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 track record with early phase and proof of concept trials validated by independent, clean and accurate clinical data.
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
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
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/
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
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
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.
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.
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.
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.
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
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:
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:
Contact details for DHB or Public Academic Tertiary Institution can be found at: http://www.medsafe.govt.nz/regulatory/CSSites.htm
Information on: Clinical Trial sites, Clinical Research Organisations, District Health Boards, University’s, funding and supporting industry bodies.
Information on, Clinical Trial sites, Clinical Research Organisations, District Health Boards, University’s, funding and supporting industry bodies.
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 offers a world class track record with early phase and proof of concept trials and independent, clean and accurate clinical data.