CCQM-OAWG Task Group on CMCs (CCQM-OAWG-TG-CMC)

Period of activity: start 25 April 2025 to end April 2027

Terms of Reference

This Task Group is being established in response to multiple needs identified by member NMIs/DIs, RMO reviewers and KCWG representatives concerning OAWG CMC submissions and reviews.

Specific activities to be undertaken

• Produce OAWG specific CMC guidance and collate existing guidance into one document
• Review of existing CMC criteria for single and broad scope claim acceptance
• Review of CMC greying-out procedures and expectation
• Production of tools/templates to assist with CMC claim writing and review
• Production of Summary Reports for Key Comparisons finalised in 2024 or later
• Determine the minimum analytical and reporting requirements to determine material purity, especially as it relates to purity assignment as part of a matrix Key Comparison
• Review KCDB Service Categories and propose changes based on applicability to existing and future CMC claims
• Review the use of uncertainty conventions and determine whether uncertainty convention one could be retired
• Propose types and minimum data expected for evidence other than Comparisons that could be used to support CMC claims
• Review the impact of archiving studies currently approved for equivalence on existing CMCs.