New Zealand Addresses ‘Significant’ & ‘Other’ Safety Issues In New PhV Guide

A revised pharmacovigilance guideline will come into effect in New Zealand on 1 July, although sponsors may start using it now.

Drug Safety
Medsafe evaluates safety issues concerning marketed drugs • Source: Shutterstock

New definitions for “significant safety issues” and the introduction of an “other safety issues” category are among the changes that New Zealand’s Medsafe has made in the latest iteration of its pharmacovigilance guideline.

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