• Q4 - Q4B Pharmacopoeias

    Code Document Title Previously coded
    • Finalised Annex:
      November 2010

      Description :

      The tripartite harmonised ICH annex was finalised under Step 4 in October 2009.
      This annex is the result of the Q4B process for Dissolution Test General Chapter.

      This annex was revised -R1- to include the Interchangeability Statement from Health Canada on 27 September 2010.

      This annex was revised -R2- under Step 4 without further public consultation on 11 November 2010.

      Implementation :

      Step 5

      EU :

      Adopted by CHMP, December 2010, issued as EMA/CHMP/ICH/645469/2008

      MHLW :

      Adopted 26 July 2011, PFSB/ELD Notification No. 0726-1

      FDA :

      Published in the Federal Register, 24 June 2011, Vol. 76, No. 122, p. 37129-31

      Frequently Asked Questions

      Finalised Document:
      April 2012

      Description :

      The Q4B Expert Working Group (EWG) developed a set of Frequently Asked Questions (FAQs) to help users of the Q4B Guideline and Annexes to understand the use and implication of these documents.