Spain, the EU leader in 2024 in advanced therapy research, with a growing prominence of biotechnological medicines
Out of the 930 studies authorized by the AEMPS last year, a total of 52 focused on advanced therapy medicines.
According to data published by the Spanish Clinical Studies Registry (REec), the Spanish Agency for Medicines and Medical Devices (AEMPS) authorized a total of 930 studies in 2024, positioning itself as the European regulatory agency with the most clinical trials approved, ahead of countries like France and Germany. This milestone was achieved in a year marked by adaptation to the European Clinical Trials Regulation, during which the REec also recorded a record number of 10,000 published clinical trials.
Analyzing the data, Spain leads the European Union (EU) in research involving medicines aimed at treating cancer, with a total of 336 oncology trials, representing 37.6% of all studies authorized nationwide. This is followed by research on immune system and nervous system disorders, accounting for 8.6% and 7%, respectively. Additionally, 22% of the clinical trials conducted in Spain focused on rare diseases.
Spain is also a European leader in research involving advanced therapy medicines, with a total of 52 trials authorized in 2024. It is worth highlighting the growing prominence of biotechnological medicines in managing severe and disabling diseases, in line with the EU’s strategic interest in biotechnology.
In 2024, the AEMPS authorized a total of 770 multinational studies, placing Spain at the forefront of this type of trial. The country also ranks first as a Reference Member State (RMS) in 28% of the studies.
Regarding the commercial nature of these studies, 17% of those authorized last year were promoted by academic or hospital institutions, scientific societies, or clinical researchers, meaning they were non-commercial. This percentage has remained consistent with figures prior to the transition to the new regulation, demonstrating that independent research has also successfully adapted to the regulatory requirements and the new CTIS system.
The AEMPS also highlights that 2024 has been marked as the first year of implementing an accelerated evaluation procedure or fast-track. This involves a Phase I clinical trial for a vaccine to be conducted at the Madrid university hospitals of La Paz, La Princesa, and Puerta de Hierro, as well as at other medical centers in the United States and Australia.