The history of Traditional Chinese Medicine in Australia can be traced back to the gold rush period of the 1850s when Chinese immigrants arrived to seek their fortune in the gold fields.
As interest in TCM grew over the following century, so did the push for regulation to ensure the quality and safety of Chinese herbal products. Today, Australia’s Therapeutic Goods Administration (TGA) is known for having some of the most stringent regulations in the world.
KPC Herbs recognizes the paramount importance of quality and safety in herbal supplement manufacturing. We work hard to achieve compliance with highly-rigorous and internationally-recognized quality management systems and national certification programs, including the Australian TGA PIC/S GMP certification.
Our adherence to TGA regulations is one of many ways we demonstrate our commitment to producing TCM products that meet and exceed the highest quality standards.
What Is the Therapeutic Goods Administration?
The Therapeutic Goods Administration is part of the Australian Government’s Department of Health. It is responsible for regulating the quality, import, export, manufacture, supply, and advertising of “therapeutic goods.” This includes:
- prescription medicines
- over-the-counter medicines
- complementary medicines
- vaccines
- medical devices
- biologicals
- blood products
- sunscreens
- products used to test for diseases or conditions
Most products that claim to have a therapeutic effect, including herbal supplements, must receive market authorization from the TGA before they can be supplied to Australian consumers. If market authorization is granted, the product is entered into the Australian Register of Therapeutic Goods (ARTG). It can then lawfully be supplied in, imported into, or exported from Australia.
What Is Considered a Complementary Medicine in Australia?
Complementary medicines include nutritional supplements, vitamins, minerals, herbs, homeopathic remedies, and aromatherapy preparations. These products are often dispensed by practitioners of traditional or alternative medicines, including Traditional Chinese Medicine, Ayurveda, and Australian Indigenous medicines.
In Australia, complementary medicines are regulated as pharmaceuticals under the Therapeutic Goods Act 1989. They must be manufactured to medicinal standards in TGA-approved and licensed facilities.
In many other countries, including the United States, these products are considered “dietary supplements” or “food supplements.” As a result, they are not subject to the same strict requirements for manufacturing standards as the complementary medicines supplied in Australia.
What Is the Difference Between Registered Medicines and Listed Medicines?
Australia has a two-tiered system for the regulation of all medicines, including Chinese herbs and other complementary medicines. Medicines considered “higher risk” must be registered on the Australian Register of Therapeutic Goods. Medicines deemed “lower risk” can be listed on the ARTG. Products in both categories need to comply with Good Manufacturing Practice (GMP).
Registered Medicines
Registered medicines are individually assessed by the TGA for quality, safety and efficacy. All prescription medicines, most over-the-counter medicines, and some complementary medicines are registered. Complementary medicines are registered only if the TGA determines that there is adequate evidence to support specific claims of efficacy in the treatment or prevention of disease.
Medicines registered on the ARTG are assigned a unique AUST R number that must be displayed on the product label.
Listed Medicines
Listed medicines make low-level health claims and contain pre-approved, low-risk ingredients. They are assessed by the TGA for quality and safety but are not evaluated for efficacy. Most complementary medicines and some over-the-counter medicines are listed.
The newer “assessed listed medicines” subcategory includes products that contain only approved, low-risk ingredients but make intermediate-level health claims. These are included in the ARTG following self-certification of the product’s safety and quality and TGA assessment of the efficacy evidence supporting the proposed indications.
Medicines in these categories are assigned a unique AUST L or AUST L(A) number that must be displayed on the product label.
Some complementary medicines compounded for individual patients are exempt from the requirement to be included in the ARTG. For example, an herbalist may create a preparation from raw Chinese herbs for a particular client’s needs and legally supply it to the client.
Does the Therapeutic Goods Administration Regulate Raw Herbs?
Although the TGA regulates the quality and safety of Chinese herbal products, it does not assess the raw herbs dispensed by TCM practitioners in Australia. Instead, raw herbs are controlled by Quarantine (infestation) and Customs (restricted substances, endangered species).
All herbal medicine manufacturers, whether they are based in Australia or located overseas, are responsible for authenticating their raw materials and testing the final products. You may learn more about KPC’s industry-leading quality assurance measures here.
What Requirements Must TCM Products Meet for TGA Approval?
For TCM products to be supplied in Australia, they must:
- contain only ingredients assessed as safe by the TGA
- contain those ingredients at levels agreed to be safe by the TGA
- have all raw materials tested and verified before the product is manufactured
- have every batch of the final product tested to ensure it contains what is on the label
- conduct ongoing quality and stability trials to ensure the product remains potent and safe for its entire shelf life
- have any adverse events monitored by the TGA so issues can be identified and acted upon quickly
Why Is TGA Certification So Important in the TCM Industry?
Within the TCM industry, TGA certification is considered one of the highest demonstrations of a manufacturer’s commitment to quality.
The TGA is one of the only regulatory bodies that evaluates Chinese herbal supplements as pharmaceuticals, meaning they are subject to the most stringent requirements for manufacturing standards and product safety. TGA requirements exceed those established by the US Food and Drug Administration. In fact, the TGA is internationally recognized for having one of the most rigorous certification processes in the world.
Before any herbal product is included in Australia’s register of approved goods, it must undergo a lengthy and comprehensive auditing process. Herbal products are also subject to both pre- and post-market reviews.
Manufacturing must take place in TGA-approved and licensed facilities that meet the high standards of Australia’s Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP. A facility that has been granted a license is inspected by the TGA regularly to ensure it continues to meet the required quality standards.
When a consumer purchases a TCM product that has been listed or registered on the ARTG, they can be confident in its authenticity, quality, and safety — the same values we have upheld at KPC for over 100 years.
KPC HERBS: EXCEEDING EXPECTATIONS SINCE 1892
KPC Herbs proudly produces Chinese herbal supplements of unparalleled quality and safety. Our manufacturing facilities have been granted PIC/S GMP certification by the TGA, a reflection of our adherence to the highest manufacturing and quality assurance standards. We invite you to learn more about our processes and our commitment to quality and to reach out to us with any questions about our products.
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*Please note: These statements have not been evaluated by the FDA. This article is not intended to suggest specific treatments for patients or that any supplements mentioned prevent or cure diseases or problems. Before taking any herbs, all patients should discuss their options with a licensed practitioner, including any other medications the patient is currently taking, as there may be contraindications between pharmaceuticals and herbs.
