ICH has published a new Reflection Paper: 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
The Reflection Paper (endorsed by the Assembly in June 2023) presents opportunities for development of new ICH Guidelines and is 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.
Stakeholders are invited to provide comments by 30 September 2023 via e-mail at firstname.lastname@example.org using the ICH public consultation comments template.
More information and the template for comments can be found HERE