New Zealand - Clinical Trial Regulatory Process

New Zealand could be an interesting choice of region for national and international organizations seeking to pursue clinical research and looking for the most preferred destination in the Asia-Pacific Region.

New Zealand, a country named the third most beautiful country in the world with stunning and diverse natural beauty, jagged mountains, is full of islands with one of Earth’s most peculiar bioregions, inhabited by flightless birds seen nowhere else such as a nocturnal, burrowing parrot and kiwi. Now, New Zealand is also been know as the preferred country for conducting Clinical Trials.

Why Clinical Trials in New Zealand?

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

Overwhelming factors:

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

Regulatory Authority in New Zealand

Director-General of Health – Approval from the Director-General of Health is required before a clinical trial using a new medicine may commence in New Zealand.
Health Research Council (HRC) – The Health Research Council (HRC) of New Zealand makes a recommendation to the Director-General on the clinical trial application.
Medsafe – The application and approval process for clinical trials is administered by Medsafe.
Health and Disability Ethics Committees – The Health and Disability Ethics Committees administer the ethics approval system, which applies to all clinical trials conducted in New Zealand. [1]

Health Research Council of New Zealand (HRC)

Health Research Council of New Zealand (HRC) recommends the approval of clinical trials to Director – General of Health
The HRC maintains two standing committees to consider clinical trial applications and make recommendations to the Director-General.
Standing Committee on Therapeutic Trials (SCOTT) considers applications for new pharmaceutical-type medicines, and the Gene Technology Advisory Committee (GTAC). [1][2]

What is 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.

Medsafe also administers a notification scheme for clinical trial sites that have patients in residence and maintains a list of sites for which it has received notification of compliance with Good Clinical Practice requirements. [1]

Health and Disability Ethics Committee (HDEC)

New Zealand has two types of approved Ethics Committee (EC) that conduct ethical reviews of clinical trials

HDECs, which are used for most clinical trial approvals, and the
Institutional Ethics Committees (IEC), used for late-phase research involving humans, originating from that specific institution.

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. [2]

Clinical Trial Sites in New Zealand

The application must include information about the site(s) at which the trial is to be conducted, and the facilities available at those sites. This information is also taken into consideration in deciding to grant approval for the trial.

The person who manages the site (where study participants stay overnight) completes a Clinical Trial Site Notification form and should notify that the site has adequate emergency procedures in place.

On receipt of a completed notification, Medsafe will add the site to a list of Notified Clinical Trial Sites on the Medsafe website (http://www.medsafe.govt.nz/regulatory/CSSites.htm). [2]

Clinical trial registry in New Zealand

The Australian New Zealand Clinical Trials Registry (ANZCTR) is an online public registry of clinical trials, held at the NHMRC Clinical Trials Centre, University of Sydney. It is a Primary Registry in the World Health Organization (WHO) Registry Network, which means that it fulfills certain criteria for content, quality, and validity, accessibility, unique identification, technical capacity, and administration.

The ANZCTR accepts both interventional and observational studies for registration from all countries and from the full spectrum of therapeutic areas including trials of pharmaceuticals, surgical procedures, preventive measures, lifestyle, devices, treatment and rehabilitation strategies, and complementary therapies. [3]

Clinical trial approval procedure in NZ

Applications for approval of clinical trials must be made using the online system. Paper-based/emailed applications will not be accepted. An online application for a clinical trial approval is made using the NZ Online at https://nz.ethicsform.org/signin.aspx
The applicant must first create an account to get access to SCOTT / GTAC and HDEC application forms.
An application for approval of a clinical trial should be made by the person responsible for the trial in New Zealand. The applicant must be the person in New Zealand who takes legal responsibility for the conduct of the trial in New Zealand.
On receipt of the online application, Medsafe will issue an acknowledgment letter and an invoice to the applicant within 7 days and Medsafe forwards the application to the Health Research Council of New Zealand (HRC). the applicant can communicate with Medsafe at clinicaltrials@medsafe.govt.nz
Application for Ethics Committees approval can be made at any time before, during, or after consideration of the application for clinical trial approval.
Within 45 calendar days of receiving the application, the applicant will be notified about the outcome of the Director-General’s consideration of the HRC’s recommendation and will liaise with the applicant regarding any proposed conditions of approval or requests for further information.
if the Director-General’s decision is to approve the trial, a letter will be issued by Medsafe. If the decision is to decline an application, the reasons for this decision will be provided to the applicant. The applicant then has 28 days in which to lodge an appeal with the Medicines Review Committee. [1][2][4]

Type of Approval

The process of approval for Clinical Trial is Parallel. The applicant can submit the application to Medsafe along with HDEC

Time of Approval

The timeline of approvals is about approx 45 Days for Director-General’s decision. [4]

Import

Medicines and Treatments

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 can be used as evidence of import approval if required.
An import license is not required.
Export approval is not required for investigational products shipped from the U.S to New Zealand.

Materials used in Clinical trials

All imports into New Zealand are subject to the Ministry of Agriculture & Forestry (MAF) and New Zealand Customs Import regulations.
A commercial invoice is required to accompany all goods. [1]

Clinical Trial Statistics in New Zealand

A total of 1,895 trials has been registered in New Zealand with 492 Ongoing Trials

The major therapeutic area in which most studies were registered are

Gastrointestinal & Digestive system disease
Oncology
Infectious disease
Respiratory disease followed by
Heart diseases [5]

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New Zealand – Clinical Trial Regulatory Process