The end of the requirement for formal pre-approval of therapeutic goods advertisements in June 2020 was the result of a long sought after approach by CMA and our industry members, as part of the review of Medicines and Medical Devices Regulations (MMDR), to reduce unnecessary red-tape and create an increased self-regulatory approach to advertising.

The TGA expect compliance with advertising legislation including the Therapeutic Goods Advertising Code (as updated from time to time), but do not require that a third party service provider assess advertisements for compliance. However, since the abolition of the therapeutic goods advertising pre-approval requirements, some advertisers (such as retailers and third party websites) choose to request that other advertisers (such as medicine sponsors) use a third party review to help ensure the compliance of proposed advertisements across shared advertising platforms.

In these situations, please be aware that the TGA does not mandate, require, nor endorse any particular review service, consultants or vetting services. The TGA have stated that they undertake their role with impartiality, and recognise that the best outcome for advertising compliance includes equitable communication and engagement across all their stakeholders.

In summary, members should be aware that there are various avenues available to advertisers for a voluntary third party review of compliance of advertisements.

CMA have a list of highly experienced regulatory affairs consultants included on the CMA Regulatory Affairs consultants webpage, whom can expertly help advertisers assess advertisements for compliance against legislation including the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021.