
Food and medicine regulation - Therapeutic Goods Administration (TGA)
Products that are classed as therapeutic goods (this includes medicines) are regulated by the TGA at a federal level while foods (including many that make health claims) are predominantly regulated by state and territory food regulatory bodies.
Food-Medicine Interface Guidance Tool (FMIGT)
Use this tool to determine if your product is a food or medicine.
Therapeutic Goods Administration (TGA) | Australian Government ...
We are Australia's government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods. We regulate medicines, medical devices and biologicals to help Australians stay healthy and safe.
关于澳大利亚【TGA】认证 - 知乎 - 知乎专栏
TGA是 Therapeutic Goods Administration 的英文缩写;它隶属于澳大利亚政府,是澳大利亚治疗商品(包括药物、医疗器械、基因科技和血液制品)的监督机构,以保证澳大利亚社会的治疗水准保持较高的水平。 在澳大利亚,所有药品制造商必须经过TGA许可,及通过药品生产规范GMP认证,才可以生产制造。 所有药物、医疗器械等产品入市前,需在TGA登记注册,进行入市前评估检测。 没经过TGA认证备案的产品,无法在市场上流通,一旦发现,澳大利亚政府除了销毁违 …
TGA updates list of permissible ingredients in Therapeutic Goods — Food …
2025年3月12日 · Therapeutic Goods Administration (TGA) of Australia has issued the "Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2024", replacing the "Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2023". Major changes involve the addition of 3 new ingredients and the revision of requirements for 37 ingredients.
Complementary Medicines or ‘Dietary Supplements’ - Engel …
Regulated in Australia as medicines by the Australian Therapeutic Goods Administration (TGA), complementary medicines include vitamins, mineral and nutritional supplements, homeopathic, aromatherapy products and herbal medicines.
Distinguishing between Food and Medicine in Australia - Freyr …
2021年4月1日 · The TGA manages medicine complaints, while local food enforcement agencies handle food complaints; Medicines must be manufactured according to Good Manufacturing Practice, while food is produced according to food safety standards in Australia; Medicines must meet scientific evidence requirements proportionate to their health claims
Searching the Australian Register of Therapeutic Goods (ARTG)
2022年6月21日 · The publicly accessible version of the Australian Register of Therapeutic Goods (ARTG) is the reference database of the Therapeutic Goods Administration (TGA) and provides information on therapeutic goods that can be supplied in Australia. Unless exempt, therapeutic goods not entered on the ARTG cannot be supplied in Australia.
A comparison of regulatory approval of clinical trial protocol with ...
2021年7月22日 · Present study, we studied the regulatory requirements, timelines of approval and guidelines according to central drug standard control organization (CDSCO), therapeutic goods administration (TGA), food and drug administration (FDA) and European medical agency (EMA).
How can I register goods with the TGA? - Food and Drugs Law - Mondaq
2022年10月25日 · The Therapeutic Goods Administration (TGA) heavily regulates the production of medicines and medical devices, and even some cosmetic products in Australia. If you want to sell or supply therapeutic goods in Australia, you will generally need to …
- 某些结果已被删除