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MMDR: Complementary medicine regulatory reforms

14 November 2018

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

Permitted indications for listed medicines

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.

Assessed listed medicines pathway

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.

Changes to the evaluation of substances for use in listed complementary medicines

New application categories and legislated timeframes for the evaluation of substances for use in listed complementary medicines.

Catalogue of permitted ingredients

Creation of a single online database for ingredients approved for use in listed medicines.

Exclusive use of new ingredients

Creation of an exclusivity period to promote innovation and allow an applicant exclusive use of an approved new complementary medicine ingredient for two years.

Review and appeal rights

Legislative changes to provide review and appeal rights for persons who apply to have a new ingredient permitted for use in listed complementary medicines.

Upcoming reforms

Claimer for listed assessed and registered 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.

Business process improvement: Use of evaluation reports from comparable overseas regulators

New processes for the better use of international evaluation reports, from comparable regulators, for the evaluation of substances for use in listed complementary medicines.

Business process improvement: Enhanced post-market monitoring for listed medicines

The introduction of a post-market compliance rating scheme to support the publication of all listed medicine review outcomes on the TGA website.

Further information

Consultations related to complementary medicines

Information on consultations related to the Medicines and Medical Devices Regulation Review.

Up-to-date information about the reforms and their status.

Information on the Review of Medicines and Medical Devices Regulation, including links to the complete Review and the Australian Government's response.