The Therapeutics Goods Administration (TGA) of Australia on 02 July 2020 has a guidance document announcing a compliance review of selected listed medicines that use traditional indications in the second half of 2020. The term traditional indications are statements that define the specific therapeutics functions of medicine based on a history of medicinal use. The scope of traditional medicines includes Ayurvedic medicine, Traditional Chinese Medicine (TCM) , Western Herbal medicine, and indigenous medicine.
The announcement came in a time when some medicines have been found not to meet the requirements of TGA ‘s guidelines. As a sponsor, the requirements listed in the document include the responsibility to ensure that the medicine is efficacious and it delivers the correct amount of active ingredient. The amount of listed medicine delivered should be consistent with the evidence of its traditional use.
In addition, sponsors should also focus on the method of preparation in terms of the solvents used, solvent concentrations, extraction ratios, chemical processing vs physical that changes the ingredients of the medicines.
The therapeutic effects of the products will be influenced if the product of the sponsors has a different method of preparation and dosage for the active ingredient. Hence the sponsors should assess the impact of the differences and reconcile the differences in the methods of preparation during the manufacturing of the products with that used traditionally.
Pursuant to the guideline, the sponsor shall reassess the evidence in possession with them in terms of preparations of active ingredients and dosages and refer to the Evidence guidelines for listed medicines for the indications.
The changes to the listed medicines can be made vide TGA Business Services to ensure the indications of the medicine comply with the regulatory requirements.
The sponsors should utilize Permitted Indications in the event there are any changes to the currently listed good since the implementation of Permitted Indications from 06 March 2018 onwards.
The guideline also provided references for transition arrangements for permitted indications and how to make changes to the listing.
Further information on the guideline could be accessed here