Following several years of development,¹ medicines are subjected to pre-clinical and clinical trials. These trials determine how well the body tolerates the product, its optimal dose, and describe the risk/benefits of the candidate molecule. This last aspect is critical in obtaining marketing authorization. All of these results go into the marketing authorization application. Only the competent national and/or European authorities, such as the FDA, ANSM or EMA, are allowed to grant marketing authorization upon review of the application.
¹Flexmag # 6 – Injectable drugs: a long winding road