How do clinical trials work in New Zealand?

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.

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.
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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

You can review an example approval process on the Te Whatu Ora – Te Toka Tumai Auckland (previously Auckland DHB) site.

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.