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TGA Unveils Online Complaint System for Drug Advertising

Posted 02 July 2018 | By Ana Mulero 

TGA Unveils Online Complaint System for Drug Advertising

Australia’s Therapeutic Goods Administration (TGA) has released an online hub for the advertising of drugs and medical devices, with a new decision support tool and timeframes for handling complaints.

The online resources were released following TGA’s takeover of the advertising complaint handling system in its entirety as of 1 July 2018. The overhaul of the previous system will “improve compliance with the therapeutic goods advertising legislation,” the regulatory authority said last July.

The Therapeutic Goods Advertising Code 2018 was created on 29 June 2018 as part of the overhaul.

Pre-approvals for advertisements of medicines will continue to be required until 1 July 2020. The date on a pre-approval will determine the code that will be used for the assessment of an application, TGA said. The regulator intends to issue advice for advertisers to further clarify the impact of the transition from the 2015 code after this is repealed and the new code takes effect on 1 January 2019.

The regulator’s new decision tree was designed to aid advertisers in determining whether a product can be advertised to the public in Australia, beginning with a search of the Australian Register of Therapeutic Goods (ARTG).

TGA also committed to handling complaints within set timeframes based on the associated level of priority, with those that are critical to be completed in 10 days vs. 14 days for lower priority complaints.

Other resources offered through the new hub include an e-learning module on the basics of the advertising regulation and TGA guidance for advertisers.

In February, TGA received mixed reactions to the consultation on the planned changes. Medicines Australia expressed concerns over campaign disruptions and reduced transparency, while Johnson & Johnson and Sanofi welcomed the move to minimize subjectivity with the new advertising code.

TGA

Categories: Regulatory News

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