Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 66

Pharmacovigilance (PV) is governed by a large body of requirements. Some are written and rigid. Others are written, but are far less rigid. Others are not requirements but only guidances or guidelines, and still others are unwritten customs and (best or optimal) practices. Obviously, laws and regulations vary from country to country. The sections that follow summarize briefly the obligations in the US and the EU for drugs and over-the-counter (OTC) products, but also provide means and references to remain “up to date” on PV requirements.