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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