ICH Topic M4S Common Technical Document Registration Pharmaceuticals Human USE Safety
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-topic-m4s-common-technical-document-registration-pharmaceuticals-human-use-safety
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