• S9 Nonclinical Evaluation for Anticancer Pharmaceuticals

    Code Document Title Previously coded
    • Finalised Guideline:
      October 2009

      Description :

      The tripartite harmonised ICH Guideline reached Step 4 of the ICH process on 29 October 2009.
      This Guideline provides information for pharmaceuticals that are only intended to treat cancer in patients with late stage or advanced disease regardless of the route of administration, including both small molecule and biotechnology-derived pharmaceuticals. It describes the type and timing of nonclinical studies in relation to the development of anticancer pharmaceuticals and references other guidance as appropriate.

      Implementation :

      Step 5

      :

      EC, EuropeAdopted by CHMP, November 2009, issued as CHMP/ICH/646107/2008

      :

      MHLW/PMDA, Japan Adopted June 2010, PFSB/ELD Notification No. 0604-1

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      FDA, United States Published in the Federal Register, 8 March 2010, Vol. 75, No. 44, Docket No. FDA/2009/D/0006, p. 10487

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      Health Canada, Canada Implemented 22 January 2016, File #: 15-114066-970

      :

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