Asia-Pacific Roundup: Medsafe seeks feedback on showing medicine bioequivalence in New Zealand
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has shared a draft update to its bioequivalence guideline for consultation, proposing changes to align its position with current international guidance and practices and clarify aspects of the framework.Some of the key changes relate to the selection of a reference product to serve as the bioequivalence comparator for the generic medicine.
The regulator’s preferred option is still for companies to compare the proposed generic medicine to the respective innovator medicine obtained from the New Zealand market. However, Medsafe gave three alternative options in its 2018 guideline, reflecting the fact “New Zealand is a small market and thus this option may not always be possible.”
Medsafe has proposed adding another option in the draft guideline. Like the existing options, the new path to bioequivalence relies on overseas reference products. The difference is Medsafe is planning to allow a “paper comparison,” as well as the in vitro comparisons that are already supported.
Generic developers that want to make a paper comparison to an overseas reference product need to provide evidence that “the reference product and New Zealand-sourced innovator product are manufactured at the same site(s) with identical manufacturing processes and formulations,” Medsafe said.
The updated guideline is intended to provide clearer guidance on the other options and clarity on other points. Medsafe has tried to clarify its definition of “essential similarity,” a term for comparative in vitro study, and provide information on the test requirements for non-oral dosage forms. Evidence of essential similarity for non-oral forms include physical appearance, certificates of analysis and labels.
Other planned changes affect the guidance on biowaivers and narrow therapeutic index products. The agency has proposed clarifying the purpose and function of Biopharmaceutical Classification System-based biowaivers and adding information on dosage-form based biowaivers. Changes to the section on narrow therapeutic index products include the use of the term “readily substitutable,” rather than “interchangeability.”
Medsafe has also proposed expanding the list of products that do and do not require bioequivalence data. The changes are intended to align “Medsafe guidance with current internationally recognized approaches to establish in vivo comparability of specific dosage forms,” the agency said.
Consultation
Malaysia’s MDA updates guidelines on device classification, borderline products
Malaysia Medical Device Authority (MDA) has released the third editions of guidelines on the regulation of products in the Association of Southeast Asian Nations (ASEAN) region.
ASEAN is a political and economic union of 10 countries in Southeast Asia. The union adopted the ASEAN Medical Device Directive to harmonize medical device regulation in the region in 2015. Malaysia signed the agreement in 2020. MDA posted the first editions of guidelines on harmonized device classification and borderline products in ASEAN in 2022. The agency updated the guidelines in 2023.
MDA has tweaked the introductions of the third-edition documents, but the main changes affect the lists of device classifications and borderline products rulings that dominate the guidelines. The agency has added recent rulings of the ASEAN Medical Device Technical Committee to both lists.
Updates to the list of borderline products include an entry for nitric oxide nasal spray. The product is used to create a barrier that provides protection against airborne viruses. The technical committee has categorized the nasal spray as a medical device.
The updated list of harmonized device classifications has almost 30 new entries across seven categories. “Clinical chemistry and clinical toxicology” and “hematology and pathology” are the two largest groups, accounting for 10 of the entries and most of the higher-risk devices. Progesterone and estrogen receptor assay kits are among the Class C devices. None of the new devices are Class D, the highest risk group.
Harmonized Classification, Borderline Products
Medsafe shares plans for additional reliance pathways, answers industry questions
New Zealand’s Medsafe has told the industry it is planning for the impact of the implementation of additional reliance pathways.
Medsafe met with the industry last month and followed up with a summary of the meetings. The report contains data on the time to process applications and the agency’s focus on performance. Early progress of the Medicines Amendment Bill in the New Zealand parliament has prompted Medsafe to start looking at how additional reliance pathways could affect its performance.
The bill includes a verification pathway that would be open to medicines that are approved by at least two trusted overseas regulators. Medsafe would have up to 30 days to reach decisions on medicines filed via the verification pathway.
The agency’s focus on performance includes work on the final steps of approving a medicine. Posting approvals in the official publication of the New Zealand government adds time and Medsafe is trying to find ways to accelerate its processes.
Medsafe published the information alongside its responses to questions submitted at industry meetings in June. Some of the questions related to the verification pathway. However, Medsafe was unable to give detailed answers to those questions because the associated legislation is before the Select Committee.
Medsafe Summary, Q&A
DRAP passes law to prioritize drug, device supply during emergencies in Pakistan
The Drug Regulatory Authority of Pakistan (DRAP) has published laws on the supply of drugs and devices “in case of war and national emergency.”
Near-identical updates to the Drugs (Licensing, Registering and Advertising) Rules, 1976 and the Medical Devices Rules, 2017 have established new requirements for product registration holders in emergencies.
The new drugs law reads: “Provided that in case of war and national emergency, the registration holder shall prioritize the supply of drugs to the civil and armed forces hospitals in order to ensure provision of critical care to both civilian and military personnel.”
DRAP’s update to the medical device rules conveys the same message. The only difference is that DRAP has replaced “drugs” with “medical devices.” DRAP released the updates around one month after a brief armed conflict between Pakistan and India threatened to escalate into a wider emergency.
Drug Law, Device Law
Other News:
DRAP has designated cysteamine as a priority drug. Cysteamine is used to treat high levels of cystine in the body. Cystine, an amino acid, builds up in the eyes and kidneys of people with a certain mutation. DRAP said it will process cysteamine applications “on a priority basis, out of queue,” for one year. The agency also extended priority processing of mexiletine by six months. Cysteamine, Mexiletine
The Pharmaceuticals and Medical Devices Agency has published two sets of Japanese Pharmacopoeia drafts for consultation. Part one features new general information on x-ray fluorescence spectrometry that is open for comment until June 30. Part two includes new monographs on aripiprazole and dilazep hydrochloride that are open for comment until August 31. Part One, Part Two
The Philippine Food and Drug Administration (FDA) published a circular confirming the suspension of new fees. The suspension will last up to 60 days. The suspension follows “feedback and concerns expressed by various sectors and key stakeholders” and an internal review that identified “several areas for service enhancement.” FDA Notice
Medsafe published the agenda for the 23 July meeting of its Medicines Classification Committee. The agenda includes a discussion of whether to extend the use of GSK’s respiratory syncytial virus vaccine to people aged 50 to 59 years who are at increased risk of disease. Meeting Agenda
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