Compliance and education for listed medicines
To improve community confidence in the quality, safety and efficacy of listed medicines, the TGA wants to enhance post-market monitoring of these medicines. One way to do this is by using the data collected from listing compliance reviews to identify trends in non-compliance. This information will also help us to prioritise our future compliance review activities.
The information on this page is aimed at providing sponsors with a better understanding of common compliance issues and how they can be avoided. We believe that sponsors want to do the right thing and hope that this information will provide clarity around regulatory requirements so that sponsors can more easily comply with the law.
The TGA wants to improve communication with sponsors. Our aim is to improve compliance and provide clarification on problematic regulatory issues. The following issues are our current priorities:
The following issues are our future priorities. More information will be provided in due course.
- Review of listed sunscreen products
- Listed medicines with eye health indications
Compliance overview - case studies
Scenario 1: John wants to market his arthritis cream
John is a retiree who has been making a cream for his osteoarthritis at home over the past few years. After seeing such good results, he started sharing it with his family and friends have started asking for it.
He wants to share his product more widely and sell it to pharmacies and health food shops. John follows the instructions in the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) and ensures that his product only has certain low risk ingredients and will be manufactured in accordance with the principles of Good Manufacturing Practice (GMP). He then lists his product on the ARTG with the following indication: 'relieves symptoms of arthritis'. When his product is randomly selected for post market review, he provides some websites and text books that state that the ingredients are used to treat osteoarthritis. When the TGA send him a Proposal to Cancel letter saying that the indication isn't supported, he is unable to provide sufficient evidence to support the indication.
The TGA cancels John's medicine and he is prohibited from selling his medicine and is left with thousands of dollars of arthritis cream that he can't sell or give away.
If John had read the Evidence Guidelines he would have known that his indication required evidence from clinical trials and the dosage of the active ingredient must be the same as in his cream. John also didn't realise that arthritis can mean osteoarthritis or rheumatoid arthritis and the TGA considers them to be very different conditions.
Scenario 2: Amazing Herbal Solutions Pty Ltd is promoting their new weight loss medicine
Amazing Herbal Solutions Pty Ltd has been selling their new green coffee bean extract which is advertised for weight loss. They thought that they could sell lots of stock if they call it 'Slim Buster' and included a range of weight loss and weight management indications on the packaging. They also thought it would help sales to put a toned slim woman on the front with a measuring tape around her waist.
The TGA later conducted a review of this product and Amazing Herbal Solutions Pty Ltd was shocked when they received a Proposal to Cancel letter. The TGA advised that they were going to cancel their medicine as their evidence was only showing an improvement in thermogenesis. It could not be assumed that this would result in weight loss when that wasn't measured in the clinical trials. As a result, the TGA considered their packaging (including the product name, indications and images) to be misleading to consumers.
Amazing Herbal Solutions Pty Ltd didn't realise this and re-listed the product with a new product name, images and indications that reflected the evidence they held. They made significant losses as they could not sell the remaining Slim Buster that they had in their warehouse.