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Medicines assessed as having a higher level of risk must be registered. The degree of assessment and regulation they undergo is rigorous and detailed, with sponsors being required to provide comprehensive safety, quality and efficacy data.
- Medicines
Search for medicines allowed to be supplied in Australia,...
- Medicines and TGA Classifications
Australia has a two-tiered system for the regulation of...
- Medicines
Search for medicines allowed to be supplied in Australia, medicine ingredients and safety information.
Australia has a two-tiered system for the regulation of medicines, including complementary medicines: Higher risk medicines must be registered on the Australian Register of Therapeutic Goods (ARTG) , which involves individually evaluating the quality, safety and effectiveness of the product.
In Australia, medical products are regulated by the TGA and, for controlled drugs such as cannabis, by the Office of Drug Control (ODC). Together, the TGA and ODC form the Health Products Regulation Group within the Department of Health and Aged Care.
The TGA assesses therapeutic goods to help ensure they are safe and effective before approving them for use in Australia. The TGA has a risk-based approach, which means higher-risk therapeutic goods undergo more extensive assessment than lower-risk therapeutic goods.
1 Δεκ 2004 · The lawful supply of any therapeutic good in Australia requires that the product is included on the Australian Register of Therapeutic Goods (ARTG). There are two types of entry on the ARTG. Some products are 'registered' and have an AUST R number on their label.
An overview of TGA-approved medications (front-line pharmacotherapy) for the treatment of alcohol dependence.