ICH Reflection Papers are intended to articulate ideas for potential future harmonisation work, lay out an area where harmonisation work is needed and make proposals for a series of future topics for harmonisation.
Upon ICH Assembly endorsement of a Reflection Paper, its objectives are agreed upon and the ICH Members work towards the achievement of these objectives accordingly.
Discussion Groups
ICH Discussion Groups (DGs) serve as a technical forum for exchange of scientific views around areas for potential future harmonisation under ICH. The need for a DG is typically identified through a Reflection Paper.
The Model-Informed Drug Development (MIDD) Discussion Group was established in January 2021 and has provided as an output considerations with respect to future MIDD related guidelines in the form of a “roadmap”.
The ICH Reflection Paper on Patient-Focused Drug Development (PFDD) identifies key areas where incorporation of the patient’s perspective could improve the quality, relevance, safety and efficiency of drug development and inform regulatory decision making. It also presents opportunities for development of new ICH guidelines to provide a globally harmonized approach to inclusion of the patient’s perspective in a way that is methodologically sound and sustainable for both regulated industry and regulatory authorities.
The Reflection Paper was endorsed by the Assembly in November 2020 and was published on the ICH and other ICH Regulators’ websites for public consultation up to March 2021. As a result of this public consultation, the Reflection Paper was revised and endorsed by the Assembly in June 2021, and can be downloaded below.
Additionally, the "Outcome of Public Consultation" document, available for download below, presents a high-level overview of the comments received with indications on how these will influence the next steps in this ICH strategic priority area.
Reflection Paper on Patient-Focused Drug Development (PFDD)
Outcome of Public Consultation on Reflection Paper on Patient-Focused Drug Development (PFDD)
The Model-Informed Drug Development (MIDD) Discussion Group was established in January 2021 and has provided as an output considerations with respect to future MIDD related guidelines in the form of a “roadmap”.
The Model-Informed Drug Development (MIDD) Discussion Group was established in January 2021 and has provided as an output considerations with respect to future MIDD related guidelines in the form of a “roadmap”.
The Model-Informed Drug Development (MIDD) Discussion Group was established in January 2021 and has provided as an output considerations with respect to future MIDD related guidelines in the form of a “roadmap”.
The Model-Informed Drug Development (MIDD) Discussion Group was established in January 2021 and has provided as an output considerations with respect to future MIDD related guidelines in the form of a “roadmap”.
The Model-Informed Drug Development (MIDD) Discussion Group was established in January 2021 and has provided as an output considerations with respect to future MIDD related guidelines in the form of a “roadmap”.
The Model-Informed Drug Development (MIDD) Discussion Group was established in January 2021 and has provided as an output considerations with respect to future MIDD related guidelines in the form of a “roadmap”.
The Model-Informed Drug Development (MIDD) Discussion Group was established in January 2021 and has provided as an output considerations with respect to future MIDD related guidelines in the form of a “roadmap”.