Asia-Pacific Roundup: TGA quarantines products over potential bacterial contamination
Australia’s Therapeutic Goods Administration (TGA) has quarantined multiple products after a cluster of patients tested positive for Ralstonia pickettii, a waterborne bacterium that causes significant mortality and morbidity in immunocompromised people.An investigation into the cluster of cases found some batches of Interpharma saline products were likely to have been used in the people who tested positive for R. pickettii. Cases of infection with the pathogen are rare, particularly in healthy people, and are often linked to contaminated medical solutions such as saline, sterile water and disinfectants.
Initially, TGA quarantined certain batches of Interpharma’s 10 ml ampules of sodium chloride 0.9% solution and all batches of 30 ml ampules of sodium chloride 0.9% solution but opted against recalling products because the link to the cases had not been confirmed. After further investigation, Interpharma recalled all batches of the 30 ml ampules. The recall followed preliminary testing that indicated the possible presence of R. pickettii in some batches. The test results are yet to be confirmed.
TGA announced the recall alongside the news that it has expanded the quarantine to cover all batches of two other sodium chloride solution products manufactured at the same facility as the Interpharma saline. The products are Yes Medical’s non-antimicrobial wound irrigation solution and Ironbark Creek Investments’ Logiwash sodium chloride for irrigation.
Like the Interpharma ampoules, the Yes Medical and Ironbark Creek products are manufactured by Legency Remedies, an Indian manufacturer of small volume parenteral products. No R. pickettii cases are linked to the Yes Medical and Ironbark Creek products and, while both are registered in the Australian Register of Therapeutic Goods, neither has been supplied in Australia.
Other regulatory agencies are monitoring the situation. The Hong Kong Drug Office issued a notice about the situation in Australia, noting that none of the ampules recalled by Interpharma and registered in its jurisdiction.
TGA Notice, More
Philippine FDA seeks feedback on use of online portal for initial medical device applications
The Philippine Food and Drug Administration (FDA) is holding a consultation into guidelines on the use of an online portal to apply for a Certificate of Medical Device Notification (CMDN). FDA’s guidelines cover the switch from the older ePortal System to the newer eServices Portal System.
FDA developed its eServices Portal System to “improve and streamline the digital application, processing and issuance of market authorizations” and advance the government’s ease of doing business. Separately, the agency has published guidelines on the use of the CMDN and Certificate of Medical Device Registration pathways depending on the risk level of a medical device and circulars on the application of ASEAN harmonized technical requirements.
In explaining the need for guidelines on the use of the technology, FDA said “it is essential to make use of the eServices Portal System in the initial application for CMDN to benefit from the system’s improvements,” adding that the guidelines will help to “streamline the processing of initial application for CMDN and update the existing procedures.”
The guidelines cover how to submit an initial CMDN application via eServices, check the status of a filing and download the notification. CMDN renewal and variation applications are outside of the scope of the document.
In the future, FDA will deactivate the current ePortal and switch to the eServices Portal System. FDA will continue to use ePortal to process applications submitted before the older system is closed to new submissions. Companies will be able to access the eServices Portal System without an account or password. FDA has provided step-by-step guides to using eServices Portal System.
FDA Guidelines
TGA warns ‘unexpected high demand’ will limit supplies of Eli Lilly’s Mounjaro until September
TGA has warned supplies of Eli Lilly’s type 2 diabetes medicine Mounjaro (tirzepatide) will be limited until 31 August 2024 because of “unexpected high demand,” now that Lilly’s Zepbound (tirzepatide) is approved for weight management in the US.
The shortage affects all strengths of Mounjaro. TGA expects availability of the six doses of Mounjaro to “vary over time” and is advising patients and healthcare professionals to check its shortage reports database for information on the strengths they need. The agency recommends patients who are unable to get the prescribed dose contact their doctor immediately to discuss their treatment. Currently, the four lowest doses of the medicine are listed as unavailable.
Lilly expects to send limited supplies of the four unavailable doses between 15 December and 15 February. TGA is also contending with the shortage of Ozempic (semaglutide), a rival GLP-1 drug sold by Novo Nordisk.
TGA Notice
Philippine FDA sets up technical working group focused on seized health products
The Philippine FDA has created a working group, Oplan Katharos, to “develop and implement guidelines in relation to proper handling, storage and disposal of seized health products.”
FDA set up Oplan Katharos earlier this year but announced it in a statement last week. The technical working group is “designed to align with national and international environmental conservation and recovery standards, demonstrating our commitment to these principles,” FDA said.
In the statement, FDA discussed recent actions such as the creation of guidelines and an order about the handling, custody and storage of seized health products. FDA is particularly concerned about the custody and storage of seized products that pose a “danger or imminent threat to public health and the environment.”
The agency is urging the public to “place their trust in the regulatory process” and only buy registered or notified health products from establishments with valid FDA licenses to operate.
FDA Notice
Indian Pharmacopoeia Commission seeks feedback on proposed changes to vaccine rules
The Indian Pharmacopoeia Commission (IPC) has released draft monographs and general chapters for feedback, offering the industry a chance to provide feedback on planned changes to vaccine rules.
IPC released amendments to four biological documents – two on vaccines – for consultation. In one document, IPC proposed changes to a general chapter on cell substrates to produce vaccines for human use. The changes cover the need to source trypsin and recombinant dissociating enzymes that are approved by the national regulatory authority for the intended use.
In the second document, IPC discusses how to test for extraneous agents in viral vaccines for human use. The other two draft documents cover blood and blood related products, as well as vaccines and immunosera for human use.
The comment periods close on 15 and 16 January. IPC plans to bring the changes into effect in 2026.
IPC Notice
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