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
Requirements:
- 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: [email protected]
