10. Roadmap of the Submission Process of a Clinical Trial

10.1 Clinical Trial with Investigational Medicinal Product

Section 30 of the Medicines Act requires that the Director-General of Health must approve clinical trials involving new medicines. This requirement applies to all types of clinical trials of new medicines, including pharmacokinetic, bioequivalence, and first-in-human studies.

10.2 Pediatric Investigation Plan (PIP)

Submission of a PIP is not required in New Zealand. The design of proposed clinical studies in pediatric patients should be discussed with Medsafe on a case-by-case basis.

10.3 Clinical Study (Interventional or Observational)

A “laboratory observational type” extension to a clinical trial where medication is not given to the subjects does not require approval.