Revised: 27 May 2013
16 October 2009
To Clinical Trial Stakeholders
Currently, Medsafe guidance on the legal, ethical and research practice requirements for clinical trials conducted in New Zealand is provided in Volume 1 of the New Zealand Regulatory Guidelines for Medicines and in an interim Good Clinical Research Practice Guideline first published in 1996.
Medsafe's intention has always been to adopt an international standard, once international consensus on good clinical research practice had been reached. Since the guideline CPMP/ICH/135/95 has become the international standard, Medsafe is proposing to consolidate and update the New Zealand guidelines relating to clinical trials and is seeking comments on a proposed new guideline.
The proposed guideline (available on the Medsafe website ( Microsoft Word document 210kb ), is intended for publication on the Medsafe website in e-format with hyperlinks to referenced legislation and documents. It provides guidance on:
Information from existing documents has been consolidated and expanded in order to provide more comprehensive guidance for those conducting clinical trials. The more significant changes reflected in the proposed guideline are:
Medsafe welcomes feedback on the proposed Good Clinical Research Practice Guideline.
Please send your submission to:
Medsafe GCRP Consultation
Ministry of Health
PO Box 5013
firstname.lastname@example.org with ' GCRP Consultation ' in the subject line.
The closing date for submissions is 30 November 2009 .
Please ensure that you provide an email address to which acknowledgement of receipt of your submission and feedback on the analysis of submissions can be sent.
Submissions may be released under the Official Information Act 1982. Any information you do not want made public should be sent separately and clearly marked CONFIDENTIAL.
Acting Group Manager Medsafe
Draft New Zealand Good Clinical Research Practice Guideline (NZRGM, Volume 3) (Microsoft Word Document 209kb)
Draft New Zealand Good Clinical Research Practice Guideline (NZRGM, Volume 3) - Forms (Microsoft Word Document 264kb)