hold the EU back from rivalling the global leaders in clinical research.

Explaining ACT EU

To understand ACT EU, one must first recognize the fundamental shift it was built on: the transition from the old Clinical Trials Directive (CTD) to the modern Clinical Trials Regulation (CTR).

The CTD, which had governed clinical research since 2001, was often criticized for requiring trial sponsors to wade through a complex web of varying national laws and requirements across the EU’s Member States. This regulatory fragmentation made running a single trial across multiple EU countries an administrative and logistical burden.

The CTR, which came into effect on January 31, 2022, changed the game by introducing a single set of rules and a single submission process for trials conducted in one or more EU Member States. At the heart of this new regulation is the Clinical Trials Information System (CTIS), the unified EU portal and database where sponsors submit all documentation.

ACT EU launched in a similar timeframe to the CTR/CTIS application, positioning itself as the engine for successful implementation, with the goal of turning the EU into a competitive, innovation-friendly hub for clinical research. It focuses on solving the operational gaps the CTR identified but didn't inherently fix. This transition has already resulted in significant activity: over 12,400 clinical trials have been submitted and more than 10,000 approved across the EU under the new system. This supports the claim that the EU remains a highly active research location, but the success of the new system is measured by how efficiently those thousands of trials can move from submission to patient recruitment.

The Multi-Stakeholder Platform (MSP)

At the core of the ACT EU architecture is the Multi-Stakeholder Platform (MSP). This body acts as a continuous feedback loop and advisory group, bringing together all critical voices in the clinical ecosystem: patient organizations, academic researchers, commercial sponsors, Health Technology Assessment (HTA) bodies, and regulators. Its primary function is to directly influence the progress of the EU clinical trials environment.

The MSP’s influence is substantial. For example, it provides direct input into critical tools like the CTIS sponsor handbook, ensuring that the operational guidance given to researchers is practical and effective. Its work is guided by consultations, surveys and targeted clinical trial workshops. This collaborative approach aims to shift the environment from a purely top-down regulatory structure to a partnership model.

ACT EU’s Targets

The initiatives branching out from the MSP are designed to maximize the impact of clinical trials. The most defining markers of ACT EU’s long-term competitive success are its quantitative targets:

1. 500 more multi-national trials authorized by 2030.

2. 66% of trials to begin patient recruitment within 200 days of submission.

The 500-trial goal aims to address perception of the EU having a reduction of global share of clinical trials and research by making the EU a favoured destination for large, complex studies. The 200-day recruitment target directly tackles the issue of speed as drug development timelines are often dictated by the ability to enrol patients quickly.

Streamlining Scientific and Regulatory Advice

Despite the scale of the task, the first three years of ACT EU have yielded concrete achievements that indicate a strong desire for systemic improvement and stakeholder alignment.

A crucial element of accelerating trials is ensuring that sponsors receive aligned, high-quality advice before they even submit their application. The EU addressed this through a pilot program focusing on consolidated advice mechanisms, which has been referred to as the SAWP-CTCG pilot. This is the result of a joint partnership between the Scientific Advice Working Party (SAWP) and the Clinical Trials Coordination Group (CTCG).

This pilot's success proves advantageous for ACT EU’s collaborative mission. Out of eleven applications received under this pilot, all eleven were approved. This approval rate is an indication that stakeholders are highly engaged, a key step in reducing the likelihood of major delays or rejections further down the regulatory pipeline. This proactive alignment minimizes friction and is proving useful for ACT EU for achieving the 200-day recruitment target.

The EU Trial Map

Transparency and information access are key competitive differentiators. A clinical trial ecosystem cannot thrive without engaged participants and informed clinicians. To address this, ACT EU delivered the EU Trial Map.

The EU Trial Map is a public portal offering integrated access to information on more than 10,000 trials. This tool empowers both patients and healthcare professionals by providing a centralized source of information on what trials are running, where they are, and what conditions they cover. With the trial map offering the empowerment to patients and clinicians, the EU takes a major step toward addressing a critical factor in trial success, namely patient recruitment. While automatic synchronization between the CTIS database and the Trial Map is anticipated to form the basis of future accuracy updates, the current existence of this tool is a clear improvement over previous fragmented approaches.

Screen Capture of EU Trial Map 08.12.2025

Ref: https://euclinicaltrials.eu/search-for-clinical-trials/trial-map/?lang=en

Operational Improvements

Beyond technology, ACT EU has pushed regulatory partners to make practical operational improvements to the new CTR system. These measures are designed to address immediate friction points, which include:

• Shorter Timelines: Regulatory partners are working to enforce and, where possible, shorten approval timelines.

• Improving the approach to oversight given to Reporting Member State’s (RMS): The CTR established that one member state acts as the RMS, responsible for coordinating the assessment of a multi-country trial. ACT EU is focused on reinforcing this coordinating role to ensure decisions are made efficiently and consistently.

• Simplified Approaches for Low-Intervention Trials: Acknowledging that not all research requires the same level of oversight, ACT EU is working on simplified approaches for less complex, low-intervention trials, making it easier for academic and non-commercial sponsors to run critical public health studies.

These targeted, continuous improvements are essential for proving to global sponsors that the EU system is adaptable and responsive to real-world challenges, a hallmark of a truly competitive environment.

The Part 2 Problem

Despite the successes in establishing a unified legal and IT framework, the debate over the EU's competitive status hinges on the processes that follow the central regulatory approval. This is where the challenge of national-level variability continues to undermine the potential of the CTR and ACT EU.

The CTR divides the clinical trial application process into two parts:

1. Part 1: Scientific and medicinal product assessment (mostly harmonized and centrally coordinated by the RMS).

2. Part 2: National/local requirements, including ethics committee opinions, informed consent documents, and local feasibility (e.g., budget and contract negotiations).

While centralizing Part 1 has undergone improvements on consolidating advice (as evidenced by the SAWP-CTCG pilot), the regulatory journey tends to become fragmented during the Part 2 process. For a multi-country trial, a relatively easy to attain Part 1 approval tends to be followed with a more challenging Part 2 approval.

This lack of Part 2 harmonization is a competitive threat to the EU landscape. The time required to wade through national-level negotiations, particularly contracting, budget, and local ethics review serve as a major bottleneck, which can result in patient recruitment delays.

Discussions are underway to address this, including the possibility of introducing an RMS-like model for Part 2. Should such a model be formalized, it would serve as an important structural change which would improve the EU’s operational efficiency and boost their competitive edge.

Performance across Member States

The overall EU activity numbers (over 10,000 approvals) are impressive, yet performance across the continent is highly variable, suggesting that some national systems are better equipped to implement the CTR than others. For example, Spain has emerged as a clear leader in overall volume in activity numbers, yet it is worth noting that the Netherlands performs strongly relative to its size.

While overall EU activity remains high, with more than 12,400 trials submitted and over 10,000 approved, performance varies significantly across Member States. Spain has emerged as a leader in total volume, and the Netherlands performs strongly relative to its size, but this variability highlights the broader challenge of uneven CTR implementation across the EU. Ensuring the strongest performers set the standard for all Member States is key to ensure ACT EU hits its goals, including smoother operational delivery and more efficient recruitment timelines.

Removing Patient Burden and Supporting Academic Sponsors

Despite the introduction of the EU Trial Map, a notable weakness in the EU system remains: the burden placed on trial participants. Specifically, the continued reliance on extensive, legalistic consent forms which prove onerous to the individuals who fill them out.

These complex documents place an avoidable burden on participants and can even hinder recruitment by confusing or irritating potential volunteers. A truly competitive and patient-centric system must ensure that information given to participants is clear, concise, and accessible. Improvements in clarity would greatly benefits in establishing trust and encouraging greater participation. Some countries, such as the Netherlands, are being targeted for specific interventions to ensure patients play a more active role in the clinical trial process.

The drug development pipeline is complex, stretching from preclinical research to patient access. Crucially, a significant portion of early-stage innovative research is conducted by academic and non-commercial sponsors. These groups often lack the extensive regulatory affairs teams that large commercial pharmaceutical companies possess. ACT EU has identified that academic research requires targeted guidance in scientific, procedural, and technical matters to thrive under the new regulatory landscape. As part of their initiatives, they are focused on ensuring that these non-commercial entities can navigate the CTIS and CTR requirements effectively, preventing a situation where essential public health research is stifled due to administrative complexity.

Conclusion

Is the EU becoming a competitive trials hub? The verdict after three years is a yes, but with caveats.

The EU has successfully established the necessary architecture for a competitive environment. The Clinical Trials Regulation (CTR) and the Clinical Trials Information System (CTIS), driven by the continuous improvement mandate of ACT EU, have created the centralized legal foundation that was missing for decades. Early successes, such as the SAWP-CTCG pilot and the launch of the EU Trial Map, show strong stakeholder engagement and a commitment to operational excellence. The targets of 500 more multinational trials and the 200-day recruitment window reflect a genuine determination to regain global standing.

However, the competitive battleground has shifted. The EU is no longer fighting regulatory fragmentation at the level of application (Part 1), but at the level of implementation (Part 2 and post-approval processes). The national-level variability in contract negotiations, local ethics, and resource allocation which are coupled with the ongoing need for continuous improvement in the CTIS system, remains the key impediment.

To fully achieve its goal, ACT EU’s remaining work must focus on resolving these operational pain points. This includes formalizing Part 2 harmonization (e.g. an RMS-like model) and streamlining administrative procedures beyond CTR approval (like budget negotiations and recruitment). The upcoming release of the European Biotech Act in 2026 will warrant further examination as to how it affects or relates to the reforms ACT EU are enforcing.

Ultimately, the EU has moved beyond setting out the rules and is now in the phase of enforcing the standard. The chance to rival the top leaders in global clinical research is present, but its realization depends on maintaining the momentum to tackle these remaining hurdles. Through this, the EU can ensure that the promise of a single, efficient trials hub is met for all stakeholders, most notably the patients whose lives depend on the EU’s ability to quicken the pace of medical innovation.

About the Author

Rhys

Rhys Wallett joined The PBC Group in October 2025 as a Conference Producer, where he researches and produces life sciences meetings for clinical-stage biopharma organisations. In his role, Rhys develops targeted conference programs that bring together key stakeholders across the clinical research ecosystem, from CROs and pharmaceutical sponsors to biotech innovators and regulatory experts. His work focuses on identifying emerging trends in clinical development and translating complex industry challenges into actionable conference content that drives meaningful dialogue and collaboration within the life sciences community.