Regulatory Requirements

Regulatory Requirements for Clinical Trials in New Zealand

Ethics Committee and Standing Committee On Therapeutic Trials (SCOTT) approvals are required before clinical trials can be conducted in New Zealand. These two processes run in parallel and on average take four to six weeks from submission to approval depending on complexity of the study.

Ethics Committee

ACS is responsible for applying for ethics approval from the relevant Ethics Committee and the Maori Research Review Committee for all studies it proposes to conduct. The information that is required by the committees include:

• Completed national ethics application form
• Study protocol
• Investigational drug brochure
• Volunteer/patient information and consent forms
• Indemnity Insurance certificate
• Any advertisements
• Investigator(s) CV

The Ethics Committees meet every two weeks and applications close two weeks prior to the meeting date. Approvals are usually obtained within 1-2 weeks of the meeting. For meeting dates see www.ethicscommittees.health.govt.nz.

SCOTT

The pharmaceutical company is responsible for the SCOTT application for the trial. The information that is required includes:

• Completed SCOTT application form
• Study protocol
• Investigational drug brochure
• Volunteer/patient information and consent forms
• Indemnity Insurance certificate
• Investigator(s) CV and the investigators agreement to conduct the study
• Application fee ($NZ6,525.00)

Applications are processed within 14 to 18 working days after the Ministry of Health receives the fee and documentation. Four copies of the above information are required with each application.