New Zealand: Demystifying Protocol Clarification Letters in Clinical Trials (w.e.f. 12 March 2025)

The Good Regulatory Practise for New Zealand (GRTPNZ) guidelines for clinical trials state that any modifications to a trial protocol must be submitted and approved before implementation. This ensures that all changes align with safety standards and ethical considerations. A new statement has been issued to clarify this requirement and is effective immediately starting 12 March 2025.

Unlike protocol amendments, clarification letters and notes to file do not require Medsafe’s prior approval before implementation. Instead, they can be submitted for notification purposes, and an acknowledgment of receipt will be provided. This streamlines the process, reducing unnecessary delays in trial execution while maintaining transparency with regulatory authorities.

Process for Submitting Protocol Changes

• Protocol Clarification Letters & Notes to File: Do not require prior approval but must be submitted for notification

• Protocol Amendments: Must be submitted and approved before implementation

• Supporting Documentation: Evidence of acceptance of protocol amendments by overseas regulators can be included to assist Medsafe’s evaluation

  
  

This clarification provides researchers with a clear distinction between amendments requiring approval and clarification letters that do not. By understanding these requirements, trial sponsors and investigators can ensure compliance with regulatory guidelines while maintaining efficiency in their research processes.

For more detailed guidance and ensuring compliance not only supports ethical research but also facilitates the smooth progress of clinical trials in New Zealand and beyond, you may contact us at info@arqon.com

Source: New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE)