Asia-Pacific Roundup: New Zealand’s Medsafe seeks feedback on planned changes to abbreviated filings

The Medicines and Medical Devices Safety Authority (Medsafe) is holding a consultation on plans to extend the abbreviated procedure for new medicine applications and certain change notifications.

Medsafe has proposed updates to two guidelines, one about new medicine applications and another about changed medicine notifications and non-notifiable changes, to extend New Zealand’s abbreviated process to more submissions. Under the abbreviated pathway, Medsafe evaluates reports from certain overseas regulatory agencies to accelerate review timelines.

The update to the new medicine application guideline would allow companies to use the pathway for some line extensions. To be eligible for abbreviated review, the parent product in line extension requests must be identical in New Zealand and the referenced overseas country. The proposed indication must be the same in both countries, too.

Medsafe reserves the right to conduct a full evaluation if it considers the reports generated by the overseas agency to be too brief. The overseas agency’s assessment must be comparable to a Medsafe review for the New Zealand regulator to accept the reports in support of an abbreviated evaluation.

Other changes are intended to give applicants more options and clarity. Medsafe has revised sections on application types, data protection, provisional consent, and priority review to achieve those goals.

Currently, changed medicine notifications and non-notifiable changes are ineligible for the abbreviated pathway. The agency today has up to 45 days to complete initial evaluations of changed medicine filings, typically finishes the task before the deadline, and does not offer abbreviated reviews.

Medsafe reiterated that position in the draft guidelines but proposed creating an abbreviated procedure for changes that must be referred to the Minister of Health or their delegate. Cases are referred when the character or complexity of the change means the post-change product should not be distributed in New Zealand without ministerial consent.

The agency has drafted a new section of the guideline about the eligibility criteria and data requirements for abbreviated changed medicine notifications. Abbreviated reviews are faster, a fact Medsafe said is recognized in the application fee. The fee for referred notifications was a point of contention in 2022 (RELATED: New Zealand’s Medsafe tweaks fee increase proposal after industry feedback, Regulatory Focus, 17 May 2022).

Medsafe is accepting feedback on the proposals until 13 March. Separately, the agency is preparing to hold a consultation on the anticipated verification process, enabled by the Medicines Amendment Act 2025. The legislation supports a truncated verification pathway for products approved by two or more recognized authorities.

The agency is also working with manufacturers of over-the-counter (OTC) drugs on ways to harmonize their requirements and develop guidance, having excluded the sector from the proposals published last week. The agency said it excluded OTC manufacturers from the abbreviated filing consultation because overseas evaluation reports are generally not available for these types of medicine products.

Medsafe Consultation

Singapore’s HSA updates registration rules, streamlines cell and gene therapy changes

The Health Sciences Authority (HSA) has made multiple changes to therapeutic product registration in Singapore. HSA published the updates the day after establishing a new process for postapproval changes to cell, tissue, and gene therapy products (CTGTPs).

As part of the changes, HSA has created a submission pathway for unregistered drugs with a long history of local clinical use and that are critical to Singapore’s healthcare system. HSA will allow applicants to use established local clinical use as evidence of safety and efficacy. A well-established efficacy and safety profile is a prerequisite for accessing the pathway.

Companies that want to use the standard essential medicine pathway must check the eligibility criteria and submit an expression of interest form at least three months before their planned registration filing. HSA will only accept a filing after completing its evaluation of the associated expression of interest.

The agency created the pathway as part of an update that affected other registration rules. HSA removed the limit of concurrent submissions for major variation applications. The agency, which previously restricted applicants to three concurrent submissions, said the change provides greater flexibility and enhances the efficiency of post-approval clinical indication extensions.

HSA also established a new procedure for requesting inspections of overseas drug-substance manufacturing facilities. The procedure allows companies to ask HSA to inspect a site that lacks the required evidence of compliance at the point of submitting a registration application. Again, companies must assess their eligibility and file expressions of interest at least three months before their planned submissions.

The agency established its new minor variation (MIV) initiative for CTGTPs the day before adopting the revised registration rules. HSA created 17 eligible MIV-2 do-and-tell changes for advanced therapies. The changes do not require prior approval. Rather, companies need only notify HSA of their actions within 6 months of implementing the changes.

HSA said the creation of the do-and-tell list is intended to enhance postapproval change management efficiency and provide greater operational flexibility for CTGTP manufacturers. Companies can bundle changes for submission in a single MIV-2 filing.

HSA Notice, More

Malaysia’s NPRA introduces reliance mechanism for variations to drug products

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated drug registration guidance, establishing a reliance mechanism for drug products and timelines for processing filings.

Under guidance published last week, NPRA has offered companies the option to use paperwork from a reference agency to support postapproval change submissions in Malaysia. Companies must submit a letter of intent or cover letter to request the use of the pathway and clearly list all relevant variation categories. NPRA has requested paperwork, including an official approval letter or notification.

“An assessment report from the chosen reference agency/WHO may be required, as the approval letter may not include details of the approved changes. For variations accompanied by an assessment report, it is strongly recommended to provide the report at the time of submission to facilitate early verification of sameness,” NPRA said.

The agency wants companies to include a table summarizing the approved and proposed changes. In some cases, NPRA may request question-and-answer documents during its review. The agency advised companies against bundling variations with and without reliance materials.

Other changes include the establishment of timelines for reviewing variation requests. NPRA has given itself between 30 and 180 working days to complete reviews, depending on the number, nature, and bundling of the variations.

NPRA Notice

HSA partners with Indonesian agency to strengthen regulatory cooperation on medicines

Singapore’s HSA has formed a memorandum of understanding with its Indonesian counterpart to bolster cooperation on medicine regulation and provide efficient regulatory pathways for businesses.

HSA called the agreement with the Indonesian Food and Drug Authority (BPOM) “a significant milestone in cross-border health product cooperation.” Priority areas for the agencies include joint assessments, clinical trial regulations, advanced therapy medicinal products, artificial intelligence, staff training, and post-market safety surveillance.

The agencies will share information on regulatory matters about medicines and complementary health products. Information dissemination is intended to protect the public through shared safety monitoring and quality assurance.

HSA disclosed the agreement weeks after BPOM joined it on the list of World Health Organization-listed authorities. Taruna Ikrar, chair of BPOM, cited the listed authority status of both agencies as a factor in the increased collaboration.

HSA Notice

Asia-Pacific Roundup: New Zealand’s Medsafe seeks feedback on planned changes to abbreviated filings

Related topics

Recommended content

Welcome to the new RAPS Digital Experience