NEWS | AEMPS Update on Fast-Track Procedure for Clinical Trials in Spain

May 24, 2024

The Spanish Agency for Medicines and Health Products (AEMPS) has launched a fast-track accelerated evaluation procedure specifically for: Phase I Clinical trials involving ATMPs

Advantages of the procedure:

  • Evaluation in maximum 26 days since validation
  • Possible authorization in 31 days, if no RFIs are raised


  • To study serious debilitating diseases or life-threatening conditions in patients who have no therapeutic alternatives
  • To be conducted exclusively in Spain
  • To select an Ethics Committee (CEIm) adhering to the fast-track procedure

This procedure represents an excellent opportunity to boost medical research of innovative medicines in Spain.

For more information about this procedure, do not hesitate to contact us at:

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