Asia-Pacific Roundup: Malaysia’s MDA updates guidance on labeling, change notifications for devices

RoundupsRoundups | 22 November 2022 |  By 

Malaysia’s Medical Device Authority (MDA) has updated its guidance on the requirement for labeling of medical devices and the handling of change notifications of authorized products.
 
MDA published the fifth edition of the labeling guidance in June, but has since identified a few things to change, resulting in a sixth edition released this week that hews closely to its predecessor. MDA has deleted two definitions “generic name” and “specific name” from the glossary and made small changes to other parts of the text.
 
The changes include an update to the information that the label should include. In the older document, MDA asked companies to include a “description and intended use of the device.” MDA has expanded on that point in the sixth edition, stating that the level should feature “details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device.”
 
More substantial changes were made to the guidance on change notifications for registered medical devices, the previous version of which dates to 2018. In the years since MDA published the third edition of the document, the EU has overhauled its approach to medtech through the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The updated MDA guidance features a section on the new EU regulations.
 
MDA covers what should happen when companies need to make changes as a result of the new MDR and IVDR requirements. For example, if a company needs to make changes to a label and instructions for use with no new information related to safety and performance, such as the addition of warnings and precautions related to the safe disposal of the device, it can carry out the revisions without submitting a change notification to MDA. Other types of updates require change notifications.
 
MDA continues to divide changes into three categories, with category 2 covering changes that require prior evaluation and endorsement from MDA and category 3 covering changes that may be implemented immediately. The agency also has revised the timelines for the change notification categories. Under the new guidance, MDA will process single submissions in 30 days, regardless of the category. Filings for combination category 2 and 3 changes take 60 days, as do multiple submissions.
 
The updated guidance features revisions to tables that describe category 2 and 3 changes. MDA has updated the documents that companies should submit to support a change in manufacturing facility, process and quality management system, adding declaration of conformity, if applicable, and annexes to the list, and clarified that a notification is not needed when rephrasing information, adding or removing
languages not required by the authority and updating the details of distributors.
 
Label Guidance, Change Guidance
 
Indonesia’s BPOM finds gaps in safety and quality assurance system across supply chain
 
The Indonesian Food and Drug Authority (BPOM) has identified gaps in the safety and quality assurance system at multiple steps in the supply chain as part of its investigation into contaminated cough syrups.
 
BPOM published a list of six gaps in an update on the status of its work to understand and prevent the problems that have been linked to the deaths of 195 children. The problems center on the presence of contaminants ethylene glycol and diethylene glycol above the acceptable threshold in solvents used in the production of medical syrups.
 
In its review, BPOM identified as potential issues the lack of supervision of the solvent and the fact it can enter the country without an import certificate. The authority also cited as problematic the lack of pharmacopeia limits on the presence of ethylene glycol and diethylene glycol in finished drug products.
 
Other issues include low uptake of the side effect reporting system among healthcare workers, the lack of precedent legal cases to deter wrongdoing, and the impact of raw material shortages. BPOM found raw material shortages and differences in the price of pharmaceutical- and chemical-grade solvents create opportunities for criminals.
 
The final point covers the maturity of the pharmaceutical industry, which BPOM expanded on elsewhere in its update. According to the authority, the maturity of the industry needs to improve and the process for assessing maturity needs to change, moving beyond just looking at good manufacturing practices to cover pharmacovigilance, good clinical practices and more.
 
BPOM Notice (Indonesian)
 
Pakistan’s DRAP highlights risk of infusion-related hypersensitivity reactions with remdesivir
 
The Drug Regulatory Authority of Pakistan (DRAP) has issued a safety update about the risk of infusion-related hypersensitivity reactions with Gilead Sciences’ Veklury (remdesivir), a COVID-19 antiviral.
 
The update follows a review by the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) that details of a cluster of three life-threatening adverse drug reaction reports from a hospital. The site saw cases of elevated heart rate, labored breathing, chills and fever after administering intravenous remdesivir to treat COVID-19.
 
A group at Pakistan’s National Pharmacovigilance Centre (NPC) performed a causality assessment and determined that all three cases have a possible relationship with drug intake. Because tests showed the suspected batch of remdesivir was of standard quality, the NPC labeled the cases as a potential signal of infusion-related hypersensitivity reactions with the injection of remdesivir.
 
PRAEC wants authorization holders to update remdesivir labels and prescribing information considering the potential safety signal, and asked healthcare professionals to consider infusion rates over periods of up to 120 minutes to potentially prevent the signs and symptoms.
 
DRAP released details of the remdesivir signal alongside safety updates on the psychiatric medicine clozapine and the non-steroidal anti-inflammatory drug diclofenac sodium. All three updates are based on discussions at the first meeting of PRAEC.
 
DRAP Notice
 
TGA grants provisional determination to Pfizer/BioNTech’s bivalent BA.4/BA.5 COVID booster
 
Australia’s Therapeutic Goods Administration (TGA) has granted provisional determination to a bivalent form of Pfizer/BioNTech’s Comirnaty COVID-19 booster vaccine that is designed to protect against the BA.4 and BA.5 subvariants of omicron.
 
The regulatory update clears Pfizer to apply for provisional approval. Pfizer and BioNTech have developed the vaccine, which is already on the market across the globe, to train the immune system to recognize both wild-type SARS-CoV-2 and the Omicron BA.4 and BA.5 subvariants.
 
Pfizer has proposed the shot for use as a booster for active immunization to prevent COVID-19 in individuals aged 12 years and older. The update comes weeks after TGA provisionally approved the bivalent BA.1 form of Comirnaty, which Pfizer developed before changes in the mix of circulating Omicron subvariants led it to add a BA.4 and BA.5 candidate to its portfolio.
 
TGA Notice
 
Other news:
 
TGA has published a product defect alert about the Omnipod DASH personal diabetes manager. The alert covers problems with the device’s battery such as swelling, leaking fluid and, in rare cases, extreme overheating that may pose a fire hazard. TGA Notice

 

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