The Therapeutic Goods Administration (TGA) is conducting a public consultation to provide industry and other interested stakeholders with an opportunity to comment on options for the TGA's proposed fees and charges for the 2022-23 financial year. Specifically, we are seeking feedback on the potential impact/s of the proposed options, prior to seeking approval from the Government for any changes.
The TGA within the Department of Health is responsible for the supply, import, export, manufacturing and advertising of therapeutic goods. The TGA recovers its costs from industry in accordance with Australian Government Charging Framework. The Therapeutic Goods Act 1989 provides the legal authority for the TGA to charge for its regulatory activities. The Therapeutic Goods (Charges) Act 1989 provides the legal authority to levy annual charges on sponsors and manufacturers of medicines, biologicals and medical devices.
Consultation paper is available through consultation hub from Tuesday, 25 January 2022.
Interested parties should respond by close of business Monday, 7 March 2022.
Members of peak industry bodies that the TGA held bilateral meetings with (listed in the consultation paper) are encouraged to present their comments through the respective peak body so that the industry body can present a consolidated industry feedback to the TGA.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.