TGA has decided to reform their medical device classification due to safety issues identified and to further harmonize to the European Union.
During the duration of the COVID-19 pandemic, the TGA will only use remote and hybrid inspections to minimize potential impacts of on-site inspection of GMP clearance.
Non-sterile face masks are regulated as medical devices under the Therapeutic Goods Act of 1989. Importation, distribution or exportation of any goods are required to be included in the ARTG (Australian Register of Therapeutic Goods).
In Australia, cosmetics that contain sunscreens (UV filters) are regulated by the Health Authority Therapeutic Goods Administration (TGA). The cosmetic can only be approved for market if it meets the legal definition of either ‘therapeutic’ or ‘cosmetic’.
Therapeutic Goods Administration (TGA) publishes the Good Manufacturing Practices (GMP) approach for oversees manufacturers to assist manufacturers who may undergo remote inspection.
For the fiscal year 2020-2021, TGA (Therapeutic Goods Administration) announces an updated fee schedule which comes in effects from July1, 2020.
Therapeutic Goods Administration (TGA) oversees advertisement of goods in Australia and has set forth the requirements of advertising
As of 1 July 2020, medicine advertisements in specified media will no longer need pre-approval from Australia’s (TGA)
TGA released new guidelines on fecal microbiota transplant (FMT) products which states how FMT products would be classified and regulated.