Publication of the update of the Guidance for submission of CTA initial dossiers, substantial amendments and end of trial notifications to the FAMHP

Submission of dossiers and documents to the Research and Development Division (human use) of the FAMHP via the CESP is compulsory since 1 October 2018. Today, the FAMHP publishes version 1.2 of the guidance.

Since 1 October 2018, submission of dossiers and documents to the Research and Development Division (human use) of the FAMHP via the CESP is compulsory for all processes: clinical trials, clinical investigations, performance studies and UMNs. In order to help professionals with the submission process, the FAMHP publishes an updated version of the guidance. Changes compared to the previous version are shown on page 2 of the document, in the "Document Revision History" table.