17 July 2026
A new study published today in the Internal Medicine Journal, published by the Royal Australasian College of Physicians found low rates of efficacy testing by the Therapeutic Goods Administration (TGA) of Australian Listed medicines.
The research also suggests many health benefits of supplements on shelves remain unproven.
The study found that of the approximately 3,000 new products that were listed on the Australian Register of Therapeutic Goods (ARTG) in 2022 and 2023, the TGA published detailed assessments of aspects of efficacy for only 62 products, or 2 per cent of those newly listed products.
The study evaluated 215 targeted reviews conducted in the two-year study period, also revealing it’s been years since there has been a random review for efficacy.
Dr John McEwen, author of the study, says this reflects a reliance solely on targeted reviews to ensure efficacy of TGA Listed medicines.
“The TGA is one of the world’s best regulators of medicines and the issue of only requiring sponsors of Listed medicines to attest they have evidence of efficacy is a unique requirement that has existed for many years,” said Dr McEwen.
TGA Listed medicines are less hazardous than Registered goods, and include products with active ingredients such as vitamins, minerals and herbal substances. Listed goods require a less rigorous assessment by TGA than registered goods but still require the sponsor’s declaration that that they have evidence to support the product’s efficacy before supply is commenced.
The study also reviewed random compliance review reports and found TGA has not published a random review report since late 2018, without any stated reason for the discontinuation. However, current TGA publications state that random assessments are being conducted.
The study found
- 215 listed products had targeted reviews, 62 of which included an efficacy review.
- Of those 215 targeted reviews, only 6 had a full report of evaluation of efficacy, including assessment of documentation provided by the sponsor to demonstrate efficacy.
- Of the 62 efficacy reports conducted, 33 reports indicated that the sponsor did not hold substantial evidence of efficacy nor were some of the claims made for their product permitted for listed medicines.
“Listed goods are reviewed post-market by the TGA to hold sponsors accountable about the efficacy of their products and to protect customers from being misled.
“In 2023, the industry captured $6.4 billion in domestic revenue and $1.2 billion in export revenue. This is a significant amount of products to ensure compliance.
“We’ve seen recent examples of insufficient evidence of listed magnesium products, published by the TGA in May of this year. Out of 21 medicines reviewed, 16 had inefficient evidence of efficacy for their exercise performance claims. 10 of these medicines have been pulled from the shelves as a result.
“There is a need for an increased number of targeted and random compliance reviews each year for listed medicines.
“It is in the interest of both producers and consumers to ensure ineffective medicines do not sit in our shelves unchecked for an extended period by the TGA.
“Those who produce listed medicines must understand that compliance is not a suggestion – it’s a duty to the general public who rely on them,” says Dr McEwen.