Victor Moreno, Director Clinical Research at START Madrid FJD, shared a post on LinkedIn:
“The Fast Track for Europe Is Here.
The Spanish Agency of Medicines and Medical Devices (AEMPS) has announced the opening of the procedure to include multinational clinical trials in the FAST-EU (Facilitating and Accelerating Strategic Trials) project, effective from 30 January 2026.
The initiative aims to reduce assessment timelines and improve coordination among EU member states.
Its main advancement is the possibility of completing the procedure within a maximum total timeframe of 10 weeks (70 calendar days) from submission of the application in CTIS to the final conclusion, including the sponsor’s response times.
This, added to the already stablished fast track in AEMPS for phase 1 studies in Spain only shows how strong is the Spanish regulation aiming to bring clinical research to Europe.
Exciting milestone for clinical research in Europe!”
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