CRED ERP 25

Day 120 LoQ Clarification Meeting • Should be a joint meeting between applicant, (Co-)Rapporteurs, and the EMA • Consider conducting meeting at EMA during CHMP week versus meeting/teleconference at agency (to enable assessment team to attend) • Aim of meeting: o Clarify scientific rationale of questions which are unclear o Provide guidance on proposed response strategy o Discuss timelines implications o It is not a meeting to discuss all responses to all questions o Do not try to review an exhaustive list of questions and proposed responses o Do try to address the strategy for responding to major objections o Consider addressing questions related to post-approval commitments or risk management strategies o At the end of the meeting, you should aim to understand: • What issues have a major impact on the approvability of the data package • What issues need to be resolved in the responses to Day 120/180 questions and which issues can be addressed as a post-approval commitment • Whether an extension to the standard 3-month clock stop is required o If required, a written request for an extension will need to be addressed to the Chairman of CHMP as soon as possible after Day 120 o Clock stop beyond 6 months not normally accepted

Secondary evaluation phase

* Comments from CHMP and PRAC members not made available to applicants