Asia-Pacific Roundup: TGA seeks feedback on increasing transparency of GMP inspection outcomes
Australia’s Therapeutic Goods Administration (TGA) is holding a consultation on its plans to publish good manufacturing practice (GMP) certificates and inspection outcomes.
Seeking to make GMP compliance more transparent, TGA has proposed publishing its certificates to international manufacturing plants that supply Australia and releasing final regulatory outcomes for its inspections of domestic and overseas facilities. The publications will provide clearer and more accessible regulatory information for industry while helping the public to understand drug quality safeguards, TGA said.
Historically, TGA has treated details of its international inspections as confidential regulatory information and not published lists of the sites it evaluates. The agency contrasted its historical approach with the practices of its peers in Canada, the European Union, and the United States.
TGA plans to move its practices closer to those of its international peers by publishing certain details of its GMP inspections, including the manufacturer’s name, the scope of the assessment, and whether the site was acceptable or unacceptable. The agency does not plan to release confidential or commercially sensitive information, such as details of individual companies’ supply chains.
Australian officials are considering two options for sharing inspection outcomes. Either way, TGA plans to publish outcomes for inspections completed after the transparency policy takes effect. The question is whether the agency should also publish outcomes from inspections completed in the 12 months prior to implementation.
If TGA implements the proposals, the agency will tell manufacturers of its intention to publish inspection outcomes once final compliance has been determined. The agency is not proposing to seek further approval from manufacturers before publishing this information.
Australian lawmakers will need to pass changes to empower TGA to publish the information. TGA aims to finalize and register its proposed legislative instrument on the Federal Register of Legislation by October. The agency wants to start publishing GMP certificates and inspection outcomes shortly after registering the instrument.
TGA is accepting feedback on its plans until 13 July. The agency has asked whether respondents support its proposals to publish GMP certificates and inspection outcomes, as well as whether they agree with the type of information it plans to disclose and whether it should retrospectively post inspection outcomes. Other questions cover TGA’s plans to publish information without consulting the manufacturer.
China sets 1 September start date for updated good clinical practice guidelines
China’s National Medical Products Administration (NMPA) has published updated good clinical practices (GCPs) for drugs and set a 1 September date for implementing the revised guidelines.
Updating GCPs that took effect in 2020, NMPA and three other Chinese government departments have added provisions on data governance. The topic was a focus of the draft NMPA released for consultation last year, when the agency proposed requirements related to metadata and audit trails, electronic system validation, unblinding, and database lock.
The draft data governance proposals echoed international standards such as the International Council for Harmonisation’s GCP guidelines. NMPA’s stated goal for the update is to enhance China’s drug research system and to support biotech innovation.
Other sections of the final guidance emphasize compliance with ethical principles, scientific rules, and relevant laws and regulations when applying new technologies and new methods. NMPA has clarified that the principal investigator is the responsible party at the trial site level.
China’s standing in global drug development has increased since the previous version of the guidelines took effect in 2020. Today, the country is a major source of new drug candidates, in part because of how quickly Chinese biotechs can advance assets to clinical proof of concept. Bristol Myers Squibb and Pfizer have struck deals in recent months to access early clinical development capabilities in China.
Hong Kong starts regulating medical gases as pharmaceuticals, threatens fines
The Hong Kong Department of Health has begun regulating medical gases as pharmaceutical products, imposing new requirements on companies that make, trade, and sell the products.
Enacting a decision made in 2024, Hong Kong authorities changed the regulatory status of medical gases on 14 June. Medical gas manufacturers, wholesalers, and retailers must obtain the relevant drug dealer’s license in accordance with the Pharmacy and Poisons Ordinance.
Medical gases must be registered with the Pharmacy and Poisons Board of Hong Kong before they can be legally sold in Hong Kong. The Board published guidance on registering medical gases in March, providing an overview of the scope of the registration requirements and details of the rules for finished product stability, container closure systems, and labeling.
The changes are intended to ensure that medical gases sold in Hong Kong meet safety, efficacy, and quality standards. Pharmaceutical products containing nitrous oxide, commonly called laughing gas, and nitric oxide are regulated as prescription drugs.
Having given the industry two years to adapt, authorities could punish people who fail to comply with the rules. It is a criminal offense to possess or sell unregistered pharmaceutical products or prescription drugs, and to manufacture or wholesale pharmaceutical products without a license. Penalties include up to two years in prison and a fine of HK$ 100,000 ($12,760) for each offense.
WHO names Hong Kong as collaborating center on influenza surveillance and response
The World Health Organization (WHO) has designated a Hong Kong health unit as a collaborating center on quality and capacity building for its Global Influenza Surveillance and Response System (GISRS).
WHO established GISRS to protect people from influenza, including by providing a global mechanism for virus surveillance and a global alert for novel respiratory pathogens. Collaborating centers in Australia, China, Japan, Russia, the United Kingdom, and the United States support the system by analyzing flu viruses to track seasonal and potentially pandemic strains and to inform vaccine recommendations.
The Microbiology Division of Hong Kong’s Public Health Laboratory Services Branch joined the list of collaborating centers last week. Hong Kong’s Department of Health has been an important partner of the GISRS for decades, Zhang Wenqing, WHO’s head of global respiratory threats, said.
Going forward, Hong Kong will work as a “‘super connector’ under the ‘one country, two systems’ principle, in order to serve the broader interests of national health and medical development and to act as a vital link between the Chinese Mainland and international health partners,” Ronald Lam, Hong Kong’s director of health, said.
Philippine FDA schedules consultation to discuss rules on sales promotion activities
The Food and Drug Administration (FDA) has arranged a public consultation to discuss proposed rules for sales promotion activities in the Philippines.
FDA’s definition of sales promotion includes raffles, contests, discounts, redemption programs, premium offers, and other promotional activities involving the products it regulates. The agency’s proposed policy sets out the requirements, procedures, and regulatory guidelines covering such activities. FDA released draft operational procedures for sales promotion permit applications for consultation in January.
Having drafted the policy, FDA has invited industry representatives to a consultation on 16 June. FDA plans to use feedback collected at the meeting to support the finalization of a “transparent, efficient, and responsive regulatory framework” for sales promotion permit applications.
Other News:
The deputy commissioner of China’s NMPA met with a delegation led by the Australian ambassador to China. The meeting covered how to broaden channels for technical exchanges and promote access to high-quality medical products. NMPA Notice
