Asia-Pacific Roundup: New Zealand adopts verification pathway rules following industry consultation
The New Zealand government has adopted rules on “consent by verification,” creating a pathway that will fast-track the review of medicines approved by two or more reference regulatory agencies.
Officials introduced the pathway last year through the Medicines Amendment Act 2025. However, the government deferred implementation of the pathway to give the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) time to establish the technical details in consultation with industry. Medsafe held a consultation from February to April.
The feedback informed the finalization of the text, which retains the main stipulations of the draft but features changes and deletions. To be eligible for the pathway, a medicine must have full marketing authorization from two or more recognized authorities. Marketing authorizations must be no older than four years. The New Zealand product must be identical “in all material respects” to the drug authorized, with allowance for minor differences.
Following the consultation, Medsafe removed the requirement for applicants to provide “appropriate evidence” of approval of each variation to the marketing authorization. More than 40% of respondents either disagreed or only somewhat agreed with the rule, noting that self-assessable variations lack an approval letter and those granted under work-sharing agreements may be issued by a different agency than the primary recognized authority.
Medsafe concluded that the requirement would not add useful information because only minor changes are allowed from the initial marketing authorization by the recognized regulatory authorities, leading it to drop the rule. The agency also updated 11 rules in response to the feedback.
Officials removed the words “and unredacted” from a requirement about the submission of assessment reports, accepting feedback that minimal redaction for privacy is needed. Only 36% of respondents fully agreed with Medsafe’s requirements for the submission of full assessment reports. However, while drug developers said the number of documents required may be significant and suggested ways to streamline the rule, Medsafe maintained that it needs two complete reports to ensure quality, safety, and efficacy.
Medsafe also received pushback on the requirement to submit the full consolidated technical dossier as it was provided to and approved by the primary regulatory authority, in common technical dossier (CTD) format, and make the document from the secondary authority available on request. The agency accepted that its original wording was not clear enough, leading it to clarify that it wants to receive the full consolidated technical dossier initially approved by the primary recognized regulatory authority.
Industry told Medsafe that accepting current eCTD sequences approved by the primary and secondary recognized regulatory authorities, including all post-approval changes, would reduce sponsors’ work. However, Medsafe said its ability to accept eCTD is limited by the Ministry of Health’s information technology systems.
The agency changed the deadline for responses to requests for information from 20 to 30 working days in response to the feedback. Medsafe made the change after sponsors raised concerns that applications might be withdrawn despite genuine efforts to meet the timeframe if it was as short as 20 days. The original timeframe reflected Medsafe’s intent to use the pathway to expedite approvals.
The verification rules will come into force on 3 July.
Verification Rules, Consultation Outcome, More
Malaysia’s MDA makes third change to medical device labeling rule in 3 months
Malaysia’s Medical Device Authority (MDA) has updated a rule on medtech labeling for the third time in as many months.
In late February, MDA revised the wording of a rule about providing information about local manufacturers, authorized representatives, and foreign manufacturers. MDA updated the rule covering foreign manufacturers in mid-May and changed the text again a few days later.
The latest text states: “Foreign manufacturers shall provide the name and address on the label. Contact details i.e: email and/or phone number and/or website address are optional for technical assistance.”
MDA’s second May update softened the requirements the agency established in the guidance it released in February. Back then, MDA said foreign manufacturers should “provide the name, address, and website address for technical assistance.”
MDA changed the wording to “shall provide the name, address and contact details [email and/or phone number and/or website address], is optional) for technical assistance” in its first May update. The latest change clarified that providing an email, phone number, and website address for technical assistance is optional.
The changes to the rule on foreign manufacturers were the only revisions adopted in the May updates. Other parts of the document, which provides guidance to manufacturers and authorized representatives on the content of medical device labeling, last changed in February.
Medsafe posts warning about black-market copies of investigational Eli Lilly drug
Medsafe has published a health warning about unapproved peptides sold in New Zealand, singling out black-market copies of Eli Lilly’s drug candidate retatrutide as a particular concern.
Like its Australian counterpart, Medsafe has detected rising imports and sales of unapproved peptides and alerted consumers to the potential health risks of the products. There is a very real risk that the products may be of poor quality and contain substantial quantities of germs or mold, Medsafe said. The products could cause serious, potentially life‑threatening reactions.
The alert included a specific warning about retatrutide, a triple receptor agonist in development at Lilly. By hitting three targets including GLP-1, retatrutide has driven deep weight loss in clinical trials run by Lilly. However, the molecule has yet to win approval.
“Any retatrutide sold to the public is sourced from the black market,” Medsafe said. “International reports have linked black‑market retatrutide to fatal overdose, contamination, severe neurological symptoms, hair loss, and other serious adverse effects.”
Discussing peptides in general, Medsafe said many sellers label the products as “for research purposes only.” The wording has no legal effect and does not permit sale, supply, or use in people, Medsafe said. If a product is being offered for personal use, injection, or consumption, it is being supplied unlawfully, the agency added.
Japan’s PMDA creates English-language webpage about orphan drug designation
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has described its orphan drug designation in a new webpage.
The page provides an English-language overview of the status, which PMDA assigns to molecules that address a serious, designated intractable disease with high medical needs that affects fewer than 50,000 people in Japan. Companies must have plans that enable development in Japan to receive the status.
Orphan drugs benefit from financial and regulatory incentives in Japan. Financial subsidies for up to 50% of drug development expenses, tax credits, reduced PMDA fees, and a 10% to 20% pricing premium are available to medicines with the designation. Companies also benefit from priority reviews and consultations from PMDA, plus an extension of the marketing exclusivity period.
PMDA’s publication of the information comes as the agency increases engagement with overseas drug developers. In recent years, PMDA has opened offices outside Japan, including a site in Washington, DC, that facilitates interactions with US biopharma companies. The agency has identified the engagement of overseas drugmakers to shorten the lag between approvals in the US and Japan.
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