As announced by the EMA, a ‘winter clock stop’ will again be implemented in CTIS this year for the period from 22 December 2025 to 8 January 2026.

This means that all written requests for information (RFIs) relating to current clinical trial applications that fall due during this period will be suspended until 8 January 2026, and the 12-day response period for these requests will only start on 8 January.