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

Overview

This consultation is aimed at pharmaceutical companies, health care professional organisations and individuals involved in conducting clinical trials in New Zealand. People who participate in clinical trials or with an interest in clinical trials regulation may also wish to participate. 

Medsafe is seeking your feedback on changes to the Guideline on the Regulation of Therapeutic Products in New Zealand: Part 11: Clinical trials – regulatory approval and good clinical practice requirements (the Guideline) and two new guidance documents which are proposed to be used alongside the Guideline:

• 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).

Medsafe last sought comment on a major revision of the Guideline in 2018.

Updates are proposed to:

• Incorporate new or updated legislation and relevant guidance issued in New Zealand and overseas;
• Reflect changes to best practice for the design and conduct of clinical trials (eg, patient involvement in study design); and
• Provide more clarity to those involved in conducting clinical trials on their obligations.

To assist in the analysis of submissions, Medsafe will only accept submissions made through this consultation website. However, the full consultation documents are attached below and can be viewed online, downloaded and/or printed.

All comments will be carefully considered and changes may be made as a result of the comments received.

To take part in this consultation, click on the online survey link below.

What happens next

This consultation is now closed and responses are being analysed.

We will publish the outcome and updated regulatory guideline on the Outcome of Consultation web page on the Medsafe website.