Australia’s Therapeutic Goods Administration will impose heavier sanctions for violations of its regulations on device advertising, but the agency also will phase out its requirement that certain advertisements be pre-approved in favor of a more self-regulated rule.
The current pre-approval system will remain in place through July 2020, with the TGA using the next two years as a transition period to ensure advertisers have access to the information they need for compliance.
The TGA’s rule requiring advertisers to secure prior approval before referencing serious diseases will remain in place even after the pre-approval requirement is phased out.
The TGA also will amend its Therapeutic Goods Advertising Code to help advertisers understand the requirements, impose more objective assessments for what constitutes a breach, and address inconsistences between rules for medicines and rules for medical devices.
As of July 2018, the TGA will become the sole body responsible for handling complaints about advertising of medical devices. It is currently developing a web form for lodging complaints.
Read the TGA’s announcement here: www.fdanews.com/03-13-18-TGA.pdf. — Zack Budryk