ICH M4E R2 Common Technical Document Registration Pharmaceuticals Human USE Efficacy
TGA (CWLTH) resource. Rules Mate indexes this as part of the Australian compliance corpus. Click through for the regulator's primary source.
https://www.tga.gov.au/resources/resources/international-scientific-guidelines-adopted-australia/ich-m4e-r2-common-technical-document-registration-pharmaceuticals-human-use-efficacy
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