The AEMPS includes bioequivalence studies in the accelerated CTIS procedure (fast-track)

The Spanish Agency for Medicines and Health Products (AEMPS) has expanded its accelerated evaluation process (fast-track), including bioequivalence studies.

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.

At APICES we have an extensive experience in CTIS submissions. Trust in us your projects!