Information on ethics process, principles of research conduct, regulatory considerations, and research governance.
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.
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.
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.
Overview of New Zealand Regulatory Enivronment
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.
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 passed Parliament in July 2023 and became the Therapeutic Products Act (2023). You can follow updates on regulatory changes here.
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.
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.
You can read more about materials shipping on the NZ Association of Clinical Research (NZACRes) website.
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.
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.
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.
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.
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.
Use the below to search through some NZ-specific clinical terms. The clinicaltrials.gov site provides a comprehensive glossary of common site terms.
The Accident Compensation Corporation (ACC) provides comprehensive, no-fault personal injury cover for all New Zealand residents and visitors to New Zealand.
Online registry of clinical trials being undertaken in Australia, New Zealand and elsewhere.
Any change to the terms of a study, including to the protocol or other supporting documentation, made after a Health and Disability Ethics Committee has approved the study.
A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The group can recommend to the study sponsor that the study be stopped if it is not effective, if it is causing harm to participants, or if it is not likely to serve its scientific purpose. Committee members are chosen based on the scientific skills and knowledge needed to monitor the particular study. Also referred to as a Data Safety and Monitoring Board (DSMB).
The Gene Technology Advisory Committee provides regulatory review of genetically modified products.
The process by which a Health and Disability Ethics Committee (HDEC) checks, in accordance with the Standard Operating Procedures, that a new application (or substantial amendment to a previously approved application) meets or exceeds established ethical standards.
The Health Research Council is the agency responsible for managing the Government’s investment in health research. The HRC’s committees provide advice on gene technology, accredit health and disability ethics committees and institutional ethics committees, monitor the safety of large clinical trials and review applications to use new medicines in trials.
The Health Research Council Ethics Committee ensure that independent ethical assessment of any proposed research submitted for a Health Research Council (HRC) grant has been carried out either by the HRCEC itself, or an ethics committee approved by the HRCEC. The HRCEC approves ethics committees to carry out this function.
An organisation responsible for a hospital, health centre, surgery or other establishment or facility in New Zealand at or from which the procedures outlined in the protocol of a study are to be conducted.
‘Locality review’ is the process by which a locality assesses its suitability for the safe and effective conduct of an intervention study.
SCOTT is the Standing Committee on Therapeutic Trials; a standing committee of the Health Research Council (HRC) whose function is to make recommendations to Medsafe regarding the approval of clinical trials of new medicines under section 30 of the Medicines Act 1981.
An administrative check carried out by the Health and Disability Ethics Committee (HDEC) secretariat to verify that an application or other item of business is complete and may be assigned for review through the full or expedited review pathway.
To illustrate some clinical trial journeys with links to supporting material, we've put together two 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).
Learn more about how a new treatment for psoriasis could navigate the Phase I clinical trial process, with links to further reading on the discussed topics.
Learn more about the clinical investigation process for a wearable diabetes monitoring device, with links to further reading on the discussed topics.