Spain, European leader in clinical drug research

The Spanish Agency for Medicines and Health Products (AEMPS) authorised a total of 930 studies last year.

In 2024, Spain once again became the country with the greatest capacity to attract clinical research into medicines in the European Union. According to the Spanish Clinical Trials Register (REec), the Spanish Medicines and Health Products Agency (AEMPS) authorised a total of 930 studies last year, making it the European regulatory agency that has approved the most clinical trials, ahead of countries such as France and Germany.

This leadership is based on the solid infrastructure of the National Health System and the high qualifications of its healthcare professionals, the commitment and collaboration of patients and the pharmaceutical industry, and the work of the AEMPS in promoting an agile and flexible regulatory framework.

The coordinated, collaborative and continuous work between these agents is what has made our country, for yet another year, one of the world leaders in clinical trials. This milestone also comes in a year marked by the adaptation to the European Regulation on Clinical Trials, in which the AEMPS has made a major effort to facilitate the transition to the new CTIS (Clinical Trial Information System), and in the year in which REec registered the record figure of 10,000 clinical trials published.

Spain leads the EU in cancer drug research in the EU, with a total of 336 oncology trials. At the national level, this represents 37.6% of all authorised studies, followed by pathologies of the immune system and the nervous system, with 8.6% and 7%, respectively. Spain is also a European leader in research with advanced therapy drugs, with 52 trials authorised in 2024, thanks to the expertise of its evaluators and the specific support structures in the reference centres for the administration and monitoring of this type of therapy. The growing role of biotech medicines in the management of serious and disabling diseases is noteworthy, in line with the strategic interest of biotechnology for the EU.  Moreover, 22% of the clinical trials carried out in Spain focused on rare diseases.

The AEMPS was responsible for authorising a total of 770 multinational studies in 2024, which places Spain at the forefront of this type of trial. Spain ranks first in evaluating as Reference State (RMS) in 28% of the studies.

Source: AEMPS