EU Clinical Trials by the Numbers 2026: 12,123 CTIS Records Analyzed

Sponsors planning European clinical trials for 2027 face a regulatory landscape fundamentally altered by the full implementation of Regulation (EU) No 536/2014. The Clinical Trials Information System (CTIS), which became mandatory for all new trial applications in January 2023 and completed the transition of legacy Clinical Trials Directive 2001/20/EC studies in January 2025, now provides a single, transparent record of trial activity across all 30 European Economic Area (EEA) member states.

Across all 12,123 public CTIS records in our July 30, 2026 snapshot, Spain leads Europe with 4,915 trials (40.5 percent of all public records), positioning itself ahead of France (4,562 trials, 37.6 percent), Germany (3,989 trials, 32.9 percent), Italy (3,739 trials, 30.8 percent), and Poland (2,748 trials, 22.7 percent). Spain maintains its lead in every single authorization-decision year from 2022 through 2026.

But participation volume and regulatory leadership are not the same thing, and this is where most country rankings mislead. The first joint European Commission/HMA/EMA quarterly report (20 May 2026) shows that for multinational applications, Germany — not Spain — is the most frequently appointed Reporting Member State: 736 appointments to Spain's 685. Spain only takes the overall RMS lead once mononational trials are folded in (1,316 versus Germany's 1,271), because a mononational trial's single member state is its own assessor by default. Sponsors choosing an RMS for a five-country dossier are, in aggregate, still choosing Germany.

However, the Clinical Trials Regulation's primary objective—to streamline and expand multinational clinical research across Europe—remains only partially fulfilled. A total of 6,787 out of 12,123 trials (56.0 percent) run in a single member state. Furthermore, the proportion of trials conducted across multiple member states fell from a peak of 54.3 percent of authorization decisions in 2023 down to 39.2 percent in 2025, stabilizing at 40.5 percent in partial 2026 data. Regulatory evaluation timelines also remain longer than intended: EMA’s official Q1 2026 progress report recorded a median time of 118 days from application submission to final decision, exceeding the statutory maximum of 106 days set by Regulation 536/2014.

Below is an analytical breakdown of the complete public CTIS dataset, detailing member state activity, regulatory review performance, sponsor composition, and phase distribution across Europe.

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Which European Country Runs the Most Clinical Trials Under CTIS?

The geographic distribution of clinical trials under CTIS demonstrates high geographic concentration. While CTIS allows sponsors to submit a single dossier covering up to 30 EEA countries simultaneously, trial activity remains centered in Western Europe, with Poland serving as the primary hub in Central and Eastern Europe (CEE).

To quantify country participation accurately, each public CTIS trial is counted once per listed country. Trials involving multiple member states contribute to the total of each participating country.

The Mechanics Behind Spain’s Leadership

Spain’s position as the leading location for clinical trials in Europe is supported by structural factors. Under Royal Decree 1090/2015, Spain aligned its national regulatory framework with the principles of Regulation 536/2014 ahead of the formal launch of CTIS. This early implementation allowed Spanish ethics committees (CEIm) and the Spanish Agency of Medicines and Medical Devices (AEMPS) to establish standardized, parallel assessment workflows.

As a result, Spain consistently captures the highest volume of trial authorizations across all individual decision years:

• 2022: 80 authorizations (ahead of France at 73 and Germany at 60)
• 2023: 838 authorizations (ahead of France at 713 and Germany at 703)
• 2024: 2,457 authorizations (ahead of France at 2,455 and Germany at 1,990)
• 2025: 999 authorizations (ahead of France at 840 and Germany at 781)
• 2026 (partial): 541 authorizations (ahead of France at 481 and Germany at 455)

The country's high national health system (Sistema Nacional de Salud) site consolidation, centralized ethics reviews, and high hospital participation in oncology contribute to its leading position. Industry comparison reports published by the Irish Pharmaceutical Healthcare Association (IPHA) in March 2026 corroborate this from an independent CTIS pull: Spain hosted 720 industry-sponsored trial starts with a 2025 EU/EEA start date, ahead of Germany (594) and France (525).

Two caveats a sponsor should hold alongside that ranking:

• Spain leads on absolute volume, not intensity. On the same IPHA data Spain ranks only 11th per capita (1.48 trials per 100,000). Belgium (2.81) and Denmark (2.75) lead per head. If your constraint is site availability rather than population reach, the density leaders look different from the volume leaders.
• Spain's real advantage is post-authorisation speed, not approval speed. CTIS timelines are set at EU level and do not vary by country. What varies is the gap between EU approval and first site ready — the contracting, budget and document phase. IPHA measures that at 105 days in Denmark and 213 days in Ireland for 2023–2025 starts, and names Spain's parallel-track site activation as the reason sponsors keep going back. Country selection under the CTR is a contracting decision dressed up as a regulatory one.

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Did the EU Clinical Trials Regulation Actually Deliver Multinational Trials?

A core goal of Regulation 536/2014 was replacing 30 disparate national filing processes with a single coordinated authorization. Under the Directive regime, sponsoring a trial in five member states required five separate applications, five independent national clinical trial approvals, and varying local ethics review timelines. CTIS introduced a unified Part I assessment (scientific and product safety review led by an appointed Reporting Member State) and Part II assessment (national site, ethics, and patient suitability evaluated by each concerned member state).

Despite this structural coordination, the CTIS registry shows that single-country trials account for 6,787 of 12,123 records (56.0 percent).

       EU CTIS Trial Distribution: Single-Country vs. Multi-Country
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|  Single-Country Trials: 6,787 records (56.0%)                          |
+-----------------------------------------------------------------------+
|  Multi-Country Trials:  5,336 records (44.0%)                          |
+-----------------------------------------------------------------------+

Analyzing authorization decisions by calendar year demonstrates that the multi-country share peaked during the early rollout phase and has since contracted:

Why Did the Multi-Country Share Decline?

Two major factors account for the decline in multi-country trial share following 2023:

1. Sponsor mix is the dominant explanation, and the official data proves it. The Q1 2026 report cross-tabulates all 11,183 authorised trials by sponsor type and footprint, and the split is close to binary:

Commercial sponsors run multinational trials 70 percent of the time. Non-commercial sponsors — universities, hospital networks, national consortia, 43.4 percent of our public snapshot (5,260 trials) — run mononational trials 86 percent of the time, constrained by single-jurisdiction grant conditions and limited infrastructure for managing 30 parallel Part II submissions. The CTR did not change either behaviour; it just made both visible in one place. The falling multi-country share after 2023 largely reflects a shifting sponsor mix, not commercial sponsors retreating from Europe.

2. The "start small, add countries later" theory does not survive the data. It is widely assumed that sponsors file with two to four key member states and bolt on the rest via additional Member State Concerned (addMSC) applications. CTIS tracks those applications, and they are rare: since 31 January 2022 there have been 2,494 addMSC applications affecting just 963 trials — under 9 percent of the 11,183 authorised trials. For comparison, the same period saw 28,070 substantial-modification applications affecting 7,926 trials. Sponsors modify constantly; they almost never expand the country footprint after the fact. A CTIS country list is effectively a one-shot decision made at submission, which is exactly why the country-selection analysis above matters more than it looks.

The distribution of countries per trial confirms this targeted approach. Among the 5,336 multi-country trials, the majority involve fewer than six countries, and the largest trial in the register spans 25:

Half of all multi-country trials (3,031 of 5,336) involve five or fewer member states. Only 140 trials — 1.2 percent of the entire register — run in more than 15 of the 30 available EEA countries. Whatever "pan-European trial" means in a CRO pitch deck, it describes about one trial in eighty.

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How Long Does a CTIS Clinical Trial Application Really Take in 2026?

Under Regulation (EU) No 536/2014, the maximum statutory review timeline for a standard Clinical Trial Application (CTA) is 106 days. That ceiling assumes the worst case at each step: up to 25 days for validation where the reporting member state raises a validation query, 45 days for the Part I assessment (with Part II assessed in parallel by each concerned member state), up to 31 further days when the assessing states issue a request for information, and 5 days for each member state to notify its decision. A clean dossier with no queries concludes far faster. For Advanced Therapy Medicinal Products (ATMPs), an additional 50-day extension has historically been permitted on top of that.

In practice, total durations exceed the ceiling. Per the first joint EC/HMA/EMA quarterly clinical trial report (20 May 2026, covering January–March 2026), the median time from submission to decision for new initial clinical trial applications was 118 days, against an average submission volume of 208 new applications per month.

One caveat the report itself flags and most coverage drops: the Q1 window includes the CTIS "winter clock stop," a designated holiday period during which regulatory timelines are paused. Q1 medians are therefore structurally worse than the rest of the year, and 118 days should be read as an upper-bound quarter, not a steady-state figure. It is still above the 106-day maximum.

                   CTIS Review Timelines (Q1 2026)
  Statutory Maximum (CTR 536/2014): [=========== 106 Days ===========]
  Actual Median (new initial CTAs):  [============== 118 Days ==============]
  FAST-EU Pilot Guarantee:          [======= 70 Days =======]
  EU Biotech Act Proposal:          [======== 75 Days ========] (47 if no RFI)

The European Union's 2030 Clinical Trial Targets

The competitiveness concern driving all of this is quantified. EFPIA, drawing on IQVIA data, reports that the EEA's share of global commercial clinical trial starts halved from 22 percent in 2013 to 12 percent in 2023, while China's rose from 5 percent to 18 percent. In absolute terms EEA trial starts fell from 2,424 to 1,978 over the same decade — a period in which global industry trials grew 38 percent. The decline is sharpest in exactly the categories Europe most wants: cell and gene therapy share fell from 25 percent to 10 percent while China's rose from 10 percent to 42 percent.

In response the EU launched the Accelerating Clinical Trials in the EU (ACT EU) initiative, which established specific Key Performance Indicators (KPIs) measured against targets over January 2026 to December 2030:

1. Multinational Trial Expansion Target: Authorize 500 additional multinational clinical trials above baseline by end-2030. The baseline is explicit: before Brexit, COVID-19 and the CTIS transition, the EU/EEA authorized 78 multinational trials per month. Five hundred extra over five years equates to 100 per year, 25 per quarter, and a working monthly target of 86.
   • Status (Q1 2026): +19 additional multinational trials, against a quarterly target of +25 — cumulatively 2,830 multinational trials versus a target of 2,836. Monthly authorizations were 58 in January, 84 in February and 110 in March, so the quarter closed with momentum but still short. As of this analysis, the Q2 2026 report has not been published; EMA has said only that "preliminary data collected after March 2026 indicate a continuing positive increase across key indicators."
2. Recruitment Timelines Target: Achieve participant recruitment initiation within 200 days of application submission in 66 percent of authorized trials by 2030.
   • Status (Q1 2026): 40.1 percent as of 31 January, 40.2 percent as of 28 February, 40.5 percent as of 31 March — a 25.5-point gap to the 2030 target, closing at roughly 0.2 points per quarter. The report notes commercial sponsors are closer to target than non-commercial ones. This KPI is the one to watch, because it measures site contracting and activation, which the CTR does not govern at all.
3. Regulatory Review Acceleration: Two separate mechanisms are often conflated. FAST-EU — Facilitating and Accelerating Strategic Clinical Trials — is a voluntary pilot, not legislation, launched by the Heads of Medicines Agencies, the Clinical Trials Coordination Group and MedEthics EU, operational since January 2026 within the existing CTR framework. It applies to initial applications for multinational trials of any product class and guarantees a maximum of 70 calendar days (10 weeks) from CTIS submission to final decision, including sponsor response time. Separately, the EU Biotech Act — proposed by the European Commission in December 2025 and still in the legislative process — would amend the CTR to cut multinational authorization from 106 days to 75 days (47 with no request for information), abolish the additional 50-day ATMP extension, and reduce substantial-modification timelines from 96 to 47 days. Nothing in the Biotech Act is in force; sponsors planning 2027 starts should budget against the 106-day statutory ceiling and treat FAST-EU as the only currently available acceleration route.

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Which Sponsors Dominate the EU Clinical Trial Register?

The CTIS database reveals a balanced composition between pharmaceutical corporations and public health institutions. Sponsoring organizations are categorized into commercial entities (pharmaceutical manufacturers, biotechnology firms, and industry SMEs) and non-commercial entities (university hospitals, research institutes, and cooperative trial groups).

Of the 12,123 public records, 6,863 trials (56.6 percent) are commercially sponsored, while 5,260 trials (43.4 percent) are non-commercial.

          CTIS Sponsoring Entities: Commercial vs. Non-Commercial
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|  Commercial Industry Sponsors:    6,863 records (56.6%)               |
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|  Non-Commercial / Academic:       5,260 records (43.4%)               |
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Top Commercial Sponsoring Entities

Commercial trial activity is led by multinational pharmaceutical corporations managing global Phase II and Phase III development programs.

Read this table with a caveat that applies to every CTIS sponsor ranking, including the ones published elsewhere: CTIS does not normalise sponsor names. The same group appears under multiple legal entities and multiple spellings, and the public export does not resolve them. Two examples from this snapshot alone: "AstraZeneca AB" (235) and "Astrazeneca AB" (51) are the same sponsor differing only in capitalisation, giving a true total of 286; "Janssen - Cilag International" (108) and "Janssen Cilag International" (88) differ by a hyphen, giving 196. Consolidated, AstraZeneca is essentially level with Merck Sharp & Dohme at the top of the table rather than a distant second, and Janssen moves into the top six. Any CTIS sponsor league table that has not been entity-resolved — most of them — is understating the largest sponsors by an unknown margin.

Top Non-Commercial Sponsoring Entities

Non-commercial clinical research in Europe is led by major hospital networks and academic centers. The second-largest sponsor overall across the entire CTIS platform is a public hospital system.

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What Phase and Therapeutic-Area Mix Does Europe Actually Attract?

Analyzing the development stage and disease indications within CTIS illustrates Europe's role in global drug development. The data shows that trial activity is heavily weighted toward late-stage, confirmatory research rather than early-stage exploratory studies.

Clinical Trial Phase Distribution

Phase II and Phase III studies comprise 57.0 percent (6,916 trials) of the entire register. In contrast, standalone Phase I studies account for 1,914 trials (15.8 percent).

                       CTIS Register Phase Breakdown
  Phase II:             [=================== 3,565 (29.4%) ===================]
  Phase III:            [================= 3,351 (27.6%) =================]
  Phase I:              [========== 1,914 (15.8%) ==========]
  Phase IV:             [====== 1,239 (10.2%) ======]
  Phase I/II:           [===== 1,108 (9.1%) =====]
  Other / Adaptive:     [=== 946 (7.8%) ===]

The lower volume of Phase I trials aligns with concerns raised by European biopharma associations regarding early-phase trial migration to the United States and Australia, where initial Phase I filing requirements and ethics approvals can be completed faster.

Therapeutic Area Concentration

Therapeutic classification in CTIS shows a high concentration in oncology. Neoplasms (Oncology) account for 3,920 trials (32.3 percent of the entire database), matching official EMA statements identifying cancer as the most frequently investigated disease category in Europe.

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Why Does the 2024 Authorisation Spike Overstate European Trial Growth?

When examining CTIS authorization decisions over time, the absolute volume of authorized trials shows a substantial spike in 2024 before contracting in 2025:

• 2022: 211 decisions
• 2023: 1,780 decisions
• 2024: 6,206 decisions
• 2025: 2,530 decisions
• 2026 (partial): 1,396 decisions

                  CTIS Authorization Decisions by Year
   2022: [== 211]
   2023: [======= 1,780]
   2024: [================================================== 6,206 *Spike*]
   2025: [========== 2,530]
   2026: [===== 1,396 (Partial)]

Deconstructing the 2024 Transition Artefact

Interpreting the 6,206 authorization decisions in 2024 as a surge in new clinical research would be incorrect. Under the transitional provisions of Regulation 536/2014 (Article 98), all clinical trials authorized under the old Directive 2001/20/EC that were anticipated to continue beyond January 31, 2025, were legally required to be transitioned into CTIS.

Sponsors submitted thousands of ongoing legacy studies during 2024 to meet the mandatory cutoff. There are two ways to size that effect, and they disagree — which is itself the useful finding.

The official split. CTIS records a structured transition flag, and the Q1 2026 EC/HMA/EMA report publishes it directly. Of the 13,778 initial applications submitted since 31 January 2022:

So 41.8 percent of authorised trials in CTIS (4,672 of 11,183) were never new European research at all — they are Directive-era studies re-papered into a new system.

Our reproducible cut, and where it fails. Applying a date-gap heuristic to the public snapshot — classifying a trial as transitioned when its European start date precedes its CTIS decision date by more than 180 days — returns 6,798 new applications (56.1%), 3,480 transitioned (28.7%), and 1,845 undetermined (15.2%) where the start-date field is incomplete.

That heuristic materially undercounts transitions: 3,480 against the official 4,672. The gap is almost entirely the 1,845 undetermined records, and it is a warning about the public CTIS export generally — the structured transition flag is not exposed in the public dataset, so any third-party analysis built on the public search portal will understate the legacy share unless it reconciles against the official report. Where the two disagree in this analysis, we defer to the official figure.

Once legacy administrative transfers are separated out, underlying European trial generation is flat to modest, not the boom the raw 2024 line implies. The 2025 and partial-2026 decision counts, which are almost entirely post-transition, are the honest baseline.

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What a Sponsor Should Actually Do With This for a 2027 Start

Five decision rules fall out of the data above, in the order they bind:

1. Budget 118 days from submission to decision, not 106. Use 106 only for a clean dossier submitted outside the winter clock-stop window. If the programme cannot absorb a Q1 submission slipping past 118 days, submit in Q2 or Q3.
2. Pick the country list once and pick it right. With only 963 trials ever adding a member state post-authorisation, treat the CTIS country list as irreversible in practice. The cost of a country you later regret is higher than the cost of one you never added.
3. Separate the RMS decision from the recruitment decision. Germany carries the most multinational RMS appointments (736); Spain carries the most trial participations (4,915) and the fastest site activation. These are different questions and there is no rule that the RMS must be your biggest recruiting country.
4. Model site activation as the real timeline, because the KPI data says it is. Only 40.5 percent of trials begin recruiting within 200 days of submission, and the assessment itself accounts for roughly 118 of those days. The rest — 80-plus days on average — is contracting, budget negotiation and site initiation, none of which the CTR governs. IPHA's country spread on this step runs from 105 days (Denmark) to 213 days (Ireland).
5. Evaluate FAST-EU on its merits, and do not wait for the Biotech Act. The pilot's 70-day guarantee is available now for multinational initial applications and is the only binding acceleration on offer. The Biotech Act's 75-day and 47-day numbers are a Commission proposal from December 2025 still moving through the legislature, with no adoption date; do not build a 2027 start-up plan on them.

Current State of the Register, in One Block

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Related Analyses and Internal Context

This analysis of the EU Clinical Trials Information System builds upon our broader examination of global regulatory frameworks, market access dynamics, and registry intelligence:

• Sponsoring organizations analyzing US trial activity can compare these EU findings against our ClinicalTrials.gov registry by the numbers analysis, which examines the 590,000+ study US database.
• For downstream regulatory decisions following clinical completion, see our report on what the EU actually approves, detailing central marketing authorizations at the EMA.
• Health Technology Assessment (HTA) and post-approval pricing strategies in Europe can be reviewed in our analysis of NICE technology appraisals by the numbers.
• Modality-specific trial distributions, such as advanced cell therapies, are analyzed in our study of cell and gene therapy clinical trials by the numbers.
• International regulatory comparisons can be found in our review of what Health Canada approves.

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Frequently Asked Questions

How many clinical trials are currently registered in CTIS?

As of our July 30, 2026 snapshot, the public CTIS database contains 12,123 public clinical trial records. Cumulatively since January 31, 2022, official EMA reports record 13,778 submitted applications and 11,183 completed authorizations across the EEA.

Is CTIS the same platform as the EU Clinical Trials Register (EudraCT)?

No. CTIS was established under Regulation (EU) No 536/2014 and manages trials authorized under the current legal framework. The older EU Clinical Trials Register (EudraCT) contains 44,406 historical trials authorized under Directive 2001/20/EC. While ongoing Directive studies transitioned to CTIS before January 31, 2025, completed legacy trials remain archived in EudraCT.

What share of CTIS trials are sponsored by commercial pharmaceutical companies?

Commercial entities (pharmaceutical manufacturers, biotechnology companies, and industry SMEs) account for 56.6 percent (6,863 trials) of the public CTIS database. Non-commercial sponsors (universities, research hospitals, and academic consortiums) represent 43.4 percent (5,260 trials).

What are the EU's official 2030 clinical trial targets under ACT EU?

The European Commission, EMA, and HMA established two primary quantitative goals measured from January 2026 to December 2030: authorizing 500 additional multinational clinical trials above the pre-Brexit/pre-COVID baseline of 78 per month, and ensuring 66 percent of authorized trials initiate participant recruitment within 200 days of application submission. As of Q1 2026, the EU had achieved +19 additional multinational trials against a +25 quarterly target, and a 40.5 percent 200-day recruitment rate.

Is FAST-EU the same thing as the EU Biotech Act?

No, and conflating them is the most common error in current coverage. FAST-EU (Facilitating and Accelerating Strategic Clinical Trials) is a voluntary pilot run by the Heads of Medicines Agencies, the Clinical Trials Coordination Group and MedEthics EU. It has been operational since January 2026, changes no legal obligation under the CTR, applies to initial multinational applications, and guarantees a maximum of 70 calendar days from CTIS submission to final decision. The EU Biotech Act is a legislative proposal published by the European Commission in December 2025 that would amend the CTR itself — cutting multinational authorization to 75 days (47 without a request for information), abolishing the 50-day ATMP extension, and reducing substantial-modification timelines from 96 to 47 days. It is not in force.

How many CTIS trials are transitioned legacy studies rather than new research?

Of the 11,183 trials authorized since CTIS launched, 4,672 (41.8 percent) were transitioned from the old Clinical Trials Directive 2001/20/EC rather than submitted as new CTR applications. This is why the 2024 authorization count spikes to 6,206 in our snapshot and then falls back: sponsors were required to migrate any Directive trial continuing past 31 January 2025. Growth comparisons that treat 2024 as an organic baseline are wrong by a wide margin.

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Sources

1. European Medicines Agency (EMA). Clinical Trials Regulation (EU) No 536/2014 Overview. ema.europa.eu
2. European Medicines Agency (EMA). Clinical Trials Information System (CTIS) Public Search Portal. euclinicaltrials.eu
3. European Medicines Agency (EMA). EU tracks progress towards 2030 clinical trial targets (20 May 2026 Press Release). ema.europa.eu
4. Accelerating Clinical Trials in the EU (ACT EU). ACT EU Dashboard & Workplan 2025–2026. accelerating-clinical-trials.europa.eu
5. U.S. National Library of Medicine / NIH. ClinicalTrials.gov International Trial Registry Comparison. clinicaltrials.gov
6. National Center for Biotechnology Information / PubMed. European Clinical Trials Regulation 536/2014 Analysis. pubmed.ncbi.nlm.nih.gov
7. EU Clinical Trials Register. EudraCT Legacy Database Counter. clinicaltrialsregister.eu
8. European Federation of Pharmaceutical Industries and Associations (EFPIA). Assessing Europe's Competitiveness as a Location for the Life Sciences Industry (March 2026 Report). efpia.eu
9. Irish Pharmaceutical Healthcare Association (IPHA). Clinical Trials Activity Comparison Report 2026 (March 2026). ipha.ie
10. Regulatory Affairs Professionals Society (RAPS). EU makes progress toward 2030 clinical trial goals. raps.org
11. European Commission / HMA / EMA (ACT EU). Monitoring the European Clinical Trials Environment, January–March 2026 (EMA/95013/2026, published 20 May 2026) — source for the 118-day median, 208 monthly applications, 13,778/11,183 submitted-versus-authorised split, 5,088 transitioned applications, sponsor-type cross-tabulation, RMS appointments, addMSC and substantial-modification counts, and both 2030 KPIs. accelerating-clinical-trials.europa.eu
12. Norwegian Medical Products Agency (DMP). FAST-EU: Accelerating Multinational Clinical Trial Assessments in the EU/EEA — 70-calendar-day pilot guarantee. dmp.no
13. European Commission. Questions and Answers on the European Biotech Act (proposal published December 2025). ec.europa.eu