Proposed updates to the Guideline on the Regulation of Therapeutic Products in New Zealand: Clinical Trials - Page 1 of 18 - New Zealand Ministry of Health

Introduction

This consultation asks questions about your views on the proposed changes to the Guideline on the Regulation of Therapeutic Products in New Zealand: Part 11: Clinical trials – regulatory approval and good clinical practice requirements and two new guidance documents:

Considerations for First-In-Human (FIH) and Early Phase Clinical Trials; and
Clinical Trial Safety Monitoring and Reporting for Investigational Products (Medicines and Medical Devices).

The questions are organised in these sections:

Your details
Publishing submissions and Official Information Act requests (Required)
Guideline on the Regulation of Therapeutic Products in New Zealand: Clinical trials – regulatory approval and good clinical practice requirement Definitions Section 1: Legislation Section 2: Overview of Regulation of Clinical Trials in New Zealand Section 3: Application for Approval of a Clinical Trial Under Section 30 of the Medicines Act Section 5: Good Clinical Practice Requirements Section 6: Records and Reporting Section 7: Clinical Trials Involving Medical Devices General comments
New guidance documents Considerations for First-In-Human (FIH) and Early Phase Clinical Trials Clinical Trial Safety Monitoring and Reporting for Investigational Products (Medicines and Medical Devices)
Final comments

You do not need to answer every question. The only compulsory questions are in the 'Publishing submissions and Official Information Act requests' section.

At any time you can use the 'Save and come back later' button at the bottom of the page to save your progress and complete the consultation at a later time. You will be emailed a unique link to return to saved submission.