This is a ready-to-use log for tracking every eCTD sequence submitted for an application over its life, and the proof of receipt for each one. Receipt is not the same as transmission: without a retained positive acknowledgment, a team can believe a sequence was filed when it was not. Replace every <<FILL: ...>> placeholder. This content is educational reference, not legal or regulatory advice.
Header
| Field | Entry |
|---|---|
| Application / product | <<FILL>> |
| Region(s) | <<FILL>> |
| Log owner | <<FILL>> |
Field definitions
| Field | Format | Required | Who | When |
|---|---|---|---|---|
| Sequence number | 4-digit, e.g. 0004 | Yes | Regulatory operations | At transmission |
| Submission type | Text (original, amendment, supplement, variation, response, etc.) | Yes | Regulatory affairs | At planning |
| Lifecycle operations summary | Count of new / replace / append / delete leaves | Yes | Regulatory operations | At publishing |
| Validation status | Pass (0 high-severity) / findings open | Yes | Regulatory operations | Before transmission |
| Gateway transmission date | Date | Yes | Regulatory operations | At transmission |
| Acknowledgment status | Positive / negative / not received | Yes | Regulatory operations | After transmission |
| Acknowledgment retained (location) | Reference / file path | Yes | Regulatory operations | After receipt |
Sequence log
| Sequence | Type | Lifecycle ops (new/replace/append/delete) | Validation status | Transmitted | ACK status | ACK retained |
|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Acceptance criteria
- Every sequence submitted for the application has a row in this log, including sequences later rejected at the gateway.
- No sequence is logged as “filed” without a retained positive acknowledgment; a negative or missing acknowledgment triggers investigation and retransmission, logged in the same row.
- The lifecycle operations summary is reconciled against the actual sequence content plan before the row is closed.
Signoff
| Role | Name | Signature | Date (periodic review) |
|---|---|---|---|
| Regulatory operations lead | <<FILL>> | ||
| Quality assurance | <<FILL>> |
References
ICH M8, Electronic Common Technical Document (eCTD) Implementation Guide. FDA Electronic Submissions Gateway documentation; EU eSubmission Gateway / Common Repository documentation (current version).
Confirm the current version of each reference before issue.
Filled specimen
A completed log excerpt for an example application. Illustrative only.
| Sequence | Type | Lifecycle ops (new/replace/append/delete) | Validation status | Transmitted | ACK status | ACK retained |
|---|---|---|---|---|---|---|
| 0000 | Original NDA | 412 new / 0 / 0 / 0 | Pass | 03 Feb 2026 | Positive | REG-ARCH/0000/ACK-20260203.xml |
| 0001 | Response to information request | 3 new / 9 replace / 0 / 0 | Pass | 22 Apr 2026 | Positive | REG-ARCH/0001/ACK-20260422.xml |
| 0002 | Prior Approval Supplement | 2 new / 4 replace / 0 / 1 delete | First attempt: 1 high-severity finding (bad replace reference); fixed and revalidated | First attempt 09 Jul 2026 (not sent, validation failed pre-transmission); resent 10 Jul 2026 | Positive (on resend) | REG-ARCH/0002/ACK-20260710.xml |
Sequence 0002 shows the gate working as intended: the high-severity validation finding was caught and fixed before transmission, not discovered by the agency, and the log records both the failed internal validation attempt and the successful resend, so the full history is visible without anyone needing to ask what happened.
Common findings this log prevents
- A sequence is believed to have been filed, but no retained acknowledgment exists to prove it, and the gap surfaces only when a review clock appears not to be running.
- A negative or missing acknowledgment is never followed up, so a genuinely failed transmission is treated as complete.
- No consolidated record exists of how many sequences an application has, making it hard to reconstruct the lifecycle history for an inspection or a due-diligence request.
How to adapt this log
- Set your application and region(s) in the header.
- Add a row for every sequence going forward, and, where feasible, backfill recent history.
- Store acknowledgment files at the referenced location and confirm the reference resolves during periodic review.
- Confirm every regulation in the references against the current published version before issue.