Research and Enlightenment of EU Drug Risk Management Plan

亚洲社会药学 ›› 2021, Vol. 16 ›› Issue (1): 23-30.

Research and Enlightenment of EU Drug Risk Management Plan

Yang Yu 1, Shi Yu 2, Hu Rongbo 2, Tian Lijuan 1*

School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China

出版日期:2021-03-20 发布日期:2021-03-19

Research and Enlightenment of EU Drug Risk Management Plan

Yang Yu 1, Shi Yu 2, Hu Rongbo 2, Tian Lijuan 1*

School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China

Online:2021-03-20 Published:2021-03-19
Contact: Tian Lijuan, associate professor. Major research area: pharmaceutical laws and regulations and drug policy, rational drug use, history of drug supervision in China. Tel: 15840095857, E-mail: tianlijuan_8@126.com. E-mail:tianlijuan_8@126.com

摘要/Abstract

摘要： Objective To study the origin and development, framework and content of the EU-RMP (European Drug Risk Management Plan) so as to provide a reference for China’s drug risk management plan (RMP). Methods Literature research and comparative research were used in this paper. Through searching Chinese and foreign literature, the website of European Medicines Agency (EMA) and the Guideline on Good Pharmacovigilance Practices (GVP), in-depth understanding of the EU-RMP content and requirements, some lessons were extracted for our reference. Results and Conclusion All departments should cooperate closely in the preparation of RMP in China. Then, the risk control measures should be further enriched to reduce the risks. Besides, the rules for implementing RMP should be clarified to promote the risk management of the whole life cycle of drugs and maintain the safety of patients’ medication.

关键词: risk management plan, risk minimization, EU

Abstract: Objective To study the origin and development, framework and content of the EU-RMP (European Drug Risk Management Plan) so as to provide a reference for China’s drug risk management plan (RMP). Methods Literature research and comparative research were used in this paper. Through searching Chinese and foreign literature, the website of European Medicines Agency (EMA) and the Guideline on Good Pharmacovigilance Practices (GVP), in-depth understanding of the EU-RMP content and requirements, some lessons were extracted for our reference. Results and Conclusion All departments should cooperate closely in the preparation of RMP in China. Then, the risk control measures should be further enriched to reduce the risks. Besides, the rules for implementing RMP should be clarified to promote the risk management of the whole life cycle of drugs and maintain the safety of patients’ medication.

Key words: risk management plan, risk minimization, EU

Yang Yu, Shi Yu, Hu Rongbo, Tian Lijuan. Research and Enlightenment of EU Drug Risk Management Plan[J]. 亚洲社会药学, 2021, 16(1): 23-30.

Yang Yu, Shi Yu, Hu Rongbo, Tian Lijuan. Research and Enlightenment of EU Drug Risk Management Plan[J]. Asian Journal of Social Pharmacy, 2021, 16(1): 23-30.

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Research and Enlightenment of EU Drug Risk Management Plan

Research and Enlightenment of EU Drug Risk Management Plan

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