Regulatory Authority

The regulatory authority in New Zealand is Medsafe which is governed by the Ministry of Health. Prior to conducting a clinical trial involving a non-licenced product, or a licenced product for a new indication or using different dosing regimes, an application must be submitted to Medsafe. An application must also be made to SCOTT (Standing Committee on Therapeutic Trials). These applications can run at the same time as that to the HDEC.

Current guidelines for conduct of clinical research are defined in “New Zealand Regulatory Guidelines for Medicines”. These guidelines are available in full on the Medsafe website.

Applications to Medsafe / SCOTT are the responsibility of the sponsor but may be delegated to a New Zealand based representative. The current fee schedule can be found here.

Click here for more information about Medsafe

Click here for Medsafe regulatory guidelines

Click here for New Zealand Regulations from Medsafe