Reforms to the regulation of complementary medicines are being implemented in response to the recommendations arising from the Review of Medicines and Medical Devices Regulation.
The reforms include changes that will create a new approval pathway for listed complementary medicines and increase availability of information to support consumer decisions.
Reforms that have been implemented
Introduction of a list of permitted indications from which sponsors of listed medicinal products must exclusively draw from when entering their product indications in the Australian Register of Therapeutic Goods.
The new assessed listed medicines pathway allows for the efficacy assessment of listed complementary medicines with higher-level indications that fall outside the permitted indications list.
New application categories and legislated timeframes for the evaluation of substances for use in listed complementary medicines.
Creation of a single online database for ingredients approved for use in listed medicines.
Creation of an exclusivity period to promote innovation and allow an applicant exclusive use of an approved new complementary medicine ingredient for two years.
Legislative changes to provide review and appeal rights for persons who apply to have a new ingredient permitted for use in listed complementary medicines.
The introduction of an optional product ‘claimer’ that allows sponsors of assessed listed and registered complementary medicines to identify that their product has been assessed for efficacy.
New processes for the better use of international evaluation reports, from comparable regulators, for the evaluation of substances for use in listed complementary medicines.
The introduction of a post-market compliance rating scheme to support the publication of all listed medicine review outcomes on the TGA website.