Overview and Discussion of VICH Pharmacovigilance Guidelines
Pharmacovigilance plays a crucial role in ensuring the long-term safety and efficacy of veterinary drugs in clinical settings.Although China has regulatory provisions for monitoring veterinary adverse drug reactions,there is a lack of specific operational-level implementation rules and guidance documents for activities such as analysis,evaluation,and guidance reports.In this paper,by interpreting the VICH guiding principles of pharmacovigilance:GL24 adverse reaction report management,GL29 regular summary update report management,GL42 to submit adverse reaction report data elements(AERS),in order to provide reference for the adverse reaction report of veterinary drug products,and to strengthen China's veterinary drug product vigilance regulations and monitoring system construction to provide reference.
万方数据
维普
