Objective To analyze the application of real-world evidence(RWE)in the field of medicine in European Union,and provide suggestions for RWE supporting the review and approval of new drugs in China.Methods The European ...Objective To analyze the application of real-world evidence(RWE)in the field of medicine in European Union,and provide suggestions for RWE supporting the review and approval of new drugs in China.Methods The European Medicines Agency(EMA)and other databases were used to search relevant documents for analyzing the European Union’s new drug review and approval process with the support of RWE.Results and Conclusion The European Union carrying out new drug review and approval with the support of RWE has just begun.The decision-making process includes three stages such as new drug research and development,review,and approval.However,there are some challenges in data quality,research methods,evidence sufficiency,and research process of RWE supporting the European Union in reviewing and approving new drugs.At present,RWE can accurately grasp the clinical effects of drugs and improve the safety and effectiveness in the process of assisting the review and approval of new drugs.At the same time,RWE also can promote the development and application of Traditional Chinese Medicine(TCM)and help find out the potential value of TCM such as new indications.展开更多
Systematically analyze the composition of post-marketing adverse drug reaction data and the open mode in the EU, and summarize its characteristics. EU post-marketing ADR data is open to six categories of stakeholders:...Systematically analyze the composition of post-marketing adverse drug reaction data and the open mode in the EU, and summarize its characteristics. EU post-marketing ADR data is open to six categories of stakeholders: EMA, EC, medicines regulatory authorities in EEA member states, healthcare professionals and the public, Marketing Authorization Holders, academia, WHO and medicines regulatory authorities in third countries. The EU has implemented hierarchical opening for ADRs, with different levels containing different data and facing different stakeholders. Openness is divided into active and passive openness. In opening up data, the EU complies with relevant personal data protection laws to protect the privacy of individuals. The EU’s post-marketing adverse drug reaction data openness is characterized by a combination of data openness and privacy protection, active and passive openness, and a hierarchy of data openness. It is hoped that this can provide a reference for the opening up of post-marketing adverse drug reaction data in China.展开更多
目的为中国实施药品风险管理提供参考。方法计算机检索中国知网、万方、维普及PubMed,EMBase,Web of Science数据库中关于药品风险管理的文献,以及美国食品和药物管理局(FDA)、欧洲药品管理局(EMA)、日本医药品医疗器械综合机构(PMDA)...目的为中国实施药品风险管理提供参考。方法计算机检索中国知网、万方、维普及PubMed,EMBase,Web of Science数据库中关于药品风险管理的文献,以及美国食品和药物管理局(FDA)、欧洲药品管理局(EMA)、日本医药品医疗器械综合机构(PMDA)和国家药品监督管理局(NMPA)官网的相关内容,时间为自建库起至2022年6月10日。归纳总结药品风险管理的概况、组成与发展。结果美国、欧盟和日本均已形成较成熟的药品风险管理体系,中国的药品风险管理正处于快速发展阶段。结论借鉴欧盟、美国、日本成熟的药品风险管理体系,完善、推动中国药品风险管理体系建设与落地实施。展开更多
基金Special Fund of the National Medical Products Administration’s Drug Regulatory Science Research Base-Research Institute of Drug Regulatory Science of Shenyang Pharmaceutical University(No.2020jgkx005).
文摘Objective To analyze the application of real-world evidence(RWE)in the field of medicine in European Union,and provide suggestions for RWE supporting the review and approval of new drugs in China.Methods The European Medicines Agency(EMA)and other databases were used to search relevant documents for analyzing the European Union’s new drug review and approval process with the support of RWE.Results and Conclusion The European Union carrying out new drug review and approval with the support of RWE has just begun.The decision-making process includes three stages such as new drug research and development,review,and approval.However,there are some challenges in data quality,research methods,evidence sufficiency,and research process of RWE supporting the European Union in reviewing and approving new drugs.At present,RWE can accurately grasp the clinical effects of drugs and improve the safety and effectiveness in the process of assisting the review and approval of new drugs.At the same time,RWE also can promote the development and application of Traditional Chinese Medicine(TCM)and help find out the potential value of TCM such as new indications.
文摘Systematically analyze the composition of post-marketing adverse drug reaction data and the open mode in the EU, and summarize its characteristics. EU post-marketing ADR data is open to six categories of stakeholders: EMA, EC, medicines regulatory authorities in EEA member states, healthcare professionals and the public, Marketing Authorization Holders, academia, WHO and medicines regulatory authorities in third countries. The EU has implemented hierarchical opening for ADRs, with different levels containing different data and facing different stakeholders. Openness is divided into active and passive openness. In opening up data, the EU complies with relevant personal data protection laws to protect the privacy of individuals. The EU’s post-marketing adverse drug reaction data openness is characterized by a combination of data openness and privacy protection, active and passive openness, and a hierarchy of data openness. It is hoped that this can provide a reference for the opening up of post-marketing adverse drug reaction data in China.
文摘目的为中国实施药品风险管理提供参考。方法计算机检索中国知网、万方、维普及PubMed,EMBase,Web of Science数据库中关于药品风险管理的文献,以及美国食品和药物管理局(FDA)、欧洲药品管理局(EMA)、日本医药品医疗器械综合机构(PMDA)和国家药品监督管理局(NMPA)官网的相关内容,时间为自建库起至2022年6月10日。归纳总结药品风险管理的概况、组成与发展。结果美国、欧盟和日本均已形成较成熟的药品风险管理体系,中国的药品风险管理正处于快速发展阶段。结论借鉴欧盟、美国、日本成熟的药品风险管理体系,完善、推动中国药品风险管理体系建设与落地实施。
