• Q1A - Q1F Stability

    Code Document Title Previously coded
    • Finalised Guideline:
      November 1996

      Description :

      The tripartite harmonised ICH Guideline was finalised under Step 4 in November 1996. This forms an annex to the main stability Guideline, and gives guidance on the basic testing protocol required to evaluate the light sensitivity and stability of new drugs and products.

      Implementation :

      Step 5

      :

      EC, Europe - Adopted by CPMP, December 1996, issued as CPMP/ICH/279/95

      :

      MHLW/PMDA, Japan - Adopted May 1997, PAB/PCD Notification No. 422

      :

      FDA, United States - Published in the Federal Register, 16 May 1997, Vol. 62, No. 95, p. 27115-27122

      :

      Health Canada, Canada - Implemented 12 February 1999, Catalogue No. H42-2/77-1998E

      :

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