Revised: 27 May 2013
Consultations
Request for comments on proposed updates to the New Zealand Good Clinical Research Practice Guideline
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:
- Legal requirements that apply to clinical trials, including the application procedure set out in the Medicines Act 1981 for obtaining consent to trial a new medicine.
- The role of the Health Research Council (and its expert committees) in the approval process.
- The interface between the Medicines Act and other legislation such as the Hazardous Substances and New Organisms Act 1996.
- The requirements and processes for obtaining ethics committee approval for trials.
- The standard for Clinical Research Practice that should be applied in New Zealand. This will be the European Guideline (CPMP/ICH/135/95) with modifications as required to meet New Zealand-specific legal or ethics requirements.
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:
- Clarification that bioequivalence and pharmacokinetic studies utilising new medicines require approval under Section 30 of the Medicines Act.
- Introduction of a process enabling applicants for approval of clinical trials to self-certify that the site(s) where the trial is to be conducted have appropriate facilities, staff and procedures to care adequately for trial subjects.
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
Wellington
OR
becci.slyfield@health.govt.nz
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.
Yours sincerely
Susan Martindale
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)
