Spain leads clinical research in the EU: 962 trials authorized and record administrative agility
The Spanish Registry of Clinical Studies points out that the country’s excellent hospital network and regulatory efficiency make it a strategic destination for the development of new drugs.
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In 2025, Spain has managed to consolidate its position as the most active country in clinical research within the European Union, maintaining its leadership in both the number of authorized trials and the diversity of therapeutic areas. Proof of this can be found in the Spanish Registry of Clinical Studies (REec), which reports that the Spanish Agency for Medicines and Health Products (AEMPS) has authorized a total of 962 clinical trials, achieving a sustained growth rate for more than 10 years.
These figures have enabled the AEMPS to position itself, once again, as the leading European agency in terms of authorizations and one of the most important in the world, guaranteeing Spanish patients the opportunity to benefit from innovative treatments and reinforcing the agency’s commitment to public health and cutting-edge research.
The AEMPS highlights that Spain is a leader in key areas such as research into drugs for treating cancer, rare diseases, advanced therapies, and innovative medicines, fields that, unsurprisingly, require a high degree of specialization and are a priority for public health.
“Spain also maintains a strategic position in attracting multinational clinical trials, with a total of 758 authorized. These studies are crucial as they allow a sufficient number of patients to be recruited in different countries to obtain solid results and accelerate the development of treatments,” explains the AEMPS.
Throughout 2025, the AEMPS authorized a total of 378 trials in oncology, with Spanish hospitals serving as European benchmarks, and managed to become the European country with the most research in this therapeutic area, accounting for nearly 40% of the studies authorized nationally. This is followed at some distance by immune system disorders, with 10.5%, the nervous system with 6.9%, cardiovascular disorders with 6.2%, and the respiratory tract with 4.4%.
“Spain maintains a strategic position in attracting multinational clinical trials, with a total of 758 authorized.”
Along the same lines, the REec reports that Spain continues to be one of the leading Member States in research into advanced therapy medicines, with 40 clinical trials. This is a very striking figure which, according to the AEMPS, is due to the expertise of its evaluators and the specific support structures in the reference centers for the administration and monitoring of this type of therapy.
In terms of therapeutic innovation, a key indicator is the number of early-stage trials being conducted, as this is where research into new medicines is concentrated. In 2015, 156 phase I and phase I/II trials were authorized (19% of the total authorized), ten years later, this figure has risen to 244, representing 25% of the total authorized and an increase that demonstrates the interest in bringing new developments to Spain.
In an attempt to understand the reasons why Spain has become a strategic hub for clinical trials at the European level, the AEMPS explains that the country has a highly trained hospital network, with nearly 1,000 centers involved in clinical research in the last five years; the growing participation of patients, with one of the best recruitment rates in Europe due to the high level of trust in healthcare professionals; public-private collaboration; close collaboration with research ethics committees and their clinical vision; and, finally, flexible regulation.
AGILITY AND COMPETITIVENESS
In addition to all these advances achieved in 2025, the AEMPS highlights the intensification of its efforts throughout the year to reduce evaluation times and increase regulatory efficiency, with the aim of ensuring that Spain remains an attractive environment for clinical research.
Among the most notable measures is the extension of the accelerated assessment procedure for early-stage national trials, allowing studies of great scientific and therapeutic relevance to begin development in significantly shorter times.
“We remain committed to collaboration with all stakeholders, including the organization of information sessions for researchers, sponsors, and patients, with the aim of encouraging participation and understanding of the value of clinical research.”
Along the same lines, they have strengthened their leadership in European initiatives, such as the first fast-track procedure (FAST-EU) for multinational clinical trials in the EU, promoted by the Heads of Medicines Agencies (HMA) network, chaired by the director of the AEMPS, María Jesús Lamas.
In addition, they have focused on digitization and process optimization, with full integration into the CTIS system following the completion of the transition period to the European Clinical Trials Regulation, which provides transparency and facilitates the simultaneous management of trials in different countries.
“We remain committed to collaboration with all stakeholders, including the organization of information sessions for researchers, sponsors, and patients, with the aim of encouraging participation and understanding of the value of clinical research,” concludes the AEMPS.
