Published: 12 March 2025

Medicines

Clinical trials – Protocol clarification letters

Purpose

To provide guidance on reporting clinical trial amendments. The GRTPNZ for clinical trials (section 6.6.1) states that any changes to the trial protocol must be submitted and approved before they can be implemented. This statement is to further clarify this requirement and is effective immediately.

Process

Clinical trial protocol clarification letters, and notes to file do not need to be approved by Medsafe before being implemented.  They can be submitted for notification only and you will receive an acknowledgement of receipt s.

Changes to clinical trial protocols should continue to be submitted and require approval prior to implementation. Evidence of acceptance of protocol amendments by overseas regulators may also be submitted if they are available to assist Medsafe’s evaluation.