Traditional Chinese medicines (TCMs) sold in Australia are carefully regulated to ensure safety and quality. They must meet limits on impurities like lead, arsenic, cadmium, and mercury, which can be absorbed by plants. To protect consumers, the Therapeutic Goods Administration (TGA) requires TCMs to comply with national and international guidelines that set safe daily limits for these impurities. Information for consumersTCMs are popular herbal treatments, but they need to be used safely. TCMs listed on the Australian Register of Therapeutic Goods (ARTG) must meet strict safety rules, including limits on heavy metals like lead, arsenic, cadmium, and mercury. These limits are based on daily exposure levels to protect consumers from potentially harmful levels of these metals. To help protect your health, always follow dosage instructions and consult a healthcare professional if you have questions.If you think you may be experiencing a side effect after using a TCM, seek advice from a health professional. You or your health professional can then report it to us. Detailed information on how and what to report is available at Report a problem or side effect.Information for sponsorsSponsors should consider the permissible daily exposure limits for certain elemental impurities, such as heavy metals, in their TCM products. Permissible daily exposure (PDE) limitsElemental impurities are measured in parts per million (ppm).‘ppm’ doesn’t account for how much elemental impurities a consumer gets based on how much medicine they take each day. This is important for TCM pills because they often need to be taken in large doses.Large doses of TCM pills can result in higher intake of these impurities, even if the ppm is within safe limits. PDE accounts for a consumer’s total daily exposure, ensuring elemental impurity levels are safe even when large doses are taken.More informationMaximum concentration limits for elemental impurities can be found in Schedule 3, Part 6 of Therapeutic Goods Order No. 101 – Standard for tablets, capsules and pills (TGO 101)PDE limits for each elemental impurity can be found in:United States Pharmacopeia’s Chapter 2232 (USP 2232); orICH Q3D Elemental impurities – Scientific guideline (see Appendix 2)Carefully review the information above along with the product specifications for all TCMs you have listed on the Australian Register of Therapeutic Goods (ARTG). If your medicine contains elemental impurities, you should:Check that it meets the PDE requirementsStop supplying any medicine(s) that do not meet these requirementsNotify the TGA (via Report a medicine or vaccine defect) if your testing shows that PDE requirements are exceededTake steps to make sure future batches of the medicine(s) comply.The TGA routinely monitors listed medicines and selects them for compliance reviews. Consequences for non-compliance with relevant laws include not only cancellation from the ARTG and financial penalties, but also civil or criminal proceedings.
Brief
On 17/12/2024, the Therapeutic Goods Administration (TGA) issued an update regarding Elemental impurities in traditional Chinese medicines (TCMs). To ensure safety and quality, TCMs sold in Australia must meet limits on impurities like lead, arsenic, cadmium, and mercury. The TGA requires compliance with national and international guidelines that set safe daily limits for these impurities, protecting consumers from potentially harmful levels of these metals through careful regulation and monitoring.
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Purpose
The purpose of this update is to inform Traditional Chinese Medicine (TCM) sponsors and consumers in Australia about the regulations and guidelines governing TCMs, specifically with regards to impurities such as lead, arsenic, cadmium, and mercury. The Therapeutic Goods Administration (TGA) ensures that TCMs sold in Australia meet strict safety standards, including limits on heavy metals.
Effects on Industry
The update affects the TCM industry in several ways. Firstly, it reminds sponsors to consider permissible daily exposure (PDE) limits for elemental impurities in their products. This means that TCM manufacturers must ensure that their products comply with national and international guidelines setting safe daily limits for these impurities. Failure to meet PDE requirements can lead to non-compliance with relevant laws, resulting in cancellation from the Australian Register of Therapeutic Goods (ARTG), financial penalties, civil or criminal proceedings.
Relevant Stakeholders
The update is relevant to various stakeholders, including:
- TCM sponsors and manufacturers
- Consumers who use TCMs for treatment
- Healthcare professionals who prescribe or recommend TCMs
- The Therapeutic Goods Administration (TGA), which regulates TCMs in Australia
Next Steps
To comply with the update, TCM sponsors are advised to:
- Review their products’ specifications and testing results to ensure compliance with PDE limits.
- Check if their products meet the maximum concentration limits for elemental impurities as specified in Schedule 3, Part 6 of Therapeutic Goods Order No. 101 (TGO 101).
- If necessary, take steps to reformulate or retest their products to ensure compliance with PDE requirements.
- Notify the TGA if their testing shows that PDE requirements are exceeded.
Any Other Relevant Information
The update provides additional information and resources for stakeholders, including:
- A link to the United States Pharmacopeia’s Chapter 2232 (USP 2232) guidelines for elemental impurities.
- The ICH Q3D Elemental Impurities – Scientific Guideline, which provides guidance on setting PDE limits.
- Information on how and what to report if a consumer experiences a side effect after using a TCM.
