Current situation of marketing authorisation holders pharmacovigilance working in Hebei Province
GUO Shasha1 LIU Hongxing1 WANG Bing2 WEI Li3 WANG Fang2
1.Center for Adverse Drug Reaction Monitoring of Cangzhou, Hebei Province, Cangzhou 061000, China;
2.Center for Drug Monitoring and Evaluation of Hebei, Hebei Province, Shijiazhuang 050090, China;
3.General Team for Durg Professional Inspector of Hebei, Hebei Province, Shijiazhuang 050090, China
Abstract：Objective To study the current situation of pharmacovigilance work in marketing authorization holders in Hebei Province and to provide reference for the development and supervision of pharmacovigilance work of marketing authorization holders. Methods The data of the 2019 annual pharmacovigilance report submitted by the marketing authorization holders in the jurisdiction collected by Center for Drug Monitoring and Evaluation of Hebei from January to March 2020 were extracted by Excel software. The pharmacovigilance system, individual adverse drug reactions, risk assessment and control, and post-marketing safety studies of the holders were analyzed retrospectively. Results Among the marketing authorization holders, 94.25% have specialized agencies and 85.06% have full-time personnel; 28.74% have a sound pharmacovigilance management system; 98.85% of self-contained collection routes established, but the number of adverse reaction reports reported self-collection was 0.58% of the total; holders who found product risk accounted for 10.34%. Conclusion Marketing authorization holders should strengthen the study and training of relevant laws and regulations, raise the awareness of law and subject responsibility, improve the pharmacovigilance management system, set up specialized agencies and provide full-time staff according to law, improve the ability of independent collection of reports and risk management, and effectively carry out pharmacovigilance work. It is suggested that the national medical products administration should further promote the construction of the system of laws and regulations on drug alert, refine the supporting technical guidelines, and provide technical guidance for marketing authorization holders.
郭莎莎1 刘红星1 王冰2 魏莉3 王芳2. 河北省药品上市许可持有人药物警戒工作现状[J]. 中国医药导报, 2021, 18(23): 152-155,164.
GUO Shasha1 LIU Hongxing1 WANG Bing2 WEI Li3 WANG Fang2. Current situation of marketing authorisation holders pharmacovigilance working in Hebei Province. 中国医药导报, 2021, 18(23): 152-155,164.
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