Medical Products and Natural Health Products Update
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- 2 days ago
- 5 min read
Welcome to the latest update from the Ministry of Health | Manatū Hauora on the regulation of medicines, medical devices and natural health products.
This newsletter includes updates on the following:
Important policy decisions on the Medical Products Bill
Community pharmacy ownership
Advertising
Statutory timeframes
Offences and penalties
Medical products regulator
Medical products exports
Supporting innovation under the Medical Products Bill
Natural health products
Regulation of xenotransplantation to continue to 2030
Update on the Medical Products Bill
In July and August 2025, Cabinet agreed to a range of policy matters for the Medical Products Bill. Read the press release from Associate Health Minister Hon Casey Costello.
These decisions will enable the Medical Products Bill to be drafted, replacing the Medicines Act 1981 with modern regulation of medicines and medical devices. The Government intends to introduce the bill to Parliament in 2026. It will come into effect around 2030. There will be a longer transition period for many medical devices.
This stakeholder update focuses on some key policy decisions made by the Government in relation to the Bill and shares materials related to these decisions.
This stakeholder update focuses on some key policy decisions made by the Government in relation to the Bill and shares materials related to these decisions.
Important policy decisions
Community pharmacy ownership
Not carrying over the Medicines Act’s ownership restrictions for community pharmacies into the Medical Products Bill.
Requiring all companies that include more than one pharmacy to have a supervisory pharmacist, who will be responsible for pharmacy standards and compliance for the company as a whole.
A Regulatory Impact Statement on pharmacy ownership can be found on the Ministry of Health website.
Advertising
Continuing to allow direct-to-consumer advertising of prescription medicines, with a power to make regulations restricting some kinds of advertising.
Ensuring the Medical Products Bill does not regulate activities such as fundraising and education as advertising.
Allowing products without a Medsafe approval to be promoted at medical conferences and trade shows, or if the Director-General of Health has approved the promotion (for example in response to a public health emergency).
Decisions on advertising were also informed by a 2025 literature view and a 2023 rapid review.
Statutory timeframes
Retaining the clinical trials decision timeframe from the Medicines Act, subject to any amendments made by the Medicines Amendment Bill.
Enabling other timeframes to be set in secondary legislation (i.e. regulations). These may be timeframes for decision making by Medsafe, or for applicants to provide information to Medsafe.
Enabling, in appropriate circumstances, a partial refund of fees if certain deadlines are not met. Specific arrangements will be determined during the development of secondary legislation.
Offences and penalties
Creating a civil pecuniary regime for corporate offending.
Creating an offence of improper inducement of a health practitioner to make a clinical decision about a medical product. The wording of this offence would be made clearer than the similar offence in the Therapeutic Products Act.
Including a fit and proper person test as part of determining whether to issue a market approval, license or permit. The test would be narrower than the test proposed in the Therapeutic Products Act.
Medical products regulator
Confirmed that Medsafe will continue to be the medical products regulator.
Agreed regulatory functions will be vested in an independent statutory officer. This officer would be appointed by the Director-General of Health and would be subject to general policy directions issued by the Minister of Health in relation to medical products.
The regulatory regime will continue to be mostly cost-recovered with a new power to set levies via regulations.
Medical products exports
Cabinet agreed in 2024 that export-only products would not need to be approved by the New Zealand regulator. Cabinet further agreed in August 2025 that:
Exporters will be able to get certificates to facilitate trade with other countries (eg, certificates of free sale)
Medical products exporters will need to register with Medsafe but will be subject only to general legal duties such as record-keeping.
The Ministry has published advice on each of these issues.
Supporting innovation and access to new treatments
In July, Cabinet agreed that the Bill will regulate ‘software-as-a-medical device’ (SaMD), including Artificial Intelligence used for a therapeutic purpose. The Bill’s definition of SaMD will be internationally aligned and not include general clinical software or general-use AI.
Cabinet agreed that the Bill will include a range of measures to enable the timely approval of novel and innovative medical products. Flexible approval pathways will support the adoption of new gene and cell therapies and personalised therapies.
Cabinet also made important decisions about clinical trials, including that:
Clinical trial approvals will be risk-based. Low-risk trials may only need to be notified to Medsafe. High-risk trials will require approval from Medsafe, including a review of the trial protocol. All trials will continue to need ethics approval.
The Bill will enable Medsafe to rely on clinical trial approvals from trusted overseas regulators. This will help encourage sponsors to start a New Zealand arm of an international trial.
Clinical trial sites will need to be registered or notify the regulator, depending on risk. This ensures sites have qualified staff and proper safety procedures.
Clinical trials will need to be listed on a public registry (eg, the Australian New Zealand Clinical Trials Registry). Registration helps patients find trials.
More details on the proposals can be found on the Ministry of Health website:
Natural health products
The Government is also considering how best to regulate natural health products.
The Ministry of Health will advise stakeholders via the Ministry’s newsletter on medicines, medical devices and natural health products, and through its stakeholder database, when it is ready to engage on any new proposals.
Dietary supplements
On 25 September 2025, new rules on the way export exemptions from New Zealand composition and labelling requirements are handled came into effect. This includes certain changes for exporting dietary supplements that will make it easier to meet importing country requirements. The Minister for Food Safety is now prioritising additional work on dietary supplements.
For further information, see Exempting food exports from New Zealand requirements | NZ Government.
Regulation of xenotransplantation to continue to 2030
Xenotransplantation is the transplantation of tissue and organs between different species, and in particular the transplantation of animal tissue into humans.
Xenotransplantation is a promising technology with some established uses, such as transplantation of pig heart valves, but many of its proposed applications remain experimental. It is regulated under the Medicines Act 1981.
In July 2025, the Government agreed to extend the existing provisions in the Medicines Act 1981 relating to xenotransplantation until 2030, by which time the Medical Products Bill will provide comprehensive and enduring regulation of this technology.
For further information, see
The Order-in-Council extending the regulation of xenotransplantation can be found on the New Zealand legislation website:
Contact us
If other people you know would like updates on the future regulation of medicines, medical devices, and natural health products, we encourage them to subscribe to this newsletter.
If you would like more information or to contact the team, please contact us at therapeuticproducts@health.govt.nz
Ministry of Health - Therapeutic Products
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