CASubmissionOfApplication object

Responsible for study submission

Sponsor
Legal representative domiciled in the EU/EEA

Guidance on submission of application available

Yes

Guidance on submission of application

Avis aux promoteurs d’essais cliniques de médicaments, y compris les essais cliniques portant sur les médicaments de thérapie innovante (MTI) - Tome 1 (31/05/2018) (855 ko)

Available at : www. ansm.sante.fr/Activites/Medicaments-et-produits-biologiques/Avis-aux-promoteurs-Formulaires/


It covers in detail the legal framework, the submission procedure and all other relevant requirements on amendments, safety reporting and trial termination .

National legal framework in place

Yes

Additional Information

PLEASE NOTE THAT WE ARE CURRENTLY UPDATING OUR DATABASE

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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