Around the Globe

New Australia TGA Website and First NASWSI Consortium Approvals
Richard Day
University of New South Wales
@osbornidayius
M

any of us can relate to the challenge of navigating regulatory agency websites, but there is good news from Australia’s Therapeutic Goods Administration (TGA). The TGA website has been redeveloped and was officially launched this past August 30 with subsequent improvements planned to continue over the next 12 months. There were over 46,000 documents on TGA’s previous website, so it was not surprising that finding information on it was challenging. Content from the previous version has been archived with the National Library of Australia web archives on a site called TROVE. In TROVE, you can find just about anything written about or from Australia. It also provides guidance about retrieving archived TGA documents. Nothing has been lost and everything can be found.

The most prominent features of this new TGA site are its improved navigation and search functions. Information is now organized for users into just four topics: 1) Products we regulate; 2) Product safety; 3) How we regulate; and 4) Guidance and resources. This will make information more easily accessible for consumers, health practitioners, students, and industry and government personnel. More easily accessible information will also engender deeper and wider understanding of TGA’s important role in Australia’s healthcare system, and our national medicines policy will be one of the significant benefits from the upgrade.

First NASWSI Consortium Approvals

In a major milestone for regulatory collaboration involving Australia, TGA has approved the first two new medicines that were jointly evaluated by all five regulatory agencies (Health Canada, Health Sciences Authority [Singapore], Swissmedic, Medicines and Healthcare products Regulatory Agency [MHRA] of the United Kingdom, and TGA) that are members of the Access Consortium New Active Substance Work-Sharing initiative (NASWSI). These like-minded regulatory agencies are striving for increased international cooperation to increase their capacity for registering safe, effective, and needed products in a timely manner for the benefit of patients in their respective countries. These two drugs are indicated for serious medical conditions: Philadelphia chromosome-positive chronic myeloid leukemia with the drug-resistant mutation T315I, in people that have failed two tyrosine kinase inhibitors (asciminib); and neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) (faricimab, a bispecific angiopoietin-2 [Ang-2] and vascular endothelial growth factor [VEGF] inhibitor). The NASWSI Consortium has now approved 23 medicines since it commenced its work in 2018, but these two drugs are the first approved after all five agencies jointly evaluated their applications.

Refreshed National Medicines Policy

A refreshed version of Australia’s National Medicines Policy (NMP) is one step closer to finalization. NMP was first gazetted in 2000, and the Commonwealth Government called for revision in 2021 to reflect “substantial changes in the health landscape.” After extensive stakeholder consultations, a draft policy was prepared with guidance from Deputy Chief Medical Officer of the Commonwealth Michael Kidd, chair of a representative Advisory Committee. Stakeholders were then asked to comment on that draft in March 2022. A revised draft was prepared in response to these comments, but this revised (still draft) NMP was not circulated before Australia’s May 2022 parliamentary elections. After the Australian government changed hands from the Liberal and National Parties Coalition to the Labour party, new Minister for Health and Aged Care Mark Butler circulated this latest draft for “final,” wide consultations from August 17-27, 2022. Butler subsequently reappointed Kidd as the “sole reviewer to complete the Review and provide a final report to Government later this year.” Stakeholders should not complain that they were not given opportunity to comment on this critical policy!

Complementary Medicines Contention

Unlike the case in many countries and under many regulatory frameworks, complementary medicines (CM), nonprescription medicines such as herbal supplements, vitamins, or minerals, are identified as medicines on the Australian Register of Therapeutic Goods (ARTG). TGA describes the approach to the inclusion of CM on the ARTG as risk-based. Most CM are found in the ARTG “listed” category of medicines, which includes over-the-counter (OTC) medicines that can be purchased not only in pharmacies but also at supermarkets and health food shops. These products are required to display “AUST L” (L = listed) on their packaging. Indication claims for listed medicines are described as “low-level” and their risk is classified as lower than those found in “registered” prescription medicines that display “AUST R” (R = registered) on their labels. TGA does not evaluate these products individually. The sponsor prepares a certificate that warrants the product meets the legislative requirements for safety, quality, and efficacy. Lists of acceptable indications and ingredients are found on the “Listed medicines” section of the TGA website. TGA can review certificates for compliance at any time.

However, efficacy of listed medicines has emerged as a contentious issue in some responses to the draft revamped NMP. In the original NMP, the sponsor of a CM was obliged to provide, if requested, the evidence for efficacy implied in the indication claims for their medicine. In practice, sponsors rarely received these requests; when they did, answers were regularly not given or considered unsatisfactory. In July 2015, an Expert Review of Medicines and Medical Devices Regulation recommended changing this obligation to compulsory publication of evidence for efficacy on sponsor or other accessible websites, but this advice has not resulted in any action to date. The draft revised NMP has once again opened calls for compulsion to make evidence for efficacy available and accessible, or, more radically, no longer “listing” medicines on the ARTG without published and accessible evidence for efficacy. What constitutes “acceptable evidence” remains an even more problematic question.

NPS MedicineWise Funding Stop Confirmed

As readers will recall, NPS MedicineWise, the internationally recognized organization funded to deliver quality use of medicines (QUM) outcomes nationally, had its federal funding withdrawn near the end of the previous government’s term. This announcement was a major shock to the medical and pharmaceutical communities across Australia and globally. Although the new government agreed to review this budgetary decision, raising stakeholders’ hopes, the decision stands and the future of this outstanding organization remains uncertain.
Back to Issue