Since September 2025, the European Union has been officially tracking two concrete targets for multinational clinical trials, both now reported quarterly. The first: 500 additional trials authorized by 2030, on top of the average of 900 per year recorded when the target was set — in practice, an increase of roughly 100 additional trials per year, sustained over five years. The second: the share of trials that begin recruiting patients within 200 days of application submission should rise from 50%, the 2025 baseline, to 66% by 2030.

Nearly a year after these targets were set, the first official progress figures are now available — and they show a stronger acceleration than might have been expected at this stage.

1. Why these targets became necessary

Since the Clinical Trials Regulation (CTR) took effect and the single authorization system (CTIS) became mandatory, the European Union has collected three years of real data on its own system's performance. The official report covering this transition period shows an average of 200 new clinical trial applications submitted monthly, of which only around 80 per month — less than half — were multinational trials.

This low share became an institutional warning sign: if most trials remain confined to a single country, the European Union isn't leveraging the competitive advantage it could offer — simultaneous access to patient populations across 27 member states, under a single authorization. Other regions of the world, where multi-country authorization is faster or administratively simpler, become more attractive to sponsors choosing where to run their research as a result.

The institutional response came through the ACT EU initiative (Accelerating Clinical Trials in the EU), a collaboration active since 2022 between the European Commission, EMA, and HMA (Heads of Medicines Agencies — the network of national medicines agency leaders across all member states). Beyond setting the two numerical targets, ACT EU works on several fronts simultaneously: direct advice for sponsors at the trial design stage, dedicated support for non-commercial researchers, and the implementation of a modernized Good Clinical Practice guideline, designed explicitly to facilitate exactly this kind of complex, multi-country trial.

The two targets — 500 additional multinational trials and 66% fast recruitment, both by 2030 — are, therefore, not isolated goals, but success indicators for a broader effort to reposition Europe as a top-tier destination for global clinical research.

2. The concrete mechanisms driving this

Reaching these targets doesn't depend on a statement of intent alone — ACT EU has activated or supported several concrete initiatives, each addressing a specific part of the problem:

FAST-EU (Facilitating and Accelerating Strategic Clinical Trials), a pilot program led by HMA, gives sponsors the opportunity to test shorter evaluation timelines for multinational trials, using the existing legal framework — without waiting for a separate legislative reform to experiment with faster procedures.

CTR Collaborate targets a different problem: even under a shared regulation, national authorities and ethics committees in different member states can interpret or apply procedures differently, creating unnecessary delays. This initiative encourages direct interaction between them, to harmonize how things actually work in practice, not just the letter of the law.

The COMBINE programme solves a specific complication in modern, complex trials: many research projects involve a medicine, a medical device, and a diagnostic test simultaneously — each governed, until now, by a separate legal framework, with separate evaluations. COMBINE synchronizes these evaluations into a single process, for trials that need all three at once.

Each of these three initiatives tackles a different cause of historical slowness — long evaluation timelines, lack of harmonization between authorities, duplicated bureaucracy for complex projects — not just the general symptom of "too few multinational trials."

3. The official progress figures, resulting from these mechanisms

The first quarterly progress report, published in May 2026, covered the period January-March 2026:

• 19 multinational clinical trials authorized in addition to the historical average

• 40.5% of all clinical trials began recruiting participants within 200 days

In the official announcement accompanying this first report, EMA noted that preliminary data collected after March already indicated a "continuing positive increase" across key indicators, suggesting further progress was already underway.

The most recent data, available directly on the official ACT EU platform and covering activity through the end of June 2026, confirms exactly this trend:

• 84 multinational clinical trials authorized in addition to the historical average — more than a fourfold increase from the previous report, in just three additional months

• 40.8% of trials now begin recruiting participants within 200 days

To reach the target of 500 additional trials by 2030, the required pace is roughly 100 additional trials per year. With 84 trials already recorded at the halfway point of the first monitoring year, progress on this component appears aligned with — or even slightly ahead of — the pace needed.

The fast-recruitment rate, by contrast, is advancing much more slowly: from 40.5% to 40.8% in three months, an increase of just 0.3 percentage points. At this pace, reaching the 66% target by 2030 will require a significant acceleration compared to the current trend — the mechanisms already in place (FAST-EU, CTR Collaborate) appear to be influencing the number of authorized trials more strongly than the actual speed of patient recruitment.

4. What this means for anyone doing clinical research in Europe

The progress measured so far shows that ACT EU isn't just a statement of intent, but a process with real, quarterly-verified results, not just long-term promises. For sponsors deciding where to run a multinational clinical trial, faster and more harmonized authorization across member states represents a concrete advantage over other regions of the world, where multi-country bureaucracy remains a significant obstacle.

For research sites in member states like Romania, a sustained increase in the number of authorized multinational trials means more opportunities to participate as a recruiting site in a larger study — with greater international visibility, access to cutting-edge protocols, and, for patients, faster access to treatments still in development.

This acceleration gains even more weight in the context of the broader reform of European pharmaceutical legislation, now in the final stages of the legislative process, with formal approval expected in the coming period. One element of that reform would explicitly reward sponsors who run clinical trials across multiple member states — a direct link to exactly the kind of trials ACT EU is now trying to multiply.

Still, there's a question the official reports don't address directly: if the number of multinational trials keeps growing at this pace, whether the research infrastructure in member states — qualified staff, recruitment capacity, administrative resources — will be able to absorb this additional volume without affecting the quality or execution speed of each individual trial. The gap between the two targets — solid progress on the number of trials, slow progress on recruitment speed — suggests that simply increasing authorizations doesn't automatically resolve every bottleneck in the system.

Halfway through the first year of official monitoring, the European Union is advancing toward its target of 500 additional multinational clinical trials at a pace aligned with expectations — real, quarterly-documented progress, confirmed by the very institutions that set the targets. The fast-recruitment rate, by contrast, remains the far harder component to accelerate, and this gap shows that authorization speed and patient recruitment speed respond to different mechanisms, not the same solutions. For anyone working in clinical research in Europe, the coming quarterly reports will show whether this initial pace holds up over the long term, or whether the early momentum gives way to the system's structural challenges.

Sources:

• European Medicines Agency (EMA). New targets for clinical trials in Europe. September 23, 2025. https://www.ema.europa.eu/en/news/new-targets-clinical-trials-europe

• European Medicines Agency (EMA). EU tracks progress towards 2030 clinical trial targets. May 20, 2026. https://www.ema.europa.eu/en/news/eu-tracks-progress-towards-2030-clinical-trial-targets

• Accelerating Clinical Trials in the EU (ACT EU). Homepage, progress data updated through June 2026. https://accelerating-clinical-trials.europa.eu/index_en