ICH Update on GCP related Topics including RWD/RWE

Recommendation

5/6 June 2024

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All relevant GMP/GDP/GACP aspects for Medical Cannabis

Following the recently published Draft ICH E6(R3) Guideline on Good Clinical Practice (GCP) the ICH announced the following progress on several new ICH Efficacy Guidelines: 

• Approval of the Concept Paper for the new ICH E21 Guideline on Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials.
• Adoption of a new ICH topic: General Considerations for Patient Preference Studies – a new ICH Guideline which will provide considerations "for a systematic approach to designing, conducting, analyzing and presenting Patient Preference Studies, when studies are considered important to be conducted to supplement information about the assessment of a product or inform drug development and related decisions".
• Publication of a new ICH Reflection Paper on RWE titled “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 paper presents opportunities for development of new ICH Guidelines and is submitted for public consultation until 30 September 2023. According to the ICH it "outlines a strategic approach for ICH to address some of these challenges. The goal is to further enable the integration of RWE into regulatory submissions and timely regulatory decision-making". In addition, the document includes a useful Annex summarizing existing regulatory initiatives and guidances related to RWD/RWE (e.g. DARWIN EU).

More information is available in the ICH Press Release and on the ICH's Reflection Papers website.