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Regulatory Reviewers In Europe Face Overtime And Cancelled Vacations Due To Submission Delays

 
• By Vibha Sharma

EU national competent authorities are stressed about having to put up with an “unacceptably high workload” due to poor submission planning by drug companies when it comes to their EU filings. Poor predictability relating to submissions could also impact industry.

Man, stress and business or night office, working late and worried for company deadline. Mental health, crisis and headache for audit preparation, corporate and dark workplace for finance advisors
Frequent changes in MAA submission dates increase stress for EU regulatory assessors (Shutterstock)

Poor predictability relating to the number of drug marketing authorization applications (MAAs) that are expected to be submitted for evaluation via the EU centralized procedure is taking a toll on regulatory assessors working at the national competent authorities (NCAs) in EU member states.

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