Asia-Pacific Roundup: New Zealand’s Medsafe seeks feedback on verification pathway for new medicines

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is running a consultation into the rules and guidelines for seeking approval of medicines via the consent by verification pathway.

New Zealand created the verification approval process in the Medicines Amendment Act 2025, providing a streamlined path to market for products with full marketing authorization from at least two recognized regulatory authorities. The legislation established high-level requirements for the pathway. Now, officials have drafted secondary legislation and guidelines to flesh out and interpret the requirements.

Under the draft secondary legislation, New Zealand’s Director-General of Health will have 10 working days to decide whether a submission meets the consent by verification pathway rules. Officials will have 30 working days to decide on applications, starting when the fee is paid. Applicants must respond to information requests within 20 working days. Medsafe is gauging support for the timeframes.

Companies will need approvals from at least two recognized authorities, which Medsafe defines as the regulators in Australia, Canada, the European Union, Singapore, the United Kingdom, and the United States. Companies must nominate a primary marketing authorization. Medsafe is seeking feedback on the requirement for two approvals and the need to nominate a primary agency.

The secondary legislation lists materials that applicants need to provide in their submissions, including appropriate evidence of each marketing authorization and full assessment reports. Medsafe is seeking feedback on each element of the submission package.

Following its peers in Singapore and the UK, Medsafe is proposing to limit how long a company can wait between winning approval overseas and leveraging the authorization to seek consent by verification in New Zealand. Medsafe said the time limits in Singapore and the UK are two to three years. The agency is considering time limits ranging from one year to more than five years in New Zealand.

Medsafe posted the secondary legislation alongside a draft guideline about the pathway, which provides more information on how to interpret the requirements. In the guideline, Medsafe notes an outstanding question about how to handle drugs approved via joint assessment initiatives, such as Project Orbis and the Access Consortium.

The agency is consulting on what assessment and approval documentation is available and what would be needed to facilitate verification assessments. The agency is considering how work sharing approvals, which many of the reference authorities participate in, can be assessed “to verify independent decision making and sameness” with the New Zealand application.

Medsafe is seeking feedback until 10 April.

Medsafe Consultation

India’s CDSCO updates pyrogen regulations to address testing discrepancy

India’s Central Drugs Standard Control Organization (CDSCO) has updated the Drugs Rules, 1945 to fix a discrepancy that made it difficult to test some products for pyrogens.

Pyrogens are fever-causing agents such as bacterial endotoxins. In recent years, authorities have moved away from traditional rabbit-based testing and supported the use of alternatives based on animal blood, human cells, and synthetic reagents.

The Drugs Technical Advisory Board (DTAB) discussed changing India’s rules in 2019. Officials raised the topic with DTAB because the original rules said the pyrogen test is intended for parenteral products that contain 10 ml or more. However, the 10 ml stipulation is absent from other legislation, leading officials to warn the rules make it difficult to test for pyrogens in small-volume products.

DTAB proposed addressing the discrepancy by removing the reference to product volume. As part of the update, the board inserted a reference to using the bacterial endotoxin test (BET) as per the Indian Pharmacopoeia. BET, which uses blood lysate of horseshoe crabs, is an alternative to the traditional rabbit-based test.

The Indian Pharmacopoeia Commission (IPC) introduced the BET in 2014. IPC introduced a chapter on the monocyte activation test (MAT), an in vitro pyrogen test based on human cells, in 2018. MAT is part of an effort to replace tests that rely on materials from animals with products that use synthetic reagents or human cells. European authorities recently removed the rabbit test from the list of accepted methods.

CDSCO Notice

Medsafe clarifies rules on declaring excipients after update causes confusion

Medsafe has provided further guidance on declaring excipients with known effects in data sheets after an earlier update caused confusion.

The New Zealand drug regulatory agency updated the explanatory guide to its data sheet template last month. Medsafe told sponsors they can refer to a European Medicines Agency (EMA) annex to declare excipients with known effects in section 2 of the data sheet. EMA’s annex covers declaring excipients in the labeling and package leaflet of medicinal products for human use.

Based on requests from the industry, Medsafe has clarified that the updated explanatory guide does not change requirements related to the label statements database (LSD). Medsafe requires sponsors to refer to the LSD on allergen entries when declaring excipients with known effects to ensure the information on the package labeling is consistent with that in the data sheet.

Sponsors should use the EMA annex and LSD to identify the excipients with known effects that must be declared, Medsafe said. The agency is advising sponsors to use the document with the lower threshold if the limits in the annex and LSD are different. Medsafe has provided a data sheet example where lactose is an excipient to demonstrate the proper procedure for sponsors.

Medsafe Notice

Philippine FDA starts consultation into medical device post-market surveillance

The Philippine Food and Drug Administration (FDA) is seeking feedback on draft guidelines intended to facilitate effective post-market surveillance of medical devices.

Through the guidelines, FDA aims to establish rules for maintaining medical device importation and distribution records to ensure traceability and facilitate regulatory actions. The guidelines are also intended to ensure the timely, standardized, and regulatory-compliant reporting of complaints, adverse events, and field safety corrective actions to FDA.

The agency framed the draft as a response to the approval of implementing guidelines in December. The guidelines cover post-marketing alert system requirements under the ASEAN Medical Device Directive. FDA plans to give marketing authorization holders six months to transition to the guidelines.

The request for feedback lists 19 March 2022 as the deadline for submitting comments. However, the request was published almost four years after that date and contains a reference to guidelines released in December 2025, suggesting “2022” is a typo.

FDA Consultation

Malaysia’s MDA withdraws guidance on importing medical devices for personal use

The Medical Device Authority (MDA) has withdrawn guidance on importing medical devices for personal use into Malaysia.

MDA published guidance on importing medical devices for personal use in 2024. The document set out the criteria for benefiting from an exemption from medical device registration and establishment license requirements. Malaysian officials established the exemption for personal-use medical devices through legislation published in 2016.

Last week, MDA withdrew the guidance. Information on importing devices for personal use is now available via an online portal. The agency is advising people to check the updated advice on the portal for the latest regulatory requirements.

MDA Notice

Other News:

Australia’s Therapeutic Goods Administration (TGA) is rescheduling oral products containing between 50 mg and 200 mg of vitamin B. The products, which are currently available for general retail sale, will only be sold over the counter with the advice of a pharmacist starting 1 June 2027. TGA Notice

Asia-Pacific Roundup: New Zealand’s Medsafe seeks feedback on verification pathway for new medicines

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