Clinical Trials

in New Zealand

New Zealand’s Clinical Trials is the primary point of contact for national and international organisations seeking to undertake preclinical and clinical research in New Zealand.

How do Clinical Trials

work in New Zealand?

More info

Connecting with Clinical

Trial sites in New Zealand

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Advantages of doing

Clinical Trials in New Zealand

More info

How do Clinical Trials

work in New Zealand?

Information on ethics processes, principles of research conduct, regulatory considerations and research governance are found in this section of the website.

How do Clinical Trials

work in New Zealand?

Information on ethics processes, principles of research conduct, regulatory considerations and research governance are found in this section of the website.

Getting Started

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.

Overview of New Zealand Regulations

New Zealand has a world-class track record with early phase and proof of concept trials validated by independent, clean and accurate clinical data.

Overview of New Zealand Regulatory Environment
New Zealand has a world class track record with early phase and proof of concept trials validated by independent, clean and accurate clinical data.
Medsafe
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. All communication regarding an application for approval of a clinical trial must be addressed to the Clinical Trial Co-ordinator at Medsafe http://www.medsafe.govt.nz/index.asp
Note: Approval from a Health and Disability Ethics Committee (HDEC) is required for all clinical trials conducted in New Zealand. This is a separate application and approval and is not administered by Medsafe.
Health Research Council (HRC)
Section 30 of the Medicines Act 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. http://www.hrc.govt.nz/
Health and Disability Ethics Committee (HDEC)

The New Zealand Health and Disability Ethics Committee 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. Ethics committee approval is a separate process from regulatory approval under Section 30 of the Medicines Act and is not administered by Medsafe. In New Zealand only one ethics committee review is required per trial New Zealand and this covers all sites. It takes around 4-6 weeks from submission to full approval. Requirements relating to New Zealand Health and Disability Ethics Committee approval of clinical trials are provided on the New Zealand Health and Disability Ethics Committee website.
https://ethics.health.govt.nz/home

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 not just District Health Boards (DHB). In order to gain full approval for a Clinical Trial, an application requires approval from an HDEC plus a Locality Authorisation. Forms for the Locality Authorisation can be found from that site via the HDEC online application system https://nz.ethicsform.org
If a Clinical Trial where one or more of the procedures described in the study protocol will be conducted at that DHB, then the Locality Authorisation will be required for that site. It is the researcher’s responsibility to ensure the DHB Research Office is informed that this has happened by providing an HDEC approval letter, and then the Locality Authorisation request will be approved by the DHB and confirmed with a DHB Research Approval Letter.

Importing Medicines/Treatments for a Clinical Trial

Ministry of Health (Medsafe) approval is required for the trial before drugs can be imported into New Zealand. The Medsafe Standing Committee On Therapeutic Trials (SCOTT) Approval Letter states that it may be used as evidence of import approval if required. An import licence is not required. Export approval is not required for investigational product shipped from the U.S to New Zealand. http://www.medsafe.govt.nz/consumers/miet/importmedicines.asp

Importing Materials for use in Clinical Trials

All imports into New Zealand are subject to Ministry of Agriculture & Forestry (MAF) and New Zealand Customs Import regulations.

A commercial invoice is required to accompany all goods. The commercial invoice should be on supplier letterhead and must specify the name and address of the importer and consignee, the terms of trade (International Chamber of Commerce – International Commercial Terms), details of goods (quantity, description and value of each item), country of origin and invoice currency.

For detailed information about New Zealand’s importing requirements, please visit the following website: http://www.mpi.govt.nz/importing/

Good Clinical Practice (GCP)

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 is required for the trial. In some cases, requirements set out in CPMP/ICH/135/95 do not cover , or are in conflict with , particular provisions in the Medicines Act 1981 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 in order to achieve compliance with New Zealand law.

 

Guideline on Regulation of Therapeutic Products in New Zealand – Part 11 – Edition 1.4 http://www.medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Part11.pdf

National Standardised Clinical Trial Research Agreements (sCTRA)

Standardised Clinical Trial Research Agreements (sCTRA) have been developed by the New Zealand Association of Clinical Research (NZWCRes) and are widely used within the New Zealand clinical trial industry. http://www.nzacres.org.nz/contract-templates

National Standardised Indemnity and Compensation Agreement (sCIA)

Standardised Indemnity and Compensation Agreements (sCIA) have been developed by the New Zealand Association of Clinical Researcher (NZACRes) and are widely used within the New Zealand clinical trial industry.

http://www.nzacres.org.nz/standardised-indemnity

National Standardised Clinical Costing Tool

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.

http://www.nzacres.org.nz/costing-template

Sponsors

In accordance with Section 30 of the Medicines Act, 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.

www.medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Part11.pdf

Recruitment and Retention

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.

https://ethics.health.govt.nz/guides-templates-forms-0

Medical Device trials

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 ethical committee, approval process in New Zealand does not require U.S FDA Investigational Device Exemption (IDE) filing prior to the start of the study.

For more information on Medical Devices – Regulatory Guidance:

http://www.medsafe.govt.nz/regulatory/DevicesNew/industry.asp

District Health Boards (DHBs)

In New Zealand, twenty District Health Boards (DHBs) are responsible for their area’s Health and Disability Services.

DHB’s and Public Academic Tertiary Institutions have research offices that act as the central entry point for approval of research.

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.

The twenty DHBs are responsible for providing or funding the provision of Health and Disability Services within their district. Funding is allocated via a population based formula by the Ministry of Health. This includes funding for primary care, public health services, aged care, and services provided by other non-government health providers, including Maori and Pacific providers.

Each DHB is responsible for ensuring healthcare within their district meets the standards and goals set by the Ministry of Health which includes:

  • improving, promoting and protecting the health of the people in their community
  • promoting the integration of health services, especially primary and secondary care services
  • seeking the optimum arrangement for the most effective and efficient delivery of health services in order to meet local needs
  • promoting effective care or support for those in need of personal health services or disability support.

DHB’s range in population size from approximately 30,000 at the smallest to over 500,000 at the largest. There are currently 220 hospitals (private and public) in New Zealand.

DHB’s 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 the local DHB’s and/or institutions governing policies and procedure are adhered to.

View New Zealand’s District Health Board Map:

https://www.health.govt.nz/new-zealand-health-system/key-health-sector-organisations-and-people/district-health-boards/location-boundaries-map

 

Contact details for DHB or Public Academic Tertiary Institution can be found at: http://www.medsafe.govt.nz/regulatory/CSSites.htm

Research Approval Requirements
All research involving DHB’s must receive approval from the DHB’s Research Review Committee before commencing. The DHB’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
Māori research assessment
As part of conducting research within DHB’s, 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 DHB 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.

Connecting with

Clinical Trials sites in New Zealand

Information on: Clinical Trial sites, Clinical Research Organisations, District Health Boards, University’s, funding and supporting industry bodies.

Connecting with

Clinical Trials sites in New Zealand

Information on, Clinical Trial sites, Clinical Research Organisations, District Health Boards, University’s, funding and supporting industry bodies.

Advantage Of Doing

Clinical Trials in New Zealand

New Zealand offers a world class track record with early phase and proof of concept trials and independent, clean and accurate clinical data.

Advantage Of Doing

Clinical Trials Sites In New Zealand

New Zealand offers a world class track record with early phase and proof of concept trials and independent, clean and accurate clinical data.

New Zealand Has:

  • High-quality research facilities
  • Efficient ethics and regulatory framework
  • Can accommodate seasonal differences
  • Diverse participant recruitment pool