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EMA Takes Steps To Improve Predictability Of Drug Submissions

 
• By Vibha Sharma

The European Medicines Agency says it will become more systematic in seeking explanations from companies who delay or withdraw their planned marketing submissions and in chasing “no-shows.”

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EMA Has Told Drug Companies That Their Planned Marketing Submissions Will Be Tracked Closely • Source: Shutterstock

The European Medicines Agency has launched an initiative to improve the predictability of new drug applications, given that only around 30-40% of planned marketing authorization applications (MAAs) are submitted for evaluation on time every year, while the rest are either postponed or withdrawn.

While the EMA usually asks companies to provide a rationale when changing their submission dates or withdrawing submissions, the agency...

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