Conducting trials in New Zealand
New Zealand has a population of four million, predominantly of European descent, but with sizeable Polynesian and Asian populations. Advantages include:
- Reverse seasonality and no holidays during July / August
- Less bureaucracy and a practical regulatory environment
- Responsive to changes in requirements as projects develop
- Relatively treatment-naïve population
- Excellent recruitment and retention rates
- English language environment
- Good infrastructure for clinical trial processes & technology
- Standard of medical practice similar to Western Europe / North America
- Lower costs and lower overheads
- Quality data to ICH-GCP and FDA standards
Regulatory Authority
The Regulatory Authority in New Zealand is the Ministry of Health's (Medsafe) Standing Committee On Therapeutic Trials (SCOTT). The submission to approval timeline currently averages at ~13 days. A SCOTT approval is required for non-registered drug formulations, but not for medical devices, nor new indications of NZ registered formulations. Ethics Committee (EC) applications can be submitted in parallel to regulatory submission and indeed both approvals are conditional on the other.
Costs
SCOTT applications cost NZ$6,525 (around A$5,000) with no charge for Ethics Committee applications.
Ethics Committee (Institutional Review Board)
Only one Ethics Committee (EC) review is required per study in New Zealand. It takes 6-8 weeks from submission to full approval. EC’s meet monthly / twice monthly except January, and require notice and prepared documents two weeks prior to a meeting to consider the application. All EC's in New Zealand use the same application form, and one regional or national committee represents all study sites, saving much paperwork. For more information including agenda and meeting dates see www.ethicscommittees.health.govt.nz. There is no cost for this.
Trial registration is through a centralised procedure in Australia and New Zealand called the Australian New Zealand Clinical Trials Registry.