There can often be some confusion between the terms ‘Critical’ and ‘Major’ deficiency. On the 1st May 2013, the TGA helped to answer this question by issuing a list of typical inspection deficiencies and their risk categorisation! This is of immense help to the industry. Critical deficiency A critical deficiency is a deficiency which has…
Recognising the impact of the European Union (EU) reforms from the overhaul of medical device directives (MDD) and in vitro device directives (IVD) to regulations (MDR/IVDR), Australia’s therapeutic goods regulator, the Therapeutic Goods Administration (TGA) have proactively engaged in public consultations to align Australian medical device regulations with the new EU framework. Consultations commenced in…
In June 2011, the Australian and New Zealand Governments announced their agreement to proceed with a joint scheme for regulation of therapeutic products (that is, medicines, medical devices, biological and others) to be administered by the Australia New Zealand Therapeutic Products Agency (ANZTPA). The new Agency will replace the Australian Therapeutic Goods Administration (TGA) and…
The advertising of therapeutic goods to consumers or health professionals is administered via a co-regulatory system which is representative of all key stakeholder groups. These stakeholders include consumers, public health advisors, health care professionals, regulated industry manufacturers, and distributors, as well as the media, advertisers, and Government agencies. Advertisement regulations Advertisements for therapeutic goods are…
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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