Asia-Pacific Roundup: TGA identifies pressing need for guidance on adaptive and generative AI

The Therapeutic Goods Administration (TGA) has completed its review of areas that Australia needs to clarify and strengthen the regulation of medical device software, including artificial intelligence (AI).

TGA held a public consultation last year. More than 90% of respondents said TGA’s existing framework and technology-agnostic approach are robust and flexible enough to effectively regulate AI. However, the consultation also revealed areas that stakeholders believe need to change, including topics related to adaptive and generative AI models.

Medical device industry stakeholders told TGA they would like clarity on how to account for the outputs of adaptive or generative AI models where the original deployer does not have oversight of the relevant output. Some stakeholders said that continuously adapting AI warrants constant monitoring and real-time, continual review of performance to ensure the quality of outputs does not degrade over time.

TGA said, “These approaches are likely to be impractical without involving further AI models and systems tasked with conducting rolling review.” With stakeholders calling for more information about regulatory processes associated with assessing and approving changes in adaptive models, TGA said guidance for technical requirements for adaptive and generative AI should be developed as expeditiously as possible.

Respondents also called for TGA to develop and share more information on how essential safety and performance principles apply to the ongoing validation of adaptive and generative AI. TGA has opted against changing its existing essential principles, choosing instead to develop more extensive guidance with examples demonstrating how the current regulations would apply to specific use cases.

The agency signaled that more fundamental changes could be considered. TGA said it may be necessary to consider changes to the essential principles and potentially to the conformity assessment procedures as issues such as the regulation of adaptive and generative AI develop.

Other regulations could change pending further reviews. TGA identified a need to review the definitions of terms such as “manufacturer” and “supply,” the language used to assign responsibility for offenses, the regulatory status of digital scribes, and the classification of predictive or prognostic technologies. The agency is planning to hold further consultations on some of the topics.

The list of actions TGA already knows it needs to take includes developing guidance on the use of open datasets and software of unknown provenance. TGA said the guidance should be developed as soon as possible, with reference to applicable available standards, amid pressure on developers to validate datasets without access to information about their origin or the accuracy of reference standards.

“The development of innovative devices trained on unvalidated open datasets is an emerging issue for regulators, as developers seek more information about acceptable validation for medical devices that incorporate software of unknown provenance or are trained on open datasets,” TGA said.

TGA Notice, AI Review, Consultation Feedback

Singapore’s HSA tweaks filing requirements, streamlines processes in series of updates

The Health Sciences Authority (HSA) has made multiple changes as part of its ongoing initiative to make Singapore’s regulations more efficient and enhance the clarity of its requirements and processes.

HSA has updated its checklists for several types of approval filings to make them easier to use, switching from Word to Excel files in the process. The agency will accept the old Word format until the end of October, but is strongly encouraging applicants to familiarize themselves with the Excel checklist before its use becomes mandatory in November.

Officials also clarified the prerequisite documents for acceptance of applications for screening. HSA said it will not accept filings if any one of the eight documents is missing. The list includes the Excel checklist and several parts of the common technical document.

HSA updated the acceptable proof of good manufacturing practice (GMP) compliance for drug product sites. The changes align Singapore’s evidence requirements with the latest guidance on GMP conformity assessments of overseas manufacturers. HSA will accept valid PIC/S GMP certificates, establishment inspection reports, and close-out letters from the US FDA.

Other changes include the introduction of a new online form for drug master file submissions and the streamlining of dossier requirements for the major variation verification evaluation route. HSA will now accept complete assessment reports obtained from the public domain for the primary reference agency to support applications via the verification evaluation route.

HSA Notice

Study identifies urgent need for changes to boost Japan’s role in multi-regional trials

Researchers have called for Japan to make urgent changes to increase its participation in multi-regional clinical trials.

The study, which was published in the journal Therapeutic Innovation & Regulatory Science, looked at the participation of Japanese sites in multi-regional clinical trials in Asia between 2013 and 2022. Japan participated in 15% to 16% of the studies that small and medium-sized pharma companies ran in the region. The participation of sites from Singapore, South Korea and Taiwan was markedly higher.

The researchers said the results raise significant concerns about future potential drug loss in Japan. If Japanese patients are to continuously receive new globally developed drugs, the researchers believe the country needs to take urgent action to increase its participation in multi-regional clinical trials.

“For that purpose, an integrated approach that includes continuous improvement in pharmaceutical regulations and the clinical trial environment, as well as market attractiveness, will be necessary in parallel with strengthening of collaborations between Japan and other Asian countries/regions,” the authors said.

Paper

Hong Kong agrees to cooperate with Chinese city on drug and medical device regulation

The Hong Kong Department of Health has signed a cooperation agreement with the market regulatory administration for the Chinese city of Guangzhou.

Officials in Hong Kong and Guangzhou, cities that are part of the Greater Bay Area megalopolis, signed the agreement to deepen their cooperation on the regulation of drugs and medical devices. Ronald Lam, Hong Kong’s director of health, said the agreement will support collaboration on the testing of Chinese medicines.

Hong Kong’s Government Chinese Medicines Testing Institute, which is moving into new permanent premises this year, will work with the Guangzhou Institute for Drug Control on the testing. The Hong Kong Department of Health said Guangzhou’s institute has “technical advantages” in testing for pesticide residue, heavy metals, mycotoxin residue and irradiated Chinese medicines.

The agreement comes as Hong Kong prepares to consolidate the regulation of Western and Chinese medicines at the Centre for Medical Products Regulation (CMPR). Officials are aiming to establish CMPR by the end of next year.

Press Release

Other news

New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) has provided an update on its monitoring of the safety of anti-CD20 monoclonal antibodies. Medsafe did not receive any case reports of pyoderma gangrenosum linked to the medicines during the six-month monitoring period. The agency concluded that no further action is required for the potential safety concern. Medsafe Notice

India’s Department of Pharmaceuticals (DoP) has given companies another month to submit self-declarations and disclose promotional spending under the Uniform Code for Pharmaceutical Marketing Practices. The extension means companies have until the end of August to provide the information required to comply with the guidelines. DoP Notice

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has updated the safety information on the GLP-1 drugs semaglutide and tirzepatide after investigating cases of a slowing of gastrointestinal motility. PMDA Review

Asia-Pacific Roundup: TGA identifies pressing need for guidance on adaptive and generative AI

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