date: 15/05/2018
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.
More information: