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...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.展开更多
文摘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.
