Let me ask a question regarding the process. It seems like the EMA really engages with a company when they are about to submit, when they submit and during the entire process meaning questions and answers are asked and given along the way. Is the clock stop actually needed? Look at this from chatgpt. Maybe we do not need to worry about this so much. If we are going to do a phase 4 and we are safe and it appears the drug is really helping, I think we might not need it.
Does the EMA have to have a clock stop for questions and answers while going through the approval process for a new drug application or can they ask questions along the way and forgo the clock stop process?
ChatGPT said:
The European Medicines Agency (EMA) does typically use "clock stops" during the evaluation of a Marketing Authorisation Application (MAA) for a new drug, especially during the centralised procedure. These clock stops are standard practice, though not absolutely mandatory in all cases.
✅ Here's how it works:
Start of the Procedure – "Day 0":
The EMA's Committee for Medicinal Products for Human Use (CHMP) starts the evaluation and has 210 active days to reach an opinion.
Clock Stop – "Day 120":
Around Day 120, the CHMP usually issues a List of Questions (LoQ) to the applicant.
The "clock" is stopped at this point to allow the applicant to prepare responses.
This pause is known as the "clock stop" period.
The applicant typically has up to 3 months (or longer upon agreement) to respond.
Clock Restart – Evaluation Resumes:
Once the applicant submits their responses, the "clock" restarts, and the CHMP continues the evaluation until Day 210.
🔄 Can the EMA skip the clock stop?
In theory: The EMA could ask questions and allow informal dialogue without a formal clock stop, especially for minor clarifications or in rolling reviews (e.g., during pandemic emergency use procedures).
In practice: For standard MAAs, a formal clock stop is expected when substantial questions arise. This is to ensure:
Transparency
Predictability of timelines
Adequate time for applicant response
✳️ Special Cases Where Clock Stop May Differ:
Rolling reviews (e.g., COVID-19 vaccines): Questions may be addressed in real time, with more flexible timelines.
Accelerated assessment procedures: Timelines are shortened, but clock stops may still occur.
Informal requests for clarification can happen, but are not a substitute for the formal List of Questions.
Summary:
✅ Yes, EMA typically includes a clock stop for questions and answers during new drug evaluations.
❌ No, they generally do not forgo this unless under special procedures like rolling review or in minor, informal clarifications.
📜 The clock stop ensures a formal, structured opportunity for the applicant to respond without being penalized for time.
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