Brief · Use case · Regulatory
Review Delay Diagnosis.
LiveDiagnosisFind out why a submission is drawing repeated agency questions and a longer review, and what would confirm the cause.
Review Delay Diagnosis is a ready-made use case for Regulatory. It ships under the Diagnosis template.
For regulatory affairs leads managing a slow review. You get what the agency questions have in common, evidence, dossier, expectation and interpretation explanations weighed against each other, the likely cause with a confidence level and what to rule out. Claims are cited or marked as gaps.
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The decision
Why has a regulatory submission for a new indication drawn repeated information requests and a longer review than the agency’s published timeline: a gap in the evidence package, an inconsistency in the dossier, a change in agency expectations, or a question of data interpretation?
The explanations weighed
The diagnosis restates the delay against the agency’s published timetable first: where each request fell, how long each clock stop lasted, and what the questions have in common.
| Explanation | What it would look like | What would confirm or refute it |
|---|---|---|
| A gap in the evidence package | The agency needs evidence the package does not hold. In the EU centralised procedure the committee adopts a list of questions at day 120 and, if issues remain, a list of outstanding issues at day 180.1 | Confirmed by questions that ask for data the dossier lacks. Refuted if the data are in the dossier. |
| An inconsistency in the dossier | Parts of the dossier disagree with each other, and the agency asks which is right. | Confirmed by questions that cite two places in the dossier. Refuted if the questions concern a single section. |
| A change in agency expectations | The agency’s expectations changed during the review, for example through new guidance. | Confirmed by a dated guidance change that matches the questions. Refuted if the questions rest on long-standing guidance. |
| A question of data interpretation | The agency reads the same data differently from the applicant, for example the choice of endpoint or analysis. | Confirmed by questions that accept the data and dispute the reading. Refuted if the agency asks for more data. |
What the diagnosis does
The timetable as the yardstick. The EU assessment of a new medicine runs to 210 active days, interrupted by clock stops while the applicant answers questions. The first clock stop follows the day-120 list of questions and a second can follow the day-180 list of outstanding issues. The diagnosis maps the submission against that frame, and separates review days from time the applicant spent responding.1
What the questions have in common. The diagnosis reads the questions as a set and groups them by section and by theme. A theme that recurs across rounds points to a cause that a single answer did not remove.
Only what the agency published. The diagnosis uses the agency’s published timeline and the questions the applicant holds. It does not infer internal discussions, and it marks any such inference as a gap.
How it could be wrong. The likely cause rests on an assumption, such as that the questions are complete. The diagnosis names it and the observation that would break it.
Recommended length
Comprehensive
The question asks you to weigh at least three explanations. The matrix that does that, and the Pareto view of where the effect sits, are in the Comprehensive length. Standard names a cause without the side-by-side.
You can pick another length on the form. The other two stay available.
Assumptions the diagnosis checks
The diagnosis states the assumptions its likely cause rests on and sets what would break each one. Examples for this problem:
- The applicant holds every question and response, including informal ones.
- The published timeline is the one that applies to this procedure.
- No change in guidance took effect during the review.
Standards, guidance and sources
Agency procedure
- EMA centralised procedure timetable: 210 active days, with clock stops after the day-120 list of questions and, if needed, after the day-180 list of outstanding issues.1
- EMA guideline on the time allowed for applicants to respond to questions raised during assessment, which sets the response windows and when an extension can be requested.1
The decision practice behind the memo itself is on the template page.
What gets flagged
Any question the applicant does not hold, any theme that recurs across rounds, and any claim about the agency’s reasoning that is not in what it published.
What arrives
- The problem as stated
- What is actually happening
- Competing explanations
- The likely cause
- What would confirm it
- Where the effect concentrates
- What to rule out
What it will not do
It does not decide what to do about the cause. A Decision Memo takes the diagnosis as its starting point.
It does not predict the outcome or the date, and it does not speak for the agency.
It does not prove the cause. It names the most likely cause, says how sure it is, and says what would show it to be wrong.
It does not assign blame. It looks for contributing causes in the system, in the way a blameless postmortem does.
It does not act. Deciding what to do about the cause is a different question; a Decision Memo is the template for it.
References
- [1] European Medicines Agency. Marketing authorisation: the evaluation process (centralised procedure timetable, day 120 list of questions and day 180 list of outstanding issues); and Time allowed for applicants to respond to questions raised during assessment of new marketing authorisation applications. Timetable as summarized in EMA documents found by search; the response times are in an older guideline, so check the current version. The scenario here is an EU procedure; a US review follows different goals.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
About the Brief service
A Brief is a written answer from one specialist, at the depth you asked for. It arrives with its sources, and it closes by saying plainly what would change the conclusion. Nothing is hidden behind a summary, and anything the expert could not source is marked as a gap rather than filled in.
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