date: 05/08/2021
A new version of the guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the FAMHP is available.
The submission of dossiers and documents via the Common European Submission Portal (CESP) to the Research and Development division (human use) of the FAMHP is compulsory. As from now, dossiers for genetically modified organisms (GMOs) for deliberate release also must be submitted via CESP. This no longer needs to be done on CD-ROM.
In the updated guidance the FAMHP provides more information on the different aspects of clinical trials. All changes are listed on the second page of the document, in the table "Document Revision History".