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EMA Prepares To Re-Start ‘Updated’ Clinical Data Publication Policy

 
• By Vibha Sharma

The European Medicines Agency has issued revised guidance on its Clinical Data Publication policy to help companies navigate procedural changes that will be introduced when the publication of clinical trial data on non-COVID-19 products is partially resumed under the policy from September 2023.

Clinical trial
Clinical Trial Transparency Can Help Avoid Duplicate Studies And Foster Innovation • Source: Alamy

The European Medicines Agency has updated the Q&A document on how companies should go about identifying, redacting, anonymizing and submitting clinical trial documents ahead of the phased re-start of its landmark transparency policy in September. 

The Q&As have been revised to clarify the scope of the Clinical Data Publication (CDP) policy, and address procedural changes that have been introduced to make the policy’s implementation more efficient

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