WebbThe 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. WebbThe TGA regulates therapeutic goods to ensure they are of high quality, safe to use and work as intended. The TGA administers the Therapeutic Goods Act 1989 (the Act) which sets out requirements and obligations for the supply , import, export, manufacture and advertising of therapeutic goods.
Australian Register of Therapeutic Goods (ARTG)
WebbThe TGA regulates therapeutic goods through: pre-market assessment, post-market monitoring and enforcement of standards, licensing of Australian manufacturers and verifying overseas manufacturers' compliance with the same standards as their Australian counterparts. TGA regulatory framework The TGA takes a risk-based approach to … WebbThe TGA issues permits for the export of human substances specified in schedule 6 of Regulation 8 of the Customs (Prohibited Exports) Regulations 1958. 'Human substances' refers to goods of human origin that may be regulated as biologicals or medicines and which are: human body fluids, organs and other tissues OR substances derived from … cytochrome c isoelectric point
Therapeutic Goods Administration (TGA) Australian Government ...
Webb20 mars 2024 · The TGA has various international agreements and arrangements with other countries and regulatory authorities. Some of these allow us to rely on each other’s Good Manufacturing Practice (GMP) inspection programs. WebbThe European Medicines Agency and the European Commission have had confidentiality arrangements with the Therapeutic Goods Administration (TGA) of the Australian … WebbThe Therapeutic Goods Administration (TGA) compliance and enforcement plan sets out our intelligence-informed, risk-based approach to compliance and enforcement activity. The TGA is seeking public comment on potential reforms to the regulation of nicotine vaping products (NVPs) in Australia. bing ai conversation style