Published: 15 January 2026

Consultations

Outcome of the consultation on the proposed updates to the Guideline on the Regulation of Therapeutic Products in New Zealand: Clinical Trials

• Summary
• About the consultation
• Submissions received
• Outcome
• Revised Guideline
• New secondary guidelines
• Implementation date
• Enquiries

Summary

• Medsafe consulted on proposed updates to the Guideline on the Regulation of Therapeutic Products in New Zealand (GRTPNZ): Clinical Trials - Regulatory Approval and Good Clinical Practice Requirements (previously 'Part 11').
•  We also consulted on two new secondary guidance documents (Considerations for First-in-Human [FIH] and Early Phase Clinical trials and Clinical Trial Safety Monitoring and Reporting).
• We received 23 submissions.
•  Download the consultation outcome document to view a summary of the submissions and Medsafe's responses: GRTPNZ: Clinical trials - Consultation outcome (PDF, 464 KB, 35 pages). 
•  We have published the revised guideline and new secondary guidelines on the Medsafe website: Current Guidelines on the Regulation of Therapeutic Products in New Zealand.
•  The revised guideline and new secondary guidelines come into effect on 1 July 2026 but may be used from the date of publication (15 January 2026).  

About the consultation

Medsafe consulted on proposed updates to GRTPNZ Part 11: Clinical trials - Regulatory Approval and Good Clinical Practice Requirements and two new secondary guidance documents (Considerations for First-in-Human [FIH] and Early Phase Clinical Trials and Clinical Trial Safety Monitoring and Reporting).

The consultation was aimed at pharmaceutical companies, health care professional organisations and individuals involved in conducting clinical trials in New Zealand.

The guideline was last updated in 2018 (edition 2.0).

The consultation opened on 23 August 2024 and closed on 1 November 2024.

More information about the consultation.

Submissions received 

We received 23 submissions. Most submissions were from clinical trial sponsors or other industry groups involved in clinical trials.

You can view the submissions that we have permission to publish.

Medsafe would like to thank all those who took the time to respond to the consultation and provided comments.

Outcome 

In general, most respondents agreed with the proposed updates to GRTPNZ: Clinical trials - Regulatory Approval and Good Clinical Practice Requirements and the introduction of the two new secondary guidance documents.

Several respondents suggested changes to wording or requested additional information be included to provide further clarity on some of the changes. Where appropriate, we have incorporated these suggestions into the revised guideline and two new secondary guidance documents. 

Please refer to the consultation outcome document for further information.

•  Proposed updates to the GRTPNZ: Clinical trials - consultation outcome (PDF, 464 KB, 35 pages) 

Revised guideline

We have published the revised guideline.

• GRTPNZ: Clinical trials - Regulatory Approval and Good Clinical Practice Requirements (Edition 3.0) (PDF, 530 KB, 33 pages) 

New secondary guidelines

We have published the new secondary guidelines.

• Considerations for First-in-Human (FIH) and Early Phase Clinical Trials (Edition 1.0) (PDF, 256 KB, 6 pages) 
• Clinical Trial Safety Monitoring and Reporting (Edition 1.0) (PDF, 345 KB, 14 pages) 

Implementation date

The revised guideline and new secondary guidelines come into effect on 1 July 2026 and must be used from this date.

However, sponsors may use the revised guideline and the new secondary guidelines from the day of publication (15 January 2026).  

Enquiries

For any questions about this consultation, please email: askmedsafe@health.govt.nz