Spain Leads Europe in Multinational Clinical Trials with 770 Authorizations in 2024
Spain leads Europe in multinational clinical trial authorizations in 2024, with 770 approvals and a key role in the upcoming FAST-EU initiative.
- • Spain authorized 770 multinational clinical trials in 2024, leading Europe.
- • AEMPS approved 930 clinical trials in total, a 10% increase from the previous year.
- • Spain's success comes from strong healthcare infrastructure and a flexible regulatory environment.
- • Spain is a leader in the FAST-EU initiative to expedite clinical trial evaluations in Europe starting 2026.
Key details
Spain has established itself as the European leader in multinational clinical trials in 2024, authorizing 770 such studies, according to recent data. This marks a nearly 10% increase in the number of clinical trials authorized by Spain’s Agency for Medicines and Health Products (AEMPS) from the previous year, totaling 930 clinical trial approvals overall and surpassing major European countries including France and Germany.
Spain’s success is attributed to several factors, including its robust healthcare infrastructure, experienced healthcare professionals, high patient recruitment rates, and a regulatory environment known for flexibility and efficiency. The AEMPS plays a pivotal role not only nationally but also within Europe, holding leadership within the Heads of Medicines Agencies Management Group (HMA), reinforcing Spain’s reputation as a premier hub for clinical research.
Additionally, Spain is at the forefront of the FAST-EU initiative, which aims to streamline and accelerate the evaluation of strategic clinical trials across Europe. Set to begin in January 2026, the FAST-EU procedure will provide expedited assessment processes, enhancing predictability and efficiency for trial authorizations.
This leadership role in multinational clinical trials underlines Spain’s growing importance in medical research and regulatory excellence, paving the way for increased innovation and collaboration within the European pharmaceutical sector.
This article was synthesized and translated from native language sources to provide English-speaking readers with local perspectives.
