CTIS fast-track: AEMPS accelerated evaluation process
The Spanish Agency for Medicines and Health Products (AEMPS) has introduced an accelerated evaluation process (fast-track) to enhance Spain’s appeal for research on innovative medicines. This process will reduce the timelines for studies meeting the following criteria:
- Phase I clinical trial
- Solely sites in Spain
- Investigation of advanced therapy treatments
- Examination of seriously debilitating or life-threatening diseases lacking therapeutic alternatives
- Submission through the EU clinical trials database CTIS (Clinical Trial Information System) solely in Spain
- Presentation of the study to a Ethics Committee adhering to the fast-track process
Interested sponsors must contact AEMPS before submitting the application to benefit from this process. This email should include the expected shipment date, the evaluating CEIm, and the trial’s details: title, indication, investigational drug, population, and all additional information justifying compliance with the requirements for accessing the accelerated evaluation process.
Upon submitting the application, the accompanying letter must indicate that adherence to the fast-track process has been approved by AEMPS.
Suppose the requirements are met, once confirmation of fast-track acceptability is received from AEMPS. In that case, the application will be evaluated within 26 days from its validation, compared to 45 days in the standard process. In cases not requiring any clarifications, AEMPS could authorize the trials within 31 days.
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Further information at: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-un-procedimiento-de-evaluacion-acelerada-de-ensayos-clinicos/#
