Asia-Pacific Roundup: New Zealand’s Medsafe finalizes bioequivalence guidelines
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has finalized its revised guidance on running studies to show products are bioequivalent.Medsafe released a draft version of the outline, which was last updated in 2018, for consultation in June. The agency ran the consultation to collect feedback from pharma companies seeking to demonstrate bioequivalence to support filings for regulatory approval of new and changed products. Such companies would be affected by changes to Medsafe’s advice on topics such as using overseas reference products.
The eight comments Medsafe received largely supported the proposed changes, but two proposals drew mixed responses. Five of the eight respondents only somewhat agreed with Medsafe’s proposed updates on reference products.
Medsafe said five respondents raised concerns with the practicality of its proposed approach to overseas reference products. With Option 2, the agency proposed allowing companies that source reference products from outside New Zealand to use paperwork to show overseas and domestic-sourced medicines are made at the same sites with identical manufacturing processes and formulations.
Respondents raised concerns about their ability to confirm that the same manufacturing process and sites are used in the production of the overseas and New Zealand reference products. In response, the agency said the paper-based option is intended to enable companies with extensive knowledge of their reference products to skip in vitro characterization studies.
“Since in vitro studies are not required to meet Option 2, a higher level of evidence in the form of paper documentation is expected,” the agency said. “Medsafe understands that this information is likely to be unobtainable in most cases. The proposed Option 2 is retained in its entirety but for an added sentence pertaining to an acknowledgement of this point.”
Respondents were also split on Medsafe’s proposals about product types that require bioequivalence, with four people saying they only somewhat agreed with the changes. Two respondents raised concerns with Medsafe’s position on fixed-dose combination products, noting that the draft states bioequivalence should be shown against products with the active ingredients in separate registered formulations.
Medsafe clarified its position in response to the feedback, acknowledging that bioequivalence studies can be conducted against innovator fixed-dose combination products. The contentious line, which the agency has clarified in the final guideline, was intended to confirm that bioequivalence studies should be run against separate registered formulations if there is no combination reference product.
The changes are part of a final guideline that is intended to align New Zealand with current international guidance and practices. Responding to feedback on the bioequivalence draft, Medsafe said it is planning to develop a new guideline covering biosimilar development.
Final Guidelines, Consultation Outcome
Medsafe explains exemption for advertising unapproved medicines at medical conferences
Medsafe has outlined the processes for obtaining a waiver to advertise unapproved medicines at medical conferences.
Under New Zealand law, companies cannot typically advertise unapproved medicines. The law features an exception for advertising at medical conferences and associated trade shows. To benefit from the exemption, the organizer of a medical conference must notify the Director-General of Health that their event will feature the advertising of unapproved medicines.
Conference organizers must send notifications at least 30 business days before their events open. The notifications should include confirmation that one or more unapproved medicines will be advertised, the dates and location of the conference, and details of whether the products are approved overseas and have been submitted for authorization in New Zealand.
All other medical advertising requirements apply to products covered by an exemption. No exemption is needed to advertise approved medicines at medical conferences and associated events.
Medsafe Notice
China names J&J, Lilly and Pfizer products on first private insurance list for innovative drugs
China’s National Healthcare Security Administration (NHSA) has included medicines from leading US drugmakers in its first commercial health coverage formulary.
NHSA created the list of 19 medicines to support access to medicines that are too expensive for state medical insurance but could be covered by private payers. Commercial insurance programs could use the list to inform which medicines they cover.
The list features multiple cancer medicines, including Bristol Myers Squibb’s Yervoy (ipilimumab), Johnson & Johnson’s Talvey (Selinexor), and Pfizer’s Empliciti (elotuzumab). Local oncology companies are also represented on the list. The list opens a new front in the fight for the Alzheimer’s disease market, with Eli Lilly’s Kisunla (donanemab), and Eisai and Biogen’s Leqembi (lecanemab) both on the formulary.
NHSA also updated the National Reimbursement Drug List, which defines state insurance coverage. The update added Lilly’s GLP-1 drug Mounjaro (tirzepatide) to the list. Starting January, the blockbuster will be listed as a treatment for Type 2 diabetes.
NHSA Statement (Chinese)
India’s CDSCO adds medtech risk classification module to portal to simplify procedures
India’s Central Drugs Standard Control Organization (CDSCO) has expanded its online system for medical devices.
The agency has added a risk classification module to the system. CDSCO said the module is designed to simplify regulatory approval procedures and the medical device risk classification process. The module covers medical devices other than in vitro diagnostics.
Having created the module, CDSCO advised companies to use the online system when seeking a risk classification. Companies need to seek the information when working with devices that CDSCO has not included on its published classification risk. CDSCO will classify the risk of applicants’ products under the Medical Device Rules, 2017.
CDSCO Notice
Japanese Pharmacopoeia seeks feedback on monographs for overactive bladder therapy
The Japanese Pharmacopoeia (JP) has released four draft documents on the overactive bladder therapy solifenacin succinate for consultation.
Solifenacin is an antimuscarinic that relaxes bladder muscles to prevent sudden, difficult-to-control urges to urinate. JP has published three draft monographs on the medicine. One monograph covers the active pharmaceutical ingredient, explaining how to identify the molecule and show the purity of a substance.
The other monographs explain processes for testing tablets and orally disintegrating tablets that contain solifenacin. The dosage form monographs explain how to test characteristics such as the uniformity and dissolution of the tablets. JP is also seeking feedback on an ultraviolet-visible reference spectra graph for solifenacin.
The comment window closes on 28 February 2026.
PMDA Notice
Other News:
Singapore’s Health Sciences Authority (HSA) has shared details of a recall of nasal spray used to treat sneezing and a stuffy, itchy, or runny nose. The product, Apo-Fluticasone Aqueous Nasal Spray, was supplied with a shelf-life discrepancy. Hospitals, clinics, and pharmacies should stop supplying the affected batch and return unused stock to Pharmaforte Singapore. HSA Notice
TGA has issued a AU$19,800 ($13,161) infringement notice to Perdays Australia for the alleged unlawful advertising of a listed medicine. Australia allows sponsors to supply low-risk listed medicines without undergoing premarket assessment but limits them to making pre-approved low-level therapeutic claims about their products. The claims must not lead to unsafe use. Perdays has paid the notice. TGA Notice
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has set up an artificial intelligence working group. The group will look into how PMDA can apply AI to improve operational efficiency and quality. As PMDA departments explore AI, the working group will share their experiences and identify considerations for using the technology. PMDA created an AI action plan in September. PMDA Notice
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