Asia-Pacific Roundup: New Zealand reviews safety of oral anticoagulants

RoundupsRoundups | 30 August 2022 |  By 

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is reviewing the risks of oral anticoagulants, focusing on the risk of changes to normal menstrual periods.
 
Officials initiated the review in response to reports of abnormal uterine bleeding (AUB) in women taking medications including Pfizer’s Eliquis, Boehringer’s Pradaxa, Bayer’s Xarelto, GSK’s Marevan and Viatris’ Coumadin.
 
Medsafe has placed the five products on its Medicines Monitoring scheme to encourage prescribers and patients to report any adverse events of abnormal uterine bleeding (UAB) with oral anticoagulant use to the Centre for Adverse Reactions Monitoring (CARM). The medicines will remain under additional monitoring until the end of February 2023.
 
What happens after February will depend on the reports submitted over the next six months. If CARM receives no further reports, Medsafe may opt to take no action to balance the benefits and risks of the treatments.
 
For example, Medsafe this week ended additional monitoring for potential vasculitis cases associated with Novartis’ Galvus and Galvumet, both of which contain vildagliptin. The agency concluded that the balance of benefits and risks of harm for the products remains positive and no further action is required. Novartis voluntarily updated its data sheets to include vasculitis as an adverse drug reaction.
 
New Zealand data sheets for Eliquis, Pradaxa, Xarelto,  Marevan and Coumadin all discuss the bleeding risks and contraindications associated with the products. However, the word “uterine” only appears in the Eliquis data sheet, which lists uterine hemorrhage and other reproductive system and breast disorders as rare adverse reactions seen in studies of the anticoagulant. The broader links between AUB and blood thinners, notably in pre-menopausal women affected with acute venous thromboembolism, are discussed in the medical literature.
 
Medsafe Notice, More
 
TGA shares details of updated manufacturing principles for medicines, active ingredients
 
Australia’s Therapeutic Goods Administration (TGA) has shared details of the changes caused by its recent adoption of version 15 of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products.
 
TGA adopted the updated guide in July, a little more than a year after its publication by PIC/S, as part of its work to provide guidance for the management of new technologies, address gaps in existing compliance requirements, manage risks identified through inspections and regulation and facilitate continuous improvements in the way medicines are manufactured.
 
The changes in version 15 relate to an annex on biological medicines. PIC/S has split the section into two sub-annexes, one, Annex 2A, on the manufacture of advanced therapy medicinal products (ATMP) for human use, and another, Annex 2B, on the manufacture of biological medicinal substances and products for human use.
 
Annex 2A features additional guidance specific to the manufacture of ATMPs, while Annex 2B is mostly unchanged from the version 14 apart from the exclusion of advanced therapy medicinal products from the scope of application. Both sub-annexes apply to biological medicines, including those derived from animal cells and/or tissues.
 
TGA is asking manufacturers to review version 15 of the PIC/S Guide to Good Manufacturing Practice and ensure they are familiar with the requirements that apply to their processes. The agency plans to publish further guidance on the adoption and interpretation of the PIC/S guide on its website.
 
TGA Notice
 
Pakistan’s DRAP seeks feedback on revised National Pharmacovigilance System guidelines
 
The Drug Regulatory Authority of Pakistan (DRAP) has released draft guidance on its National Pharmacovigilance System for consultation. DRAP has updated the guidelines considering the recently enacted Pharmacovigilance Rules, 2022.
 
After publishing the first version of the guidelines in 2019, DRAP issued separate documents focused on the processes and requirements for healthcare professionals, patients and registration holders. With the dedicated documents now in place, DRAP has proposed removing the sections that duplicate their content from the National Pharmacovigilance System guidelines and redrafting the text in line with the Pharmacovigilance Rules, 2022.
 
The result is a 119-page document that describes the structure of Pakistan’s pharmacovigilance program, the guidelines for reporting pharmacovigilance data, signal management, safety communications and other topics. The overall aim is to operationalize the pharmacovigilance program of Pakistan, to detect, validate and assess new signals in the national pharmacovigilance database and to guide stakeholders about the reporting of pharmacovigilance data.
 
DRAP, which uploaded the draft on 24 August, is accepting comments for 15 days.
 
DRAP Notice
 
Nepalese officials visit Pakistan to discuss DRAP’s push to implement WHO, ICH standards
 
The director general of Nepal’s Department of Drug Administration (DDA) has led a delegation to Pakistan to understand DRAP’s work toward the implementation of the common technical document (CTD).
 
DRAP adopted the CTD for the registration of human drugs in 2018 and, as part of its progressive introduction of the format, published guidance to ensure consistent applications two years later. The work caught the attention of DDA director general Bharat Bhattarai and his colleagues, leading them to ask DRAP about the implementation of the format on a recent visit to Pakistan.
 
In a statement to disclose the meeting, DRAP framed the visit as part of an effort to foster cooperation between the drug regulatory authorities of Pakistan and Nepal. Officials from the US Pharmacopeia were present at the meetings.
 
DRAP Notice

 

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