ICH - Reflection Paper on Harmonisation of RWE Terminology available for public consultation

5th July 2023

This Reflection Paper was endorsed by the Assembly in June 2023.

The Reflection Paper presents opportunities for development of new ICH Guidelines and is herewith submitted for public consultation recognising the value of broader input on this topic. Comments received will be considered for inclusion in a finalised Reflection Paper which is anticipated for adoption in June 2024.

Public Consultation Process

Stakeholders are invited to provide comments on this Reflection Paper by 30 September 2023 via e-mail at rwecomments@ich.org. For this purpose please make sure to use the ICH public consultation comments template in excel format available below.

Please note that comments provided will be shared with ICH representatives concerned with the development and approval of this Reflection Paper.

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