SINC
21/12/2025 – 21:06h.
The Spanish Agency for Medicines and Health Products (Aemps) has authorized the first phase I clinical trial of an innovative drug for cancer and rare diseases through the new accelerated procedure or fast track, thanks to which the regulatory process has been reduced from 100 to 60 days.
This is the Embold study, promoted by GSK, in which an investigational oncological drug will be evaluated in patients with advanced solid tumors, as reported by Farmaindustria in a press release.
The authorization comes a year after the first fast track pilot trial authorized by the agency dependent on the Ministry of Health, a vaccine also developed by GSK.
Novel therapies
This step consolidates the new regulatory framework that seeks to expedite the development of innovative therapies in early phases, which has allowed the regulatory procedure of this clinical trial to be completed in just 60 days compared to the usual 100.
From the presentation in CTIS (Clinical Trial Information System), carried out on September 22, until the final authorization, the process has advanced in an agile manner thanks to the collaboration between Aemps, researchers, institutions, Farmaindustria and GSK.
The Embold phase I/II study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of a new compound in combination with standard of care or other agents in patients with advanced solid tumors.
The first patients are already participating in the trial, which is being carried out in five reference centers in oncology in three autonomous communities: the Vall d’Hebron University Hospital (UITM-CaixaResearch), in Barcelona; the Jiménez Díaz Foundation, the HM Sanchinarro University Hospital and the Ramón y Cajal, in Madrid; and the Virgen de la Victoria, in Malaga.
A historic demand
Farmaindustria has welcomed “with great satisfaction” the extension of the procedure to all national phase I trials in oncology or rare diseases, a historical demand from researchers, industry and patients, because this type of measures “are welcome to strengthen Spanish leadership in clinical trials.”
In 2024, the Aemps authorized 930 clinical trials, which placed Spain in the lead in Europe, ahead of countries such as France or Germany.
