An announcement referring to an "EMA inspection" does not necessarily mean that EMA inspectors will visit your manufacturing site. The European Medicines Agency (EMA) coordinates certain inspection activities, while national competent authorities (NCAs) carry them out. The inspectors arriving at your site will therefore normally represent a national authority. The practical questions are which authority is responsible, why an inspection is being requested, and what EMA coordinates behind the scenes. Scope This article examines the European Union's inspection framework for finished medicinal products for human use and active pharmaceutical ingredients (APIs),...