Asia-Pacific Roundup: TGA adopts 23 international scientific guidelines
Australia’s Therapeutic Goods Administration (TGA) recently announced that it has adopted 23 international scientific guidelines from European Medicines Agency (EMA), the International Council for Harmonisation (ICH), and the US Food and Drug Administration (FDA).
The guidelines cover a wide range of topics, including ICH guidelines on rodent carcinogenicity testing, quality risk management, and validation of analytical procedures, and an FDA guideline on considerations for real-world evidence and real-world data in evaluation of drugs and biologics.
TGA also adopted a number of EMA guidelines on the development of products for specific diseases, product-specific bioequivalence guidances for oral tablets, considerations for pharmacovigilance in pediatric products, quality documentation for biological products, stability testing for active substances and finished products, and guidance documents on the clinical evaluation, product information, and use of adjuvants in vaccines, among others.
While most guidelines contain no comments, a few EMA guidelines have been annotated to note when certain guidance documents or legislation in the European Union referenced in the adopted guidelines do not apply to medicines and biologics being evaluated by TGA.
TGA adopted the guidelines after a public consultation period that took place between November 2025 and February 2026.
India’s CDSCO releases new guidance on medical device software
The Central Drugs Standard Control Organisation (CDSCO) has released a new guidance document for manufacturers, importers, researchers, and other stakeholders on the submission of applications for medical device software in India.
CDSCO defined a medical software device as software that is required for a medical device to perform its intended use, including cloud-based and artificial intelligence-based software systems. Risk classification of the device is dependent on the intended use of the device and the significance of the software to the operation of the device.
In the guidance document, CDSCO also describes the requirements of the quality management system for the software, the regulatory pathway for marketing of the software device, and requirements for submission of applications, and post-market regulatory requirements.
Philippine FDA publishes roadmap for 2026-2030
The Philippine Food and Drug Administration (FDA) has published its five-year development plan for 2026 through 2030 that aims to modernize and streamline the agency’s processes.
“The Plan reflects the Agency’s shared vision and collective commitment to building a more efficient, transparent, and responsive FDA through the collaboration of its officials, personnel, and partners,” the agency said in a press release.
In a statement, the agency said the roadmap was designed to improve regulatory systems, operational efficiency, delivery of public service, and transparency. It is a response to challenges the Philippine FDA found through past performance reviews as well as improvements in inter-agency collaboration, harmonization of processes, modernization, political support, technology, and emerging opportunities.
The regulator said the plan will help create a “nimble and future-ready agency that can effectively ensure the provision of health products that meet the highest standards of safety and quality ensuring access, equity to every Filipino, thereby empowering national development and being a part of the broader effort toward global regulatory convergence.”
TGA, Malaysia’s NPRA issue safety concerns for GLP-1s
Two regulators recently issued safety alerts for glucagon-like peptide-1 (GLP-1) receptor agonists, citing risks of a severe eye disorder and severe acute pancreatitis.
Australia’s TGA said GLP-1 receptor agonists carry a risk of developing non-arteritic anterior ischemic optic neuropathy, a rare but severe eye disorder. This condition has no treatment and can lead to permanent visual impairment and blindness.
TGA noted the product warning applies to all GLP-1 receptor agonists authorized for use in Australia, including dulaglutide, liraglutide, semaglutide, and the dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist tirzepatide.
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) also released a safety alert stating patients who use GLP-1 receptor agonists are at risk of developing severe acute pancreatitis. The agency said it identified the issue through its global safety signal monitoring and based the warning on the United Kingdom Medicines and Healthcare Products Regulatory Agency drug safety update on GLP-1 receptor agonists released in January.
In Malaysia, the product warning applies to dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, and tirzepatide, NPRA said in the statement.
Other News:
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published an English language translation of its document of considerations for clinical evaluation of blood coagulation factor products for congenital hemophilia. The document notes that children 12 years and older may be evaluated with adults when developing products for blood coagulation factor VIII and factor IX products for congenital hemophilia. PMDA
