Revised: 17 May 2011
To: Clinical Trial Stakeholders
Medsafe, in consultation with the Standing Committee on Therapeutic Trials (SCOTT), has reviewed the processes involved in the approval of bioequivalence studies utilising new generic medicines. As a result of this review an abbreviated approval process has been implemented that recognises the lower risk profile for these types of studies.
To be eligible for the abbreviated approval process the application must be for a clinical trial that meets the following criteria:
SCOTT has advised that it considers bioequivalence studies meeting the above criteria to be approvable under section 30 of the Medicines Act 1981 without the need to review the individual trial applications.
For further information on current requirements, please refer to:
Guideline on the Regulation of Therapeutic Products in New Zealand. Part 11: Clinical trials - regulatory approval and good clinical practice requirements (Microsoft Word document, 3.5 MB, 24 pages)
The reduced fee for eligible applications will be backdated to 1 January 2011 .
Applicants who have submitted eligible applications and paid the full fee will need to contact to the Clinical Trials Co-ordinator at Medsafe, Becci Slyfield (firstname.lastname@example.org) to obtain a partial fee refund.
The ongoing utility of the abbreviated approval process will be regularly reviewed. To assist with this review, a proportion of applications approved under the abbreviated process will be audited.
Medsafe welcomes feedback on the new abbreviated clinical trial approval process. Please send feedback to:
Clinical Risk Management
PO Box 5013