The TGA does this by administering the Therapeutic Goods Act 1989, 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.
We are able to assist in determining whether a product or chemical requires registration. Alternatively it may be possible to modify the product claims or ingredients to overcome the need for registration.