The healthcare industry is big business. The sale of medicines, medical devices and complementary therapies total billions of dollars in sales in Australia each year. The Therapeutic Goods Administration (TGA) regulates these products to ensure Australian consumers enjoy peace of mind knowing that the therapeutic goods that are manufactured here or imported meet an acceptable standard of safety and quality.
What is the TGA?
The Therapeutic Goods Administration is part of the federal government’s Department of Health. As mentioned, the TGA regulates therapeutic goods, and it does this through assessing and monitoring the market, enforcing standards, licensing Australian manufacturers, and ensuring that overseas manufacturers are compliant with Australian standards.
What Does the TGA Do?
The TGA is responsible for ensuring that therapeutic goods available for sale in Australia are safe. This includes any therapeutic goods that are manufactured in Australia, as well as imported or exported therapeutic goods. These goods include prescription medications, over-the-counter medications, vitamins, minerals, herbal and aromatherapy products, vaccines, blood products, medical devices and surgical implants. Therapeutic goods are used to:
Prevent, diagnose, cure or alleviate a disease, ailment, defect or injury.
Influence, inhibit or modify a psychological process.
Test the susceptibility of people to disease or ailment.
Influence, control or prevent conception.
Test for pregnancy.
If a product has a therapeutic claim, it must be approved and entered in the Australian Register of Therapeutic Goods (ARTG) database before it can be supplied in Australia.
Classification of Therapeutic Goods
The TGA has an interactive tool that helps businesses decide if their goods are therapeutic and which type of goods they are likely to be. If you find your goods fit a classification for being therapeutic, you will need to seek TGA approval before you can advertise or supply the goods in Australia. There are three kinds of therapeutic goods - medicines, medical devices and biologicals.
All medicines that are available in Australia must be included in the Australian Register of Therapeutic Goods (ARTG). Medicines are categorised in the ARTG as complementary, over the counter or prescription. It’s also important to note that not all medicines carry the same amount of risk, with more rigorous controls being put in place to handle medicines that have been recognised as high risk. The two types of classifications used to identify the levels of risk are:
‘AUST L’, which identifies lower risk medicines such as vitamins and herbal supplements, which have not been assessed for efficacy.
Those that are listed as ‘AUST R’, which identifies higher risk medicines such as those that need to be prescribed, as well as painkillers.
Consumers are protected by the Australian Competition and Consumer Commission (ACCC), which regulates advertising and acknowledges that the accuracy and truthfulness of claims about medicines must be assessed; as well as the TGA, which takes action against any organisation or individual who makes unsubstantiated health claims.
Listed over-the-counter medicines can only contain pre-approved low-risk ingredients, which means the claims about the efficacy of the particular medicine must also be low-risk. Listed medicines that have been assessed are able to be advertised with slightly higher risk health claims.
The TGA monitors medical devices including medical gloves, bandages, syringes, blood pressure monitors, and X-ray equipment. Medical devices are those that are used for monitoring or those that have a physical or mechanical effect on the body. The TGA ensures that all devices, both Australian made and imported, are safe and effective, and encourages the public to report any listed devices that have an unknown side-effect or problem. Furthermore, the TGA issues any relevant alerts and recalls for any products or devices where there are unexpected issues.
Biologicals include but aren’t limited to:
Cell-based products (genetically modified, in vitro cell expansion or depletion).
Immunotherapy products containing human cells.
Combination products (e.g. cell therapy and medical device).
Products that comprise or contain live animal cells, tissues or organs.
Autologous human cells and tissue products (including stem cells).
Faecal microbiota transplant (FMT) products.
Why Consumers Need Products Assessed by the TGA
If therapeutic goods were unregulated, individuals and businesses may use ingredients that are unsafe for human consumption in medicines and vitamins. There could also be cases where medical devices do not work as they are intended and endanger life as a result. Consumers also need protection from individuals or businesses that make false or misleading health claims about the products they sell.
Process to Have Goods Added to the ARTG
When a manufacturer or individual (known as a sponsor) wants to have their product assessed by the TGA for possible inclusion in the ARTG, they must make an application for market authorisation.
The market authorisation process and application comprises of the following:
The applicant compiles the required data and information for the therapeutic good.
The applicant submits the application for market authorisation.
The TGA assesses the application.
If the good is found to meet regulatory requirements, market authorisation is granted and included in the ARTG.
After admission to the ARTG, the sponsor is responsible for reporting adverse events involving the good. Any good may be randomly selected or targeted for a post-market review. There were almost 91,000 products listed on the ARTG in October 2019.
Helix Products Listed on ARTG
Early in the pandemic, Helix Solutions confirmed that its hospital grade disinfectant product Chlor-Clean was effective in killing the COVID-19 virus on surfaces. Before Helix could make the claim, we needed to submit an application with evidence to the TGA to gain approval. Organisations that have made unsubstantiated claims can receive hefty fines as a result of misleading the public.
Chlor-Clean was already TGA compliant because it’s a hospital grade disinfectant used to kill bacteria and viruses in healthcare settings.
The TGA makes the Australian Register of Therapeutic Goods (ARTG) available online for consumers to access if they need more information about a therapeutic good they may be considering to buy or use.
If you have any queries about Helix Solutions products, please call us on 1300 29 32 32 or contact us online.