February 2022: Spain Update

The Spanish Agency of Medicines and Medical Devices (AEMPS) has published an updated version of document of instructions of the Spanish Agency of Medicines and Health Products for the realization of clinical trials in Spain.

As per updated version, from 31 January 2022 until 30 January 2023, the sponsor may request the authorization of a clinical trial, applications for substantial modifications through the CTIS or ECM Portal.

All requests and communications subsequent to the authorization of a clinical trial not uploaded to CTIS must continue to be made through the ECM portal no later than the date on which the transition of the clinical trial was requested in the CTIS Portal.