Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Australia Suspends Sales of Eight Breast Implants After Safety Review
Australia’s Therapeutic Goods Administration (TGA) has suspended the sale of eight breast implants after finishing its review of the safety of the product class. The action gives affected manufacturers a chance to meet patient safety requirements, but TGA thinks there are likely grounds to permanently ban the products.
Like many of its peers, TGA began reviewing the safety of breast implants in response to reports of a link between certain products, notably Allergan’s Biocell devices, and a form of lymphoma. Allergan has since recalled its Biocell textured breast implants and tissue expander from all markets, but TGA’s analysis of around 100 Australian cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) suggest other products pose an ongoing risk.
To mitigate that risk, TGA has suspended supply of eight models of breast implant for six months. The action affects macro-textured implants and some micro-textured devices associated with a higher rate of BIA-ALCL or other clinical concerns. Allied Scientific Products, Emagin, Euro Implants and JT Medical sell the affected devices in Australia.
The suspensions reflect TGA’s belief that “BIA-ALCL is more likely to occur in implants with a greater surface area and roughness of their wall.” That conclusion led TGA to suspend breast implants that “have a higher degree of texturing, or a higher risk of BIA-ALCL, or deficiencies in evidence to demonstrate the manufacturer has adequate risk detection and mitigation measures in place.”
TGA has imposed additional conditions on all breast implants that remain on the market. The agency is demanding that companies report cases of BIA-ALCL within 10 working days and share data on all adverse events and complaints every six months. Companies must also discuss the risk of BIA-ALCL in the instructions for use and patient information leaflets.
Those requirements apply to all breast implants on the Australian market, including products sold by Allergan and Johnson & Johnson. TGA has placed additional conditions relating to clinical data onto micro-textured implants and tissue expanders sold by J&J.
Australia Considers Relaxing Rules on Self-Test IVDs to Improve Screening
TGA is collecting feedback on the regulation of self-test in vitro diagnostic (IVD) devices. Australia has allowed the sale of self-test IVDs for HIV since 2014 and is now assessing whether to relax the rules on other types of diagnostic.
The effect of the 2014 HIV reforms was delayed, with TGA only approving the first self-test kit for the virus late last year. Despite that, TGA thinks the experience with HIV self-testing can now inform a decision on whether to expand use of at-home IVDs to other serious diseases, including infectious conditions, and permit direct-to-consumer genetic testing. Today, some consumers are bypassing the restrictions on the availability of these tests in Australia by ordering them online.
TGA sees downsides to expanding self-tests to additional therapeutic areas. The agency is concerned about the accuracy of tests and the provision of support services. However, TGA thinks these risks may be outweighed by the benefits if steps are taken to mitigate its concerns.
As such, TGA is considering permitting the sale of more self-test IVDs. To inform its decision, TGA has asked the public sets of questions relating to three types of IVD. One set of questions covers the use of self-test IVDs for infectious diseases other than HIV. TGA cites self-tests for influenza, hepatitis C and sexually transmitted diseases as examples of IVDs that could have positive effects, for example by lessening pressures on healthcare services and decreasing numbers of undiagnosed cases.
TGA worked through the concerns about allowing self-testing of infectious diseases at the time of the HIV reforms, giving it a playbook of methods for mitigating the risks. In contrast, direct-to-consumer genetic tests present TGA with new problems.
The agency proposes two ways to mitigate its concerns with genetic tests. One mitigation strategy is to limit the authorization of tests to IVDs that are “supported by appropriate clinical evidence and analytical performance data.” TGA’s second idea is to only allow companies to supply genetic tests to consumers in Australia if they provide “appropriate consumer information and referrals to health professional services.”
Those mitigating measures reflect the unnecessary alarm and harm that could arise from results that are inaccurate or misinterpreted. TGA has similar reservations about permitting self-testing of serious noninfectious diseases such as diabetes, cancer or myocardial infarction.
TGA is accepting feedback on the proposals until 22 November.
Measles Outbreak Prompts New Zealand to Permit Foreign Vaccine Import
New Zealand’s Pharmaceutical Management Agency (PHARMAC) has asked Merck to import a batch of vaccines originally destined for Singapore to tackle a measles outbreak. The Singaporean batch of measles, mumps and rubella (MMR) vaccines has a different label than shots sold in New Zealand.
PHARMAC asked Merck to import the batch in response to a measles outbreak that affected more than 1,500 people over the first nine months of 2019. Around one-third of those cases happened in the past month. Almost 1,300 of the confirmed cases occurred in the Auckland region, which is home to around one-third of all people living in New Zealand.
The New Zealand Ministry of Health wants to ensure that all children in the country are vaccinated on time according to the two-dose schedule. The ministry also wants to vaccinate certain at-risk groups in the Auckland area, including people aged 15 to 29 years.
Merck, at PHARMAC’s request, has contributed to this effort by importing a Singapore-labeled batch of MMR II. To help healthcare professionals safely use the vaccine, Merck has sent a letter comparing the labels of products sold in New Zealand and Singapore and pointing to other relevant information.
TGA Reform Agenda Shifts Focus as MMDR-Triggered Actions Near End
TGA has set out its regulatory reform priorities for the coming year. The roadmap marks a shift in the priorities at TGA, which can focus on new tasks now that it has largely worked through changes required by the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR).
MMDR, which began late in 2014, has shaped TGA’s priorities in recent years but the reform cycle is now coming to an end. In its 2019 to 2020 business plan, TGA states that the MMDR review “has largely been completed.” There is some MMDR-related work on medical devices and complementary medicines outstanding, but for the most part TGA has made the required changes.
Freed of the need to enact MMDR recommendations, TGA has created a business plan that covers new priorities. TGA’s agenda for the coming year features new items including support for utilization of appropriate comparable overseas regulator reports for registration of medicines and indications.
The roadmap also covers topics that were absent from the 2018 to 2019 business plan but have been discussed by TGA in recent months. For example, TGA lists adoption of a unique device identification system and voluntary pilot program of good clinical practice inspections among its list of regulatory reforms for the year ahead.
’s Center for Drug Evaluation
(CDE) has warned the industry about upcoming IT downtime. The relocation of the IT infrastructure will result in people being unable to access certain regulatory systems at times later this month. CDE Notice