EMERGO SUMMARY OF KEY POINTS:

• Australian advertising complaint oversight for medical devices and drugs will be consolidated under the Therapeutic Goods Administration.
• Full TGA oversight will begin in July 2018.
• Additional advertising requirement reforms for medical devices are planned for 2018.

The Australian Therapeutic Goods Administration (TGA) plans to roll out “simplified and improved arrangements” for managing complaints regarding medical device and drug advertising.

Ahead of a planned July 2018 takeover of healthcare product advertising oversight, TGA has issued new information on consolidated management of advertising complaints under a single entity in an effort to reduce compliance headaches and improve public health.

According to TGA, the new advertising complaint management regime will improve upon current processes that involve various regulatory bodies and industry associations, which have created difficulties for all parties involved. Under the new system launching next year, parties will be able to utilize a single online portal to lodge complaints against medical device or drug advertising directly to TGA. Complaint resolutions and outcomes will also be communicated to stakeholders with more transparency and efficiency.

The new TGA oversight system will also undergo external review in 2021 following three years of operation to evaluate whether intended benefits for consumers, advertisers and other stakeholders are being realized.

Additional medical device advertising reforms planned

The TGA’s simplified complaint handling process is part of a broader effort to improve Australian regulatory oversight of medical device and drug advertising.

Additional reforms planned for 2018 include improving consistency of advertising rules and requirements to make compliance more straightforward; establishing a formal advertising compliance education program for advertisers; and broadening enforcement and compliance powers to deter noncompliant advertising of health products.

Related resources and support for the Australian market:

• Australian TGA medical device registration support
• Australian medical device vigilance reporting support
• Australian TGA regulatory process chart
• Video overview: Australian medical device registration and approval