Asia-Pacific Roundup: Singapore advances legislation to build ‘more coherent, future-ready’ regulatory system
Singapore’s Parliament has advanced legislation to build “a more coherent, future-ready system” that provides clarity and predictability for the healthcare industry.
Currently, Singapore splits regulatory responsibilities across three agencies. The Ministry of Health (MOH) regulates healthcare services, health information, human biomedical research, and biosafety; the Health Sciences Authority (HSA) oversees health products such as medicines and medical devices; and the Secretariat of healthcare Professional Boards (SPB) covers healthcare professionals.
The model has served Singapore well, politician Rahayu Mahzam told Parliament, but “services, products, professionals, and health information increasingly intersect.” The overlaps created oversight and regulatory touchpoints across different agencies, raising the risk of “gaps in handling complex or cross-cutting cases,” Mahzam said. The politician named AI as a field overseen by all three agencies.
In response, the government plans to consolidate health regulatory functions. Under the plan, officials will establish an integrated health regulatory function under HSA, allowing licensing applications and inquiries to be managed by one agency. The government sees the single-agency approach making information and responses more coordinated and clearer for stakeholders. The proposals are also intended to achieve greater regulatory alignment across the research and clinical care continuum.
“Researchers and clinicians across the research and clinical care continuum will experience clearer and more consistent guidance upstream, thereby strengthening protection for research participants while providing a clearer pathway from research to eventual clinical application,” HSA said.
The legislation expands HSA’s functions, transferring oversight of the Human Biomedical Research Act and the Biological Agents and Toxins Act from MOH to the agency. HSA officers will assist MOH and the Director-General of Health in administering or enforcing specified acts and assume SBP’s responsibilities for helping healthcare professional boards deliver their regulatory mandate.
HSA will take on the expanded role across two phases. MOH’s regulatory functions and manpower will transfer to HSA in November 2026. HSA will take over SPB's functions and manpower by the end of next year.
Australia amends clinical decision support exemptions, rules for some combination products
The Australian government has amended the therapeutic good legislation covering exemptions of clinical decision support systems (CDSS) and the rules for some combination products.
Australia’s Therapeutic Goods Administration (TGA) defines CDSS as “software that can perform a broad range of functions to enable and support clinical practice.” Some CDSS are excluded from the scope of TGA regulation, freeing companies from the need to add the software to the Australian Register of Therapeutic Goods (ARTG).
While TGA has advised on how to determine if software is excluded, the government identified a need to provide more clarity about when the exemption applies. The scope of the exemption and regulatory requirements are unaffected by the clarification, which will take effect on 1 November.
The government issued the clarification as part of an amendment that addressed the classification rules for noninvasive medical devices that are used to maintain the patency of, or flush the lumen of, another medical device. TGA named prefilled saline flush syringes and vascular access device locking solutions as examples of such noninvasive devices.
Australia will assign medical devices that meet the definition, and only contain saline for maintaining patency or flushing the lumen, to Class IIa. Other classification rules apply to medical devices that contain a medicine.
TGA began applying the classification rules to applications for inclusion in the ARTG on 7 September. A five-year transition period applies to existing ARTG entries and applications lodged before 7 September.
Legislation Amendment, CDSS Notice, Classification Rules
Philippine FDA seeks feedback on minimum number of samples for laboratory analysis
The Philippine Food and Drug Administration (FDA) is holding a consultation into draft guidelines on the minimum number of sample units required for laboratory analysis.
FDA collects and tests samples as part of its postmarketing surveillance activities. The impact of the activities depends on FDA having sufficient suitable samples for analysis. FDA published guidelines on the topic in 2014. However, advances in analytical methods, evolving regulations, and other changes mean the rules “no longer adequately address current testing needs and operational realities,” FDA said.
In response, FDA has proposed updating and harmonizing requirements. FDA plans to incorporate new product categories and sample types, streamline testing requirements for certain analyses, and “ensure the efficient utilization of resources.”
The guideline includes annexes listing the minimum number of samples for different types of medicines, medical devices, and other products regulated by FDA. For example, 20 sample units are needed for bacterial endotoxin testing of sterile medical devices used in parenteral routes of administration. FDA provided the new minimum numbers alongside updated submission requirements.
Companies can submit samples in accordance with the old quantity requirements and test parameters for 60 calendar days after the new guidelines take effect. During the transition period, FDA will not reject submissions solely because they contain too few samples.
Indian authorities intensify oversight after detecting substandard rabies vaccines again
India’s Central Drugs Standard Control Organization (CDSCO) has issued a warning about misbranded and substandard rabies vaccines.
Police and drug inspectors found products purported to be the rabies vaccine Abhayrab during a search of a flat. The vaccines were misbranded because they were not made by the registered manufacturer, Indian Immunologicals (IIL). Subsequent CDSCO testing revealed that the vaccines were substandard. The vaccines failed a potency test. Multiple aspects of the product label differed from authentic Abhayrab.
The findings mark the second time in two years that authorities have found counterfeit Abhayrab in India. Last year, IIL issued an alert about another batch of purported Abhayrab that shipped in packaging that differed from the authentic product.
After the latest discovery, the Drugs Controller General of India (DCGI) told state officials to “maintain strict vigilance over the movement, distribution, and availability” of the misbranded and substandard batch. DCGI asked state officials to take “appropriate regulatory action, as deemed necessary.”
China and Hong Kong agree to collaborate on Chinese medicine testing and standards
Health authorities in China and Hong Kong have signed a cooperation agreement on testing technologies for Chinese medicine and the internationalization of standards for the products.
China’s National Medical Products Administration and Hong Kong’s Department of Health signed the agreement. The signing supports information exchanges and collaborations related to the traditional pharmacopeia, plants or fungi processed for medical use, testing technologies, safety tests, and quality risk control.
The two sides plan to hold expert meetings, seminars, and training sessions under the cooperation pact. Other objectives include deepening “talent training and technical interfacing” to promote standards and testing technology innovation in alignment with international practices.
Other News:
The Pharmaceuticals and Medical Devices Agency (PMDA) is seeking feedback on planned changes to the Japanese Pharmacopoeia. Draft texts open for comment until 30 September cover topics including the assessment and control of DNA-reactive impurities in chemically synthesized drug substances and drug products. Draft monographs are open for comment until 30 November. PMDA Notice, More
TGA is holding a consultation into proposed amendments to the classification of nitrous oxide. Seeking to manage the increasing public health risks from misuse of nitrous oxide, TGA is soliciting feedback on two potential changes to the rules. A private applicant proposed one of the changes. TGA Notice
