[Description of postauthorisation observational prospective studies with drugs in the valencian region between 2010 and 2015. Factors associated with their authorisation.].

Objective: Postauthorisation observational studies are crucial source of information on drug effectiveness and safety. The objectives of this work were to describe the characteristics of the postauthorisation observational prospective studies (EPA-SP) for which authorisation was requested in the Valencian region, as well as to explore which factors influenced the aforementioned authorisation.

Methods: We performed a retrospective analytical study comprising all the EPA-SP for which authorisation was requested in the Valencian region between 2010 and 2015.