New guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the R&D (human) Division of the FAMHP.

The FAMHP informs you about the new guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the R&D (human) Division of the FAMHP.

 

This guidance updates and supersedes the circular letter 575.

 

It also foresees the possibility for submissions via CESP (Common European Submission Portal).

The submission of applications/documents via CESP to the R&D (human) Division will become mandatory for all processes from 1 October 2018: clinical trials, clinical investigations, performance studies and UMNs.

 

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Last updated on
15/05/2018