• E2A - E2F Pharmacovigilance

    Code Document Title Previously coded
    • Finalised Guideline:
      November 2003

      Description :

      The tripartite harmonised ICH Guideline was finalised under Step 4 in November 2003. This document provides a standardised procedure for post-approval safety data management including expedited reporting to relevant authority. The definitions of the terms and concept specific to post-approval phase are also provided. E2A definitions in clinical safety data management was maintained in this document as post-approval safety data management, such as seriousness definition. The practices of the data management were standardised in such cases obtained from consumers, literatures, internets which are all specific to post-approval data management. Good case management practice was focused and recommended for expedited reporting with clear definitions.

      Implementation :

      Step 5

      :

      EC, EuropeAdopted by CPMP, 20 November 2003, issued as CPMP/ICH/3945/03

      :

      MHLW/PMDA, Japan -  Adopted 28 March 2005, PFSB/SD Notification No. 0328007

      :

      FDA, United States Published in the Federal Register, 15 September 2003, Vol. 68, No. 178, p. 53983-4

      :

      Health Canada, Canada Implemented 02 March 2011, ISBN: 978-1-100-17663-5

      :

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