Spain has established itself as one of the major European centers of clinical researchSpain has positioned itself at the forefront of the European Union in both the number of authorized trials and the breadth of therapeutic areas covered. This leadership is not a stroke of luck, but the result of a strategy sustained for over a decade, combining a robust regulatory system, the capacity of the hospital network, and the involvement of patients and healthcare professionals.
According to the most recent data from the Spanish Registry of Clinical Studies (REec)Managed by the Spanish Agency for Medicines and Health Products (AEMPS), 962 clinical trials were authorized in Spain in 2025. This figure confirms an upward trend maintained for more than ten years and reinforces the role of the AEMPS as leading regulatory agency in Europe and international benchmarkThis translates into earlier access for Spanish patients to innovative therapies, such as those that A new drug will be manufactured in Spain..
Spain, the most active European country in clinical trials
The dynamism of the Spanish clinical research ecosystem was reflected when Spain overtook Germany as the European country that initiated the most clinical trialsAccording to the report "Assessing the Clinical Trials Ecosystem in Europe," prepared by IQVIA for EFPIA and Vaccines Europe, Spain stood out as an example of good performance in a context where Europe as a whole was losing ground to the United States and China.
The report linked this jump to the early implementation of the European Clinical Trials Regulation (CTR)which Spain began to implement in a pioneering way in 2016. This regulatory anticipation, coupled with a very active public-private collaboration environment, has allowed it to attract a growing flow of international studies and consolidate the country as preferred partner for the pharmaceutical industry and academic promoters.
In parallel, investment in clinical research has maintained an upward trajectory. Between 2012 and 2022, spending associated with these studies increased from 479 to 834 millones de euroswith an average annual growth of close to 6%. This sustained increase in economic resources strengthens the capacity of hospitals and research teams to participate in highly complex projects.
The AEMPS has emphasized that Spain stands out not only for the volume of trials, but also for the therapeutic diversity and the level of specialization of the studies. Oncology, rare diseases, advanced therapies and innovative medicines have become the pillars of a model that combines clinical excellence, regulatory speed and a healthcare network highly involved in the generation of scientific evidence.
962 clinical trials in 2025: a consolidated leadership
Official REec data confirms that in 2025 the AEMPS authorized 962 clinical trials in SpainThis consolidates the country's position as the most active in the European Union in this area. This figure maintains a continuous growth trend for more than ten yearsconsolidating a model that has proven to be stable, competitive and attractive to international developers.
The Spanish regulatory body highlights that this evolution has allowed the Agency to position itself as the European authority with the highest number of clinical trial authorizations and one of the most influential globally. This position reinforces Spain's role as a gateway for new medicines and healthcare technologies, which has a direct impact on patients' early access to cutting-edge treatments.
At the European level, the AEMPS does not limit itself to processing files: leads key community initiatives in clinical research and is part of the core group of agencies that set the regulatory agenda. Its active role allows it to influence the development of more agile and coherent processes among the different Member States, something especially relevant for multinational trials.
Of the 962 trials authorized in 2025, a very significant portion are international studies. Specifically, 758 multinational clinical trials They included the participation of Spanish centers, which puts the country in a strategic position when it comes to recruit patients and provide robust data in the development of new drugs. This ability to attract researchers reinforces Spain's image as a reliable and efficient environment for research.
The AEMPS itself highlights that this volume of studies, combined with regulatory stability and speed in evaluation, has made Spain a European hub for clinical trialsThe country combines regulatory experience, healthcare resources, and a growing culture of participation in research, elements that allow it to compete on equal terms with other major global centers.
Oncology, rare diseases and advanced therapies, at the center of the map
The distribution of authorized trials in 2025 shows a clear prominence of the oncology as the main therapeutic areaThat year, the Spanish Agency for Medicines and Health Products (AEMPS) approved 378 cancer-related trials, representing nearly 40% of all studies approved in Spain. With these figures, Spain ranks as the European country with greater number of ongoing cancer research projects, with a wide margin compared to other Member States.
These projects are developed in hospitals that have become European benchmarks In the approach to cancer, with specialized multidisciplinary teams and an organization focused on integrating research into clinical practice. Participation in trials offers many patients the opportunity to access treatments in development that would otherwise take longer to become available.
Following oncology, other therapeutic areas stand out with a significant presence in the total number of authorized trials. immune system disorders They represent 10,5% of the studies, nervous system disorders 6,9%, cardiovascular diseases 6,2%, and respiratory tract problems 4,4%. This distribution shows a growing interest in chronic and complex pathologies that require new therapeutic options.
One of the most striking figures is that which refers to the rare diseasesAround 22,5% of clinical trials conducted in Spain in 2025 focused on these types of diseases, which have traditionally been under-researched due to their low prevalence. The participation of Spanish centers in this field reinforces the commitment to patient groups who, for years, have had limited access to innovation.
At the same time, Spain remains among the European elite in research with advanced therapy drugsThis field includes gene, cell, and tissue engineering therapies. During 2025, 40 clinical trials were authorized in this segment, supported by the expertise of the AEMPS evaluators and in highly specialized structures in leading hospitals, capable of administering and monitoring these complex therapies with all the necessary guarantees.
Early stages and a commitment to therapeutic innovation
A key indicator for measuring a country's level of innovation in clinical research is the number of trials in early stages of developmentespecially phase I and phase I/II trials. These studies are at the initial stage of human evaluation and account for a large part of the research on new drugs and mechanisms of action.
In Spain, the evolution in this area has been clearly positive. In 2015, authorizations were granted 156 phase I and phase I/II trialsThis represented around 19% of all studies. Ten years later, the figure rose to 244 early trials, which account for approximately 25% of all those authorized in 2025. This increase reflects the interest of the developers in locating the initial developments in our country, a sign of confidence in the regulatory and scientific capacity of the system.
The AEMPS has prioritized the evaluation of these projects, aware that the early phases are crucial for attract high value-added investment and to position Spain at the forefront of pharmaceutical innovation. The combination of competitive response times, technical expertise, and a clear regulatory framework has been one of the factors explaining this growth.
In this context, the strengthening of clinical trial units in hospitals and research centers has played a significant role. The progressive professionalization of these teams, with profiles dedicated to the management, monitoring and coordination of studiesIt has allowed us to absorb a greater volume of projects without losing quality or safety.
In addition to early-stage trials, Spain maintains a strong presence in Phase II and III trials, where efficacy and safety are validated in larger populations. This continuity between early and late stages facilitates the advancement of many developments that begin in our country. complete a significant part of their clinical training within the same network of centers, reinforcing the accumulated experience of the research teams.
Interest in innovative therapies, such as advanced therapy medicinal products or treatments targeting specific molecular targets, adds to this trend. The combination of early trials, cutting-edge therapies, and a solid foundation of later-phase studies It creates a particularly attractive ecosystem for companies and research groups seeking mature environments in which to test their developments.
Strong hospital network, engaged patients, and public-private collaboration
One of the pillars of Spain's leadership in clinical research is its extensive network of hospitals and healthcare centers involved in conducting trials. In the last five years, nearly 1.000 different centers have participated in a clinical study, reflecting a broad territorial presence and a progressive integration of research into daily clinical practice.
Patient participation is another distinguishing factor. Spain is among the European countries with improved recruitment rates in clinical trialsThis is largely due to the public's trust in healthcare professionals and the public health system. This positive response makes it easier for studies to reach the required number of participants within competitive timeframes, a key factor for international sponsors.
Collaboration between the public and private sectors has become one of the strengths of the Spanish model. The presence of stable agreements between hospitals, universities, research centers and pharmaceutical companies It allows the sharing of resources, knowledge and structures, which increases Spain's competitiveness compared to other European countries when it comes to attracting projects.
Research ethics committees also play a central role. close coordination with the AEMPS and with the research teamsThrough regular meetings and continuous monitoring systems, it helps to ensure that studies are conducted with full ethical guarantees and protection of participants, while avoiding unnecessary delays in the review processes.
Taken together, these elements have allowed Spain to be perceived as an environment where clinical research is integrated into the organization of health servicesand not as a marginal activity. This integration encourages professionals to see clinical trials as part of their routine practice and gives patients more options to access them when appropriate.
An agile regulatory framework: fast-track, European leadership and digitalization
The role of the AEMPS as regulatory engine of clinical research This has been crucial in enabling Spain to maintain its leading position. In recent years, the Agency has intensified measures to shorten evaluation times, increase efficiency, and offer a competitive environment without compromising safety or scientific rigor.
Among the most relevant initiatives, the following stands out: expansion of accelerated or fast-track assessment procedures to national clinical trials in areas such as oncology and rare diseases. These mechanisms allow for a significant reduction in authorization times, with targets that, in certain cases, are around 26 days. For example, the first study under this scheme, known as EMBOLD and sponsored by GSK, has already been authorized.
Furthermore, the Agency has promoted the the first multinational fast-track procedure in the EU, known as FAST-EUWithin the framework of the Heads of Medicines Agencies (HMA) Network, chaired by the Director of the Spanish Agency for Medicines and Health Products (AEMPS), MarÃa Jesús Lamas, this European leadership reinforces Spain's role as a leading player in coordinating trials among member states.
Digital transformation is another key axis. Full integration into the CTIS (Clinical Trials Information System)Once the transitional period of the European Clinical Trials Regulation was completed, this platform has increased transparency and simplified the simultaneous management of studies in several countries. This centralized platform reduces administrative burdens and makes it easier for sponsors to monitor their projects throughout the European Union.
The AEMPS has also strengthened its training and support role, organizing Information sessions aimed at researchers, promoters and patients, including maternal vaccination against pertussisThese sessions explain the regulatory changes, the opportunities offered by the new European framework, and the key role played by participants in trials, with special attention to the protection of their rights and the quality of the information they receive.
All of this is based on a flexible and adaptive regulation, based on continuously updated guidelines - the so-called "living guidelines" - that allow procedures to be adjusted to the changing reality of biomedical innovation, always maintaining the safety and efficacy standards required by regulations on investigational medicines.
The set of data and measures described paints a picture in which Spain has established itself as European leader in clinical researchCombining trial volume, therapeutic diversity, innovation capacity, and regulatory agility, the coordination between the Spanish Agency for Medicines and Health Products (AEMPS), the hospital network, ethics committees, industry, and patients has enabled the creation of a robust and attractive ecosystem. In this ecosystem, clinical trials have become a standard component of healthcare practice and a key driver for bringing the most innovative treatments being developed in Europe and around the world to the public health system.
