Insight contacted the TGA in regards to the episode, Integrating Natural Medicines. A spokesperson from the TGA provided Insight with the below statement.What response does the TGA have to critics who say the organisation does not place enough emphasis on efficacy when approving a product?The Therapeutic Goods Administration’s (TGA) regulatory framework is established under an Act of Parliament – the Therapeutic Goods Act 1989 – and this Act of Parliament determines whether medicines need to be approved by the (TGA ) prior to sale or can be listed on the register without pre-market assessment of the particular product (including without pre-market assessment of efficacy). As a government regulator, the TGA’s function is to administer the current regulatory frameworks as laid down in law.Medium to high risk medicines – ranging from analgesic products sold in supermarkets through to cancer medicines only available on a doctor’s prescription – are termed registered medicines and require extensive evaluation by the TGA of efficacy, safety and quality prior to them being permitted for sale in Australia.In contrast, certain low risk medicines such as herbal or (lower dose) vitamins and minerals and certain low risk traditional medicines are not required by Australian law to be evaluated for efficacy prior to marketing.There are some products that can be purchased without consultation from a healthcare professional (or self-selectable medicines) that make traditional indications. This is only a proportion of what ‘traditional medicines’ encompasses, as most aspects of traditional medicines are ensured by a health practitioner, and or systems that may be in place to regulate the practitioner. The TGA does not regulate health practitioners or their practices.
Many self-selectable medicines that have traditional indications are listed medicines. Listed medicines are low risk medicines and sponsors (the legally responsible entities for these medicines) must certify that they meet certain legal requirements to be included in the ARTG and permitted for sale in Australia. This includes that the medicine:
- only contains low risk ingredients from a TGA approved list of ingredients
- only makes low-level indications (e.g. cannot refer to treatment of serious conditions and preventing/curing any condition) from a list of TGA approved indications
- has evidence …….