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

http://www.medsafe.govt.nz/

 

 

Contacts

  • Medsafe

    Via Email:
    Or:
    Phone (04) 819 6800
    P O Box 5013
    Wellington
    New Zealand

  • National Co-ordinator of HDECs

    Via Email:
    Or:
    phone 0800 4 ETHICS (or from outside NZ +64 4 819 6877)
    Ethics Committees
    Ministry of Health
    PO Box 5013
    Wellington 6145
    New Zealand

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