Integrating Natural Medicines: Therapeutic Goods Administration Statement

Insight contacted the TGA regarding the episode, Integrating Natural Medicines. A TGA spokesperson provided Insight with the statement below.
What response does the TGA have to critics who say the organization does not put enough emphasis on effectiveness when approving a product?
The regulatory framework of the Therapeutic Goods Administration (TGA) is established by an Act of Parliament – the Therapeutic Goods Act 1989 – and this Act of Parliament determines whether medicines must be approved by the (TGA) before sale or may be listed on the registry without a pre-marketing evaluation of the particular product (including without a pre-marketing evaluation of efficacy). As a government regulator, the function of the TGA is to administer the current regulatory frameworks, in accordance with the law.
Medium to high risk drugs – ranging from painkillers sold in supermarkets to cancer drugs only available with a doctor’s prescription – are called registered drugs and require a thorough assessment by the TGA of efficacy, safety and suitability. quality before being authorized for sale in Australia.
In contrast, some low-risk medicines such as herbal or (low-dose) vitamins and minerals and some low-risk traditional medicines are not required by Australian law to be evaluated for efficacy prior to marketing.
Some products can be purchased without consultation from a healthcare professional (or self-selecting medications) that do traditional indications. This is only part of what “traditional medicine” encompasses, as most aspects of traditional medicine are provided by a health practitioner, and/or systems that may be in place to regulate the practitioner. The TGA does not regulate healthcare practitioners or their practices.

Many self-selecting drugs that have traditional indications are scheduled drugs. The medicines listed are low-risk medicines and the sponsors (entities legally responsible for these medicines) must certify that they meet certain legal requirements to be included in the ARTG and authorized for sale in Australia. This includes that the drug:

  • contains only low-risk ingredients from a TGA-approved ingredient list
  • only makes low level indications (e.g. cannot refer to treatment of serious conditions and prevention/cure of any condition) from a TGA approved list of indications
  • has evidence that supports all indications and claims made for the drug
  • is manufactured in accordance with the principles of good manufacturing practice
The Therapeutic Goods Act requires that a post-market surveillance system be in place for these and all other drugs, and that the TGA review certain drugs listed on the market to ensure they comply with regulatory requirements .
Is the TGA overly permissive in allowing drugs to cite “traditional evidence” and not “scientific evidence” as proof of efficacy?
Parliament, not the TGA, sets the regulatory framework through the Therapeutic Goods Act 1989 – this is not a case of the TGA being overly permissive or restrictive – the TGA administers laws such that they are in force.
The law requires regulation of drugs based on risk, so the level of evidence required depends on the “indications” given by the product (ie the condition to be treated).
The law specifies that traditional indications used in listed drugs can only be low-risk (for example, traditionally used to relieve constipation) and must be supported by evidence of a long history of traditional use. . This provides an accumulated repository of systematic observations and underpins the use of these drugs in a traditional setting. By law, these traditional indications also cannot refer to serious conditions that would be inappropriate for self-diagnosis or self-management, or whether use of the drug may delay consumers seeking necessary medical treatment.
It is also a legal requirement that the relevant traditional paradigm (eg, traditionally used in Chinese medicine) be clearly disclosed on the label to allow consumers to make an informed choice.

It is also required that traditional indications not use misleading terminology that is not contemplated within the traditional paradigm; for example:

  • reference to the modulation of biomarkers such as “hemoglobin”
  • use of qualifiers that would require scientific justification such as “increases bone density by 10%”
  • imply scientific efficacy such as being “clinically tested”

It would be inappropriate for traditional indications to also need to be supported by scientific evidence, but scientific evidence can be used as additional support for the long history of use.

About Michael Bill

Check Also

Putin doesn’t think invading Ukraine a ‘mistake’: Scholz | Russo-Ukrainian War

German Chancellor says there is no indication Putin has changed his stance on Ukraine as …