Australian OTC guidelines
This article was originally published in The Tan Sheet
Australia's Therapeutic Goods Administration releases revised 1guidelines for submitting safety, efficacy data for registration of OTC products and ingredients Nov. 28. Guidelines cover submission of clinical and bibliographic data, generic equivalents, "new" substances and ingredients that have been well-documented in countries with similar regulatory systems. Australian Self-Medication Industry has been involved with revision and is working with Office of Complementary Medicines to help develop a draft of Guidelines for Complementary Medicines by year end...
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