The TGA will be undertaking a targeted review of medicines making traditional claims in the second half of 2020. Traditional medicines include those making claims based in traditional paradigms such as Traditional Chinese Medicine (TCM), Ayurvedic medicine, Western herbal medicine and indigenous medicine.
The TGA says this is a result of signals of non-compliance for some of these products. The TGA’s preliminary assessment of the compliance of these medicines indicates that two key issues with these types of products:
- the preparation methods for herbal ingredients used by sponsors are often different to the methods described in the literature held by sponsors; and
- the dosage of herbal ingredients recommended on product labels is often lower than the dosage that is documented to achieve a therapeutic effect in the literature held by sponsors.
Our experience here at Avicenna Consulting is that these are the two areas that sponsors often struggle with.
Need help meeting your obligations? Concerned about whether you can respond to a review of your products? Contact the team at Avicenna Consulting today.
Sponsor Next Steps
If you currently supply traditional medicines to the Australian market, it is important that you review the claims that you make to ensure that they all come from the TGA’s Permitted Indications list. If you would like to make claims above what is included in the list, you need to apply for a new indication.
You will then need to check the evidence you hold to support your indications. Remember, all indications made on listed medicines (including complementary medicines) need to be supported by evidence per the TGA’s Evidence Guidelines.
Be prepared to receive a ‘Request for Information’ from the TGA which may request your product labels, evidence to support claims, and/or manufacturing documentation. This will require you to submit your evidence to the TGA, usually within 30 days.
Key Things to Check
We recommend that you urgently review your traditional medicines to check:
Are you using the right indications?
Have you selected the right traditional indications from the Permitted Indications list? Is the version you’ve chosen right for your paradigm? Do you need to add qualifiers? Are your existing qualifiers appropriate? Have you complied with any requirements or restrictions for using the indication?
Have you misused scientific indications that are only supported by traditional evidence? Should indications be removed from your ARTG listing?
Is your traditional medicine claim supported by evidence from an appropriate paradigm?
That is, does your claim reflect the source of evidence? For example, your TCM claim is supported by evidence from the TCM paradigm rather than western herbal medicine.
Do you have proof of three generations of use?
Is your product supported by evidence of at least 75 years of traditional use in the way that your product is going to be used?
Does your preparation and dosage align with your evidence?
It is very important that the evidence you hold to support your claims describes a preparation method and dosage that aligns with your product.
You need to check how the ingredient was traditionally prepared and compare that to your modern manufacturing technique. Can you justify why there are differences between the traditional and modern preparations?
You also need to check the dosage. We often find that the dosage used in modern traditional medicines is far less than the traditional dosage. If this is the case for you, can you adequately justify the difference to the TGA?
Is your product appropriately presented?
Is your label compliant with the TGA’s requirements? Are you ensuring that the indications and claims on your label and advertising are consistent with your ARTG listing?
Get regulatory help
Compliance with the TGA’s regulatory framework for traditional medicines can become simple once you understand the rules.
If you feel unsure about whether you can answer these questions or don’t know whether your product would be deemed compliant after a TGA review, don’t hesitate to contact us. Our team at Avicenna Consulting understand the TGA’s Evidence Guidelines and how they apply to traditional complementary and listed medicines.
We have regulatory affairs consultants who can help you navigate the TGA’s complementary medicines regulations. We have research associates who can help you source and assess traditional medicine sources such as monographs, pharmacopeia, materia medica, and other literature.