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Big Win For EMA On Transparency

Court Says Clinical Study Reports Are Not Presumptively Confidential

 
• By Vibha Sharma

The European Court of Justice has confirmed the European Medicines Agency’s approach to disclosure of data submitted as part of a marketing authorization application. It is a big disappointment for industry, which nonetheless says it supports responsible data sharing and will support efforts to develop a balanced approach.

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Court Order Is A Victory For Transparency • Source: Shutterstock

In a major victory for the European Medicines Agency and proponents of transparency in clinical trials, the top EU court has upheld the legality of the EMA’s access to documents policy under which third parties may access almost all information in a drug dossier following a marketing authorization decision, including clinical study and toxicology reports.

This development is a big disappointment for the life sciences industry. While the industry is keen to be seen as...

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More from Geography

Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
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To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
• By Sarah Karlin-Smith

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.