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.

  • Harmonisation of technical scientific requirements for pharmacoepidemiological studies

    • Description :

      This ICH Reflection Paper was endorsed by the Assembly in June 2019.

       

      This Paper proposes a strategic approach to international harmonization of technical scientific requirements for pharmacoepidemiological study data submitted to regulatory agencies. In recent years, the sophistication of pharmacoepidemiological studies conducted in various countries worldwide has advanced dramatically alongside more active use of Real-World Data. Many regulatory agencies and industries are now conducting epidemiological safety assessments based on data gathered during the post-marketing stage. The goal is to harmonise the technical scientific requirements related to pharmacoepidemiological studies submitted to regulatory agencies. Harmonisation in this area facilitates utilization of Real-World Data and promote a globally-harmonised approach in post-marketing safety-related regulatory actions based on the most current scientific evidence.

       

      This Paper furthermore describes the remit of the Pharmacoepidemiology Discussion Group (PEpiDG), which will serve for a two-year period to support the advancement of harmonisation of scientific and technical requirements related to pharmacoepidemiological studies.

  • Harmonisation of Standards for Generic Drugs

    • Description :

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

       

      Harmonization of technical and scientific standards for generic drugs presents an opportunity for significant public health benefits by streamlining drug development across regulatory jurisdictions and increasing patient access globally to high quality affordable pharmaceuticals. This ICH Reflection Paper outlines a strategic approach for developing and enhancing ICH Guidelines to support the harmonization of scientific and technical standards for generic drugs. As part of this approach, this paper outlines recommendations to develop a series of ICH Guidelines on standards for demonstrating equivalence (e.g., bioequivalence) for (1) non-complex dosage forms and (2) more complex dosage forms and products.

       

      This ICH Reflection Paper furthermore describes, in the annex, the remit of the Informal Generic drug Discussion Group (IGDG), which will serve for issues relevant to harmonisation of scientific and technical standards for generic drugs.

    • Rapporteur :

      Dr. Nilufer Tampal (FDA, United States)

      Regulatory Chair :

      Dr. Jan Welink (EC, Europe)

      Description :

       

      The Informal Generic drug Discussion Group (IGDG) is to be established in 2019 following endorsement of the ICH Reflection Paper on Further Opportunities for Harmonization of Standards for Generic Drugs.

       

      The IGDG will serve as a technical discussion group for issues relevant to harmonisation of scientific and technical standards for generic drugs. The IGDG will recommend areas for harmonisation under ICH and assess feasibility of harmonisation of various topic areas within existing regional regulatory frameworks.

       

      More information can be found in the remit document for the IGDG available for download.

  • 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.

    • Rapporteur :

      Mr. Roger Nosal (PhRMA)

      Regulatory Chair :

      Ms. Nanna Abby Kruse (EC, Europe)

      Description :

      The Informal Quality Discussion Group (IQDG) was established in February 2019 following endorsement of the ICH Reflection Paper on Advancing Biopharmaceutical Quality Standards to Support Continual Improvement and Innovation in Manufacturing Technologies and Approaches.

       

      The IQDG serves as a technical discussion forum for issues relevant to the ICH Quality Vision to develop a harmonised pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science, as described in this ICH Quality Reflection Paper.

       

      Activities of the IQDG include reviewing the need for new ICH Quality-related harmonization work, reviewing and recommending training needs related to the content and/or implementation of ICH Quality Guidelines, reviewing and recommending any necessary updates to the ICH Quality Reflection Paper and ICH Quality Vision statement as needed.

       

      More information can be found in the remit document for the IQDG available for download.

  • 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.

    • Description :

       

      Summary:

       

      ICH is announcing a public meeting entitled “ICH Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials.” The purpose of the public meeting is to provide information and solicit input from a broad range of non-ICH Member/Observer stakeholders on the draft revised E8(R1) Guideline “General Considerations for Clinical Trials.”

      In January 2017, the ICH Assembly endorsed the ICH Reflection Paper on Good Clinical Practice (GCP) Renovation: Modernisation of ICH E8 Subsequent Renovation of ICH E6, further to which ICH initiated a revision of the E8 Guideline to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources being employed to support regulatory and other health policy decisions, while retaining the underlying principles of human subject protection and data quality.

      The first version of ICH E8 Guideline was adopted in 1997 and sets out general principles on the conduct of clinical trials. Since its finalisation, clinical trial design and conduct have become more complex, impacting the time and cost required to develop drugs. An increasingly wider range of both trial designs and data sources play a role in drug development and are not adequately addressed in the original E8 Guideline.

      In May 2019, the E8(R1) draft Guideline was released for public consultation, and as part of the consultation process, and in line with the ICH Reflection Paper on GCP Renovation, ICH will hold public meetings before the finalization of the revised E8 Guideline. This will allow important concerns expressed by stakeholder groups, not represented in ICH, to be further discussed and feed into the essential modernization of these foundational guidelines.

       

      Date:

      October 31, 2019  

      Time:

      08:30 a.m. to 5:00 p.m. ET 

      Location:

      10903 New Hampshire Ave. Bldg 31 Conference Center, Rm. 1503 (Great Room) Silver Spring, MD 20993, USA Or Webcast (A website to access the webcast will be emailed to those who register for the meeting as a remote attendee)

       

      Agenda:

      For the agenda, please click here

      Registration:

      If you wish to attend the public meeting either in-person or via webcast, please register at the following website: https://ichglobalmeeting_e8r1_2019.eventbrite.com

      Please note that you may also find additional information regarding the event on this webpage.