• Clinical Safety E1 - E2F

    Code Document Title Previously coded
    • E2EPharmacovigilance Planning

      Finalised Guideline:
      November 2004

      E2E
      Concept Paper
      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

      EU:

      Adopted by CHMP, 1 December 2004, issued as CPMP/ICH/5716/03. Coming into operation in June 2005

      MHLW:

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

      FDA:

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