• E2A - E2F Pharmacovigilance

    Code Document Title Previously coded
    • Finalised Guideline:
      November 2012

      Description :

      The tripartite core harmonised ICH Guideline was finalised under 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.

      Based on the comments made by the members of the Expert Working Group on CIOMS V recommendations and the PhRMA-EFPIA working document, an addendum has been finalised and reached Step 4 in February 2003 (R1).

      The revised (R2) Guideline reached Step 4 of the ICH process in November 2012.

      The purpose of this Guideline’s revision is to ensure that the periodic safety update reports for marketed drugs have the role of being periodic benefit-risk evaluation reports by covering: Safety evaluation, evaluation of all relevant available information accessible to marketing authorisation holders (MAHs) and benefit-risk evaluation.

      Implementation :

      Step 5


      EC, EuropeAdopted by CHMP, December 2012, issued as EMA/CHMP/ICH/544553/1998


      MHLW/PMDA, Japan Adopted 17 May 2013, PFSB/ELD Notification No. 0517-1


      FDA, United States Published in the Federal Register, 19 July 2016, No. FDA-2012-D-0315, p. 46938 - 40


      Health Canada, Canada Implemented 29 November 2010, File #: 10-123674-389


      Swissmedic, Switzerland - Refer to the press release on Swissmedic, Switzerland's website