• Q5A - Q5E Quality of Biotechnological Products

    Code Document Title Previously coded
    • Finalised Guideline:
      November 1995

      Description :

      The tripartite harmonised ICH Guideline was finalised under Step 4 in November 1995. This document augments the stability Guideline (Q1A above) and deals with the particular aspects of stability test procedures needed to take account of the special characteristics of products in which the active components are typically proteins and/or polypeptides.

      Implementation :

      Step 5

      :

      EC, EuropeAdopted by CPMP, December 1995, issued as CPMP/ICH/138/95

      :

      MHLW/PMDA, Japan Adopted January 1998, PMSB/ELD Notification No. 6

      :

      FDA, United States Published in the Federal Register, 10 July 1996, Vol. 61, p. 36466

      :

      Health Canada, Canada Implemented 5 January 2001, Catalogue No. H42-2/67-20-2000E

      :

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