By Zsuzsanna Sipos
The TGA was established to safeguard and enhance the health of Australians through effective and timely regulation of therapeutic goods. It does this through the application of the Therapeutic Goods Act 1989 (the Act). The Act outlines a risk-based regulatory framework for therapeutic goods, with the level of regulation reflecting the assessed risk of the product.
One of the roles of the TGA is to regulate therapeutic products based on a scientific and clinical assessment of the evidence of both the risks and the benefits of those products. It is important to recognise that in doing so, the TGA cannot avoid all risks, but that its approach is about managing risks.
Therapeutic goods on the market in Australia are required to be manufactured to an appropriate quality, and while no therapeutic good can be considered risk free, when used as intended the benefits of any product should outweigh the risks associated with its use.
The TGA actively monitors the quality, safety and performance of therapeutic goods when they become available to consumers to ensure the on-going compliance of the products with TGA’s regulatory requirements and has an on-going program of verifying the suitability of manufacturers to produce therapeutic goods for supply in Australia.
The TGA also actively monitors unlawfully supplied products and takes appropriate regulatory action where these are identified.
Complementary Medicines and the TGA
Medicinal products containing ingredients such as herbs, vitamins, minerals, nutritional supplements, homoeopathic and certain aromatherapy preparations are referred to as ‘complementary medicines’ and are regulated as medicines under the Act.
There is a two-tier system for the regulation of complementary medicines:
- Lower risk medicines can be listed on the Australian Register of Therapeutic Goods (ARTG).
- Higher risk medicines must be registered on the ARTG.
Most complementary medicines are listed medicines and are assigned an AUST L number which must be displayed on the medicine label.
To be listed on the ARTG, a product:
- can only contain certain low risk ingredients in acceptable amounts that are permitted for use in listed medicines by the TGA;
- must be manufactured in accordance with the principles of Good Manufacturing Practice (GMP);
- can only make indications (for therapeutic use) for health maintenance and health enhancement or certain indications for non-serious, self-limiting conditions.
Additionally, you will need to hold evidence for the therapeutic claims or indications of your product. This evidence is typically compiled in a dossier called an Evidence Package. This evidence is not evaluated by the TGA at the time of applying for your product listing; however, The Act requires that you certify that you hold the evidence on file and make this available to the TGA upon request.
What Happens if I Don’t Comply?
The TGA frequently conduct random and targeted compliance reviews as part of their risk management approach. As part of this process, the TGA issue a compliance review rating based on the number and level of deficiencies identified. Failure to rectify any non-compliance issues can result in a product being recalled or cancelled from the ARTG. Further penalties, including fines and court action, may also apply under The Act.
If a medicine is cancelled from the ARTG, it can no longer be imported, exported, manufactured or supplied for use in Australia. To do so is an offence under the Act. It can be either a criminal offence or a civil offence.
It is also an offence to advertise therapeutic goods that are not on the ARTG. Therefore, penalties can apply if you are advertising and distributing a therapeutic product that has not been listed or registered on the ARTG.
TGA. (2013). Regulatory Compliance Framework. Sourced from: https://www.tga.gov.au/regulatory-compliance-framework
TGA. (2013). An Overview of the Regulation of Complementary Medicines in Australia. Sourced from: https://www.tga.gov.au/overview-regulation-complementary-medicines-australia
TGA. (2018). Listed Medicine Compliance Reviews. Retrieved from: https://www.tga.gov.au/listed-medicine-compliance-reviews#action