Clinical trials that involve use of an unregistered medicine, for which the Minister has not given consent for distribution, require approval under Section 30 of the Medicines Act 1981. The HRC's Gene Technology Advisory Committee (GTAC) undertakes scientific assessment of clinical trials that involve the introduction of nucleic acids, genetically manipulated micro-organisms, or viruses or cells into human subjects. It also makes recommendations to the Director-General of Health on whether or not trials should be approved.

Applications for GTAC approval are to be made by letter following the Guidelines for preparation of applications for GTAC review (section B of the Process and guidelines for applications for approval of trials involving gene and other biotechnology therapies, PDF 375kb). The investigator seeking approval under Section 30 of the Medicines Act will also be required to lodge a fee, which in the case of public good research may be waived by the Ministry of Health on the recommendation of the HRC's Chief Executive (for further information on the timeframe of review and fees, refer to Guideline on the regulation of therapeutic products in New Zealand part 11, www.medsafe.govt.nz).

 

Committee members:

Professor Ian Morison - Chair
University of Otago, Dunedin
Professor Ian Alexander
Sydney Children’s Hospitals, Sydney
Dr Lynley Anderson
University of Otago, Dunedin
Professor Stephen Chambers
Christchurch School of Medicine & Health Sciences, University of Otago
Dr Jade Hollis-Moffatt
University of Otago, Dunedin
Professor Stephen Robertson
University of Otago, Dunedin
Associate Professor Richard Robson
Christchurch Clinical Studies Trust, Christchurch
Dr Deborah Young
The University of Auckland, Auckland

Ex officio member:
Professor Kathryn McPherson

Chief Executive, Health Research Council of New Zealand

Terms of reference for GTAC (PDF 449kb)

Useful links

Regulation of clinical trials
Ethics approval