The first fast track for multinational clinical trials in Europe will start in January 2026 and will help strengthen European competitiveness in this area.
The Spanish Agency for Medicines and Health Products has been one of the driving forces behind this accelerated assessment procedure, which will provide trial sponsors with greater predictability, strengthen industry confidence in the European regulatory system and facilitate the attraction of investment in research.
It is essential that the Agency has the human, technical and organisational resources commensurate with the importance and intensity of its work.
The FAST-EU (Facilitating and Accelerating Strategic Trials) project represents an unprecedented advance for multinational clinical trials in Europe. The first accelerated assessment procedure has been promoted by the Heads of Medicines Agencies (HMA) network, currently chaired by María Jesús Lamas, director of the Spanish Agency for Medicines and Health Products (Aemps).
Spain has played a leading role in the development of this initiative, which will increase the predictability of evaluation and authorisation timelines, strengthen industry confidence in the European regulator and facilitate the attraction of investment in research.
‘The approval of FAST-EU is great news for European patients, who will have earlier access to innovative therapies in the research phase. At the same time, it will strengthen the biomedical innovation ecosystem and reinforce Europe’s competitiveness in attracting investment in research, which is critical in the current global context,’ emphasises Amelia Martín Uranga, Director of Clinical and Translational Research at Farmaindustria.
The procedure will be launched in January 2026 and represents a qualitative leap forward for multinational clinical trials, which account for a significant percentage of authorised studies in Europe. These studies are vitally important, as they involve a large number of patients, enabling solid results to be obtained and accelerating the development of innovative treatments.
Spain and other European Union countries already have fast-track evaluation procedures in place, but these are limited to single-country trials. In September 2025, Spain launched a fast track for early-stage trials, with the aim of promoting research into oncology and rare diseases. The first trial authorised under this procedure was approved in less than 60 days, compared to the usual timeframes of over 100 days.
This initiative will strengthen Europe’s global competitiveness in biomedical research and will also help to reinforce Spain’s leadership, which has established itself as the European leader in clinical drug research, ranking among the countries with the highest number of authorised trials and a solid network of hospitals and research centres. This leadership is based on a combination of scientific rigour, regulatory flexibility and high patient commitment, with one of the best recruitment rates and public-private collaboration that drives the arrival of international projects. In addition, Spain has been the country that has most often acted as the reference Member State in coordinated European evaluation.
Farmaindustria would like to give special recognition to the work of the Aemps at a time of great challenges in Europe related to the regulation of clinical trials and the evaluation of health technologies, for which it is essential that it has the human, technical and organisational resources appropriate to the relevance and intensity of its work.
