Regulatory Approach
Regulatory Approval in New Zealand is straight forward, one approval covers all sites
Regulatory approval in New Zealand is required for either:
A. conducting a clinical trial involving a non-licensed product
B. conducting a clinical trial involving a licensed product that is to be investigated via a new route or dose
Regulatory approval in New Zealand is governed by The Ministry of Health’s Medsafe Division, the Standing Committee On Therapeutic Trials (S.C.O.T.T). The maximum turn around time for approval is 45 days however approval is usually obtained more quickly. One approval covers all participating clinical trial sites in New Zealand and currently costs NZ $6,525 (including Goods & Services Tax). The S.C.O.T.T submission can be submitted in parallel with Ethics Committee applications.
More information about S.C.O.T.T submissions, including the application form can be found at
