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EMA Looks For Efficiencies For Companies Ahead Of Relaunching Clinical Data Transparency Policy

 
• By Vibha Sharma

Based on its learnings from proactively publishing clinical trial data on COVID-19 products, the European Medicines Agency is making procedural changes to its clinical data publication policy that is set to resume after being temporarily suspended in 2018.

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Companies must justify the redaction of any commercially confidential information in clinical reports • Source: Shutterstock

The European Medicines Agency is making procedural changes to improve the efficiency of its landmark transparency policy on the proactive publication of clinical trial data, which is set to be relaunched in September in a phased manner.

Key Takeaways

  • The EMA’s policy on proactive publication of clinical trial data is set to resume in September after being temporarily suspended in 2018 to support business continuity.

  • Procedural changes and updated guidance will be introduced to help companies prepare and submit their redaction packages earlier for review

The clinical data publication (CDP) policy – also known as policy 0070 – currently remains suspended for all products

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