• E2A - E2F Pharmacovigilance

    Code Document Title Previously coded
    • Finalised Guideline:
      November 2004

      Description :

      The tripartite harmonised ICH Guideline was finalised under Step 4 in November 2004. 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.

      Implementation :

      Step 5


      EC, EuropeAdopted by CHMP, 1 December 2004, issued as CPMP/ICH/5716/03.

      Coming into operation in June 2005


      MHLW/PMDA, Japan Adopted 16 September 2005, PFSB/ELD Notification No. 0916001 & PFSB/SD Notification No. 0916001


      FDA, United States Published in the Federal Register, 1 April 2005, Vol. 70, No. 62, p. 16827-16828


      Health Canada, Canada Implemented 16 February 2009, File #: 09-103644-626


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