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

Closes 3 Aug 2018

Opened 22 Jun 2018

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 is seeking comments 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.

Invitation to comment

Medsafe is seeking comments from interested parties on the updated regulatory guideline and Clinical Trial Site Notification Form.

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

Give Us Your Views

Audiences

  • Members of the public
  • Health sector
  • Pharmaceutical companies

Interests

  • Therapeutic products