Asia-Pacific Roundup: TGA posts guide to rapid COVID-19 test performance requirements, risk mitigation strategies

RoundupsRoundups | 14 September 2021 |  By 

Australia’s Therapeutic Goods Administration (TGA) has provided guidance on performance requirements and risk mitigation strategies for rapid COVID-19 antigen tests ahead of its anticipated move to lift its ban on self-testing.
TGA disclosed plans to publish the guidance earlier this month in a call for expressions of interest in supplying self-tests in Australia. The guidance explains that rapid antigen tests, like the self-tests that Australia already allows under its recently liberalized rules, must comply with essential principles that impose requirements related to topics such as reducing the risk of error through design choices.
The rest of the guidance sets out considerations specific to COVID-19 self-tests. After setting out the analytical requirements for the kits, TGA describes the clinical performance requirements it expects manufacturers to achieve. The requirements echo those proposed in the European Union. TGA wants COVID-19 rapid antigen self-tests to have a clinical sensitivity of at least 80% and a clinical specificity of at least 98%. The guidance lacks details of how many samples companies need to test, saying only that “statistically appropriate specimen numbers” are needed and referencing the EU guidance.
TGA’s sensitivity and specificity requirements apply to samples from symptomatic people. Multiple studies have found sensitivity falls significantly in asymptomatic people, but TGA still sees “particular circumstances” in which there may be value in testing people without symptoms. Companies that want to make claims related to the use of their tests in asymptomatic people need to show how the kits perform in the population and present the data separately in the instructions for use. The studies should test at least 20 positive and 100 negative consecutively collected asymptomatic specimens.
As lay people will perform the tests, TGA also expects companies to perform usability studies that assess the ability of at least 100 people to self-test in a real-world or simulated setting. Companies can use data generated overseas, provided the studies take place in settings and populations that are comparable to how they will be used in Australia. TGA wants the studies to include people with varying levels of education, ages and English language capabilities. Lay users should interpret at least 100 contrived test results to show people understand the range of possible outcomes.
Even after imposing the requirements, TGA sees risks to the use of self-tests, noting that if the virus is at 0.5% prevalence up to 90% of positives may be false and half of cases may be missed. TGA plans to mitigate the risks by subjecting the tests to mandatory application audits before they are added to the Australian Register of Therapeutic Goods. Risk mitigation strategies proposed for test developers include providing online videos to guide sample collection, clear statements about the risk of false negatives and warnings about the need to supervise self-testing by children.
It remains unclear when Australia will allow the sale of COVID-19 self-tests. The government will decide the timing of the change based on the vaccination rate and the establishment of procedures for reporting results.
TGA Guidance
Asia-Pacific regulators act against use of ivermectin to treat or prevent COVID-19
Regulatory agencies in Australia, Japan and New Zealand have issued notices in response to the use of ivermectin to prevent and treat COVID-19.
TGA took the strongest action by imposing restrictions on the prescribing of the drug. The changes stop general practitioners from prescribing ivermectin in conditions other than scabies and certain parasitic infections, the only indications in which it is approved by TGA. Certain specialists such as dermatologists will retain the right to prescribe ivermectin for off-label use.
The restrictions are intended to stop the use of oral ivermectin in COVID-19. TGA has seen a three- to four-fold increase in the dispensing of oral ivermectin in recent months, creating shortages for those who need the drug to treat scabies and parasitic infections. As well as stopping essential use of the drug, TGA fears prescribing ivermectin in COVID-19 could support the spread of the virus by making people falsely think they are protected and cause serious side effects when given at high doses.
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) highlighted the safety risks of ivermectin in their notices. PMDA is assessing the risk of disturbed consciousness in patients receiving ivermectin, and Medsafe issued a notice about the drug’s side effects and the lack of evidence to support its use.
Medsafe is yet to impose restrictions like those rolled out in Australia. However, the agency said prescribers must obtain informed consent and consider the risks and benefits before providing the drug for off-label use.
TGA Notice, PMDA Notice, Medsafe Notice
TGA warns Actemra stocks will run out unless use is slashed to 25% of normal level
TGA has warned stocks of intravenous Actemra will run out unless use is cut to 25% of the level that preceded the pandemic-driven surge in demand. TGA is cutting supply to manage the situation.
With evidence of the efficacy of Roche’s Actemra in COVID-19 driving up global demand, TGA expects patient-level shortages to continue until early next year. TGA, having already taken several steps to manage the shortage, has now warned the supply from wholesalers to public and private hospitals will be reduced to respectively 25% and 10% of the level seen over the year up to May 2021.
TGA is asking physicians to move patients to alternative treatments when possible. Based on the severity of the conditions and lack of alternative treatments, Australia is prioritizing the use of the drug in cytokine release syndrome, systemic juvenile idiopathic arthritis and polyarticular juvenile idiopathic arthritis. Off-label use in some COVID-19 patients is also a high priority for available stocks.
In India, Hetero has won emergency use authorization for a biosimilar copy of Actemra. Hetero is set to start supplying the copycat for use in the treatment of hospitalized COVID-19 patients by the end of the month.
TGA Notice, Hetero Notice
China’s CDE discusses work to ensure COVID-19 vaccines meet regulatory requirements
The Center for Drug Evaluation (CDE) has described the work it has undertaken to ensure COVID-19 vaccines provided in China comply with quality requirements.
Chinese authorities have sent 77 inspectors to 14 vaccine manufacturing facilities. The inspectors have assessed the entire production process, according to CDE, and worked to ensure compliance with good manufacturing practices. Out of the 24 COVID-19 vaccines to enter the clinic in China, four have gone on to be approved subject to certain conditions.
The inspections have complemented batch testing. China has released more than 8,000 batches that covered more than 3 billion doses of vaccines against the coronavirus.
CDE Notice (Chinese)
Other News:
China’s CDE is seeking feedback on hepatitis C clinical trial technical guidelines. The guidelines cover the development of direct antiviral drugs against the virus and feature sections about the different phases of development and how to design and select patient populations for the studies. CDE is accepting feedback on the draft for one month. CDE Notice (Chinese)
India’s Central Drugs Standard Control Organization (CDSCO) has shared timelines for the issuance of no-objection certificates at its port offices. The timelines range from two to 72 hours, depending on the checks and tests that are needed. CDSCO Notice


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