The expedited assessment procedure or fast-track in Spain applies to Phase I trials with biological or biotechnological medicinal products for oncology or rare diseases, as well as to bioequivalence trials, provided that the application is submitted exclusively in our country.
The Spanish Agency for Medicines and Medical Devices (AEMPS) offers an expedited assessment procedure for Phase I clinical trials with biological or biotechnological medicinal products for oncology or rare diseases, submitted through the Clinical Trials Information System (CTIS) exclusively in Spain.
The Ethics Committee for Research with Medicines (CEIm) must be one of the CEIms adhering to the fast-track procedure. Contact details for these CEIms are available in the directory of accredited CEIms in Spain.
Sponsors interested in applying for this procedure must contact AEMPS prior to submitting the application by writing to aecaem@aemps.es. This email should include the expected submission date, the evaluating CEIm, and the trial characteristics: title, indication, investigational medicinal product, population, and any additional relevant information.
AEMPS will confirm its availability to conduct an accelerated evaluation, considering the proposed dates and the characteristics of the trial and investigational product. If multiple applications coincide within the same timeframe, AEMPS will assess the most appropriate timelines for each application and will communicate its decision to the sponsor.
Once AEMPS confirms acceptability for fast-track, the application will be validated expeditiously and evaluated within 26 days from validation, with authorization granted within this period if no clarification is required. If the complexity observed during evaluation makes timeline reduction unfeasible, AEMPS will inform the sponsor of the adjusted timelines.
When submitting the application, the cover letter must indicate that AEMPS has accepted the fast-track procedure. Given that accelerated evaluation involves a multidisciplinary team with dedicated effort, if the sponsor fails to meet the expected submission date, a new request for accelerated assessment will be required to optimize dedicated resources.
Accelerated evaluation also applies to clinical trial applications investigating bioequivalence between two medicinal products submitted through CTIS exclusively in Spain.
Timelines for these trials will apply automatically, without the sponsor needing to contact AEMPS prior to submission or include specific information in the cover letter. The application will be validated expeditiously and evaluated within 26 days from validation. Authorization will be granted within this period if no clarification is required.
The Ethics Committee for Research with Medicines (CEIm) selected by the sponsor must be one of the CEIms adhering to the fast-track procedure. Contact details for these CEIms are available in the directory of accredited CEIms in Spain.
