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
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.
More from Drug Safety
More from Pink Sheet
• By
European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.
• By
Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
• By
Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.