Therapeutic goods regulation
The regulatory framework reflects and upholds the Australian community’s expectations around the safety and quality of therapeutic goods on the market.
- Counterfeit semaglutide vialsThe TGA has detected fake semaglutide, also known as Ozempic, being illegally imported into Australia.
- Lifeblood sexual activity and PrEP deferralsThe TGA has approved applications submitted by Australian Red Cross Lifeblood (Lifeblood) to remove most of the sexual activity ineligibility criteria for plasma donors used for fractionated products only. Lifeblood refers to this approach as ‘the plasma pathway’.
- Phase out of ISO 13485 certificates for IVD medical devicesTransition period for accepting ISO 13485 ends 26 May 2023.
- Queensland individual fined nearly $16,000 after allegedly importing unregistered nicotine vaping productsIt is alleged that the individual attempted to import six different types of nicotine vaping products (prescription medicines). The unapproved nicotine vaping products were intercepted by the Australian Border Force and have been seized and will be destroyed under advice from the TGA.
- Public notice of interim decisions on proposed amendments to the Poisons Standard - ACMS#40, ACCS#35, Joint ACMS-ACCS#32 - November 2022Interim decisions and invitation for further comment. Closing date: 3 March 2023
- Pharmacovigilance Inspection Program metrics report: Jan - Dec 2021The TGA Pharmacovigilance Inspection Program (PVIP) metrics report for 2021 is now available.
- Notice of interim decisions on proposed amendments to the Poisons Standard – ACMS #38, ACCS #34, Joint ACMS-ACCS #31 – June 2022Interim decisions and invitation for further comment. Closing date: 24 November 2022
- Consultation: Clarification and updates to the regulation of sunscreensThe TGA is seeking feedback on proposed clarification and updates to the regulation of sunscreens. Closing date: 31 May 2023