Spain Secures European Leadership in Clinical Trials with 962 Authorizations in 2025

Spain has firmly reaffirmed its position as the European leader in clinical trial authorizations in 2025, with the Spanish Agency of Medicines and Medical Devices (AEMPS) authorizing a record 962 trials this year. This marks a 25% increase since 2015, highlighting a steady growth over the past decade that places Spain ahead of other key European countries like Germany.

A key driver of this leadership is Spain's pioneering adoption of the European Clinical Trials Regulation (CTR) in 2016, which has streamlined regulatory processes. In oncology, Spain remains dominant, with 378 authorized trials accounting for nearly 40% of all Spanish clinical research studies. Other prominent areas of focus include rare diseases, immunology, cardiovascular and respiratory conditions, and particularly advanced therapy medicinal products, where Spain authorized 40 clinical trials in 2025.

Early-phase trials, critical for innovative drug development, have seen a marked increase from 156 in 2015 to 244 in 2025, representing 25% of total trials. The country's robust infrastructure—nearly 1,000 centers dedicated to clinical research—combined with high patient recruitment rates, public-private partnerships, and flexibility in regulation, underpin this success.

The AEMPS continues to expedite trial evaluations through accelerated review procedures and the digitalization of processes to enhance efficiency. Spain also leads the FAST-EU initiative, a coordinated fast-track assessment system designed to reduce approval timelines for multinational trials within the EU.

Looking ahead, the AEMPS plans to further strengthen collaboration with sponsors, researchers, and patients through informative sessions aimed at promoting participation in clinical research. This strategic focus ensures that Spanish patients gain timely access to cutting-edge treatments while maintaining Spain's status as a hub for innovative medical research in Europe.