Published:  28 August 2026

Medicines

Clinical Trials Processes – Guidance for sponsors

Background
Applications for Phase I trials
Protocol Amendments
New Investigators
Drug Safety Update Reports

Background

This page provides additional guidance for sponsors of clinical trials.

For more information, see the following Guideline on the Regulation of Therapeutic Products in New Zealand (GRTPNZ) documents:

Applications for Phase I Trials

Only submit applications for Phase I and First in Human Trials once all the safety data from the previous phase has been collected and analysed, so it can inform the protocol for the submission.

Medsafe will reject First in Human trials that are submitted prior to all the pre-clinical information being available. We will ask applicants to resubmit the application once this data has been incorporated.

Similarly, Medsafe will ask applicants that submit Phase I studies prior to the completion of the First in Human trials to resubmit the application once this data has been incorporated.

Protocol Amendments

Submit protocol amendments using the SCOTT post approval form in the Ethics Review Manager.

While we aim to review these changes within a week, for substantial changes this may not be possible.

To help with our evaluation of protocol amendments, and avoid requests for further information, please:

  • clearly describe all substantial amendments and provide a rationale for each change
  • clearly identify substantial changes if you are making minor changes at the same time
  • provide tracked/redline versions of updated documents. A summary table of changes is also helpful.

We will not accept amendments that fundamentally change the approved clinical trial such that the resulting protocol is, in effect, a new study. Examples of changes that we may consider to constitute a new study include, but are not limited to, a new investigational product, a substantially different study population, or major changes to the study design, study purpose, or therapeutic indication. Sponsors must submit such proposals as a new clinical trial application.

New Investigators

Please provide the following information for new clinical trial investigators.

  • Signed protocol signature page (PSP)
  • An up-to-date CV, which clearly details relevant qualifications, training, and clinical trial experience. If in doubt, use the Investigator CV template
  • Evidence of recent Good Clinical Practice (GCP) training.

Drug Safety Update Reports (DSURs)

Section 30(7)(d)(ii) of the Medicines Act 1981 requires progress reports to be submitted for approved trials every 6 months. You may use Drug Safety Update reports instead of one of the standard 6-monthly progress reports.

To synchronise the timing for 6-monthly reporting with the production of the annual DSUR:

  • if the DSUR is available within 6 months, submit this as the first progress report when it becomes available (early submission is acceptable)
  • if the DSUR is only available after 6 months, submit a standard progress report first, then submit the DSUR as the second progress report (early submission is acceptable).

For example, if the DSUR is scheduled for 9 months from approval of the trial, submit a progress report 3 months after the trial start. Submit the DSUR as the second progress report 9 months after the trial start date. Then continue to report 6-monthly (alternating the standard progress report and the DSUR).

Submit DSURs via Ethics RM. To avoid duplication, submit each DSUR only once (ie, there is no need to submit the same DSUR for multiple trials). If a DSUR is relevant to more than one trial currently ongoing in New Zealand, please list all the trials the DSUR applies to in the initial submission (ie, in a cover letter or a free text field).

Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /