
Spain again tops Europe in clinical trials
Spain has once again secured the top position in Europe for clinical trials. According to various Clinical Research Organisations at BioSpain 2025 (7–9 October, Barcelona), this is largely due to the speed with which the Spanish Medicines Agency (AEMPS) approves clinical studies.
With 930 new approvals for drug trials, Spain clearly led Europe, particularly in oncology and studies involving new modalities. “Spain’s comparatively low cost structure has also contributed to its development as Europe’s leading location,” said Martin Krauss, CEO of the CRO FGK GmbH, in an interview with European Biotechnology at BioSpain. Currently, Spain ranks third globally as a location for clinical trials.
Spain was the first European country to fully implement the EU Clinical Trials Regulation (EU Regulation No. 536/2014). Royal Decree 1090/2015, enacted in 2015, allowed for the harmonisation and simplification of national procedures. According to the European pharmaceutical association EFPIA, France and Germany follow Spain in Europe, while China (7,100 trials as of 2024) and the United States (6,000) lead globally.
The number of clinical trials is an important economic indicator. In 2023, the pharmaceutical industry invested more than €834 million in clinical research in Spain, with over 50% allocated to early and complex Phase I and II trials. Clinical trials also generate jobs in research institutions as well as in logistics, IT, and administration.