Published: 8 December 2016

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The Medsafe Files – Episode Two: Clinical Trials

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Prescriber Update 37(4): 54
December 2016

Approval is required from the Director-General of Health before a clinical trial using a ‘new medicine’ or ‘investigational product’ may commence in New Zealand. The application and approval process for clinical trials is delegated to and administered by Medsafe.

A ‘new medicine’ is a medicine for which consent for distribution in New Zealand has not been granted or the approval has lapsed. In some circumstances, a substance that is commonly used as an ingredient in food, dietary supplement or cosmetic is used in a clinical trial. That substance, when administered to human beings for a therapeutic purpose, as defined by the Medicines Act 1981, as part of a clinical trial, is considered to be a new medicine and approval for the trial under Section 30 of the Medicines Act 1981 is required. ‘Investigational product’ is defined in the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP). Definitions of the regulatory status of medicines are on the Medsafe website (www.medsafe.govt.nz/Medicines/registration-situation.asp).

Clinical trial approval process

Section 30 of the Medicines Act 1981 authorises the Director-General of Health to approve a clinical trial and to allow importation of a ‘new medicine’. All applications, except for bioequivalence trials, are considered by a committee of the Health Research Council of New Zealand (HRC) and the approval is given on the recommendation of this committee. The HRC maintains two committees to consider clinical trial applications involving a new medicine.

• The Standing Committee on Therapeutic Trials (SCOTT) considers applications for pharmaceutical-type medicines.
• The Gene Technology Advisory Committee (GTAC) considers applications for gene and other biotechnology therapies.

Medsafe notifies the applicant of the committee’s decision within 45 days of receiving the application. If the decision is to approve the trial, an approval letter will be issued. The Medsafe approval letter serves as a customs clearance document to import an investigational product. If the decision is for a provisional approval or to decline an application, the reasons will be provided to the applicant.

Interface with ethics

An ethics approval system applies to all clinical trials conducted in New Zealand. This is a separate process administered by the New Zealand Health and Disability Ethics Committee. At present, medical devices do not require approval under the New Zealand Medicines legislation. However, the Health and Disability Ethics Committee approval should be obtained for clinical trials of medical devices.

Good Clinical Practice

All clinical trials in New Zealand are expected to be conducted in accordance with internationally accepted GCP standards (www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html). In order to achieve compliance with the New Zealand law, some requirements of the GCP guidance have been modified as outlined in Part 11 of the Guideline on the Regulation of Therapeutic Products in New Zealand (www.medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Part11.pdf).

Compliance with other legislation such as the Hazardous Substances and New Organisms Act 1996 or the Misuse of Drugs Act 1975 may also be required.