Regulations

In order for a clinical trial to be carried out in New Zealand it must be approved by Medsafe – which is given officially by the Director-General of Health after advice from:-

- the Health Research Council. Through it’s Standing Committee on Therapeutic Trials (SCOTT). This committee assesses the clinical, scientific validity of the trial, the ability of the investigator to conduct the study and the study design and quality of clinical pharmacological research; and
- an accredited ethics committee.

The Ministry of Health’s business unit, Medsafe have prepared Interim Guidelines for Good Clinical Research Practice (GCRP) which provides the means for ensuring that clinical studies conducted in human participants are designed and conducted to the highest scientific and ethical standards. Whilst GCRP in conjunction with other consumer based legislation safeguards the interests of all parties involved in clinical research, GCRP does not replace or reduce the obligations to consumers or rights of consumers described in legislation such as the Privacy Act 1993 and the Code of Health and Disability Services Consumers Rights. The principles contained in the guideline are pertinent to all phases and types of clinical investigation in human participants. Its spirit, therefore, should permeate all clinical research. Pharmaceutical companies conducting clinical research have to comply with the principles contained in the guideline. It is essential that doctors are familiar with Good Clinical Research Practice requirements and assess the proposed research for compliance prior to participation.

The guidelines are based on the EU, UK, Nordic, Australian, WHO and Committee for Proprietary Medicinal Products (CPMP) guidelines and codes for Good Clinical Research Practice. The New Zealand guideline remains interim until the CPMP guideline, whilst finalised, is accepted as the de facto world standard.

Click here for a copy of the Interim Guidelines for Good Clinical Research Practice

Guidelines on clinical trials compensation for injury resulting from participation in an industry-sponsored clinical trial

The RMI favours a simple and expeditious procedure in relation to the provision of compensation for injury caused by participation in clinical trials. The RMI recommends, therefore, that a member company sponsoring a clinical trial should, without legal commitment, provide to the investigator - and through him/her to the relevant research ethics committee - a written assurance that the following guidelines will be adhered to in the event of injury caused to a patient that is attributable to participation in the trial in question. These guidelines are an adaptation of those used by the Association of British Pharmaceutical Industry.

Click here to download a copy of these guidelines. These guidelines were updated in August 2008.