Targeted: Enhanced information sharing to support health emergency preparedness and response to supply chain vulnerabilities

Where the Therapeutic Goods Administration (TGA) has a need to share information, it typically does so under s 61 of the Therapeutic Goods Act 1989 (the Act). Section 61 outlines circumstances in which ‘therapeutic goods information’ (a defined term) can be released. Generally, these circumstances are connected to their role in securing positive public health outcomes for Australians.

Under the TGA’s current regulatory framework, s 61 does not explicitly authorise the sharing of information about the manufacturing and supply of approved therapeutic goods with other Australian Government and state and territory agencies to support health emergency preparedness.

The TGA is seeking your feedback on a proposal to make a new legislative instrument under section 61(5AB) of the Act that would enable the TGA to share information that it holds about the manufacture and supply of approved therapeutic goods, including commercially sensitive information, with Australian Government agencies and state and territory counterparts, to support future health emergency preparedness, monitoring and response to supply chain vulnerabilities.