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.

The revised guideline, which is replacing its predecessor that was published in 2020, had been issued for consultation late...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Drug Safety

Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By 

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

US FDA Will Help States Apply To Import Cheaper Drugs From Canada

 
• By 

The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

International Group Aims To Shape The Inevitable Future Of AI In Pharmacovigilance

 

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

More from Pink Sheet