TGA Assessed Claim for Assessed Listed and Registered Complementary Medicines
The TGA has implemented the ‘TGA assessed’ claim for sponsors of assessed listed medicines and registered complementary medicines.
In response to the Medicines and Medical Devices Regulation Review (MMDR), the Government accepted a recommendation to allow sponsors to publish a claim that their medicine has been assessed by the TGA for efficacy where that medicine has undergone pre-market evaluation by the TGA.
What is the TGA assessed claim?
The TGA assessed claim is a symbol and/or statement that indicates that a medicine has the efficacy for its indications (a medicine’s claimed purpose or health benefit) assessed by the TGA. It can only be used in accordance with the TGA’s authority.
The implementation of the TGA assessed claim is intended to:
- support consumers to make better informed purchasing decisions by improving the transparency about whether efficacy claims for certain medicines have been independently assessed by the TGA
- improve consumer awareness about the medicines regulatory framework and the different levels of assessment undertaken by the TGA
- provide an incentive for product sponsors to improve the standards of evidence and extend the evidence base for certain medicines.
What medicines does it apply to?
Assessed listed medicines and registered complementary medicines which have undergone a pre-market assessment of efficacy by the TGA are eligible to use the TGA assessed claim on their medicine label and other advertising material. Prescription and over the counter (OTC) medicines will not display the TGA assessed claim.
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