Information on ethics processes, principles of research conduct, regulatory considerations and research governance are found in this section of the website.
Information on ethics processes, principles of research conduct, regulatory considerations and research governance are found in this section of the website.
Researchers initiating clinical trials in New Zealand must take into consideration trial protocol and/or design, resource issues, ethics review, regulatory oversight, institutional policies, research governance and many other issues.
New Zealand has a world-class record of accomplishment with early phase and proof of concept trials validated by independent, clean and accurate clinical data.
Ethics committee approval is a separate process from regulatory approval under Section 30 of the Medicines Act 1981 and is not administered by Medsafe. The New Zealand Health and Disability Ethics Committee (HDEC) administers the ethics approval system, which applies to interventional clinical trials regardless of whether they are trials that require approval under Section 30 of the Medicines Act.
Clinical trials that require sample collection and storage, or the use of disclosure of health information are in most cases also subject to ethics approval.
In New Zealand only one ethics committee review is required per trial, and this covers all sites. It takes around 4-6 weeks from submission to full approval. Requirements relating to New Zealand HDEC approval of clinical trials are provided on the New Zealand HDEC website.
The Medicines Act 1981*, Misuse of Drugs Act 1975, and other legislation control the supply of medicines and medical devices in New Zealand. Ministry of Health approval is required for a trial before medicines can be imported into New Zealand.
Detailed information about New Zealand’s medicine control requirements and relevant legislation can be found on the Ministry of Health’s website.
Regulatory guidance for importing medical devices into New Zealand can be found on Medsafe’s website.
*Note: The Therapeutic Products Bill was introduced to Parliament on 30 November 2022 and will replace the Medicines Act 1981. The Bill details an updated regulatory process that may change import requirements. You can follow updates on the Bill here.
All imports into New Zealand are subject to the Ministry for Primary Industries (MPI) and New Zealand Customs Import regulations. Detailed information about New Zealand’s importing requirements can be found on the MPI website.
From 1 January 2011 all clinical trials conducted in New Zealand are expected to be conducted in accordance with the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95). This applies whether or not approval under the Medicines Act 1981 is required for the trial.
In some cases, requirements set out in CPMP/ICH/135/95 do not cover or conflict with provisions in the Medicines Act or in other relevant New Zealand legislation (e.g. legislation relating to reporting requirements or the retention of records). For this reason, some of the requirements specified in CPMP/ICH/135/95 must be modified to achieve compliance with New Zealand law.
Medsafe Guideline on the Regulation of Therapeutic Products in New Zealand.
Standardised Clinical Trial Research Agreements (sCTRA) have been developed by the New Zealand Association of Clinical Research (NZACRes) and are widely used within the New Zealand clinical trial industry.
You can access sCTRA templates on the NZACRes website.
Standardised Indemnity and Compensation Agreements (sICA) have been developed by the New Zealand Association of Clinical Research (NZACRes) and are widely used within the New Zealand clinical trial industry.
You can access sICA templates on the NZACRes website.
A national costing tool has been developed by the New Zealand Association of Clinical Research (NZACRes) and is widely used by sites to facilitate accurate and transparent trial costing and to support transparent price discussions.
You can access the costing tool on the NZACRes website.
In accordance with Section 30 of the Medicines Act 1981, an application for a clinical trial of a new or unregistered medicine for approval for distribution in New Zealand must be lodged by, or in the name of, a person or company residing in New Zealand. Further guidance is also available in Section 3.3 of the Medsafe Guideline on the Regulation of Therapeutic Products in New Zealand.
The aim is to provide accurate and balanced information for patients. The focus of discussions should be to raise awareness of clinical trials and discuss the risks and benefits of participation. This is to ensure that patients can make a fully informed decision on participation in a clinical trial study. A Patient Information Form and Consent Form must be provided to the potential participant and completed.
You can access templates on the HEDC website.
Medical device developers looking for a rapid, cost effective means of gaining early proof of concept for their products should consider conducting their initial clinical trials in New Zealand. The simple, one ethics committee approval process in New Zealand does not currently require U.S FDA Investigational Device Exemption (IDE) filing prior to the start of the study.
More information on Medical Devices – Regulatory Guidance on the Medsafe website.
To illustrate some clinical validation journeys with links to supporting material, the HealthTech Activator (HTA) has put together fictional case studies for example health innovations in collaboration with the New Zealand Association of Clinical Research (NZACRes), Te Tītoki Mataora and the National Institute of Health Innovation (NIHI).
You can review these case studies on the HTA website.
In July 2022, New Zealand’s, twenty District Health Boards (DHBs) were disestablished.
To begin reforming the health system, the DHBs’ functions were merged into Te Whatu Ora – Health New Zealand, which now leads the day-to-day running of the system for the whole country. Te Whatu Ora also assumed the operational functions of the Ministry of Health, such as managing national contracts.
An interim Māori Health Authority was also established in September 2021, ahead of the creation of Te Aka Whai Ora – Māori Health Authority as an autonomous legal entity in July 2022. Te Aka Whai Ora’s role is to provide a more consistent, national leadership of health service delivery with a Te Ao Māori perspective.
New Zealanders receive healthcare through a mixture of private and publicly funded services. The public healthcare system is primarily funded through general taxation and is therefore only available to NZ residents.
New Zealand’s districts range in population size from approximately 30,000 at the smallest to over 500,000 at the largest. There are currently over 150 hospitals listed as certified providers (private and public) in New Zealand. You can view certified provider maps on the Ministry of Health website.
Te Whatu Ora regions and Public Academic Tertiary Institutions have a research office or similar. The research offices facilitate close working relationships between researchers, clinical staff, ethics committees, funding bodies and commercial sponsors. These offices act as the central entry point for the approval of research and ensures that governing policies and procedure are adhered to.
Contact details for certified clinical trial sites can be found on the Medsafe website.
Information on clinical trial sites, contract research organisations, universities, funding and supporting industry bodies are found in this section.
The below directory is not exhaustive, and inclusion does not imply endorsement or recommendation. To request a new listing, or an update to an existing listing, please email hta@callaghaninnovation.govt.nz.
Contact persons for all certified clinical trial sites can be found on the Medsafe website.
Information on clinical trial sites, contract research organisations, universities, funding and supporting industry bodies are found in this section.
The below directory is not exhaustive, and inclusion does not imply endorsement or recommendation. To request a new listing, or an update to an existing listing, please email hta@callaghaninnovation.govt.nz
Contact persons for all certified clinical trial sites can be found on the Medsafe website.
New Zealand offers a world class record of accomplishment with early phase and proof of concept trials and independent, clean and accurate clinical data.
New Zealand offers a world class record of accomplishment with early phase and proof of concept trials and independent, clean and accurate clinical data.