Benefits of Conducting Clinical Research in New Zealand
- Well established clinical trial infrastructure
- Excellent recruitment and retention rates
- High standard of clinical trial data
- High standard of medical practice
- Adherence to ICH/GCP and FDA regulations
- Regulatory framework based on European and American systems
Regulatory Authority
The New Zealand Ministry of Health’s MedSafe Division, Standing Committee on Therapeutic Trials (S.C.O.T.T) reviews and approves regulatory applications in New Zealand. The review process takes a maximum of 45 days, although this is usually less. The fee for the S.C.O.T.T submission is NZ$6,525 including 12.5% Goods & Services Tax. EC (IRB) applications can be submitted in parallel with the S.C.O.T.T. application. For further information, visit Medsafe.
Ethics Committee (IRB)
Seven Ethics Committees operate in New Zealand, all using the same National Application Form. For studies with more than one participating site, only one EC submission is required (covering all New Zealand sites). The EC process takes approximately 1-2 months with no submission fees. Ethics Committees meet on a monthly basis and require the completed National Application Form be submitted 3 weeks prior to the meeting. For further information (including agenda closing dates and meeting dates), visit the New Zealand Health and Disability Ethics Committees website.