Spain, Europe’s leading country in clinical drug research
The Aemps authorised a total of 930 studies last year, making it the European regulatory agency that approved the most clinical trials, ahead of countries such as France and Germany.
Larazon.es
Drug research has become a new source of national pride in the health sector. Since 2024, we are the leading country in Europe in the production and conduct of clinical trials, and the second in the world after the United States.
Last year, the Spanish Agency for Medicines and Health Products (AEMPS) authorised a total of 930 studies, making it the European regulatory agency that approved the most clinical trials, ahead of countries such as France and Germany, according to the Spanish Clinical Trials Register (REec).
‘This leadership is based on the solid infrastructure of the National Health System and the high qualification of its healthcare professionals, the commitment and collaboration of patients and the pharmaceutical industry, and the work of the AEMPS in favour of an agile and flexible regulatory framework,’ the AEMPS states.
The Agency also points out that this milestone comes ‘in a year marked by the adaptation to the European Regulation on Clinical Trials’. In this regard, the AEMPS stresses that it has made a ‘significant effort’ to facilitate the transition to the new CTIS (Clinical Trial Information System). It also highlights that during 2024, the REec recorded a record 10,000 published clinical trials.
Leading Europe in research activity as a whole
Spain leads the EU in cancer drug research in the EU, with a total of 336 oncology trials, according to the Spanish Medicines Agency (Aemps). These represent nearly 38% of authorised research in our country, followed by immune system and nervous system pathologies, with 8% and 7%, respectively.
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It is also the country with the highest number of trials with advanced therapy drugs, with 52 authorised in 2024, ‘thanks to the expertise of its evaluators and the specific support structures in the centres of reference for the administration and monitoring of this type of therapy’, according to the Agency.
In addition, the Aemps stresses the ‘growing prominence’ of biotechnology medicines in the management of serious and disabling diseases ‘in line with the strategic interest of biotechnology for the EU’. In addition, 22% of the clinical trials conducted in Spain focused on rare diseases.
The Agency headed by María Jesús Lamas was also responsible for authorising a total of 770 multinational studies in 2024, which places Spain at the forefront of this type of trial. Spain also ranks first as the Reference Reporting State (RMS) in 28% of the studies.
The first accelerated assessment trial
Another of the major milestones achieved by the Aemps in 2024 was to launch for the first time an accelerated or ‘fast-track’ evaluation procedure for research. ‘This is a phase I clinical trial of a vaccine that will be carried out in the Madrid university hospitals of La Paz, La Princesa and Puerta de Hierro, as well as in other hospitals in the United States and Australia,’ the Agency reports.
The accelerated assessment procedure is a measure provided for in the European regulation for those drugs that have the most obvious therapeutic value and are not in competition with others that would prevent the current delay in their access.
Why do they reach patients late?
In the face of these overwhelming data on Spanish research leadership, it is surprising that we continue to be at the bottom of Europe in terms of the time it takes for patients to access innovative medicines. According to the latest report ‘Indicators of access to innovative therapies in Europe 2023 (W.A.I.T. Indicator)’, it takes 661 days (22 months) from the time the European Medicines Agency (EMA) gives the green light to a drug until it receives public funding from the National Health System. And our country’s position in the European rankings for access to innovative drugs is worsening year after year.
