Australia TGA Publishes Information on Regulation Essentials

The Therapeutic Goods Administration (TGA) Australia has published a general overview of the regulatory process, along with information about relevant resources. 

The TGA is involved with the regulation of therapeutic goods in Australia and there are interactive decision tools available on their website to help determine if a particular product is considered a therapeutic good. Veterinary medicines, food, health insurance, cosmetics, chemicals, healthcare professionals and clinical practice do not fall under the umbrella of the TGA’s responsibilities. 

As for therapeutic goods, medicines, biologicals, medical devices, and other therapeutic goods fall under this section.  

For manufacturers and manufacturing sites (involved in the manufacture of medicines, biologicals, or other therapeutic goods) that are located overseas, GMP certification or GMP clearance is required.  

More details can be found in “Regulation essentials, February 2022”: https://www.tga.gov.au/sme-assist/basics-therapeutic-goods-regulation  

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