New Zealand Addresses Need For Guidance On FIH Studies & Trial Safety Monitoring

Medsafe is seeking feedback on proposals to update its clinical trials guidelines, and on two new guidance documents, one of which is dedicated to the “specific considerations” relating to the review and approval of first-in-human studies.

Medsafe has drafted guidance dedicated to first-in-man trials • Source: Shutterstock

New Zealand’s Medsafe is working on revising its six-year old guidance on clinical trials and has also proposed two new dedicated guidelines, one on first-in-human (FIH) and early-phase trials, and the other on safety monitoring and reporting requirements for investigational products.

Key Takeways

  • Medsafe’s public consultation on the revisions it plans to make to it guidance on clinical trials closes on 27 October.
  • As well as proposing to revise the current 2018 guidance on applying for and conducting clinical trials, Medsafe has drawn up two guidance documents that focus on first-in-human/early-phase trials and trial safety monitoring and reporting respectively

The agency has issued for public consultation a number of

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