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    Australian Regulatory Framework of Over-the-Counter and Complementary Medicine

    This article discusses Australia’s regulatory framework for Over-the-Counter (OTC) and complementary medicines as defined by the Medicines and Medical Devices Regulation (MMDR) and provides medicine-related classifications, types of postapproval changes, labeling, stability and advertising requirements. The author recommends measures for reinforcing regulatory compliance of complementary medicines. Introduction OTC and Complementary Medicine Australia has been acknowle...
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    The Drug Regulatory Landscape in the ASEAN Region

    By Abhishek Tongia This article provides an overview of critical regulatory requirements to be considered for Association of Southeast Asian Nations (ASEAN) pharmaceutical markets and covers certificates of pharmaceutical products, regulatory submissions, pharmacopoeia, halal compliance, stability requirements, pharmacovigilance, product labeling, and drug variation information. Introduction The Association of Southeast Asian Nations (ASEAN) has diverse regulatory re...