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EMA To Restart Landmark Clinical Trial Transparency Policy In September

 
• By Vibha Sharma

The European Medicines Agency is preparing to resume proactively publishing clinical trial data submitted by companies to support their marketing authorization applications for non-COVID-19 products.

A businessman in formal wear signing a contract. Padlock Hologram icons over the working desk.
Business and personal information is reacted from clinical trial data before publication • Source: Shutterstock

The European Medicines Agency has set a September deadline to gradually restart its policy on proactive publication of clinical trial data, having previously suspended this activity for all products except COVID-19 treatments and vaccines.

The EMA’s clinical data publication (CDP) policy – also known as policy 0070 – was first launched in 2016 as...

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EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
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Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
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EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
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EU’s Life Sciences Strategy Faces Race Against Time, Says Clinical Trials Community

 
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More from Geography

EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
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EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
• By Eliza Slawther and Sarah Karlin-Smith

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.