Asia-Pacific Roundup: TGA updates uniform recall procedure

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| 05 July 2022 | By Nick Paul Taylor 

Two key changes highlight the updated version 2.3 of the uniform recall procedure from Australia’s Therapeutic Goods Administration (TGA) – the removal of a section on crisis management guidelines and the addition of details on what the agency expects to receive in relation to recalls.
 
Deletion of the section on crisis management guidelines is notable. In version 2.2, TGA urged sponsors to implement the guidelines “as quickly 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 organizations. A version of the guidelines, published in 2017, is still available online but TGA no longer includes it in the information about immediate recalls.
 
TGA also has added to the list of information that sponsors should provide to the agency. The list now features the names and locations of customers who received the affected therapeutic goods. TGA wants sponsors to list each impacted site if a customer has distributed the goods to multiple locations. The agency wants sponsors to list the name and location of each customer in a spreadsheet that also states the number of goods supplied to each buyer and features comments such as “retail pharmacy.”
 
TGA also has changed a section on submitting recall information. The guidance still advises sponsors to submit information through the TGA Business Services (TBS) portal but now provides additional details of the implications of that recommendation. TGA has clarified that all sponsors, regardless of whether they already have a client identification number or are yet to submit a recall notice, should use TBS. The new guide also includes a link to information about getting 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. While that deadline has passed, TGA will still accept email notification but only under “exceptional” circumstances or if a sponsor cannot access TBS.
 
Other changes include the expansion of a section on the information sponsors should include in the final reports they submit, which typically happens three months after the implementation of a recall. Previously, TGA said the report should include a root cause analysis of what led to the recall and proposed corrective and preventive actions (CAPA) to stop the issue from happening again.
 
In version 2.3, TGA has expanded on the recommendations, advising sponsors to submit information on the root cause that addresses “the fundamental reason why the problem occurred, or the goods were defective and not reiterate the reason for the recall.”
 
TGA wants sponsors to go beyond terms such as “manufacturing defect” and “software issue” and thereby provide enough information to “adequately explain the case.” Similarly, TGA said terms such as “new design” and “software updated” are insufficient to explain the proposed CAPA. TGA will request additional information on “inadequate” responses.
 
TGA Guidance
 
Malaysia’s MDA establishes transitional period for new medical device labeling requirements
 
Malaysia’s Medical Device Authority (MDA) has published the fifth edition of its labeling requirements and given the industry until the end of the year to comply with the new rules.
 
The new document states medtech products “shall be labeled with Malaysian medical device registration number” within six months from the date of registration. MDA is encouraging the industry to use QR codes to indicate the medical device registration number. The guidance lists seven formats that companies can use for the registration number.
 
MDA also highlighted requirements related to the location of labeling. The agency wants the industry to provide the information needed to identify and safely use a medical device on the product itself “as far as it is practical and appropriate.” Accompanying leaflets, manuals and packaging inserts are acceptable when it is impractical or inappropriate to provide information on the device itself.
 
Other parts of the document noted that electronic instructions for use are acceptable only for devices intended for use by professional users. Even then, MDA expects companies to give users the option to obtain paper forms on request “without undue delay” and at no additional cost.
 
MDA published the changes late last month but will hold off on enforcing 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 authorized SK bioscience’s SKYCovione COVID-19 vaccine, marking the first time a domestically developed vaccine for SARS-CoV-2 has come to market in the country.
 
SKYCovione is a self-assembled nanoparticle vaccine that uses GSK’s pandemic adjuvant to enhance the immune response. KMFDS authorized the vaccine after seeing data from a Phase 3 clinical trial that found it increased neutralizing antibody titers to three times the level achieved by the control product, AstraZeneca’s Vaxzevria.
 
SK bioscience now plans to expand globally. Submissions for emergency use listing with the World Health Organization and for inclusion through the COVAX facility are planned. The vaccine can be stored under normal refrigeration conditions.
 
KMFDS has also authorized AstraZeneca’s Evusheld for use in the prevention of COVID-19 in people with a poor immune response.
 
Press Release, Reuters
 
New Zealand’s Medsafe posts alert about withdrawal of Pfizer’s Accuretic over nitrosamines
 
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has issued an alert about the withdrawal of Pfizer’s high blood pressure medication Accuretic.
 
Pfizer is recalling the tablets from countries around the world over the presence of nitrosamines, namely N-nitroso-quinapril. The company detected the nitrosamine above the acceptable daily intake level but there is no immediate risk to patients.
 
Medsafe has asked patients on the medication to contact their healthcare professional as soon as possible to discuss changing to an alternative treatment.
 
Medsafe Notice
 
TGA publishes FAQ on medicinal cannabis reforms
 
TGA has released responses to frequently asked questions about the medicinal cannabis reforms that it is making to clarify the minimum safety and quality requirements and ensure the equivalence of local and overseas standards.
 
The document clarifies that medical cannabis may be imported from any country, but that starting 01 July 2023, all imports must be manufactured in accordance with one of the identified good manufacturing practice (GMP) standards. TGA will accept proof of GMP issued by countries including the United Kingdom, members of the European Union, Israel, South Africa and Canada. Medical cannabis imported from other countries may be required to undergo GMP inspection by the agency.
 
Another set of responses address the inspection process, explaining that TGA will apply the approach that it already uses to assess sites producing other medicines. The nature of the inspection will “depend on the circumstances and the agreed scope and cost.”
 
TGA Document

 

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