Regulatory Services

ACS has extensive regulatory experience and is able to provide support for submissions to the NZ regulatory authorities. Regulatory Requirements for Clinical Trials in New Zealand are:

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 one of four Health and Disability Ethics Committees (HDECs) for all studies it proposes to conduct. ACS can act as local agent acting on behalf of Sponsors for regulatory submissions. The information that is required by the committees include:

 

  • Completed national ethics on-line 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 week and applications close two weeks prior to the meeting date. Approvals are usually obtained within 1-2 weeks of the meeting.

Meeting dates can be provided upon request.

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

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.

Application fee ($NZ6,525.00)