• E2A - E2F Pharmacovigilance

    Code Document Title Previously coded
    • Finalised Guideline:
      October 1994

      Description :

      The tripartite harmonised ICH Guideline was finalised under Step 4 in October 1994. This document gives standard definitions and terminology for key aspects of clinical safety reporting. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development.

      Implementation :

      Step 5

      EU :

      Adopted by CPMP, November 1994, issued as CPMP/ICH/377/95

      MHLW :

      Adopted March 95, PAB/PCD Notification No. 227

      FDA :

      Published in the Federal Register, 1 March 1995, Vol. 60, No. 40, p. 11284-11287

      Health Canada :

      Implemented 1 June 1995, H42-2/67-8-1995E

      Swissmedic :

      Please refer to the press release on Swissmedic’s website for information on implementation