On October 30, 2019 the Italian Medicines Agency (AIFA) published the final version of the agreement on conducting clinical trials for profit on medicines (“Agreement”), taking into account the comments submitted by stakeholders during the previous public consultation.
The Agreement was finalized by the “Center for the coordination of territorial ethics committees for clinical trials on medicines for human use and medical devices” and aims to ensure uniformity in the agreements between the Promoter and the Institution and to facilitate negotiations between them.
The Agreement contains the minimum provisions to be implemented and it may be integrated by the parties in the case of specific requirements for the clinical trial.
In order to guarantee a constant and homogeneous application on Italian territory, the Agreement covers different cases, for instance the case of an international trial and stipulation by the local affiliate of a multinational pharmaceutical company or the case of participation in a contract research organization (CRO).
