Medicine or Dietary Supplement? Understanding Australian TCM Regulatory Bodies

Who governs the safety and quality of traditional Chinese medicine (TCM) products? There is much ambiguity around the import/export and sale of TCM items in Australia. Depending on whether the product is a dietary supplement or medicine, TCM products undergo differing compliance assessments. Here's a brief summary of the main regulatory bodies: 

 Food/Dietary Supplement

Medicine

Food Standards Australia New Zealand (FSANZ)

FSANZ regulates the safety of food production, processing and handling in Australia and New Zealand. The country of origin, ingredient listing (including additives, preservatives), and the Nutritional Information Label are all requirements of the FSANZ.

Australian Therapeutic Goods Administration (TGA)

The TGA determines which medicinal products and ingredients are permitted in Australia by maintaining Australian Register of Therapeutic Goods (ARTG) and auditing GMP standards of production, storage and quality control. TGA also reviews the safety and efficacy of medicines, including monitoring of adverse events and labelling of manufactured products. 

Other Food Certification Bodies

Food and dietary supplements can also undergo additional independent accreditation for Hazard Analysis and Critical Control Points (HACCP), Australian Certified Organic (ACO), Halal, Kosher, Gluten-Free etc. 

Australian Health Practitioner Regulation Agency (AHPRA)/ Chinese Medicine Board Australia (CMBA):

AHPRA accredits and defines who is eligible to consult and prescribe medical treatments in Australia.

CMBA audits the dispensing of TCM herbal products, including labelling, nomenclature, packaging and advertising. 
  • Accessible by the public
  • Flexibility in marketing but no therapeutic claims permitted
  • Safety assessed for products manufactured, processed or handled in Australia only
  • Trade and availability internationally governed by the Codex Alimentarius Commission (Codex)
  • Can be more affordable as less costs in quality control and safety assessments
  • Larger range of products available
  • Renewal by other food certification bodies required over regular periods to ensure compliance
  • Access restricted or limited to accredited practitioners 
  • Marketing must satisfy TGA efficacy requirements on listing
  • Safety internationally governed by Good Manufacturing Processes (GMP) and Pharmaceutic Inspection Cooperation Scheme (PIC/S) at cultivation, manufacturing and processing sites 
  • Can be more expensive as pharmaceutic processing and TGA listing costs
  • Undergoes continuous strict auditing and assessments

 

Global categorisation for complementary products differ according to federal legislation. As a product with the prescribed intention of eliciting a therapeutic effect, all medicines both conventional and complementary sold in  Australia are required to be listed or approved by the TGA. At Serica, we are practitioners who support the advancement of our profession as an allied health modality and compliance with Australian medical standards. We support the dispensing of Sun Ten herbal products as a medicine rather than a dietary supplement to ensure quality and safety for our own patients as well as the public community. 

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