Comparison of post-authorisation requirements between regulatory agencies for medicinal products

Abstract

A poster presentation regarding a comparison of post-authorisation requirements between regulatory agencies for medicinal products. Introduction: Information submitted during the initial registration phase of medicinal products may not be sufficient to fully assess the benefit-risk balance of the product. Post-authorisation studies for new medicinal products are often requested by regulatory agencies to address this limitation and better assess the product. Aims: To compare the post-authorisation study requirements requested by the European Medicines Agency (EMA) and the U.S Food and Drug Administration (FDA) using cardiovascular-related medicinal products as examples.