Issue Date: April 1, 2005
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Efficacy
Status: Final
E2E Pharmacovigilance Planning
This guidance is intended to aid in planning pharmacovigilance activities, especially in preparation for the early postmarketing period of a new drug (in this guidance, the term drug denotes chemical entities, biotechnology-derived products, and vaccines). The main focus of this guidance is on a safety specification and pharmacovigilance plan that might be submitted at the time of license application. The guidance can be used by sponsors to develop a stand-alone document for regions that prefer this approach or to provide guidance on incorporation of elements of the safety specification and pharmacovigilance plan into the Common Technical Document (CTD).
Download the Guidance Document
