医学EMA指南是指欧洲药品管理局(European Medicines Agency)针对药品治疗领域发布的指南。这些指南包括临床试验、药品开发、随访和审批等多个领域。它们是为了帮助药品制造商和临床医生理解和遵守欧盟的法规标准。医学EMA指南的作用和意义非常重要,它们不仅对药品制造商和临床医生有指导作用,同时对欧盟卫生管理...
The European Medicines Agency (EMA) is a decentralized agency of theEuropean Union(EU) whose goal is to promote and protect human and animal health. The EMA is the European Union’s equivalent to the U.S.Food and Drug Administration(FDA). The EMA is sometimes called the European Medicines ...
EMA是欧洲药品管理局(European Medicines Agency)的英文缩写。EMA审计一般指欧洲药品管理局对医药企业生产经营过程、GMP质量管理体系以及药品生产等方面进行的审核和监管。EMA审计的主要目的是确保药品的质量、安全和有效性符合欧盟法规标准,保障公众健康和安全。EMA审计一般包括预审、现场审计和报告阶段,主要针...
European Medicine AgencyCurrent ReviewPublic ConsultationThe European Medicines Agency (EMA) is examining the transparency of its operations after a ruling by the European Ombudsman that EU rules on access to documents apply to all documents held by the agency. Responding to the Ombudsman's findings,...
EMA制药用水指南对制药企业人用和兽用API和制剂生产中所需使用水的级别提供了明确的指导。所有API及制剂的新申请,以及对已批准申报的任何相关变更申请均应考虑本指南。EMA制药用水指南原文可通过以下链接下载:Quality of water for pharmaceutical use - Scientific guideline | European Medicines Agency (europa.eu)
The European Medicines Agency (EMA) raised the safety signal, which is a way to monitor potential adverse events from the use of approved drugs, Novo Nordisk said. Such a signal from the EMA does not mean that the medicine is the cause of any reported adverse events. ...
海外监管★ 欧盟EMA和药物管理局负责人(HMA)制定了未来五年的联合战略《European medicines agencies network strategy to 2025》概述了该网络的六个优先领域:✔Availability and accessibility of medicines✔Data analytics, digital tools and di...
European Medical AssociationRegulatory ScienceWest's Knowledge Center European Medicines Agency's (EMA) Strategy on Engaging with Regulatory Science Where science and technology are evolving quickly, a good networking structure is needed to keep pace of advancements. This is especially relevant for regulat...
12月1日,欧洲药物管理局(European Medicines Agency,EMA)建议采取措施减少含伪麻黄碱药物的严重副作用风险。 EMA安全委员会建议采取新的措施减少含伪麻黄碱药物的可逆脑病综合征(posterior reversible encephalopathy syndrome ,PRES)和可逆脑部血管综合征(reversible cerebral vasoconstriction syndrome ,RCVS)。
同学你好,很高兴为您解答!EMA(European Medicines Agency),您说的这个英文词语在CMA的考试中比较常见,学会这个词语对考取英文CMA资格证书特别有帮助。这个词语的汉语意思是:欧洲药品管理局。希望高顿网校的回答能帮助您解决问题,更多CMA的相关问题欢迎提交给高顿企业知道。高顿祝您生活愉快!