Asia-Pacific Roundup: PMDA discusses changes to warning letters
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is considering adopting its own version of a warning letter system to publish the names of manufacturers, sites, and products with quality risks.Quality failings detected by the US Food and Drug Administration (FDA) can trigger warning letters that publicly disclose the nature and location of the issues, with some commercially sensitive information redacted. PMDA’s Office of Manufacturing Quality for Drugs lacks an equivalent system.
The Japanese regulatory agency proposed implementing such a system in its annual good manufacturing practice (GMP) report. PMDA said, “Any recurrence of a critical deficiency at a manufacturing site due to insufficient GMP control needs to be widely publicized as soon as possible once it is determined no appropriate improvement for risk reduction is expected.” That thinking informed PMDA’s intent to discuss implementing a warning letter system with Japan’s Ministry of Health, Labour and Welfare of Japan and prefectural governments.
PMDA framed its pursuit of new powers to publicize recurrences of critical deficiencies as a continuation of its existing efforts to share the knowledge it has gained, including through GMP inspections of local and overseas drug manufacturing sites.
“By initiating risk communication activities to share this knowledge with society, while ensuring that the intellectual property rights of manufacturers are not infringed, PMDA aims to enhance synergy with efforts to improve quality through GMP inspections,” the agency said. “This initiative also represents a new approach to utilizing PMDA’s knowledge as part of its technical support for drug manufacturing sites.”
The annual report shares the major deficiencies PMDA inspectors reported in the agency’s 2023 financial year. PMDA’s global inspection activities bounced back in 2023 after the pandemic hindered assessments of overseas sites in 2020, 2021, and, to a lesser extent, 2023. The agency resumed inspections in China, assessing 41 sites in its first visits to the country since it evaluated 40 facilities in 2019. Inspections in India, other parts of Asia, and the Middle East rose too, driving overall activity beyond the high of 2019.
PMDA performed 233 on-site GMP inspections and 1,884 desktop GMP assessments. “A significant proportion of the major or critical deficiencies pertained to deviation handling and validations,” PMDA said, and deficiencies related to organizational management and quality management fell after rising the previous year. The agency attributed the rise in 2022 to a clarification of the rules.
PMDA Report
Singapore introduces online system for cell, tissue, and gene therapy product filings
Singapore’s Health Sciences Authority (HSA) has launched an online system for handling cell, tissue, and gene therapy product licenses and certificates.
Starting 10 February, companies can log in to SHARE (Singapore Health Product Access and Regulatory E-System), with Corppass to carry out certain regulatory activities. Companies can use the system to apply for a dealer’s license or to change or cancel an existing license.
The system also supports requests for good manufacturing or distribution practice certificates and allows users to track and withdraw applications and check their active licenses and certificates.
HSA stopped accepting submissions via the FormSG platform on 7 February and activated SHARE on 10 February. The switch to the new platform is the only change to the regulatory and submission requirements for cell, tissue, and gene therapy products.
HSA Notice
Roche alerts DRAP to sale of counterfeit drug in Pakistan
The Drug Regulatory Authority of Pakistan (DRAP) has published a rapid alert about counterfeiting and trademark infringement after receiving information from Roche.
DRAP posted an alert about the sale of counterfeit laroscorbine platinum injection, a product “believed to brighten the skin and maintain skin elasticity” in Pakistan. The product carried the Roche logo, and the label claimed it was manufactured by the Swiss drugmaker. Yet Roche sold the product and brand to Bayer in 2005. The company told DRAP that any products sold under the Roche logo today are, therefore, counterfeit.
“The regulatory field force has been directed to conduct surveillance activities throughout the supply chain to confiscate the counterfeit product,” DRAP said. “All pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock.”
DRAP Notice
Malaysia’s MDA sets 1 March deadline for moving ad applications to online form
Malaysia’s Medical Device Authority (MDA) will move the entire advertisement application process to Google Forms on 1 March.
Ads that promote the use or supply of medical devices to the public must receive approval from MDA. Devices intended for use by healthcare professionals are exempt from the ad approval requirement. MDA currently accepts applications via email but will close that channel and switch all filings to a Google Form on 1 March.
The agency said the change is intended to “enhance efficiency, streamline submissions and improve the overall experience for applicants” and ensure “a more organized and accessible process.” MDA will stop sending hard copies of ad approvals and will only contact successful applicants by email.
The Google Form is already available online. MDA plans to provide more information and instructions as the switch to the new process approaches. Applicants that use channels other than the Google Form starting 1 March will need to re-apply using the new process.
MDA Notice
HSA: Fewer illegal product seizures in 2024
HSA has reported a decline in the results of its activities to counter illegal health products. The agency seized fewer products and removed fewer product listings in 2024 than in 2023.
In 2023, the agency seized more than 1.12 million units of illegal health products and removed more than 12,000 listings from local e-commerce and social media platforms. Last year, the numbers of seizures and removals fell to around 970,000 and 7,000, respectively.
Removals fell despite HSA collaborating with organizations including Amazon, eBay, Facebook, and TikTok to delete product listings from online platforms. Two international operations led by Interpol inflated the number of removals in 2023. HSA removed 477 illegal online listings in 2022.
The number of seizures also compares more favorably to 2022 than 2023, an outlier in which activity spiked. HSA seized 737,000 units of illegal health products in 2022. Last year, codeine cough syrup made up more than half of the 970,707 units of illegal health products seized by HSA. Sexual enhancement medicines and sedatives were the next two most seized products.
HSA Notice
Other news
The Philippine Food and Drug Administration (FDA) has started offering an over-the-counter payment system for all applications at its central office. FDA, which launched the service on 10 February, has set conditions to ensure the security and convenience of the payment system. Only companies with an approved schedule of payment can use the service. FDA Notice
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