Question 15 of 20 Intermediate Concept
What happens between day 120 and day 210 of an EU marketing authorisation review?
Short answer
At day 120 the CHMP adopts a list of questions and the clock stops while the applicant answers, usually within about three months. Assessment restarts, and by day 180 the CHMP adopts a list of outstanding issues, often with a second clock stop of about a month and possibly an oral explanation, before an opinion by day 210.
Why
EMA describes the process step by step. Two rapporteurs from the CHMP assess the dossier independently, PRAC rapporteurs assess the risk management plan, and peer reviewers challenge the reasoning. Inspections of manufacturing, clinical sites or pharmacovigilance may be requested in this first phase.
The single assessment report and list of questions are adopted at day 120. Major objections at this point are serious, because unresolved ones can block approval. The applicant answers during the first clock stop and updates the risk management plan.
Assessment of the answers leads to the day 180 list of outstanding issues. If major objections remain, an oral explanation lets the company address the committee directly. The CHMP adopts an opinion by day 210, and the European Commission decides within 67 days.
Because the clock counts only active days, a 210 day review usually takes about a year. Good planning starts before submission: teams draft answers to likely questions and plan resources for the clock stops so the first response is complete.
A strong answer covers
- Day 120 list of questions and first clock stop
- Day 180 list of outstanding issues
- Major objections and oral explanation
- Opinion by day 210, Commission decision within 67 days
- Active days versus calendar time
Common mistakes
- Assuming the review ends after the day 120 questions are answered.
- Treating major objections like minor comments.
- Leaving clock stop responses unplanned until questions arrive.
The interviewer might ask next
How would you decide whether to request a longer clock stop?