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www.fdanews.com/articles/179390-tga-to-reform-process-for-drug-advertisement-complaints

TGA to Reform Process for Drug Advertisement Complaints

November 21, 2016

Australia’s Therapeutic Goods Administration is proposing to designate a single authority to receive and manage complaints on drug and device advertisements.

The proposal is intended to make the agency’s advertising requirements consistent for drugs and medical devices by implementing new rules and recommendations that will remove the requirement for certain advertisements to be pre-approved.

Furthermore, the measure would enhance penalties on noncompliant drugmakers, strengthen post-market monitoring and ensure advertising claims are consistent with the approved indications.

Comments on the proposal are due by Dec. 21.