The TGA will no longer be assessing Herbal Component Names (HCN’s) as part of pre-market evaluations, effective immediately. Effective 1 October 2018, sponsors will not be able to select HCNs from the TGA list of approved HCNs for use in new listings.
Certain herbal components are mandatory to declare in listed medicine applications. These mandatory herbal components are identified in the Therapeutic Goods (Permissible Ingredients) Determination, and are mandated by the Poisons Standard or for safety reasons. There is no legislative requirement to use non-mandatory herbal components for listing a medicine on the ARTG.
Existing ARTG entries will not be affected by this change. Sponsors will not be required to amend or remove any HCNs from their ARTG entries. Sponsors will not be able to add new non-mandatory HCNs to the ARTG entry for any medicines. Sponsors can of course still use a HCN as a quality marker as part of the product manufacturing process or on product labels as long as they are true and comply with regulatory requirements.
The naming of the component(s) is up to the sponsor as long as it can be scientifically justified and is not confusing or misleading to consumers. Note that the label should not indicate a therapeutic role for quality marker components as this is potentially misleading to the consumer. Herbal Component Names will be assessed as part of post market reviews completed by the TGA. As part of a post market review, sponsors may be asked to verify the label information including:
- Supply evidence that the component occurs in the herbal species, such as published scientific literature or original scientific analysis showing the presence of the component.
- Details of the method of analysis used to identify and/or quantify the individual component declared on the label.
- If therapeutic activity is claimed against the component, evidence supporting the indications relating to that component, as per usual evidence expectations.
Whilst we have had information from the TGA that “It would be acceptable to state the final result based on QBI so long as the component was quantified in the raw material and the manufacturing records confirm that the correct amount of the ingredient was dispensed into the batch” they have also indicated that method of analysis for HCN’s may be requested in the event of a post market review. As such, it is unclear what type of QBI justification the TGA will expect for a claim for a herbal component post October 1st based on the specific requirement to provide the details of the method of analysis for HCN’s in the event of a post market review.
If you would like further information on the Changes to Herbal Components, click here