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Clinical Trials

Medsafe administers the approval process for clinical trials using new medicines.

For information on Good Clinical Practice requirements for clinical trials conducted in New Zealand and obtaining regulatory approval for clinical trials using new medicines please see Guideline on the Regulation of Therapeutic Products in New Zealand. Part 11: Good Clinical Research Practice and obtaining approval for clinical trials

 

Introducing an abbreviated approval process for eligible clinical trials

• Letter to Clinical Trial stakeholders – Abbreviated approval process for eligible bioequivalence studies