欧洲药品管理局

欧洲药品管理局（EMA）是欧洲的一个相当于美国食品药物管理局（FDA）的机构。

The European Medicines Agency ( EMA ), the European equivalent of the US Food and Drug Administration ( FDA )

欧洲药品管理局（EMEA）最近完成了有关非类固醇抗炎药（NSAID）吡罗昔康的安全性评价。

The European Medicines Agency ( EMEA ) has recently completed a review of the safety of the non-steroidal anti-inflammatory drug ( NSAID ) piroxicam .

它是中国唯一一家临床前CRO实验室，其研究数据被美国食品药物管理局（FDA）和欧洲药品管理局（EMEA）接受为重要规章备案文件的一部分。

It is the only preclinical CRO laboratory in China whose data have been accepted by both the FDA and EMEA as part of successful regulatory filings .

在欧洲药品管理局提出建议后，欧盟委员会开了绿灯。

The Commission gave the green light following recommendations from the European Medicines Agency .

诺华预计将于今年年底向欧洲药品管理局提出申请。

An application with the European Medicines Agency is expected to be filed by the end of the year .

欧洲药品管理局执行董事埃默·库克表示，没有迹象表明血栓事件由疫苗引起，但他们正在调查相关报告。

EMA Executive Director Emer Cooke says there is no indication that the blood clot incidents were caused by the vaccine , but they are investigating the reports .

欧洲药品管理局公布了其计划给予公众获取信息的数据库的潜在副作用的人力和兽医药品。

The European Medicines Agency has published its plans for granting public access to the information held in its databases of the potential side effects of human and veterinary medicines .

欧洲药品管理局的一个专家小组将于周一召开会议，评估美国辉瑞公司和德国合作伙伴生物新技术公司联合开发的疫苗，预计该疫苗可在圣诞节前获得批准。

An expert panel of the European Medicines Agency will convene on Monday to evaluate the vaccine made by U.S. company Pfizer and German partner BioNTech , with an approval expected before Christmas .

欧洲药品质量管理局及欧洲药典简介

Brief Introduction of European Directorate for the Quality Control of Medicines and European Pharmacopoeia

赛诺菲在欧洲的药品食品监督管理局宣布Acomplia的神经副作用超过其有效作用后，于上个月暂停其销售。

Sanofi suspended sales of Acomplia last month , after the European version of the FDA said the drug 's psychiatric side effects outweighed its benefits .

欧盟希望这项计划能在六月中旬前得到欧盟各国政府和欧洲议会的批准。该计划称，欧洲药品管理局认可的所有疫苗都应自动得到成员国的认可。

The commission 's plan , which it hopes will be approved by national governments and the European parliament by mid-June , says all vaccines approved by the EMA should be automatically recognised by member states .