Revised: 17 May 2011

Medicines

Introducing an Abbreviated Approval Process for Eligible Clinical Trials

To: Clinical Trial Stakeholders

Abbreviated approval process for eligible bioequivalence studies (effective from 1 January 2011)

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.

Eligibility criteria

To be eligible for the abbreviated approval process the application must be for a clinical trial that meets the following criteria:

• The clinical trial is a bioequivalence study that utilises an investigational product that contains an active pharmaceutical ingredient included in a medicine that is approved for distribution in New Zealand; and
• The proposed route of administration for the investigational product is the same as that for the approved medicine; and
• The proposed dosage for the investigational product is within the recommended dosage range for the approved medicine.

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.

What changes?

• The fee has been reduced for eligible applications (to $360 GST incl.)
• Approvals for eligible trials will be issued within five working days
• The clinical trials guideline has been updated to reflect the new approval process (see www.medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Part11.pdf (PDF, 273 KB, 26 pages))
• The application form for 'Approval of a Clinical Trial under section 30 of the Medicines Act 1981' has been updated (see Form 11.1 (Microsoft Word document, 195 KB, 8 pages))

What does not change?

• The need to submit an application and to obtain regulatory approval before commencing the trial
• Information requirements for obtaining regulatory approval
• Good Clinical Practice requirements
• The clinical trial site self-certification scheme
• Requirements for reporting on the progress of approved trials

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 (PDF, 273 KB, 26 pages)

Implementation

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 (askmedsafe@health.govt.nz) to obtain a partial fee refund.

Review

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.

Feedback

Medsafe welcomes feedback on the new abbreviated clinical trial approval process. Please send feedback to:

The Manager
Clinical Risk Management
Medsafe
PO Box 5013
Wellington

or askmedsafe@health.govt.nz