Marketing authorization application scientific evaluation

Regulatory evaluation of marketing authorization applications must be completed within strict time limits. The EM EA is given a 210-day window to evaluate an application and provide a scientific opinion. However, during the application process, if the EMEA officials seek further information/clarification on any aspect of the application, this 210-day clock stops until the sponsoring company provides satisfactory answers. The average duration of active EMEA evaluation of biotech-based product applications is in the region of 175 days, well within this 210-day time frame. The duration of clock stops can vary widely - from 0 days to well over 300 days. Most applications, however, incur clock stops of the order of 30 to 80 days. Upon receipt of the... 

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