New Approach Methodologies (NAMs) HREC Review Checklist
Bellberry and ASCEPT, the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists, are pleased to release the draft NAMs HREC Review Checklist for consultation.
This Checklist has been developed for Australian Human Research Ethics Committees and is informed by several years of work and sector-wide consultation.
The Checklist is intended for First-In-Human or Phase 1 clinical trial applications involving investigational medicines where NAMs make a material contribute to the nonclinical evidence package. It is intended to support HREC review within the Australian regulatory environment.
This draft will be open for consultation until 31 August 2026, and a full report of the project will be released with the revised Checklist soon after.
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