Sampling Investigation of Current Situalion of Pharmacovigilance in Pharmaceutical Manufacturers in Jiangsu Province

doi:10.19803/j.1672-8629.2021.02.07

Abstract

Abstract: Objective To investigate the status quo of pharmacovigilance by drug manufacturers in Jiangsu Province, and to offer recommendations on how to improve pharmacovigilance by manufacturers amid the transition from monitoring of adverse drug reactions to pharmacovigilance. Methods After representatives of drug manufacturers in Jiangsu Province were selected, a questionnaire survey was conducted regarding the pharmacovigilance system, drug safety monitoring and risk management. SPSS 22.0 software was used for data entry and statistics. Results The survey covered 108 drug manufacturers of different types. The results indicated that most of the enterprises had established basic pharmacovigilance systems. Although the input into and effectiveness of ADR monitoring systems are increasing among those manufacturers, the level of risk management is relatively low. Conclusion It is recommended that manufacturers improve their awareness of drug safety, strengthen their pharmacovigilance systems, overcome their weaknesses, and that regulatory authorities and agencies provide related support in a timely manner.

Key words: pharmacovigilance, marketing authorization holder, drug manufacturers

CLC Number:

R969.3

SHEN Mengqiu, LI Ming, WANG Jiayu, GAN Ge, LIU Pengcheng, SUN Jun. Sampling Investigation of Current Situalion of Pharmacovigilance in Pharmaceutical Manufacturers in Jiangsu Province[J]. Chinese Journal of Pharmacovigilance, 2021, 18(2): 133-137.

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