Investigation and Analysis of Pharmacovigilance Inspection of Drug Marketing Authorization Holders / 医药导报

ABSTRACT

Objective To investigate the current situation,problems and suggestions of pharmacovigilance activities conducted by drug marketing authorization holders(MAH)and pharmacovigilance inspections carried by regulatory authorities.Methods A questionnaire survey was conducted on relevant institutions and personnel responsible for pharmacovigilance inspections in 31 provinces,autonomous regions,municipalities and the Xinjiang Production and Construction Corps.The MAH pharmacovigilance activities were rated from 5 aspects(5 major items and 27 specific items).Results The average overall score for 5 major items was 3.46;The average score for 27 specific activities was 3.50.The MAH scored the highest in terms of pharmacovigilance organization,personnel,and resources,and scored the lowest in terms of drug risk identification and assessment.Conclusion MAH needs to further strengthen their awareness of primary responsibility,gradually improve the pharmacovigilance system,and constantly improve the ability and level of pharmacovigilance;The drug regulatory department should also provide guidance to enterprises,establish and improve the team of inspectors,and systematically advanced various aspects of pharmocovigilance inspection.