E2C(R1): Clinical Safety Data Management : Periodic Safety Update Reports for Marketed Drugs

Regulatory Resource: E2C(R1): Clinical Safety Data Management : Periodic Safety Update Reports for Marketed Drugs

Description:

The tripartite core harmonised ICH guideline was finalised (Step 4) in November 1996. This document gives guidance on the format and content of safety updates, which need to be provided at intervals to regulatory authorities after products have been marketed. The guideline is intended to ensure that the worldwide safety experience is provided to authorities at defined times after marketing with maximum efficiency and avoiding duplication of effort.
E2C Final Concept Paper, October 1994

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