Asia-Pacific Roundup: TGA moves to updated PIC/S GMP guide, seeks feedback on AI changes
Australia’s Therapeutic Goods Administration (TGA) has adopted the 2023 version of the PIC/S Guide to Good Manufacturing Practice (GMP).TGA adopted the 2022 edition of the guide, apart from annexes 4, 5, and 14, last year. The regulatory agency switched to the 2023 edition, again with the exception of the three annexes, on 1 September. The updated version of the guide contains revised information and requirements related to the manufacture of sterile medicinal products.
Most of the changes clarify existing GMP regulatory expectations, TGA said, but some companies may need to implement or modify operational processes and procedures to comply with the updated guide. The introduction of the contamination control strategy (CCS) concept is among the bigger changes.
“A CCS should be implemented across the facility in order to define all critical control points and assess the effectiveness of all the controls (design, procedural, technical, and organizational) and monitoring measures employed to manage risks to medicinal product quality and safety,” TGA said. “The combined strategy of the CCS should establish robust assurance of contamination prevention.”
The previous GMP expectations required manufacturers to maintain appropriate process knowledge and establish and maintain a state of control, rules that overlap with the CCS terms. As such, TGA said it is “highly likely” that manufacturers that complied with the previous rules have existing documents for the assessment of CCS.
Even so, companies may need to collate their documents and develop an overarching policy to comply with the updated guide. TGA listed several other areas where companies may need to take steps to meet the new requirements. The steps include the development of lists to control materials introduced into cleanrooms, the incorporation of air-flow visualization into training, and the addition of isolate testing.
TGA has created a transition plan for complying with revised requirements. The agency expects sites to comply with most of the guide from 1 September. For the most significant changes, TGA is giving facilities until the start of 2026 to have reviewed the impact of the updated guide and begun to make changes. The agency expects sites to fully comply with the guide by 1 March 2026.
Australia’s adoption of the updated guide coincided with the Drug Regulatory Authority of Pakistan’s (DRAP) move to the PIC/S document. DRAP has updated legislation to replace references to “Schedule B,” which provides GMP guidance, with references to the PIC/S guide.
TGA is considering adopting more PIC/S changes but is seeking feedback first. The consultation covers changes related to digital technology and artificial intelligence that affect one chapter and two annexes. TGA is accepting feedback until 7 October.
TGA Notice, DRAP Legislation, TGA Consultation
TGA seeks feedback on proposed annotations to incoming international GCP guidelines
TGA is running a consultation into its annotations to the International Council for Harmonisation’s (ICH) latest revision of a guideline for conducting clinical trials.
ICH endorsed the third revision of its E6 good clinical practice guideline in January. Because Australia has local clinical trial requirements, TGA has annotated the ICH document to cover how the international text will be implemented in the country.
The TGA annotations include a comment on ethics committees’ responsibilities, composition, function, operations, procedural, and record keeping requirements. TGA is recommending that Australia’s National Statement on Ethical Conduct in Human Research takes precedence over the ICH guideline to the extent that there is “a perceived inconsistency” between the domestic and international documents.
TGA expects to adopt the annotations in January 2026 but will defer full enforcement for 12 months. During the transition period, TGA will expect clinical trials to comply with either ICH E6(R2) or ICH E6(R3) with its annotations. Sites should maintain training records on the ICH guideline version used. The agency will start fully enforcing ICH E6(R3) with annotations in February 2027.
TGA is accepting feedback on the annotations and transition period until 10 October. The agency is also planning a consultation on ICH E6(R3) Annex 2 but is yet to set a date or provide further information.
TGA Consultation
CDSCO starts consultation into standard protocols for evaluating tuberculosis diagnostics
India’s Central Drugs Standard Control Organization (CDSCO) is seeking feedback on draft protocols for the evaluation of in vitro diagnostics (IVDs) for pulmonary tuberculosis.
Working with the Indian Council of Medical Research, CDSCO has developed standard protocols for evaluating the analytical and clinical performance of IVDs for pulmonary tuberculosis. The collaborators have also developed a standard protocol for evaluating the clinical performance of IVDs for drug-resistant forms of the bacterial infection of the lungs.
The consultation follows calls for feedback on protocols for evaluating tests of human metapneumovirus and IVDs against chikungunya, dengue, and zika viruses. As in the earlier consultations, CDSCO is calling for feedback on frameworks for facilitating the availability of quality-assured diagnostic kits.
The tuberculosis protocols describe procedures for evaluating nucleic acid amplification tests, analyzing the data, and otherwise showing the IVDs meet performance requirements. CDSCO wants companies to use leftover sputum specimens collected for routine diagnostic evaluation in their studies, rather than collect new samples.
CDSCO is accepting feedback on the draft protocols until 7 September.
Draft Protocols
Hong Kong approves 3 drugs under 1+ mechanism as industry inquires continue to rise
Hong Kong has approved three drugs under its 1+ mechanism, bringing the total number of medicines authorized via the pathway up to 14.
The mechanism provides a route to market for medicines that are authorized in at least one reference drug regulatory authority. Hong Kong previously required two reference approvals but, as it works to set up drug review capabilities, the government has begun accepting products that have one authorization. Products must also be supported by local clinical data and recognized by local experts.
Interest in the approval mechanism has risen this year. In February, the Hong Kong Department of Health said it had received more than 370 inquiries from over 100 pharmaceutical companies. By April, the department had received 460 inquiries from 120 companies. The latest tally is more than 620 inquiries from over 160 pharmaceutical companies.
Press Release
Other News:
DRAP has told manufacturers and importers of human and veterinary medicines to regularly submit antimicrobial batch production or import data. The regulator said the data is critical for use in implementing antimicrobial stewardship policies to combat drug resistance in Pakistan. DRAP plans to analyze the data yearly for regulatory purposes. DRAP Notice
CDSCO has changed how it presents not of standard quality (NSQ) alerts on its website. The agency has created a dedicated link to the alerts on its website. CDSCO said the newly implemented alerts contain information such as the name of the product, manufacturing details, and NSQ results. The agency has designed the resource to be easily searchable. CDSCO Notice
TGA said it is “stepping up its efforts to make sure that software-based medical devices meet Australia’s regulatory requirements.” The agency is currently focused on artificial intelligence digital scribes, tools that capture conversations between patients and healthcare practitioners. New digital scribe features such as diagnostic and treatment suggestions may meet the medical device definition. TGA Notice
TGA has approved substitutions to mitigate a shortage of the blood pressure drug Presolol 100. TGA Notice
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