ICH Reflection Papers are intended to articulate ideas for potential future harmonisation work, lay out an area where harmonisation work is needed, or make proposals for a series of future topics for harmonisation.

Upon ICH Assembly endorsement of a Reflection Paper, its objectives are included into the ICH Association Multi-Annual Strategic Plan and the ICH Members work towards the achievement of these objectives accordingly.

  • Advancing Biopharmaceutical Quality Standards

    • Description :

      This Reflection Paper was endorsed by the Assembly in June 2018.

       

      This ICH Reflection Paper outlines a strategic approach to enhance the portfolio of ICH Quality-related guidelines to support continual improvement and innovation in biopharmaceutical manufacturing technologies and approaches. Accordingly, ICH will continue to advance the ICH Quality Vision to “develop a harmonised pharmaceutical quality system applicable across the lifecycle of the product emphasising an integrated approach to quality risk management and science”.

       

      This ICH Reflection Paper furthermore describes, in the annex, the remit of the Informal Quality Dicussion Group (IQDG), which serves as a technical discussion forum for issues relevant to the ICH Quality Vision.

  • GCP Renovation

    • Description :

      This Reflection Paper was endorsed by the Assembly in January 2017.

       

      The ICH Reflection Paper on Good Clinical Practice (GCP) "Renovation" contains the ICH proposal for further modernisation of the ICH Guidelines related to clinical trial design, planning, management, and conduct. The scope of the renovation includes the revision of the current E8 General Considerations for Clinical Trials, and the further revision of the E6 Guideline for Good Clinical Practice, which had last been revised in November 2016 as E6(R2). 

       

      For the E8(R1) Concept Paper and Business Plan, please refer to the E8(R1) page.

       

      The goal of the potential renovation is to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of study types and data sources that are being employed to support regulatory and other health policy decisions, as appropriate. The underlying principles of human subject protection and data quality would remain.