European Medicines Agency updated the page Clinical Trials Information System: training and support by adding the document ‘Clinical Trial Information System (CTIS) evaluation timelines‘ over the What’s New Section on September 23, 2022:
This document provides an overview of the timelines and deadlines for the activities across the Clinical Trial Application (CTA) evaluation process including initial CTA, substantial modification in CTA and additional member state concerned (MSC) CTA. CTIS further classifies the tasks to be undertaken by the Member States (MS) into hard tasks (mandatory) and soft tasks (non-mandatory). These tasks are reflected on the ‘Timetable’ section of the ‘Clinical trials’ tab.