Asia-Pacific Roundup: TGA seeks feedback on Australian regulations for digital mental health tools
Australia’s Therapeutic Goods Administration (TGA) is holding a consultation to inform changes to the regulatory framework for digital mental health tools (DMHTs).
DMHTs, which have been a focus for regulators in countries including the United Kingdom, are software products that offer assessments, therapy, or self-management strategies to support mental health care. TGA’s definition of DMHTs includes apps, websites, and platforms. TGA regulates software that meets the definition of a medical device.
The consultation asks respondents if they use or provide any DMHTs, citing apps that provide cognitive behavioral therapy and online surveys that help determine whether someone has a mental health condition as examples of the tools. TGA wants respondents to disclose the name, end user, and intended purpose of the DMHT, plus whether they developed it and added it to the Australian Register of Therapeutic Goods.
Respondents must state which mental health conditions their DMHTs are intended to be used for. TGA has provided a list of mental health conditions for users to select from. Respondents also need to say whether their tools are based on established clinical practice guidelines and, if so, which ones.
The agency wants to know whether the established clinical practice guidelines are referenced and displayed within the DMHT. Organizations with DMHTs that reference or display guidelines must say how users can access and review the materials. Options include “the guidelines are referenced within the tool and are accessible while the tool is in use” and “the user is provided with a link to a paywalled copy.”
Another section of the consultation covers software other than DMHTs that organizations use to provide services. TGA has questions about software including programs that make or display calculations, tools for clinical workflow management, and electronic health records.
The sections of the consultation about DMHTs and other software each cover AI. Officials asked whether DMHTs incorporate or use AI. Organizations with DMHTs that have AI elements should provide details of the functionality enabled by the artificial intelligence.
In the section on non-DMHT software, TGA has asked whether organizations use digital scribes, tools that capture conversations between patients and healthcare practitioners and generate clinical notes, summaries, or letters. In January, TGA shared guidance on when digital scribes are classed as medical devices.
TGA also wants to know whether software used by organizations as part of service provision contains AI functionality, including generative AI tools like ChatGPT or Microsoft Copilot. Respondents must tell TGA whether they have policies or procedures to address the use of AI in their products.
The consultation closes on 7 August.
Philippine FDA starts consultation into clinical trials of medical devices and IVDs
The Philippine Food and Drug Administration (FDA) is seeking feedback on the rules and regulations for clinical studies of medical devices and in vitro diagnostics (IVDs).
FDA’s draft guidelines cover clinical investigations of medical devices and clinical performance studies of IVDs. Through the guidelines, the agency aims to fully protect the rights, safety, and well-being of human subjects, create an efficient, effective, and transparent process, and ensure compliance with regulations including good clinical practices.
The draft guidelines propose education requirements for qualified persons and make adherence to those requirements part of the criteria for receiving and maintaining a license to operate (LTO). Sponsors and contract research organizations (CROs) need LTOs to conduct device and IVD studies in humans.
Another section of the guidelines describes the process for applying to run a study. If FDA rejects a request to run a study, the applicant has 15 calendar days to ask the agency to reconsider its decision. The appeals process, which entails a fee, takes up to 20 working days.
FDA has proposed a six-month transition period for the guidelines. Sponsors and CROs running studies of Class B, C, and D devices or IVDs will need to apply for FDA approval of their trials. Active studies can continue while FDA is processing the application but must be suspended if the agency rejects the filing. Sponsors and CROs can resume suspended studies if FDA approves a subsequent application.
The consultation is open for feedback until 25 August.
Japan’s PMDA shares checklist for drugs derived from human or animal cell lines
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has shared a checklist for companies filing quality-related documents to support clinical trials of drugs derived from human or animal cell lines.
The document provides a checklist for clinical trial notifications (CTNs) subject to 30-day reviews. PMDA has split the checklist among different CTN items. For the initial CTN form, the checklist asks whether the applicant has stated that the product is manufactured using recombinant DNA technology and whether the dosage form is specified in the manufacturing process section.
Quality documents can be submitted in English. The quality materials referenced in the checklist include manufacturing flow diagrams, the results of viral clearance studies, and evidence that the master cell banks are free from infectious agents. An annex to the checklist features an example table of test results for adventitious agents in the master cell bank.
PMDA also provided specific examples of descriptions to be included in informed consent documents and related materials. The agency said it provided the examples in light of the increasing number of consultations and inquiries at its overseas offices from “overseas startups, venture companies, and other entities engaged in the development of innovative pharmaceuticals.”
NPPA clarifies India’s revised drug price filing rules, requests strict compliance
The National Pharmaceutical Pricing Authority (NPPA) has clarified the impact of changes to drug price law that the Indian government passed last month.
NPPA’s clarifications center on a provision to streamline the process for companies launching versions of existing drugs. The streamlined process applies to products with the exact composition of a reference drug that received a fixed retail price in the past 12 months. In that scenario, the company can launch the drug without having to go through the process of setting a retail price.
Companies that use the streamlined pathway must not sell their product above the price set for the existing drug. NPPA requires companies to inform it of launches within one month. When completing the notification form, manufacturers must “refrain from making any false or incorrect claims ... which may lead to initiation of appropriate penal proceedings,” NPPA said.
The authority ordered drugmakers to “strictly comply” with the revised requirements.
Indian committee demands clinical data to justify using higher dose of Wegovy
An expert committee has asked Novo Nordisk to provide data in Indian subjects to justify the use of a higher dose of Wegovy over the existing formulation.
Novo received approvals for high-dose Wegovy in markets including Europe and the US after linking the 7.2-mg formulation to a greater mean change in body weight than the existing 2.4-mg product. Yet the Indian expert committee concluded that the 7.2-mg dose “has not demonstrated any additional clinically meaningful benefit over the already approved 2.4-mg dose.”
Neither study of the 7.2-mg dose cited on the US Food and Drug Administration’s Wegovy label included sites in India, according to ClinicalTrials.gov. The committee wants Novo to submit data from Indian subjects to justify the use of the 7.2-mg dose over the existing 2.4-mg treatment. Novo should also share evidence to justify the lack of intermediate doses between 2.4 mg and 7.2 mg, the committee said.
