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Review of listed medicines with traditional indications
The TGA will be initiating targeted compliance reviews of a selection of listed medicines that use traditional indications in the second half of 2020.
If you are a consumer, please be aware that this is part of our normal review process and there is no immediate concern associated with the use of listed traditional medicines.
What are traditional indications?
Traditional indications are statements that describe the specific therapeutic use of a medicine based on evidence of a history of medicinal use. The indications must relate to a recognised paradigm outside modern medicine. Examples of traditional medicine paradigms include Traditional Chinese Medicine (TCM), Ayurvedic medicine, Western herbal medicine and indigenous medicine.
Why is the TGA targeting traditional indications?
We have received signals that traditional indications on some medicines are unlikely to be supported by appropriate traditional evidence and therefore may not meet regulatory requirements.
We have conducted a preliminary analysis based on compliance reviews of several listed medicines that use traditional indications, prompted by complaints submitted to the TGA. This analysis has revealed the following issues with some of the evidence held by sponsors in support of the indications:
- 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.
I am a sponsor, what should I do?
A critical aspect that ensures that a medicine is efficacious is that it delivers the correct amount of an active ingredient. In the case of listed medicines, this means that the amount delivered should be consistent with the evidence of its traditional use.
The method of preparation (the solvents used, extraction ratios, solvent concentrations, physical vs chemical processing, etc.) can significantly affect the constituent chemical profile of the resulting ingredient.
Modern methods of ingredient preparation and manufacturing processes are often necessary for production at a commercial scale as well as for facilitating innovation. However, if your product has a different method of preparation and dosage for the active ingredient compared to what to that described in the evidence you hold, you should critically assess the impacts of these differences and how they may affect the therapeutic effect of your product. As the sponsor of a listed medicine, you are expected to be able to reconcile the differences in the methods of preparation in the manufacture of your product with that used traditionally.
If you are a sponsor of a listed medicine with traditional indications, you are encouraged to:
- re-evaluate the evidence you currently hold, particularly in relation to the comparability of the preparations of the active ingredients in your products and their dosages; and
- • reconsider the indications made for your medicines with reference to the Evidence guidelines for listed medicines.
You can make changes to the listing of your medicine via TGA Business Services to ensure the indications for your medicine comply with regulatory requirements.
- Permitted Indications for listed medicines were implemented on 6 March 2018.
- Any changes made to a currently listed good since the above date that results in a new listing or a grouped listing, such as a change to the indications for a listing, will require Permitted Indications to be used. The list of permissible indications can be accessed at: Therapeutic Goods (Permissible Indications) Determination No.1 of 2018.
- Further information on the transition arrangements for permitted indications is available on the TGA website and guidance on how to make changes to your listing is available in the Listed medicines application and submission user guide.
Please refer to the Listed medicines application and submission user guide for guidance on this process. Any changes to your medicine's entry on the Australian Register of Therapeutic Goods (ARTG) must also be reflected on the medicine's label and any advertising material.
If and when your listed medicine is selected for review, you will receive a Request for Information notice. Explanation of the review process, information you are required to submit and relevant due dates for your response will be included in this notice.
What will the TGA do?
We will conduct desktop compliance reviews for a selection of listed medicines with traditional indications, commencing in the second half of 2020. These may either be selected randomly or on the basis of regulatory intelligence.
We will send sponsors of selected medicines a Request for Information notice informing them of the commencement of the review and explaining the review process. Upon receipt of the information provided to us by sponsors, we will assess the evidence held by the sponsor in relation to the traditional indications used and other listing requirements.
If no compliance deficiencies are identified for a selected medicine, the review will be concluded and there will be no further regulatory action. If deficiencies are found, the medicine may be cancelled from the ARTG, unless the sponsor takes corrective action to rectify the deficiencies.
Should sponsors cancel their listing rather than respond to the Request for Information notice, we may still request certain documentation be provided to ensure that certifications made at the time of listing were correct.
A summary of the outcomes from this compliance activity will be published after the conclusion of the reviews.