Proposed updates to the Guideline on the Regulation of Therapeutic Products in New Zealand: Clinical Trials
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
|
New guidance documents
|
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.