Guidelines for Complementary Medicines (ARGCM) The Australian Regulatory Guidelines for listed medicines and registered Complementary Medicines was published in May 2020. It replaced ARGCM V8.0. History of the ARGCM The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) was first published in 2001 to provide information on the supply and use of complementary medicines. The TGA is…
History of TGA & Medsafe ‘Early Warning System’ project discussions One of the projects identified by the TGA and Medsafe when they formed ANZTPA in 2011, was to develop an early warning system to assist in the communication of potential safety issues with therapeutic products. This article provides a historical overview of the efforts of…
What the requirements are and how to cost effectively comply The TGA’s code of GMP recommends that all suppliers be qualified – “The process of assessing the reliability of a supplier to consistently provide material of acceptable quality”. For complementary manufacturers with many, many suppliers, qualifying them all is an onerous and expensive exercise. For…
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