Australia’s Therapeutic Good Advertising Code is due for a revamp. Current reforms promise a more streamlined approach, more direct TGA control, and tougher penalties for those who get it wrong. But current reforms promise a more streamlined approach, more direct TGA control, and tougher penalties for those who get it wrong. We look at the announced and proposed changes and what this all means for consumers and the industry.
On October 3, the TGA announced a revision to the URPTG, which is accompanied by a 3 month “familiarisation period” before taking effect on 15th January 2018. We take a look at the new expectations TGA has of manufacturers and sponsors. What would you do – are you prepared for a recall?
The annual TGA Sponsor Information day provides a focused full day program on Australian regulatory requirements. here from TGA officials and leading industry experts on how it all works. Still time to register….
Sponsors of AIMD, Class III, IIb implants and Class 4 IVDs are required to submit annual postmarket reports to TGA for 3 years after first registration. Failure to do so is an offense and risks cancellation of the registration. The deadline for this year’s reports is drawing close.
In mid-July, TGA updated the Standard Conditions of ARTG registration and hard wire them into the regulations. They are no longer needed to be included on each certificate and will be much more consistently applied – and policed. Standard conditions matter. This may seem like boring regulatory small print, but standard conditions set up real world obligations which if not met provide straightforward grounds for regulatory action. At a minimum, breach of any of these conditions constitutes grounds for cancellation of a product registration. In serious cases criminal or civil penalties may apply.
This week Australia’s TGA issued letters to multiple sponsors calling in technical data on custom surgical implants. The agency is taking a closer look at the evidence held by manufacturers for safety and performance of custom devices. This will inform TGA’s planned reforms for regulation of advanced manufactured devices. In the short term, those without adequate data may be in for an uncomfortable time.