Did you know that Australia is a global leader in the regulation of vitamins and other complementary medicines?1 2 3 4 5
Here, we have a regulatory system which aims to provide consumers with access to the highest quality vitamin products in the world. 6 7 These products are often called ‘dietary supplements’ or ‘food supplements’ in other countries where the requirements for manufacturing standards are mostly not as stringent as the pharmaceutical level of manufacturing quality that is mandatory for any such products that are supplied in Australia.8 We classify these products as ‘complementary medicines’. This category of medicine includes products containing vitamins and minerals, as well as Western herbal medicine, Traditional Chinese medicine, Ayurvedic medicine, and Indigenous medicine. They are all regulated by the Therapeutic Goods Administration (TGA). To be legally marketed in Australia, all medicines (including complementary medicines) must be included on the Australian Register of Therapeutic Goods (ARTG).
There are currently over 16,700 complementary medicines listed on the Australian Register of Therapeutic Goods.
Details that must be provided before being accepted on to the ARTG include the formulation (ingredients) of the product, all manufacturers involved in producing the product (all of whom must be licensed to manufacture medicines), and the indications (medical claims) for use proposed for the product.9 There are strict guidelines in place which detail the type of published scientific evidence required to support such claims. Generally, the stronger the therapeutic claims made for the product, the stronger is the evidence required to support such a claim. Typically, the indications for use are restricted to health maintenance, health enhancement, or for the alleviation of non-serious, self-limiting conditions. 10 11
There is no pre-market evaluation of these requirements but the TGA does conduct a number of post-marketing assessments12 . Over the last few years, the TGA has been increasing the number of post-marketing assessment of listed medicines.
In 2016-17 the TGA reviewed 417 products, of which, 330 (80%) were found to have some compliance breach. These reviewed products were not necessarily representative of the wider market as over 75% were targeted reviews made after the TGA had identified a problem and specifically targeted a group of products. 13 14 The most common problems identified included labelling errors, potentially misleading or confusing statements on packaging or advertising material, and an inability to produce specific enough evidence to substantiate the claims made. 15 The level of reported non-compliance is an outcome of the extremely rigorous nature of the Australian regulations.
It has been stated by the TGA that the vast majority of these outcomes are very minor in nature and have no discernible impact on product safety or quality of the product. 16
Australia’s strict regulatory system is the envy of health professionals and consumers around the world, who admire our approach to manufacturing standards and the requirement of suitable evidence to support any health claims. 17
About the Author Robert Forbes
Robert Forbes is the founder of RFA Regulatory Affairs, a privately owned regulatory consultancy that assists both companies and individuals with the regulatory requirements on suppliers of complementary medicines. He contributes regularly to industry organisations in Australia and is an active member of ARCS and CMA. Robert worked with the Vitamania team to provide an industry perspective on the vitamin and dietary supplement industry.
REFERENCES
[1]https://www.tga.gov.au/sites/default/files/presentation-trends-in-australian-and-international-regulation-and-regulatory-cooperation.pdf
[2]https://www.tga.gov.au/media-release/panel-review-transparency-therapeutic-goods-administration“The TGA is acknowledged as an internationally respected medicines regulator. Our Review will focus on the ways in which the TGA communicates its regulatory processes and decisions,” Professor Pearce, said today.
[3]https://www.tga.gov.au/how-tga-regulates
[4]http://www.health.gov.au/internet/main/publishing.nsf/Content/8ADFA9CC3204463DCA257D74000EF5A0/$File/Review%20of%20Medicines%20and%20Medical%20Devices%20Stage%20One%20Report.pdf
[5]http://burdockgroup.com/dietary-supplements-in-the-u-s-and-abroad-similarities-and-differences/
[6]https://www.tga.gov.au/quality-listed-complementary-medicines
[7]https://www.austrade.gov.au/news/latest-from-austrade/2017/new-report-spotlights-australias-complementary-medicine-capabilities
[8]https://www.sciencedirect.com/science/article/pii/S0965229905000555
[9]https://www.tga.gov.au/australian-register-therapeutic-goods
[10]https://www.tga.gov.au/book-page/permitted-indications-listed-medicines
[11]https://www.tga.gov.au/sites/default/files/presentation-spotlight-complementary-medicines-mmdr-reforms.pdf
[12]https://www.tga.gov.au/product-regulation-according-risk
[13]https://www.tga.gov.au/book/export/html/731370Executive Summary: “Labelling, advertising and evidence continued to be the major compliance breaches for listed medicines. In 2015-16, 13 products were found to have safety related issues, compared to no products in 2014-15. This increase in 2015-16 was largely a result of targeted work undertaken on safety of ingredients”; (Sections 3.3; 3.4) “For both random and targeted reviews, the most common compliance issues have consistently been labelling/ advertising and evidence issues. In this period, evidence and labelling/advertising issues were comparable for targeted reviews, whereas last period there were a significantly higher proportion of labelling/advertising issues. This is likely the result of a number of targeted compliance projects that we have undertaken during this period that focussed on evidence issues identified during our random review program”
[14] http://www.tga.gov.au/sites/default/files/presentation-how-do-listed-medicines-shape-up-in-the-post-market-compliance-space.pdf
[15]https://www.tga.gov.au/book/export/html/731370 Executive Summary As Above
[16]https://www.tga.gov.au/book/export/html/731370 Executive Summary: As Above proportion of labelling/advertising issues. This is likely the result of a number of targeted compliance projects that we have undertaken during this period that focussed on evidence issues identified during our random review program”
[17]https://www.tga.gov.au/media-release/panel-review-transparency-therapeutic-goods-administrationAs above
