Overview of comments received on 'ICH reflection paper on proposed ICH guideline work to advance patient focused drug development’

Stakeholder no.

Section No.

Comment and rationale

Proposed change / recommendation

EFPIA appreciate and support ICH’s commitment to advancing a Reflection Paper that identifies key areas of incorporation of the patient perspective to improve the quality, relevance, safety and efficacy of drug development and inform regulatory decision-making in a globally harmonized approach that is methodologically sound, sustainable for the regulated industry and regulatory authorities, and spans the full lifecycle of drug development. Moreover EFPIA support the ICH Reflection Paper’s proposed plan to enable broader stakeholder participation by applying lessons learned and best practices from the ICH E6(R3) public consultation so that stakeholders beyond ICH participants can contribute. We also support the ICH proposal to progress the development of a harmonized acceptable approach for how to assess applicability of results across regions and/or cultures, similar to how the ICH E5 Ethnic Factors in the Acceptability of Foreign Clinical Data addressed extrinsic factors (e.g., cultural and environmental). Finally, we are encouraged to see that ICH plans to leverage existing regulatory guidances, a number of ongoing collaborative efforts, and a large body of existing literature that would support the efficient development of these proposed PFDD guidelines. EFPIA have the following general issues: • Patients’ involvement: Patients’ insights should be collected throughout the drug development process, however the Reflection Paper focuses primarily on clinical

9

Overview of comments received on 'ICH reflection paper on proposed ICH guideline work to advance patient focused drug development’ (EMA/CHMP/ICH/415588/2020) EMA/194133/2021

Page 9/60