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Australia's TGA consults on proposed overhaul of OTC drug guidelines

This article was originally published in SRA

Executive Summary

Australia's Therapeutic Goods Administration is inviting comments on its proposal to substantially revise its guidance document for over-the-counter medicines1. The revisions are being made to clarify the data requirements for submitting OTC medicine applications to the TGA and to provide guidance on OTC drug market authorisation processes that are also currently being reviewed.

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