Asia-Pacific Roundup: Australia to permit some self-test IVDs after industry calls for change

The Therapeutic Goods Administration (TGA) is set to allow the sale of a limited range of self-test in vitro diagnostics (IVDs) in Australia. TGA proposed the regulatory change after GlaxoSmithKline and other organizations used a consultation to voice their dissatisfaction with the current system.
 
Home-use tests for serious diseases have been banned in Australia for the past decade. TGA made an exception for HIV tests in 2014 but has otherwise maintained the position adopted in 2020. With the 2010 law up for a mandatory review this year, TGA began a consultation 10 months ago to learn if there is an appetite for expanding self-testing beyond HIV.
 
TGA emerged from the consultation with plans to allow the sale of home-use tests in 11 therapeutic areas. Most of the therapeutic areas are different infectious diseases, with HIV joined by pathogens including seasonal influenza, hepatitis C and neisseria gonorrhoea on the list of bacteria and viruses eligible for self-tests. TGA will also permit at-home tests of some chronic conditions, namely diabetes and cardiovascular and kidney disease.
 
The plan reflects a belief that, in select therapeutic areas, it is preferable for the public to have access to self-tests that have undergone evaluation by TGA. To mitigate the potential harms of self-tests, TGA plans to only allow the sale of IVDs with “a high level of sensitivity and specificity” and evidence that they perform “satisfactorily” in consumer usage studies.
 
Australia is set to bring legislation supporting the use of a wider range of at-home tests into force at the start of next month. TGA is developing guidance to clarify its expectations and requirements for the performance of self-tests, as well as to provide more details on the conditions it will impose to mitigate risks. The guidance is intended to help companies apply for inclusion of their products in the Australian Register of Therapeutic Goods.
 
TGA established the plan after hearing from companies including GlaxoSmithKline and 23andMe. The industry feedback revealed concerns with the outgoing regulatory situation, which GSK called “not fit for purpose” in its submission to TGA. GSK’s criticism centered on the ban on testing for influenza.  
 
“Self-testing devices for influenza virus may allow for early screening and intervention if required. It may also make testing accessible to consumers who would not otherwise be tested. This would include individuals who are not comfortable accessing current health services or do not have ready access to health services,” GSK wrote.
 
23andMe focused its feedback on the availability of direct-to-consumer genetic tests in Australia. While 23andMe said it adheres to Australia’s prohibition of at-home genetics tests, it found “at least 20” companies that currently sell such products in the country. 23andMe said US-based companies are selling prescription tests that have not undergone regulatory review in any market to Australian consumers.
 
In light of that situation, 23andMe said there is an “urgent need” for a regulatory framework that permits the legal sale of home-use genetic tests in Australia. 23andMe sees the creation of such a framework as a way to reduce the risks posed by “unvalidated overseas products of specious safety and quality.”
 
However, other stakeholders expressed worries about permitting home-use genetic tests, citing concerns about the use of data, risk of misinterpretation of results and prospect of increased burden on healthcare providers. TGA sided against 23andMe in the debate.
 
TGA Summary, Consultation Responses
 
TGA shares guidance on new approach to medicine shortage notifications
TGA has published a user guide to support its decision to publish all medicine shortage notifications for reportable medicines on its website starting this week. The guide covers how sponsors can ask for delays in the publication of anticipated shortages and future discontinuations.
 
On 14 September TGA began immediately publishing details of current shortages, regardless of the impact they are expected to have on patients. TGA will publish anticipated shortages and planned discontinuations but is giving sponsors the chance to request a delay to the release of information about problems and changes with no immediate effect on supply.
 
At some point, TGA will update the Medicine Shortages Notification form to support its new protocol for the publication of details of supply disruptions. Until then, TGA wants sponsors to use the current form.
 
The user guide explains how the interim solution will work in practice. TGA wants sponsors to share requests for delays to publications either using a box on the current form for further comments or by attaching a separate document to the notification. Sponsors can submit additional information by email within two working days of sending the notification.
 
If TGA sees a public health reason to delay publication, it may agree to the revised date proposed by the sponsor without further discussion. On other occasions, TGA may only agree to a delay after consulting with the sponsor or reject the request outright and publish the shortage information immediately.
 
The user guide cites the risk of stockpiling or panic buying as an example of a public health reason that could support delayed publication. TGA will not delay publication “because of a medicine’s low market share, small patient population or the availability of exact alternatives.”
 
TGA Guidance
 
Philippine regulators ally to improve postmarket drug surveillance
Leaders at the Philippine Food and Drug Administration (FDA) have teamed up with their counterparts at the national Drug Enforcement Agency (DEA) to strengthen postmarket surveillance of dangerous health products.
 
Under a memorandum of understanding signed by FDA and DEA, the Philippine regulatory agencies will share data, support each other’s investigations, cooperate on the implementation of programs and otherwise collaboratively try to strengthen the control of dangerous drugs.
 
FDA framed the collaboration as a way to strengthen its postmarket surveillance capabilities and, in doing so, ensure “that all registered health products, specifically the pharmaceutical products strictly comply to the rules and regulation of the agency.”
 
FDA Notice
 
TGA revises ibuprofen label in line with feedback from GSK
TGA has revised the draft changes to ibuprofen labels that it released for consultation earlier in the year. The change clarifies that the rescheduling of small packs of ibuprofen only applies to immediate-release formulations.
 
In May, TGA proposed classing ibuprofen in Schedule 2 when it is sold “in divided preparations, each containing 400 mg or less of ibuprofen in a primary pack containing not more than 12 dosage units.” An applicant proposed the change on the grounds that such small packs could provide short-term relief from acute pain and fever without raising safety and tolerability risks.
 
GSK called for TGA to amend the proposal after noticing that its wording would also reclassify 300 mg modified-release ibuprofen products as Schedule 2 medicines. The products were only approved in May, leading GSK to argue there is a lack of experience to support their rescheduling.
 
TGA appears to have concurred with the feedback. In an interim decision published last week, TGA revised the text to clarify that only small packs of immediate-release ibuprofen fall into Schedule 2.
 
TGA Notice, GSK Feedback
 
Other news:
New Zealand’s Medicines Classification Committee is set to reconsider the proposed reclassification of pholcodine from a pharmacy-only medicine to a restricted medicine. The reassessment follows the submission of five valid objections to the change to the Medicines and Medical Devices Safety Authority. Medsafe Notice