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EMA Discusses Disruptive Impact Of ‘Bad Submission Planning’ By Pharma

 
• By Vibha Sharma

The European Medicines Agency has shared real-life examples of how poor planning by companies results in repeated delays to their planned marketing authorization applications, which in turn causes a drain on resources.

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Companies Should Avoid Being Overly Optimistic When Deciding On Their Planned Filing Date (Shutterstock)

When it comes to submitting plans for a drug marketing authorization application (MAA) for evaluation via the EU’s centralized procedure, the European Medicines Agency says there are clear examples of “good and bad behavior” from companies that can affect the efficiency of its processes.

The EMA requires companies to notify their intent to submit an initial MAA around seven months prior to the intended...

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