• Q8 Pharmaceutical Development

    Code Document Title Previously coded
    • Finalised Guideline:
      August 2009

      Description :

      The core tripartite harmonised ICH Guideline was finalised under Step 4 in November 2005. 
      This Guideline is intended to provide guidance on the contents of Section 3.2.P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH topic M4). The guideline does not apply to contents of submissions for drug products during the clinical research stages of drug development. However the principles in this guideline are important to consider during these stages. This guideline might also be appropriate for other types of products. To determine the applicability of this guideline for a particular type of product, applicants should consult with the appropriate regulatory authorities.

      The annex to the tripartite harmonised ICH text was finalised under Step 4 in November 2008 and incorporated into the core Guideline, which was then renamed Q8(R1).

      The annex provides further clarification of key concepts outlined in the core Guideline. In addition, this annex describes the principles of quality by design (QbD). The annex is not intended to establish new standards: however, it shows how concepts and tools (e.g., design space) outlined in the parent Q8 document could be put into practice by the applicant for all dosage forms. Where a company chooses to apply quality by design and quality risk management (Q9: Quality Risk Management), linked to an appropriate pharmaceutical quality system, then opportunities arise to enhance science- and risk-based regulatory approaches (see Q10: Pharmaceutical Quality System).

      The Q8(R1) Guideline was revised in Summer 2009 to reflect minor corrections to Example 2 on page 23 (Q8(R2)).

      Implementation :

      Step 5


      EC, EuropeAdopted by CHMP, June 2009, issued as CHMP/ICH/167068/04


      MHLW/PMDA, Japan Adopted 28 June 2010, PFSB/ELD Notification No. 0628-1


      FDA, United States Published in the Federal Register, November 2009, Vol. 71, No. 98


      Health Canada, Canada Implemented 11 February 2016 File #: 16-101390-659


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