Asia-Pacific Roundup: Singapore, Hong Kong sign cooperative regulatory agreement for health products
Singapore and Hong Kong have signed a memorandum of understanding that allows cooperation between their regulatory agencies to manage issues regarding health products such as pharmaceuticals, medical devices, advanced therapy products and traditional medicines.As part of the memorandum of understanding, Singapore’s Health Sciences Authority (HAS) and the Hong Kong Department of Health (DoH) can exchange information, best practices, expertise, and engage in technical cooperation. The regulatory authorities can also share experts and staff, participate in conferences and meetings, and attend training courses and joint projects.
“This partnership represents a significant step forward in regulatory cooperation between Singapore and Hong Kong,” HSA CEO Raymond Chuasaid in an announcement. “By combining our expertise and sharing best practices, we can better tackle the emerging challenges in healthcare regulation, harness opportunities and strengthen public health protection in both jurisdictions."
Announcement
Korean Ministry of Food and Drug Safety becomes WHO listed authority
The Korean Ministry of Food and Drug Safety (MFDS) announced it has had its listing scope as an official World Health Organization (WHO) listed authority expanded to include all regulatory functions.
The regulatory authority was one of the first to complete the WHO-listed authority assessment for vaccines and medicines in October 2023 and was also the first to be designated as a WHO-listed authority.
A full-scope listing is expected to “significantly support the global expansion of Korea's pharmaceuticals and vaccines,” MFDS Minister Oh Yu-Kyoung said in a statement.
Announcement
TGA warns against use of at-home fetal heart monitors
Australia’s Therapeutic Goods Administration (TGA) recently published a safety alert warning against using fetal heart monitors at home.
Despite removal of all at-home fetal heart monitors from the Australian Register of Therapeutic Goods in September 2024, TGA noted that there appear to be illegal sales of new and secondhand devices on the market.
The regulatory authority emphasized caution for anyone considering using these devices for home use and encouraged expectant parents with concerns to seek the advice of healthcare professionals.
“Using a home-use fetal heart monitor to check a baby’s heartbeat may seem reassuring but it can be dangerously misleading,” TGA said in the safety alert. “We have received reports of instances where they have provided false reassurance, leading to delayed medical attention and deaths.”
Alert
Medsafe seeks consultation from providers, patients on proposed clozapine blood monitoring, prescribing changes
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is asking healthcare professionals, consumers, and their families about a proposed prescribing change to clozapine.
The regulator said it has identified “several opportunities” to optimize blood monitoring requirements. It wants feedback from healthcare professionals on who should initiate treatment and which prescribers can continue treatment. Medsafe is proposing to change the duration of blood monitoring, monitoring thresholds, management of low blood count results, and who can prescribe clozapine.
The consultation questions for healthcare professionals propose that blood monitoring be stopped for patients who have been taking clozapine for 1-3 years and are adherent to treatment, able to manage their own care, and have a history of absolute neutrophil counts ≥ 1.0 x 109 /L and no history of severe neutropenia/agranulocytosis.
Medsafe is accepting survey submissions from the public and healthcare professionals until 8 October 2025.
Consultation 1, 2
DRAP streamlines review process for liquid injectable products
The Drug Regulatory Authority of Pakistan (DRAP) has announced it is streamlining its review of Form 5-F used in submissions for certain liquid injectable products.
According to DRAP’s policy update, dossiers of liquid injectable products will only require a complete Form 5-F for a designated representative fill volume if it contains different fill volumes that have the same strength per unit.
DRAP noted that the submission requirements for the single Form 5-F are that the fill volume should have the same active pharmaceutical ingredient or drug substance source, have an identical container-closure system, and have the same strength per unit regardless of fill volume.
Update
ICMR, CDSCO publish draft of IVD standard evaluation protocols for influenza, RSV, SARS-CoV-2
The Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organization (CDSCO) have published draft standard evaluation protocols for in vitro diagnostic (IVD) kits that identify various strains of influenza, respiratory syncytial virus (RSV), and SARS-CoV-2.
ICMR and CDSCO said that the protocols align with international standards, and include protocols for performance evaluation of influenza, RSV, and SARS-CoV-2 in single-plex or multiplex molecular assay formats for accuracy, sensitivity, specificity, and reliability.
“Although SARS-CoV -2 is no longer a public health emergency globally, it is prudent to implement integrated surveillance for Influenza, SARS-CoV-2 and other respiratory viruses, making differential diagnosis for these viruses essential,” ICMR and CDSCO wrote.
The protocols are open for public comment until 25 August 2025.
Draft
×
Welcome to the new RAPS Digital Experience
We have completed our migration to a new platform and are pleased to introduce the updated site.
What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.
We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.
We welcome your feedback. Please let us know how we can continue to improve your experience.