New Zealand

Medsafe is the primary regulatory authority responsible for the safety, quality, and efficacy of medicines, medical devices, diagnostics, and related health products in New Zealand. The principal governing legislation is the Medicines Act 1981, supplemented by the Medicines Regulations 1984, the Medical Devices (Consultation and Notification) Regulations 2023, and the Therapeutic Products Act 2023, which is progressively reshaping the regulatory framework. Medicines require consent from the Minister of Health, administered by Medsafe, before they can be marketed, while medical devices currently operate under a notification-based system requiring conformity with recognised international standards. The approval process involves submission of a product application, scientific evaluation by Medsafe, and where relevant, consideration by the Medicines Assessment Advisory Committee (MAAC) or the Committee on the Safety of Medicines (CSM).

New Zealand accepts dossiers prepared in the International Council for Harmonisation (ICH) Common Technical Document (CTD) format, and Medsafe participates in the Australia New Zealand Therapeutic Products Agency (ANZTPA) harmonisation initiative alongside the Australian Therapeutic Goods Administration (TGA). Applications may leverage prior approvals from reference agencies, including the TGA, the US FDA, the European Medicines Agency (EMA), Health Canada, and the UK MHRA, through an international reliance pathway that can substantially reduce review timelines. Local resident or New Zealand-based agent representation is required for all product sponsors without a domestic presence. A landmark reform, the Therapeutic Products Act 2023, will eventually consolidate the regulatory oversight of medicines, medical devices, natural health products, and digital health tools under a single modernised framework, with phased implementation expected across the mid-2020s.

Public procurement of health products in New Zealand is primarily centralised through Health New Zealand (Te Whatu Ora), the national statutory body established in 2022 following the abolition of the 20 district health boards (DHBs). Health New Zealand manages national contracts and hospital supply chains across all public health facilities, with strategic medicines funding and reimbursement decisions made by the Pharmaceutical Management Agency (PHARMAC). PHARMAC operates a national formulary and negotiates on behalf of the Crown to determine which pharmaceuticals and, increasingly, medical devices are subsidised for use in the public health system. Suppliers seeking public market access typically engage PHARMAC's tender and listing process, which evaluates clinical benefit, cost-effectiveness, and total budget impact. Medical devices and diagnostics are procured through PHARMAC's Medical Devices Scheme, and digital health solutions must align with the national digital health strategy overseen by Health New Zealand.

New Zealand is a high-income country and does not significantly rely on donor-funded procurement channels such as UNICEF Supply Division, the Global Fund, USAID, or Gavi, which are more relevant in low- and middle-income market contexts. The private sector represents a meaningful parallel channel, served by private hospitals, specialist clinics, and pharmacy networks operating independently of PHARMAC's subsidised formulary, where suppliers may negotiate directly without public tender obligations. New Zealand does not enforce formal local manufacturing preference policies, and the market is predominantly supplied through importation. However, sustainability and supply chain resilience considerations are increasingly influencing procurement decisions, and suppliers demonstrating reliable local distribution infrastructure and post-market support capabilities are viewed favourably in both public and private procurement evaluations.