Reflection Paper on Patient-Focused Drug Development for Public Consultation

On 7 December 2020 the ICH Published the Reflection Paper on PFDD for Public Consultation by 7 March 2021.

The ICH Reflection Paper on Patient-Focused Drug Development (PFDD) was endorsed by the Assembly in November 2020.

This Reflection Paper 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.

As part of ICH public consultation on this Reflection Paper, stakeholders are invited to provide their comments to their respective Regulatory Authorities or directly to the ICH Secretariat by 7 March 2021 at This email address is being protected from spambots. You need JavaScript enabled to view it..

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