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Complementary medicines: the regulatory framework
Behind the news
This TGA behind-the-news article was published on 13 May 2011. Behind-the-news articles are published in response to issues that are of interest to the community at a point in time, for example, subjects that have been in the media.
How complementary medicines are regulated
Complementary medicines, also known as 'traditional' or 'alternative' medicines, include vitamin, mineral, herbal and aromatherapy products. In general, like other therapeutic goods (such as prescription medicines and medical devices), complementary medicines must be included on the Australian Register of Therapeutic Goods (ARTG) before being made available within, or exported from, Australia. At the beginning of May 2011 there are more than 10,000 complementary medicines on the ARTG.
Australia has a two-tiered system for the regulation of medicines, including complementary medicines:
- Higher risk medicines must be Registered on the ARTG, which involves individually evaluating the quality, safety and effectiveness of the product.
- Lower risk medicines containing pre-approved, low-risk ingredients and that make limited claims can be Listed on the ARTG.
The majority of complementary medicines, but not all, are Listed on the ARTG because of their low-risk ingredients.
Unlike many other countries in the world Australia ensures that complementary medicines are manufactured safely and only contain approved, safe ingredients.
Listed medicines may only contain pre-approved low-risk ingredients and must not make claims nor impute they have benefit for the treatment or prevention of serious illness. There are strict advertising rules about making health claims.
Unlike higher risk registered medicines, listed medicines are not evaluated for efficacy before entry on the ARTG and consumers should be aware that the TGA regulates these products for safety but cannot guarantee if they work.
Listed medicines may only contain low-risk ingredients and to ensure the safety of preparations used in complementary medicines, certain restrictions are applied including dosages and labeling. For example, herbal ingredients containing caffeine require label warnings.
Sponsors of Listed medicines are required to hold evidence in support of claims made for their products and to produce this to the Therapeutic Goods Administration (TGA) for review upon request. If this is found to be inadequate, the TGA can take appropriate regulatory action.
A description of how the TGA regulates complementary medicines can be found on the TGA Internet site.
Post market monitoring
Post market monitoring is an important part of the regulation of complementary medicines and the TGA's program includes:
- targeted and random desk-based compliance reviews of Listed medicines
- monitoring and expert review of adverse reactions
- a laboratory testing program
- targeted and random surveillance in the market place
- GMP audit of manufacturers
The TGA actively monitors the extent to which sponsors fulfil their obligations. The TGA conducts both random and targeted reviews to assess sponsors' compliance with their regulatory obligations. During these reviews, issues such as inappropriate claims being made for the medicines; incorrect ingredients being used; inappropriate or inaccurate labels; sponsors not having evidence to substantiate claims; and manufacturing or quality issues are identified. The TGA then requires the sponsors to remedy the situation or face cancellation of the product listing.
Advertising and health claims
Concerns are also raised about the claims being made in advertisements about Listed complementary medicines. Consumers and health care professionals are able to raise concerns by lodging a complaint about advertising of the product to the Complaints Resolution Panel.
Complaints may be made anonymously, although you will be asked to provide your contact details so that you can be advised of the outcome of your complaint. Individuals making complaints can also request that their personal details are not provided to the advertiser or included in the published determination. In 2010, the CRP is estimated to have received 297 complaints, 41% of which related to the advertising of complementary medicines.
Purchasing over the Internet
If a product is a therapeutic good and not included in the ARTG, the product is regarded as unapproved and unevaluated and as such may pose a public health risk.
Many of these products are imported by Australians from overseas suppliers over the Internet. Some of these products have been found to contain undeclared prescription only ingredients.
In such cases the TGA warns consumers to exercise extreme caution about purchasing medicines over the internet. Products purchased in this way may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia, and may contain unauthorised and potentially harmful ingredients.
Improving the compliance rate
The TGA is currently examining the current arrangements with the aim of enhancing levels of transparency, accountability and responsiveness within the regulatory framework. The TGA has convened a working group made up of consumers, healthcare professionals, academics and industry to examine ways of improving compliance with the current regulatory framework for complementary medicines. The outputs of this working group will be considered in the context of recommendations for reforms to the advertising framework, particularly complaints handling, and the transparency of TGA activities. The TGA is seeking mechanisms to ensure that consumers are better informed about the products they buy and fully understand the difference between the levels of assessment of Listed products and Registered products.
The objective is to deliver a coherent, consistent package of reforms that will improve the rates of compliance within what is regarded as a world's best practice framework for regulating complementary medicines.