Landmark report recommends that the Therapeutic Goods Administration step up its random testing of products amid high levels of non-compliance

This article is more than 4 years old

This article is more than 4 years old

A landmark review has called for stricter labelling and more rigorous testing of complementary medicines in Australia.



The independent Review of Medicines and Medical Devices Regulation report recommends that the Therapeutic Goods Administration (TGA) step up its random testing of complementary medicines listed on the register of therapeutic goods amid high levels of non-compliance.



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It says the medicines regulator should be authorised to refuse to list complementary medicines and wants companies to be restricted in what claims they can make about their products, recommending a set list be devised to curb unsubstantiated claims.



The report, released by the Department of Health on Friday, says one in four products selected for random review in 2014, and 61% subjected to targeted reviews, were in breach of regulatory requirements.



Compliance monitoring is low, penalties are insufficient and companies can just withdraw a product once notified of a review, forcing the review to be terminated.



The report recommends the TGA step up the number of reviews it conducts, publish the results for consumers and be allowed to complete reviews even if the product is subsequently withdrawn.



Australians are increasingly self-medicating and using complementary medicines including vitamins to manage their health, “predicated on the assumption that all therapeutic products on the Australian market have been assessed for safety, quality and efficacy”.



But low-risk medicines can obtain market approval without any pre-market assessment by the TGA, with sponsors allowed to self-declare that their product is compliant.



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The report recommends three new options for sponsors to have their medicines listed on the register: the existing self-declaration that the medicine is compliant; self-declaration and TGA assessment of the product’s efficacy; and registration by the TGA for higher risk complementary medicines.



Under option one, sponsors would need to put a prominent disclaimer on all promotional materials and online that their efficacy claims had not been independently assessed, or were based on traditional use.



The report recommends all sponsors be required to publish online any evidence to support claims about the complementary medicines they are selling.