The Spanish Medicines Agency authorises for the first time in Spain a phase I clinical trial under the accelerated assessment procedure
The trial, which will evaluate a vaccine under clinical investigation by GSK, will be conducted in Phase I units at La Paz, La Princesa and Puerta de Hierro University Hospitals in Madrid, as well as at centres in the United States and Australia.
Through this process, clinical trials are evaluated in a maximum of 26 days, compared to the usual 45 days, and approved in 31 days, which could mean hope for patients with serious diseases or without therapeutic solutions.
This milestone reaffirms Spain’s leadership in clinical research and the AEMPS as a leading and innovative agency in Europe.
Farmaindustria.es
The Spanish Medicines and Health Products Agency (AEMPS) has approved for the first time in its history the fast-track procedure for a single-national phase I trial in Spain of a vaccine from the biopharmaceutical company GSK. The study will be carried out at Madrid’s La Paz, La Princesa and Puerta de Hierro university hospitals, as well as other hospitals in the United States and Australia.
The Aemps has launched for the first time this year the fast-track clinical trial process in order to make Spain a more attractive environment for research into innovative therapies. Thanks to this procedure, phase I studies can be assessed in a maximum of 26 days (compared to the usual 45 days) and authorised in up to 31 days, reducing the timeframe by 30%. To be eligible for fast-track, clinical trials must meet a series of requirements such as being in phase I (the first stage of the study, in which the safety of the drug in humans is assessed) and be aimed at advanced therapies and diseases with no therapeutic alternative, among others.
This first approval by the Aemps of a Phase I fast-track trial, in this case of a GSK vaccine, has been possible thanks to the collaboration of all the parties involved: the agency itself, the Ethics Committee for Medicines Research (CEIm) of the Community of Madrid, the three hospitals involved, the researchers and GSK.
This approval reaffirms Spain’s commitment to clinical research, the Aemps as a leading agency in Europe, the pharmaceutical industry as an innovative sector and GSK as a company committed to improving the health of the population.
‘The Aemps, in line with the European pharmaceutical strategy, has among its strategic objectives to strengthen Spain’s leadership in clinical drug research and contribute to making the EU a global research hub,’ says Juan Estévez, head of the Clinical Trials Area of the Aemps. ‘That is why it is important for regulators to have adequate capacities and procedures, such as this fast-track procedure, so that clinical trials of the most innovative or strategic medicines are carried out here and are more accessible to the public,’ stresses Estévez.
‘Once again, the AEMPS is adopting initiatives that will undoubtedly benefit Spanish patients in the first place and, on the other hand, will help us to simplify clinical trial procedures, in line with what the Draghi Report establishes to boost competitiveness in Europe,’ says Juan Yermo, director general of Farmaindustria, which brings together innovative biopharmaceutical companies in Spain. ‘In any case, work must continue so that this accelerated procedure can be applied to all types of phase I clinical trials that are launched in our country,’ he adds.
María Cardenal, Director of Registrations and Market Access at GSK Spain, said: ‘This milestone demonstrates the excellent collaboration between the Aemps and ethics committees, institutions, researchers and GSK to promote clinical research and continue to be at the forefront worldwide.
Spain, leader in clinical trials in Europe
Spain is the European country with the highest participation in clinical trials of new medicines. Of the 1,944 clinical trials authorised in the European Union in 2023, Spanish centres participated in 845, 43% of the total. This has been possible thanks to the scientific level of healthcare professionals, the excellence of hospitals, the support of the health administration and the regulatory agency, the growing involvement of patients and the strong commitment of the pharmaceutical industry in Spain.
In addition, Spain also leads the coordination and authorisation of multinational trials within the European Medicines Agency (EMA). Thus, through the AEMPS, Spain was responsible for coordinating the authorisation of 350 clinical trials in the European Union, a figure that puts us ahead of Germany, with 314, and France, with 248.
Investment in drug research and development (R&D) by the pharmaceutical industry in Spain set a new record in 2022 with almost 1.4 billion euros, 10% more than the previous year, and 834 million euros invested in clinical trials.
