Clock-stop: pause in the procedure timetable
A clock-stop is a pause in a regulatory procedure's timetable while the applicant prepares responses to questions from the assessing authority.
Clock-stops occur in centralised, decentralised and variation procedures. In the centralised procedure the clock stops at Day 120 (list of questions) and Day 180 (list of outstanding issues); in a DCP it usually stops at Day 105. Statutory timelines such as 210 days count only active assessment days, so calendar time to approval is always longer.
Typical problems: treating the default response time as a target rather than a ceiling, asking for an extension too late, and answering with new data that raises further questions. Responses should address each question in turn and update every dossier module they affect.
Timing
Default clock-stop durations depend on the procedure. For centralised applications the Day 120 clock-stop is commonly up to three months and can be extended on justified request; DCP and variation clock-stops follow CMDh or EMA timetables. In the centralised procedure, responses must meet published submission dates tied to CHMP meetings, so missing one by a day can add weeks.
Used in
Teams keep response deadlines alongside renewals and variations in the lifecycle planning workflow.
Related terms
- DCP: decentralised procedureThe decentralised procedure (DCP) authorises a medicine in several EU/EEA Member States at once when it is not yet authorised in any of them.
- Type II variation: major change requiring prior approvalA Type II variation is a major change that may significantly affect a medicine's quality, safety or efficacy and needs approval before implementation.
- Centralised procedure: single EU marketing authorisation via EMAThe centralised procedure grants one marketing authorisation valid across the EU and EEA after a single EMA assessment and a Commission decision.
- CHMP: Committee for Medicinal Products for Human UseThe CHMP is the EMA committee that assesses centralised applications and referrals for human medicines and adopts the opinions behind Commission decisions.
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