Asia-Pacific Roundup: TGA creates regulatory requirements for COVID-19 testing software

RoundupsRoundups | 21 September 2021 |  By 

 Australia’s Therapeutic Goods Administration (TGA) has published the regulatory requirements for software used with COVID-19 rapid antigen self-tests. The document is part of a series of actions to prepare Australia for the lifting of the ban on self-testing for the pandemic coronavirus.
TGA has created the guidance to help test developers understand if it regulates their software and, if so, what requirements they need to meet. If the software analyzes or enables interpretation of the test sample or results, TGA will treat it as a medical device and require its inclusion in the Australian Register of Therapeutic Goods (ARTG). In contrast, software that is used for registration, recording of results or the generation of a digital health record is not regulated by TGA.
The guidance features five scenarios to explain when TGA will regulate software. One example covers the use of a QR code to link to a form that prompts the user to manually enter their result. TGA will not regulate such software. However, if the form asks the user to upload a photo of the test result for analysis by software or interpretation by the provider, TGA will class the product as a medical device. TGA will also regulate software that asks a user to enter symptoms to inform a diagnosis.
In the rest of the document, TGA sets out the requirements that apply to software that is categorized as a medical device. Generally, TGA expects software that analyzes or reads rapid antigen test results to improve the overall accuracy of the results. TGA wants developers to run clinical performance tests to show the effect of using software on the accuracy of the results.
Developers also need to run usability and user comprehension studies. TGA wants developers to evaluate the ease of using the testing software with at least 100 lay users and a range of results such as non-reactive, reactive, weak reactive and invalid. If applicable, the studies should show how the results generated by the software compare to visual reading of the results by a lay person.
Other sections of the guidance address requirements for minimum certification, technical elements such as cybersecurity, the use of artificial intelligence, instructions for use and postmarket review and monitoring. TGA also shared details of how to file to market a COVID-19 rapid antigen self-test, although the government is yet to permit the sale of such products.
TGA Requirements
PMDA answers questions about drug master file regulation in Japan
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published its third set of answers to questions about the regulation of drug master files (DMFs). The document covers communication with foreign companies, confidentiality and the role of contract manufacturing organizations (CMOs).
Foreign manufacturers cannot apply directly to PMDA to register a DMF. Rather, foreign companies need to go through an in-country caretaker (ICC). PMDA responded to a question about the need for an ICC that was prompted by concerns about differences between original documents and translations by the caretaker.
The agency clarified that forms must be completed in Japanese and an ICC must be appointed. However, under a system established in April, it is possible for the ICC and DMF registrant to consult directly with PMDA about master files for generic drugs.
PMDA also clarified that a CMO can be a DMF registrant, but the company that outsourced the work cannot be the DMF registrant. Another PMDA answer covers requests to DMF holders to disclose confidential information, explaining that registrants can submit the details directly to PMDA’s review office, rather than disclosing the secrets to the marketing authorization applicant or holder. 
China’s CDE seeks feedback on technical guidelines for CAR-T therapies
China’s Center for Drug Evaluation (CDE) is seeking feedback on technical guidelines on managing the risk of CAR-T therapies. The guidelines cover the possible safety risks of the cell therapies and the use of pharmacovigilance to monitor for adverse events.
In recent months, Chinese authorities have approved two CAR-T cell therapies for use in patients with large B-cell lymphoma, marking the start of the commercial use of the modality in the country. CDE has responded by proposing technical guidelines that address the specific safety risks associated with the cell therapies, such as cytokine release syndrome.
The guidance describes specific risk minimization measures that are required, on top of routine safety actions, to mitigate the unique dangers posed by CAR-T therapies. CDE is proposing that license holders certify and regularly recertify CAR-T treatment centers and perform long-term safety monitoring of patients. The certification process should cover apheresis, if needed, pre-infusion care, infusion, the treatment of adverse reactions and other aspects of the administration of CAR-Ts.
CDE is accepting feedback on the draft for one month.  
CDE Notice (Chinese)
TGA accuses political party of breach of copyright over COVID-19 vaccine messages
TGA has accused an Australian political party of breaching copyright by sharing incomplete extracts of adverse event reports relating to COVID-19 vaccines with members of the public.
Lawyers representing TGA wrote to Craig Kelly, the leader of the United Australia Party (UAP), to lay out their concerns. According to the lawyers, UAP, which is campaigning under the slogan “Make Australia Great,” has selectively taken extracts from TGA’s Database of Adverse Event Notifications and distributed them to the public in text messages that could be “seriously misleading.”
The lawyers allege the text messages breach copyright and have demanded that UAP stop sharing the incomplete information. UAP’s messages allegedly exclude a TGA statement that clarifies that reports in the database cannot be used to determine if a vaccine caused an adverse event. The messages also allegedly exclude a statement about the copyright status of the information.
TGA has previously accused Clive Palmer, the chair of the UAP, of paying for radio ads that gave “an incorrect picture of the safety of COVID-19 vaccines.”
TGA Notice
Philippine FDA moves to streamline process for donating COVID-19 products
The Philippine Food and Drug Administration (FDA) has updated its guidelines on the donation of health products solely intended for use in the response to COVID-19 to streamline the process.
FDA established a process for evaluating donated products in the early weeks of the pandemic and first updated the text in May 2020. The updated text is largely the same as the version released last year, with revisions limited to changes such as the addition of syringes and other products used in the administration of COVID-19 vaccines to the list of materials covered by the guidance.
The revised guidelines are now in effect and are set to last until the end of the year. FDA has already extended the duration of the temporary rules on donated products multiple times.
FDA Guidelines
Other News:
India’s COVID-19 committee has recommended the emergency authorization of Russia’s Sputnik V vaccine. The recommendation positions Hetero Biopharma to manufacture the vaccine for restricted use in emergency situations. Hetero received the recommendation on the strength of Phase 3 data on the safety and immunogenicity of the vaccine. Meeting Minutes
The Drug Regulatory Authority of Pakistan (DRAP) has expanded the scope of its existing exemptions of foreign manufacturers from inspections. DRAP will rely on approvals from overseas authorities to maintain standards in the absence of inspections of foreign facilities. DRAP Notice


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