Asia-Pacific Roundup: Australia’s TGA seeks feedback on planned adoption of 23 international guidelines
Australia’s Therapeutic Goods Administration (TGA) is holding a consultation to gauge support for plans to adopt 23 international guidelines.TGA has adopted about 370 international scientific guidelines as part of Australia’s policy of aligning with comparable overseas regulatory counterparts wherever possible. While most of the guidelines in the latest batch would replace those already adopted, two European guidelines are new.
TGA has proposed adopting a guideline on the quality, non-clinical, and clinical aspects of medicinal products containing genetically modified cells, which came into effect in the European Union in 2021. The EU guideline defines scientific principles and provides guidance for developing and evaluating CAR-T treatments, as well as other genetically modified cell therapies.
The other new document provides guidance for individual laboratories for the transfer of quality control methods validated in collaborative trials with a view to implementing the 3R principles (replacing, reducing, and refining animal testing). The European Medicines Agency (EMA) adopted the text in 2017 to support the use of new 3Rs methods for regulatory purposes.
The other 21 international guidelines under consideration would replace documents previously adopted by TGA. In most cases, TGA has only asked whether the respondent supports the adoption of the document and given them an opportunity to explain their position. The exceptions are four documents that include annotations from the Australian regulator.
TGA has proposed adopting the general principles of US Food and Drug Administration (FDA) guidance on the use of real-world data and real-world evidence in regulatory decisions for drug and biological products. The Australian agency added that FDA processes are not applicable to TGA filings and that it may consult again or further annotate the text once its American counterpart finalizes the guidance.
Another annotation states that an EMA paper on Creutzfeldt-Jakob disease “is not entirely accurate.” The reflection paper states TGA has removed the deferral of blood and plasma donors with a history of living in the UK, where variant Creutzfeldt-Jakob disease emerged in the 1980s. TGA clarified that certain UK residents remain ineligible to give blood and plasma, but it has exempted some sponsors from the rule.
TGA seeks feedback on plans to adopt the guidelines by 10 February 2026.
TGA Notice
India’s DCC acts on reports that regulatory enforcement lags in some states
The Drugs Consultative Committee (DCC) has called for Indian states to take proactive to ensure the uniform nationwide implementation of regulatory standards.
DCC, an advisory body, made the recommendation at a recent meeting after learning of state-by-state variability in adherence to medicine standards. The committee heard that some states are lagging in implementing prescribed drug standards, establishing testing facilities, developing staff, and creating centralized agencies for the effective enforcement of drug standards.
Variable progress in these areas has been accompanied by low conviction rates. DCC attributed the conviction rates to insufficient investigations, delays in receiving test results, and ineffective prosecution services. The committee also received reports of failures to “implement rigorous scrutiny of adulteration in imported pharmaceutical products.”
In response, DCC emphasized the need for uniform implementation of drug standards and recommended that a letter be sent to all states to prompt action addressing the issues. The committee also suggested that India’s government may write to its state-level counterparts to provide the necessary infrastructure, including adequate manpower, as highlighted under the State Health Regulatory Excellence Index.
The recommendations were part of a broader set of deliberations about state-level regulatory oversight and activity. DCC heard that “only the few states” are sharing not of standard quality (NSQ) reports with the Central Drugs Standard Control Organization (CDSCO). The committee stated that NSQ data will be shared with the CDSCO on a monthly basis, in the format provided.
DCC made the statement as part of a discussion on the benchmarking of national regulatory authorities by the World Health Organization (WHO). The committee heard proposals about the implementation of market surveillance and control work. DCC also considered a plan to allow states with well-established regulatory systems to participate in self-assessment in preparation for WHO benchmarking voluntarily.
Another section of the meeting considered a proposal to use separate forms for drug ingredients and finished products. DCC heard that the sale and distribution of active ingredients, excipients, and finished drugs is currently covered by the same licensing forms, despite differences between the activities. The committee agreed to separate the requirements and forms for ingredients and finished products.
Meeting Minutes
Malaysia’s NPRA answers questions about good laboratory practice compliance
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has answered frequently asked questions (FAQs) about its good laboratory practice (GLP) compliance program.
As NPRA explains in the document, participation in the GLP compliance program is voluntary and open to labs in Malaysia. Facilities that obtain GLP certification show the reliability, integrity, and traceability of their non-clinical safety data, NPRA said. Certification promotes confidence among sponsors and global regulators, the agency said, and supports more widespread acceptance of the site’s data.
A section of the FAQ covers regulatory acceptance and compliance. NPRA has used the section to clarify when non-clinical safety studies must be conducted in line with GLPs, the application of the practices to cell and gene therapies, and the implications of losing compliance status. Facilities removed from the program can reapply. NPRA will decide whether labs that reapply need to complete a pre-inspection.
Other sections of the FAQ address study conduct and quality assurance responsibilities, data, records, and documentation, facilities, equipment, and systems, as well as test item management. The sections answer questions about subcontracting parts of GLP studies, retaining records, replacing paper documents with electronic archives, using computerized systems, and ensuring the required environmental conditions.
NPRA FAQ
Microsoft’s end of Windows 10 support prompts TGA advice on mitigating steps
TGA has told manufacturers of medical devices that use Microsoft Windows 10 to provide a solution for users who are unable to upgrade their operating system.
Microsoft provided the final Windows 10 security updates in October. TGA stated that devices using the operating system will no longer be supported and may be vulnerable to unauthorized users or malicious actors. Users can maintain support through an Extended Security Updates (ESU) program that runs until October 2028.
“Manufacturers and sponsors should consider a transition timeline to maintain Windows 10 ESU support and eventually upgrade all systems to Windows 11 where feasible,” TGA said. “Manufacturers and sponsors are required to ensure, and notify customers, if their existing hardware requirements are insufficient for a Windows 11 upgrade and provide an alternative solution.”
TGA said operating system upgrades must maintain compliance with the Essential Principles to protect patient data and ensure device functionality. New devices should be supplied with Windows 10 with the ESU and a transition plan, or with Windows 11.
TGA Notice
Other news
A CDSCO Subject Expert Committee has asked GSK to provide the complete Phase III study report for its respiratory syncytial virus (RSV) vaccine. SEC wants to see stratified data for adults aged 60 years or older and six-month safety data. The committee recommended that CDSCO sees the RSV data before granting a new drug permission. Meeting Minutes
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