This includes:
- medicines (prescription, over the counter and complementary medicines)
- medical devices
- in vitro diagnostic tests
- vaccines
- biologicals (such as human cell- and tissue-derived products)
- blood and blood products
- other therapeutic goods including sunscreens, sterilants and disinfectants, tampons and menstrual cups.
The TGA does this by administering the Therapeutic Goods Act 1989 (the Act), which applies a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality and safety. When required by the Act, the TGA will also ensure that efficacy or performance standards are acceptable.
The TGA monitors the ongoing risks and benefits of therapeutic goods once they are authorised for use, and is able to take action if the benefits are not realised or additional risks become apparent. Possible regulatory actions vary from minimal intervention, such as changes to labelling, to withdrawing the therapeutic good from the market.
The role of the TGA
Watch this video to learn more about what the TGA do.
Benefits versus risks approach to regulating therapeutic goods
Watch this video to learn how the TGA ensure that the benefit of therapeutic goods outweigh any known risks.
