ICH E2E PHARMACOVIGILANCE PLANNING

Title:
ICH E2E PHARMACOVIGILANCE PLANNING

https://www.gmp-compliance.org/files/guidemgr/E2E_Guideline.pdf

Origin/Publisher:

ICH

Content:
This Guideline is intended to aid in planning pharmacovigilance activities, especially in preparation for the early postmarketing period of a new drug (in this Guideline, the term "drug" denotes chemical entities, biotechnology-derived products, and vaccines). The main focus of this Guideline is on a Safety Specification and Pharmacovigilance Plan that might be submitted at the time of licence application.

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