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Regulatory Focus™ > News Articles > 2022 > 1 > Asia-Pacific Roundup: TGA posts Q&A on conditions for supplying point-of-care rapid antigen COVID-19

Asia-Pacific Roundup: TGA posts Q&A on conditions for supplying point-of-care rapid antigen COVID-19 tests

Posted 18 January 2022 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA posts Q&A on conditions for supplying point-of-care rapid antigen COVID-19 tests

Australia’s Therapeutic Goods Administration (TGA) has published a question and answer document on the conditions for supplying rapid antigen tests of COVID-19 at the point of care. TGA released the text within days of providing guidance on advertising the tests and issuing a fine in relation to an allegation of unlawful importation.
The Q&A is focused on point-of-care tests, as opposed to the home-use products that became available in Australia late last year, while the advertising update applies to both classes of diagnostics. Providers of point-of-care rapid antigen tests can only supply the products for use by trained health practitioners, and trained staff under their supervision. The tests are designed for larger-scale professional testing and ship in packs that contain large numbers of individual tests, unlike the individually packaged at-home kits.
TGA updated its conditions on the legal supply of point-of-care tests as part of an effort to ensure the kits are used appropriately and interpreted correctly. The new conditions clarify in what circumstances the tests can be supplied, who can perform the test and the requirements for supervision of testing with a view to ensuring the correct interpretation of results, advice and treatment are available at the time of testing.
The conditions allow for rapid antigen tests to be supplied for use at sites that can facilitate supervision of the collection of the sample via video. Even then, TGA wants trained staff to be available onsite to perform or supervise collection of the sample and carry out the test in consultation with the remote medical practitioner. There are exceptions to that requirement, with TGA allowing some essential workers to take and test their own samples if they are trained in the process and supervised remotely.
TGA published the Q&A the day after it issued a notice about the advertising of rapid antigen tests. The notice, which covers both at-home and point-of-care tests, sets out the conditions companies need to meet to lawfully advertise the products. TGA allows sponsors and other advertisers of COVID-19 rapid antigen tests to use the particular “restricted representations” about the kits, for example by clearing them to say the products may be used to detect possible infection with SARS-CoV-2.
The guide also explains what information cannot be included in ads. TGA is prohibiting the inclusion of statements that PCR testing will never be required, that the tests are capable of early detection and more. The agency has also barred sponsors from using testimonials or endorsements.
Ezy Company is among the businesses to have allegedly breached some of the rules on COVID-19 rapid antigen tests. TGA issued two infringement notices, totaling AU$26,640 ($19,170), in relation to imports of COVID-19 rapid antigen tests and nicotine vaping products. The agency alleges the company brought tests into the country that were not included in the Australian Register of Therapeutic Goods at the time of importation.
TGA Q&A, Advertising Notice, More
India’s NPPA plans study of global drug pricing policies and best practices
India’s National Pharmaceutical Pricing Authority (NPPA) is planning to study drug pricing policies around the world to better understand how to provide access to medicines at affordable prices. NPPA is looking to engage a research company or institution to carry out the study of global drug pricing policies.
In India, NPPA is responsible for implementing the Drugs (Price Control) Orders. The role leads NPPA to impose ceilings on the prices of many medicines and to monitor compliance with the rules. However, the limits of the organization’s powers has been a point of contention over the past decade, with the Indian government blocking a push by NPPA to control the prices of more drugs in 2014 and forming a committee to consider how to reform the body three years later.
Now, NPPA is taking its own steps to understand if there are better ways to ensure access to affordable medicines. The authority has released a request for proposal covering a study designed to help it to understand the drug pricing methodologies used internationally and lessons learned and best practices for the availability and affordability of medicine from other countries and regions.
Specifically, NPPA wants the researchers to look at “operational implementation” of drug pricing policies  in Sri Lanka, Bangladesh, China, the European Union, United Kingdom, Australia, United States, Brazil, South Africa and Thailand. NPPA is aiming to hold the “Opening of Financial Bid” for the work in early March.
NPPA Notice
South Korea approves Novavax’s recombinant protein COVID-19 vaccine
South Korea's Ministry of Food and Drug Safety (MFDS) has approved Novavax’s recombinant protein COVID-19 vaccine Nuvaxovid for use in the prevention of COVID-19 in people aged 18 years and older.
Novavax, working with local partner SK bioscience, secured the approval after putting Nuvaxovid through two Phase 3 clinical trials that enrolled participants in the UK, US and Mexico. The studies linked the vaccine to overall efficacy of 90%, although they took place before the omicron variant that has reduced the performance of leading COVID-19 vaccines.
SK bioscience will manufacture and market Nuvaxovid in Korea, where the government has placed an order for 40 million doses.
Press Release
TGA recognizes Sputnik V vaccine for international travel to Australia
TGA has recognized Russia’s Sputnik V vaccine against COVID-19 for international travel to Australia. The action means travelers who have received the vaccine meet Australia’s vaccination status requirements.
Australian authorities left Sputnik V off the initial list of vaccines recognized by TGA last year. However, the agency changed its position this week after information provided by the Russian government with the assistance of the Australian embassy in Moscow persuaded it the vaccine provides protection and potentially reduces the likelihood of COVID-19 transmission and severe illness.
The information showed two doses of Sputnik V provides 89% protection against symptomatic infection and 98% to 100% protection against hospitalization or death. The recognition does not cover the single dose vaccine course branded Sputnik Light. TGA said the recognition will expand options for the return of international students and travel of business people, elite sports people and workers to Australia.
TGA Notice
China’s NMPA posts guidelines to support development of drug-device combinations
China’s National Medical Products Administration (NMPA) has released guidelines and guiding principles to support the development and registration of drug-device combination products.
The update consists of two documents, a guideline that covers registration of drug-device combinations and a set of guiding principles that provides additional technical information. The guideline starts by setting out basic requirements, such as the need to test the device component of a combination as a single entity while paying attention to potential risks created through its interaction with the drug.
NMPA provides additional information about the research that is required in the guiding principles, where it sets how and why different studies are needed depending on whether the device delivers the drug to a particular site, as happens with drug-coated stents, or not.
The document goes on to discuss topics including drug characterization, quantification, in vitro release and methodological validation, including details such as the international and national standards that developers should follow when evaluating their drug-device combinations.
NMPA Notice (Chinese)


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