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
Medsafe is the Medicines and Medical Devices Regulatory Authority for New Zealand. Medsafe administers the regulatory application for clinical trials under Section 30 of the Medicines Act 1981, involving the use of new medicines, unregistered medicines, scientific assessment of gene technology and medical devices. Approvals are issued by Medsafe under a delegation from the Director-General of Health.
Medsafe receives and processes applications, liaises with the relevant Health Research Council committee (Standing Committee on Therapeutic Trials (SCOTT) or Gene Technology Advisory Committee (GTAC)) and the applicant, and issues approval letters as part of the approval scheme for clinical trials.
Further information about the scheme can be found in the Guideline on the Regulation of Therapeutic Products in New Zealand – Part 11: Clinical Trials – Regulatory Approval and Good Clinical Practice Requirements. You can find the current regulatory guidance on the Medsafe website.
One component of the clinical trials scheme is the self-certification of sites that have study participants in residence while the clinical trial medicines are administered. Further information about the self-certification scheme can be found in Section 4 of the Guideline. A list of sites for which self-certification has been lodged with Medsafe can be reviewed on the Medsafe website.
Section 30 of the Medicines Act 1981 authorises the Director-General of Health to approve a clinical trial involving the use of new and unregistered medicines on the recommendation of the Health Research Council of New Zealand (HRC).
The HRC maintains two standing committees to consider clinical trial applications and make recommendations to the Director-General. The Standing Committee on Therapeutic Trials (SCOTT) considers applications for new pharmaceutical-type medicines, and the Gene Technology Advisory Committee (GTAC) considers applications for trials involving new and unregistered gene and other biotechnology therapies. The Terms of Reference for these committees are published on the HRC website.
The sponsor of a clinical trial should read these documents before submitting a regulatory approval application, as they provide guidance on the committee processes and the data requirements for applications to be considered by each committee.
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. Requirements relating to New Zealand HDEC approval of clinical trials are provided on the New Zealand HDEC website.
Locality Authorisation for Ethics
The term “Locality Authorisation” refers specifically to the process used by the NZ Health and Disability Ethics Committees (HDECs) for ascertaining that all local governance issues have been addressed at sites participating in a clinical trial. Locality Authorisation approval is required by all sites. To gain full approval for a clinical trial, an application requires approval from HDEC plus a Locality Authorisation.
Guides, templates, and forms can be found on the HDEC 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.
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.
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.
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.
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.
All research involving Te Whatu Ora – Health New Zealand sites must receive approval from the relevant Research Review Committee before commencing. The relevant Te Whatu Ora site’s Research Office registers the project and organises the review process.
The approval process will involve:
• Research Office Application Form
• Protocol
• Ethics Application
• Research Budget
• Participant Information Sheets and Consent Forms
• Contract or Clinical Trial Agreement
• Indemnity and Compensation Agreement
• Investigator Brochure
• Funding Letter
• Evidence of consultation with Māori
• Locality Authorisation for Ethics
• Scientific peer review
• Ethics Approval Letter
As part of conducting research within Te Whatu Ora – Health New Zealand, an applicant must demonstrate responsiveness to Māori. The Research Application has a section titled Responsiveness to Māori which must be completed for all projects. In most cases, the review is performed either by the Māori Advisor for Research or a similar entity. The Te Whatu Ora Research Office facilitates the review. On completion of the Māori research assessment, a letter of support will be sent to you showing that a process of formal research review has taken place.
Use the below to search through some NZ-specific clinical terms. The clinicaltrials.gov site provides a comprehensive glossary of common site terms.
