What does it mean if something is TGA approved?
The ‘TGA assessed’ claim (symbol and/or statement) shows that the Therapeutic Goods Administration (TGA) has assessed the medicine’s indications (conditions the medicine says it will treat) and found they are supported by scientific evidence. This is also called an ‘efficacy’ assessment.
Does Australia have a TGA?
The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health , and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.
Can you sue the TGA?
Effectively, regardless of how negligent the TGA is in carrying out its job as the regulator, it cannot be sued by anyone who is harmed by its actions, unless the harmed party can show that the TGA was acting in bad faith.
Who is the government body responsible for coordinating a recall action?
The NSW Food Authority coordinates food recalls within NSW.
Is the TGA trustworthy?
After considering the current regulatory framework for therapeutic goods, the Panel found that the TGA has a strong reputation as a regulator both domestically and internationally, and benchmarks well against comparable overseas regulators.
Who funds TGA Australia?
DFAT
The testing is fully funded by DFAT. There are 11 countries participating: Federated States of Micronesia, Fiji, Kiribati, Nauru, Palau, Papua New Guinea, Samoa, Solomon Islands, Tonga, Tuvalu and Vanuatu. Details of our international activities are outlined in the following table.
Who owns TGA Australia?
The TGA is a part of the Australian Government Department of Health, and is responsible for regulating the import, supply, manufacture, export and advertising of therapeutic goods. This includes: medicines (prescription, over the counter and complementary medicines) medical devices.
Why do we need TGA?
Many of us use medicines or medical devices in our daily lives. The TGA is responsible for regulating the supply, import, export, manufacturing and advertising of therapeutic goods.
Are product recalls mandated by the government?
Who recalls a product: Recalls are generally voluntary and performed by the manufacturer or distributor. The business may initiate it or it may be requested by the FDA. The FDA has the authority to issue mandatory recalls for the following products: Certain medical devices.
Who is responsible for food recalls in Australia?
The NSW Food Authority
Retailers must remove recalled food from sale. Food Standards Australia New Zealand (FSANZ) coordinates all food recalls on a national level. The NSW Food Authority is responsible for monitoring food recalls. and liaising with manufacturers, wholesalers and importers in NSW.
Why is TGA important?
The TGA is responsible for regulating therapeutic goods including medicines, medical devices, blood and blood products. What are ‘therapeutic goods’? Many of us use medicines or medical devices in our daily lives.
Who is head of the TGA?
John Skerritt
Therapeutic Goods Administration
| Agency overview | |
|---|---|
| Annual budget | A$170 million (2020–21) |
| Agency executive | John Skerritt, Deputy Secretary, Health Products Regulation Group |
| Parent department | Department of Health |
| Website | tga.gov.au |