Usage Examples
- Our DIBD is 4 March, so the DSUR data lock point is 3 March and the filing is due 60 days later.
- Pull the cumulative exposure tables now; the DSUR covers all eleven trials, not just the US ones.
- That signal cannot wait for the DSUR - it needs an expedited report this week.
What is DSUR (Development Safety Update Report)?
DSUR is the annual clinical-trial safety report a sponsor submits to regulators for an investigational drug, consolidating all trials of that drug worldwide, unlike the PSUR, which covers products already on the market.
The DSUR exists because periodic safety reporting for drugs in development differed in content, format, and timing across regions, forcing sponsors to write a separate annual report for each regulator. ICH E2F set a common standard so that regulators in the three ICH regions receive a uniform, high-quality, comprehensive report on the same evolving safety picture, rather than three partial views assembled on three different calendars.
The DSUR covers interventional clinical trials of drugs and biologicals under investigation, whether or not they hold a marketing approval, plus Phase IV trials, expanded access and other therapeutic use, non-interventional studies, non-clinical findings, and literature. The DSUR does not carry expedited reporting. It must not be the initial notification of significant new safety information, nor the mechanism by which new safety issues are detected.
The DSUR runs on one clock and one reference document. The Development International Birth Date, the sponsor's first authorisation to run a trial anywhere in the world, fixes the annual period; the data lock point is that period's last day, and the report goes to every concerned authority within 60 calendar days. The Investigator's Brochure in effect at the start of the period is the reference safety information everything is assessed against.
Not to be confused with
- PSUR / PBRER
- the PSUR reports the post-approval experience of a marketed product; the DSUR reports the development programme. When development continues after approval both are required, and ICH E2F expects each to stand alone rather than cross-reference the other.
- SUSAR and other expedited reports
- expedited reports transmit individual cases as they arise, on their own short clocks. The DSUR is the periodic look-back, and ICH E2F is explicit that it must never be the first notification of a new safety issue.
- IND Annual Report
- the 21 CFR 312.33 progress report is a US filing due within 60 days of the anniversary of the IND going into effect. A DSUR can take its place, but its period is anchored to the DIBD, not to the IND effective date.
- Investigator's Brochure
- the IB is the reference safety information the DSUR is measured against, not a periodic report. The DSUR states what changed relative to the IB version in effect at the start of the reporting period.
The obligations come from ICH E2F, with the US filing requirement it can satisfy.
What you must do
- 1Use the DSUR as the single annual periodic safety report across ICH regions instead of maintaining separate regional annual reportsICH E2F Section 1
- 2Prepare one DSUR per active substance covering all dosage forms, strengths, indications, and patient populations under study, and explain in the introduction if that is not feasibleICH E2F Section 2.1
- 3Start the annual period on the Development International Birth Date, the sponsor's first authorisation to conduct a clinical trial in any country worldwideICH E2F Section 2.2
- 4Submit the DSUR to all concerned regulatory authorities no later than 60 calendar days after the data lock pointICH E2F Section 2.2
- 5Keep expedited reporting separate: never use the DSUR to give the initial notification of significant new safety informationICH E2F Section 1.2
- 6For a US IND, file the progress report within 60 days of the anniversary date the IND went into effect, covering the status of every study in progress and completed that year21 CFR 312.33
Common mistakes
Assuming the DSUR clock and the IND clock are the same
The DSUR period is anchored to the DIBD, the first clinical trial authorisation anywhere in the world, while 21 CFR 312.33 runs from the anniversary of the IND going into effect. Those dates are rarely identical, and the mismatch has to be reconciled with the agency before the first filing, not discovered 60 days out.
Letting a new safety issue surface for the first time in the DSUR
ICH E2F states the DSUR must not provide initial notification of significant new safety information or be the means by which new issues are detected. A signal that appears there first is evidence the expedited reporting and signal-detection processes failed, and reviewers read it exactly that way.
Fragmenting one active substance into several DSURs
Splitting by indication, formulation, or business unit destroys the pooled cumulative exposure and serious-event picture the report exists to produce. ICH E2F expects a single DSUR wherever feasible; if it genuinely is not, the explanation belongs in the introduction section. Sponsors filing in eCTD should also agree the DSUR's placement in the eCTD structure with the receiving authority in advance, since E2F deliberately leaves it open.
When This Matters
- Our DIBD is 4 March, so the DSUR data lock point is 3 March and the filing is due 60 days later.
- Pull the cumulative exposure tables now; the DSUR covers all eleven trials, not just the US ones.
- That signal cannot wait for the DSUR - it needs an expedited report this week.
Frequently Asked Questions
A DSUR covers an investigational drug in clinical development, while a PSUR covers a product already approved and marketed. ICH E2F expects both when development continues after approval: they focus on different subject matter, have different periodicities and recipients, and each must stand alone as a complete report.
