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Investor2014

01/18/24 4:28 PM

#448373 RE: Steady_T #448331

The evaluation of medicines, step-by-step

This time is interrupted by one or two ‘clock-stops’ during which the applicant prepares the answers to any questions raised by the CHMP. The maximum duration of a clock-stop depend on how long the applicant thinks it will take to respond, but must be agreed by the CHMP. The first clock-stop usually lasts 3 to 6 months and the second one 1 to 2 months.

Overall, the assessment of a new medicine usually lasts around a year.


Probable because most applications do have clock-stop timeout, don't you think?