raidsPosted on 05 July 2022 | Through
Asia-Pacific Roundup: TGA Updates Unified Recall Procedure
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Two major changes highlight the updated version 2.3 of the Australian Therapeutic Goods Administration (TGA) Uniform Recall Procedure – the removal of a section on crisis management guidelines and the addition of details on what the agency expects to receive regarding recalls.
Notable is the deletion of the section on crisis management guidelines. In version 2.2, TGA urged sponsors to “implement the guidelines as soon as possible and ensure that appropriate personnel are trained in their operation.” The Australian self-medication industry developed the text in collaboration with TGA and other organisations. A version of the guidelines, published in 2017, are still available online, but TGA no longer includes them in its immediate recall information.
TGA has also added to the list of information sponsors must provide to the agency. The list now includes the names and locations of customers who have received the affected therapeutic goods. TGA wants sponsors to list each affected site if a customer has distributed the goods to multiple locations. The agency wants sponsors to list each customer’s name and location in a spreadsheet that also lists the number of goods delivered to each buyer and includes comments such as “retail pharmacy.”
TGA has also changed a section on how to file recall information. The guideline still advises sponsors to submit information through the TGA Business Services (TBS) portal, but now provides additional details on the implications of that recommendation. TGA has clarified that all sponsors, whether they already have a customer identification number or have yet to file a recall, must use TBS. The new guide also includes a link to information on how to get started on the portal.
The changes follow a shift in TGA’s acceptance of information via email. In version 2.2, TGA said sponsors could email recall information until the end of June 2020. Although that deadline has passed, TGA will still accept email notifications, but only under “exceptional” circumstances or if a sponsor is unable to access TBS.
Other changes include the expansion of a section on the information sponsors must include in the final reports they submit, which typically occurs three months after a recall is implemented. Previously, TGA said the report should include an analysis of the root cause of what led to the recall and propose corrective and preventive action (CAPA) to prevent the issue from reoccurring.
In version 2.3, TGA expanded the recommendations and advised sponsors to submit root cause information that “reports the fundamental reason the problem occurred or the goods were defective and does not reiterate the reason for the recall.”
TGA wants sponsors to go beyond terms like “manufacturing error” and “software problem” and provide enough information to “adequately explain.” Likewise, TGA said terms such as “new design” and “software updated” are insufficient to explain the proposed CAPA. TGA will request additional information about “inadequate” responses.
Malaysia’s MDA sets transition period for new medical device labeling requirements
The Malaysian Medical Device Authority (MDA) has published the fifth edition of its labeling requirements, giving the industry until the end of the year to comply with the new rules.
The new document states that within six months of the registration date, medtech products “will be labeled with the Malaysian medical device registration number”. MDA encourages the industry to use QR codes to indicate the registration number of medical devices. The guideline lists seven formats that companies can use for the license plate.
MDA also emphasized requirements regarding labeling location. The agency wants the industry to provide the information needed to identify and safely use a medical device on the product itself “to the extent that it is practical and appropriate.” Accompanying leaflets, manuals and inserts are acceptable where it is impractical or inappropriate to provide information about the device itself.
Other parts of the document noted that electronic instructions for use are only acceptable for devices intended for use by professional users. Even then, MDA expects companies to offer users the ability to obtain paper forms on request “without undue delay” and at no additional cost.
MDA published the changes late last month, but will delay enforcement of the rules until January 2023.
MDA Notice (Malaysian)
SK bioscience wins first authorization for home-grown COVID vaccine in South Korea
The Korean Ministry of Food and Drug Safety (KMFDS) has approved SK bioscience’s SKYCovione COVID-19 vaccine, marking the first time a domestically developed vaccine for SARS-CoV-2 has been marketed in the country .
SKYCovione is a self-assembled nanoparticle vaccine that uses GSK’s pandemic adjuvant to boost the immune response. KMFDS approved the vaccine after seeing data from a Phase 3 clinical trial that showed it increased neutralizing antibody titers to three times the level achieved by the control product, Vaxzevria from AstraZeneca.
SK bioscience now plans to expand globally. Submissions for emergency use at the World Health Organization and for admission through the COVAX facility are planned. The vaccine can be stored under normal refrigeration conditions.
KMFDS has also approved AstraZeneca’s Evusheld for use in the prevention of COVID-19 in people with poor immune responses.
New Zealand Medsafe issues warning about withdrawal of Pfizer’s Accuretic over nitrosamines
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has issued a warning about discontinuing Accuretic, Pfizer’s high blood pressure drug.
Pfizer is recalling the tablets from countries around the world due to the presence of nitrosamines, namely N-nitroso-quinapril. The company discovered the nitrosamine was above the acceptable daily intake, but there is no direct risk to patients.
Medsafe has asked patients taking the medication to contact their healthcare professional as soon as possible to discuss switching to an alternative treatment.
TGA publishes FAQ on medical cannabis reform
TGA has released answers to frequently asked questions about the medical cannabis reforms it is pursuing to clarify minimum safety and quality requirements and ensure the equivalence of local and foreign standards.
The document clarifies that medicinal cannabis may be imported from any country, but from July 1, 2023, all imports must be manufactured in accordance with one of the identified standards of good manufacturing practice (GMP). TGA accepts GMP certificates issued by countries such as the United Kingdom, members of the European Union, Israel, South Africa and Canada. Medical cannabis imported from other countries may need to undergo GMP inspection by the agency.
Another set of comments addresses the inspection process, explaining that TGA will adopt the approach it already uses to assess sites that produce other drugs. The nature of the inspection will “depend on the circumstances and the agreed scope and cost”.
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