ICH E2E Pharmacovigilance planning (Pvp) - Scientific guideline

This document provides guidance on planning pharmacovigilance activities, especially in preparation for the early postmarketing period of a new medicinal product. It applies to chemical entities, biotechnology-derived products and vaccines.

Keywords: Pharmacovigilance activities, safety specification, pharmacovigilance plan, safety database, risk, interactions, epidemiology, class effect, observational studies

Current effective version

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 E: Pharmacovigilance planning - Step 5

Adopted Reference Number: CPMP/ICH/5716/03 Legal effective date: 01/06/2005