Compliance and education for listed medicines
The TGA conducts post-market monitoring of the quality, safety and efficacy of listed medicines to support community confidence in these products. We use the data collected from this monitoring, in particular desktop compliance reviews, to identify trends in non-compliance. This information is used to help prioritise our future compliance review activities.
This page is aimed at informing sponsors of our review activities and provides them 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.
Current priorities
- Listed medicines using indications related to diarrhoea requiring a warning statement
- Stability requirements for listed medicines
- Efficacy of listed medicines for exercise performance
Past priorities
- Listed medicines containing Valeriana officinalis requiring warning statements
- Efficacy of Lysine Hydrochloride containing medicines for cold sores
- Efficacy of medicines containing Vitamin D that use indications relating to bone
- Listed medicines at risk of containing safrole
- Listed medicines containing Artemisia species requiring warning statements
- Listed medicines containing mollusc-derived ingredients requiring warning statements
- Listed medicines containing caffeine
- Listed aerosol sunscreen products
- Listed medicines containing Andrographis paniculata requiring warning statements
- Listed medicines containing fennel requiring warning statements
- Listed medicines requiring a pregnancy warning statement
- Listed medicines referencing macular degeneration
- Oral probiotics indicated for vaginal conditions
- Listed medicines with blood glucose and cholesterol indications
- Listed medicines that are required to be tested for the presence of Aristolochic acids
- Folate and folic acid for use in listed medicines
- Listed sunscreen products
E-learning modules
The following module has been designed for sponsors of listed medicines:
- Evidence requirements for listed medicines
This module may serve as a supplement to the Evidence guidelines for listed medicines that focuses on how to determine if a piece of evidence is suitable for inclusion as part of an evidence package for listed medicines.
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.