• Q4 - Q4B Pharmacopoeias

    Code Document Title Previously coded
    • Finalised Annex:
      June 2012

      Description :

      The tripartite harmonised ICH annex was finalised under Step 4 in June 2012.

      This annex is the result of the Q4B process for Bulk Density and Tapped Density of Powders General Chapter.

      It contains the Interchangeability Statement from Health Canada.

      Implementation :

      Step 5

      EU :

      Adopted by CHMP, July 2012, issued as EMA/CHMP/ICH/405290/2010

      MHLW :

      Adopted 8 November 2012, PFSB/ELD Notification No. 1108-3

      FDA :

      Published in the Federal Register, 28 May 2013, Vol. 75, No. 102, p. 31944-5

      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.