The standard assessment of a marketing authorization application (MAA) for a new medicine at the European Medicines Agency takes up to 210 ‘active’ days. This time may be interrupted by one or two “clock-stops” during which the sponsor prepares responses to any questions raised by the EMA's drug evaluation committee, the CHMP.

The maximum duration of a clock-stop depends on how long the company thinks it will take to respond but must be agreed by the CHMP. The first clock-stop usually lasts three to six months and the second clock-stop one to three months.

The first clock stop usually takes place at Day 120 of the evaluation process, while the company prepares responses to the CHMP’s “list of questions” and updates the medicine’s risk management plan. If a “list of outstanding issues” is agreed by Day 180, the evaluation is paused again (second clock-stop) while the company prepares responses. Overall, the assessment of a new medicine under standard review timelines usually lasts around a year.

Source: European Medicines Agency

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