Asia-Pacific Roundup: Singapore's HSA seeks feedback on exempting more AI software devices from requirements

Singapore’s Health Sciences Authority (HSA) is running a consultation into plans to exempt more types of artificial intelligence (AI)-software as a medical device (SaMD) products from its license and registration requirements. HSA is accepting feedback until 19 June.

The current regulations free specified healthcare service licensees that develop an AI-SaMD for in-house use from the requirements for a manufacturer’s license and product registration. Singapore adopted the policy to free healthcare providers from regulatory burdens that could impede their ability to develop and launch products quickly to meet the clinical needs of their patients.

Rather than apply the license and product registration requirements, Singapore relies on the regulated healthcare setting’s clinical governance frameworks, safety protocols and oversight of SaMDs to protect patients.

HSA identified a need to expand the exemption as Singapore’s Ministry of Health Office for Healthcare Transformation (MOHT), healthtech agency Synapxe and public healthcare clusters stepped up work on AI-SaMD. The organizations “are increasingly leveraging technology to develop AI-SaMDs customized for our public healthcare institutions, to facilitate and improve their provision of patient care,” HSA said.

Because the organizations span multiple healthcare service licensees, AI-SaMDs they develop are outside of the scope of the current exemption. HSA believes AI-SaMDs developed in public healthcare should be used across multiple institutions, both to spread the benefits and to prevent the duplication of activities. The current limitations of the exemptions prevent the cross-institution use of AI-SaMDs.

HSA is proposing to extend the exemption to cover AI-SaMDs that are developed by MOHT, Synapxe and public healthcare clusters and institutions and classified as low or moderately low risk. To be eligible, AI-SaMDs must also be developed under the supervision of a senior public healthcare clinician, only used in-house by public healthcare licensees and notified to HSA at the point of deployment.

The proposal includes safeguards and controls. HSA wants AI-SaMDs developers to “self-attest annually to a quality management system (ISO 13485), and check against an internal product control checklist.” Requirements to report adverse events to HSA will continue to apply. HSA will monitor the exemption for 12 months, or longer if more time is needed “to allow for a more robust assessment.”

HSA CEO Raymond Chua Swee Boon discussed the agency’s approach to AI at an event last week, telling attendees that the agency is “investing in regulatory science, leveraging real-world evidence and exploring sandbox approaches to test novel regulatory models.”

HSA Consultation, Speech Transcript

DRAP starts consultation into Pakistan’s draft guidelines on clinical trial conduct, inspection

The Drug Regulatory Authority of Pakistan (DRAP) is seeking feedback on planned changes to guidelines on the conduct of clinical research and inspection of good clinical practices (GCPs).

DRAP published the current versions of the guidelines in March 2024. The draft update to the guideline on GCP inspections includes new information on the risk-based selection of clinical trials. DRAP said the risk-based approach is a way to “proactively identify, assess and manage potential risks that could affect the quality, safety and integrity of the trial and the well-being of participant.”

The agency will start risk calculations once it receives a clinical trial application and include the initial risk calculation report in the “Summary Evaluation Report.” DRAP said it will assess risks related to the trial, sponsor oversight, site performance, patient safety, data integrity and regulatory or public interest. The agency has proposed a scoring system for quantifying the risks and informing inspection priorities.

Proposed changes to the clinical research conduct guideline center on the need to obtain approval from an institutional review committee, ethics review committee or institutional review board. The draft says such approvals are the first step in securing ethical clearance for a study.

DRAP has provided standardized templates for notification letters to the boards and committees and for ethical clearance letters. The templates are intended to ensure the review groups issue “consistent and comprehensive approvals.” DRAP has also provided standardized templates for progress reports, clinical study reports and the composition of the committees and bodies.

Both draft guidelines are open for comment until 5 June.

Conduct Draft, Inspection Draft

PMDA translates early considerations for running externally controlled clinical trials in Japan

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a translation of its advice on using external datasets to evaluate the results of single-arm clinical trials.

PMDA published the early consideration document in Japanese in March. In the translated version, the agency calls randomized clinical trials the “fundamental approach to obtaining evidence of the efficacy and safety of medicinal products.” Yet, PMDA accepts that single-arm trials may be run when it is hard to conduct randomized trials because of the small number of eligible patients.

“In such cases, the results of the trial may be evaluated by comparing them with the results of an external group that did not receive the treatment,” the agency said. “It is assumed that such externally controlled trials will be used to evaluate the efficacy and safety of the drug, and that the results may be utilized as part of the documentation for applications for marketing approval.”

External control arms can consist of people treated before the study began or patients treated at the same time as the single-arm trial but under different conditions. Either way, “bias arises from the fact that the comparison group is not randomized and that the clinical trials conducted as externally controlled trials are generally open-label,” PMDA said. Bias is a key limitation of the approach.

The early consideration document features advice for managing the limitations of externally controlled trials, covering topics such as the choice of external data source, how planning can mitigate bias and key considerations for the statistical analysis.

PMDA Advice

DRAP proposes draft guidance on emergency use authorization in Pakistan, seeks feedback

DRAP is seeking feedback on the regulatory framework for granting emergency use authorization (EUA) of medicinal products during a declared public health emergency in Pakistan.

The draft, which will become the first edition of the guidance, provides guidance on fast-track approvals “when the public health authorities may be willing to tolerate less certainty about the efficacy and safety of products, given the morbidity and/or mortality of the disease and the lack or paucity of treatment, diagnosis/detection or prevention options,” DRAP said.

DRAP will issue EUAs when there is an emergency that can cause a serious or life-threatening disease or condition, it is reasonable to believe that the product may be effective, and no adequate alternative is available. Applicants also need to show the known and potential benefits outweigh the known and potential risks, comply with good manufacturing practices and agree to complete development.

The rest of the draft covers instructions for the applicant and for DRAP. Applicants need to provide the available safety and efficacy information and a discussion of the risks and benefits. DRAP has proposed specific evidence and documentation requirements for vaccines. The agency will assess the nature of the emergency, type of product and other factors when prioritizing activities and setting timelines.

“Although the length of time required for action will vary, DRAP recognizes that it is likely that, in [an emergency] that is occurring or believed imminent, a request for consideration for an EUA will be acted upon with highest priority,” DRAP said.

DRAP Consultation

Asia-Pacific Roundup: Singapore's HSA seeks feedback on exempting more AI software devices from requirements

Related topics

Recommended content

Welcome to the new RAPS Digital Experience