• S5 Reproductive Toxicology

    Code Document Title Previously coded
    • Finalised Guideline:
      November 2000

      Description :

      The core tripartite harmonised ICH Guideline was finalised Step 4 in June 1993. This document provides guidance on tests for reproductive toxicity. It defines the periods of treatment to be used in animals to better reflect human exposure to medical products and allow more specific identification of stages at risk.

      The addendum to the core ICH Guideline above with respect to male fertility studies was finalised  Step 4 in November 1995. The guideline has been amended on November 9, 2000, under the Maintenance Process.

      The amendments provide a better description of the testing concept and recommendations, especially those addressing flexibility, pre-mating treatment duration, and observations.

      Implementation :

      Step 5

      :

      EC, EuropeAdopted by CPMP, September 93, issued as CPMP/ICH/386/95

      :

      MHLW/PMDA, Japan Adopted July 94, PAB/PCD Notification No.470

      :

      FDA, US Published in the Federal Register, Vol. 59, No.183, p. 48746-48752, 22 September 1994

      :

      Health Canada, Canada Implemented 23 December 2002, File #: 02-122028-691

      :

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

      Addendum: Toxicity to Male Fertility (incorporated in S5(R2))

      Implementation :

      Step 5

      :

      EC, EuropeAdopted by CPMP, December 95, issued as CPMP/ICH/136/95

      Amended Guideline : CPMP/ICH136/95 modification

      :

      MHLW/PMDA, Japan Adopted April 97, PAB/PCD Notification No.316

      Amended Guideline : Adopted 27 December 2000, PMSB/ELD Notification No. 1834

      :

      FDA, US Published in the Federal Register, Vol. 61, No. 67, April 5, 1996, p. 15360

      Amended Guideline