Implementation of some key changes announced as part of the review of medicines and medical devices regulation will likely be delayed.
The TGA Amendment Bill (No.1) did not navigate the parliamentary approval process during the last sitting week. As a result, implementation of improvements to the variations process and priority review designations will likely be delayed.
BiotechDispatch understands the Bill is now expected to secure parliamentary support in mid-June. However, royal assent and adoption of the relevant regulations is considered unlikely by the planned 1 July implementation date.
Most are now planning for implementation on 1 September or even early 2018.
According to TGA head John Skerritt, who yesterday spoke at the AusMedtech 2017 conference in Melbourne, the timing of implementation is ultimately a matter of parliament.
A separate Bill, the TGA Amendment Bill (No 2), is expected to be considered by parliament during the Spring sitting.
The Bill is more complex, involving the introduction of new arrangements covering advertising and provisional approvals.