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EMA Pilots Partnering With Companies To Gain Efficiencies In Preparing Drug Assessment Reports

 
• By Vibha Sharma

The European Medicines Agency is looking to increase the review efficiency and consistency of its assessors by experimenting with a US FDA-style approach in which companies can voluntarily submit certain information in advance to facilitate the product’s review.

Time, Savings, Time is Money.
Time Saved On Completing Assessments Reports Can Be Used To Better Focus On A Drug’s Evaluation • Source: Shutterstock

The European Medicines Agency is inviting more drug sponsors to participate in a pilot it launched last year to reduce the time its regulatory reviewers spend on preparing assessment reports on initial marketing authorization applications (MAAs) by allowing companies to pre-fill these reports with factual data beforehand.

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