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Europe's drug regulator wins court backing for data transparency policy.
The BMJ ( IF 105.7 ) Pub Date : 2020-01-23 , DOI: 10.1136/bmj.m302
Clare Dyer 1
Affiliation  

The European Union’s highest court has decisively upheld the European Medicines Agency’s right to publish clinical trial data from drug companies’ applications to market their products in the EU.
In two keenly awaited judgments, the European Court of Justice has comprehensively rejected appeals by two companies against rulings in 2018 by the General Court of the European Union upholding the European Medicines Agency’s open data policy.12
In 2010 the agency adopted a policy of making available all documents underlying a successful drug licence application from January 2014, setting aside its previous presumption of confidentiality. But the move was resisted by pharmaceutical companies, which mounted legal challenges, arguing that their commercial confidentiality was at risk.
Now the European Court …


中文翻译:

欧洲的药品监管机构在数据透明性政策方面赢得了法院的支持。

欧盟最高法院坚决维护了欧洲药品管理局发布药品公司在欧盟销售其产品的临床试验数据的权利。
在两项迫切等待的判决中,欧洲法院全面驳回了两家公司针对欧盟总法院2018年维持欧洲药品管理局开放数据政策的裁决的上诉。1 2
2010年,该机构采取了一项政策,即从2014年1月起公开提供成功申请毒品许可证所依据的所有文件,同时保留先前的保密性假设。但是此举遭到制药公司的抵制,制药公司提出了法律挑战,认为其商业机密性处于危险之中。
现在欧洲法院…
更新日期:2020-01-23
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