Swissmedic launches the Public Consultation on a Reflection Paper on Real-World Evidence Terminology (RWE) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), with a deadline of 30 September 2023 for comments.
International Harmonisation of Real-World Evidence Terminology and Convergence of General Principles Regarding Planning and Reporting of Studies Using Real-World Data, with a Focus on Effectiveness of Medicines
07.07.2023
Stakeholders in Switzerland have until September 30th, 2023 to comment on the ICH Reflection Paper on “International Harmonisation of Real-World Evidence Terminology and Convergence of General Principles Regarding Planning and Reporting of Studies Using Real-World Data, with a Focus on Effectiveness of Medicines”.
This Reflection Paper was endorsed by the ICH 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 can be provided using the feedback form specified by ICH to networking@swissmedic.ch or to rwecomments@ich.org. Stakeholders will receive confirmation of receipt of their comments but no feedback on the individual comments. Comments received will be considered for inclusion in a finalised Reflection Paper which is anticipated for adoption in June 2024.
Links to the reflection paper and feedback form can be found on the following page:
www.ich.org