Complementary medicines play a significant role in healthcare in Australia; the Therapeutic Goods Administration (TGA) oversees them. Australians widely use these medicines, which include vitamins, minerals, herbal remedies, and other natural supplements, for various health purposes. The TGA ensures that these products are safe, effective, and high-quality.

The TGA’s Regulatory framework for complementary medicines follows a risk-based approach. The regulation imposed on a particular product is determined by its risks it poses to public health. The TGA categorizes complementary medicines into the following three (03) levels of risk:

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  • Listed Medicines: These are lower-risk products that have been assessed by the TGA for quality and safety but have not been evaluated for efficacy.
  • Registered Medicines: These are higher-risk products that have been assessed by the TGA for quality, safety, and efficacy.
  • Assessed Listed Medicines: These are products that are similar to “listed medicines” but have also been assessed by the TGA for efficacy.

The TGA’s Regulatory framework includes requirements for the manufacturing, labeling, and advertising of complementary medicines. Manufacturers must comply with Good Manufacturing Practices (GMP) requirements to ensure that their products are consistently of high quality. Labeling requirements include information such as product ingredients, dosage, and potential side effects.

The TGA also includes specific requirements for the advertising of complementary medicines. The regulations involve ensuring that the advertising claims are truthful, accurate, and not misleading. For instance, advertisements should never imply that a product can cure a disease, and they should not make exaggerated claims about the product’s benefits. Moreover, the TGA monitors the safety of complementary medicines in the market. It has a system in place for the reporting of adverse events associated with the use of complementary medicines. Manufacturers and consumers can report adverse events to the TGA, and it will investigate the reports further and take appropriate actions, if necessary.

The TGA has also introduced a new Regulatory pathway for listed medicines. This pathway, known as the Listed Complementary Medicines (LCM) pathway, will replace the existing AUST L pathway. It requires manufacturers to provide more evidence of the safety and quality of their products.

Lastly, the TGA has formulated new guidelines for the assessment of complementary medicines. The guidelines provide manufacturers with more detailed information on the requirements for the assessment of their products. They cover areas such as the evidence required to support claims about a product’s efficacy and the clinical trial requirements. Therefore, the regulation of complementary medicines in Australia is a crucial aspect of healthcare. The TGA’s Regulatory framework ensures that the products are safe, effective, and high-quality. Manufacturers of complementary medicines must comply with the Regulatory requirements for the entire corpus of manufacturing, labeling, and advertising. The TGA also monitors the safety of complementary medicines on the market and takes appropriate action whenever required. If you are a manufacturer of complementary medicines and want to stay up to date with the changing regulations for your products in Australia and ensure that they comply with the TGA’s requirements, reach out to Freyr experts!


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