Update to the Guideline on the Regulation of Therapeutic Products – Part 11: Clinical trials

Overview

This consultation is aimed at pharmaceutical companies, health care professional organisations, and individuals involved in conducting, or who are subjects of, clinical trials of medicines.

Medsafe sought comment on a major revision of the Guideline on the Regulation of Therapeutic Products in New Zealand. Part 11: Clinical trials – regulatory approval and good clinical practice requirements.

Part 11 of the regulatory guideline was last reviewed in January 2015. Since then, Medsafe has changed procedures regarding some aspects of clinical trial applications, for example a move to online applications. As a result, applications made on paper will no longer be accepted. The self-certification of clinical trial sites presented some problems also, resulting in the duplication of information provided to Medsafe. Changes are being made to the guideline and Clinical Trial Site Notification Form to address these issues.

As Medsafe intends that the process will change from self-certification to a notification procedure, Medsafe proposes requiring managers of clinical trial sites to resubmit details using the new form. This will allow Medsafe to publish updated information that will be of assistance to investigators.

A side-by-side version of the current guideline and the proposed changes is presented, with commentary on the reason for the changes. A simplified Clinical Trial Site Notification Form is also presented for comment.

Consultation documents

• Guideline on the Regulation of Therapeutic Products in New Zealand. Part 11: Clinical trials – regulatory approval and good clinical practice requirements. Edition 2.0 (PDF, 442 KB)
• Clinical Trial Site Notification Form Edition 1 (PDF, 301 KB)

What happens next

All comments will be considered. Once the analysis of submissions is complete, the guideline document may be revised to include suggested changes.

We will publish the outcome and updated regulatory guideline on the Outcome of Consultations web page on the Medsafe website. To subscribe to an automatic email notification of website updates, please register here.