Pharmacovigilance Planning Tool

Aggregate Safety Report Calendar

Estimate PBRER, PSUR, DSUR, and ad hoc PBRER due dates from a data lock point, then translate the deadline into draft, QC, and approval planning milestones.

PBRER/PSUR 6 or 12 month: DLP + 70 days PBRER >12 month or ad hoc: DLP + 90 days DSUR annual: DLP + 60 days

Quick Answer

Aggregate safety reports are anchored to a data lock point (DLP)—the cutoff for cases and literature included in the report. Under common ICH planning conventions, PBRER/PSUR for 6- or 12-month cycles are due DLP + 70 calendar days; intervals longer than 12 months or ad hoc PBRERs often use DLP + 90 days; annual DSURs commonly target DLP + 60 days. IBD anchors post-authorization cycles; DIBD anchors development DSURs. This planner is for scheduling only—confirm deadlines against EURD lists, FDA commitments, and SOPs.

Report parameters

Report type

Choose the reporting cycle that matches the aggregate safety report plan.

Data lock point date

Use the safety data cutoff date, not the planned submission date.

Estimated Deadline

Report due date

Select a report type and DLP to calculate.

The calculated interval will appear here.

Draft target

Internal authoring target, 30 days before the estimated due date.

QC target

Quality control and consistency review, 14 days before due date.

Approval target

Final medical, safety, and regulatory sign-off, 7 days before due date.

Report Type Context

PBRER/PSUR vs DSUR

PBRER and PSUR

Periodic Benefit-Risk Evaluation Reports, historically aligned with Periodic Safety Update Reports, summarize worldwide post-authorization safety experience, benefit-risk evaluation, interval findings, cumulative data, and actions taken for a marketed medicinal product.

Usually anchored to the international birth date.
Typically includes post-marketing cases, literature, signals, benefit-risk conclusions, and regulatory actions.
Regional formats and submission schedules can vary even when ICH E2C(R2) principles are used.

DSUR

Development Safety Update Reports provide an annual safety summary for investigational drugs under clinical development, including interval safety findings, cumulative exposure, significant risks, and the sponsor's assessment of participant protection.

Usually anchored to the development international birth date.
Focuses on clinical trial safety, emerging risks, and changes to the investigator brochure or development plan.
Commonly planned as DLP plus 60 calendar days, subject to regional expectations.

Anchor Dates

DLP, IBD, and DIBD in aggregate reporting

Data lock point

The DLP is the inclusive cutoff date for report data. Safety operations teams usually align case reconciliation, literature search periods, signal outputs, and cumulative line listings to this date.

International birth date

The IBD generally anchors recurring post-authorization aggregate reporting for marketed products. It is commonly based on the first marketing authorization for the product in any country.

Development international birth date

The DIBD generally anchors annual DSUR timing for investigational products. It is commonly linked to the first authorization to conduct an interventional clinical trial in any country.

Regional Caveats

Use the estimate as a planning clock, not a submission rule

Aggregate safety reporting schedules can be affected by EU reference date lists, FDA postmarketing commitments, local authority requirements, product-specific risk management measures, birth-date harmonization, work-sharing procedures, regional holidays, and internal SOPs. Confirm the final deadline against the current regulatory commitment and submission channel before locking the project plan.

Workflow Help Docs

Planning checklist for aggregate report teams

Confirm the anchor date. Verify IBD or DIBD, reporting interval, and whether the report follows a standard cycle or an ad hoc request.
Freeze source inputs. Align case processing cutoff, literature searches, safety database outputs, exposure data, and signal review material to the DLP.
Build the authoring schedule. Use the draft, QC, and approval milestones to reserve clinical safety, medical writing, regulatory, and QPPV or safety governance review time.
Check regional obligations. Compare the planner output with EU, US, national authority, and product-specific commitments before submission.
Document assumptions. Record the interval rule, DLP, source extract dates, reviewers, and final sign-off evidence in the report planning file.

Primary Sources

ICH references used for this planner

ICH E2C(R2) - Periodic Benefit-Risk Evaluation Report ICH E2F - Development Safety Update Report FDA: DSUR — data lock point and 60-day submission convention

Competitive landscape: IntuitionLabs DSUR vs PSUR/PBRER and Assyro PSUR guide explain DLP, IBD, and 70/90-day conventions in long-form articles without an interactive calendar or draft/QC/approval milestones. PROMETRIKA covers DSUR/PBRER harmonization for sponsors but not a free due-date calculator. NovaPharmaNews provides an interactive DLP→due-date planner with internal milestone targets and pharmacovigilance hub cross-links—not a substitute for EURD lists or authority commitments.

FAQ

Aggregate safety report calendar questions

How are PBRER and PSUR due dates estimated?

For standard 6-month or 12-month PBRER/PSUR cycles, this tool estimates the submission due date as the data lock point plus 70 calendar days. For PBRER intervals greater than 12 months or ad hoc PBRERs, it estimates the due date as the data lock point plus 90 calendar days.

How is a DSUR due date estimated?

This page estimates a DSUR due date as the data lock point plus 60 calendar days, consistent with the common annual DSUR planning convention described in ICH E2F and FDA DSUR guidance.

What is a data lock point in aggregate safety reporting?

The data lock point is the cutoff date through which safety information is included in the aggregate report. Case inclusion rules, literature searches, signal review, and final cumulative summaries should align to that cutoff.

What is the difference between IBD and DIBD?

The international birth date is generally the date of first marketing authorization for a medicinal product in any country. The development international birth date is generally the first authorization date for an interventional clinical trial in any country. These dates anchor recurring aggregate reporting cycles.

Can this calendar replace regulatory or SOP due date rules?

No. It is a planning aid only. Regional requirements, product-specific risk management commitments, national holidays, submission portals, and company SOPs can change operational deadlines.

What are draft, QC, and approval milestones in this planner?

This tool suggests internal targets 30, 14, and 7 calendar days before the estimated regulatory due date for authoring, quality control, and sign-off. Organizations should align these buffers to medical writing capacity, QPPV review, and submission gateway cutoffs in their SOPs.

How does the EU EURD list affect PSUR timing?

In the EU, the EURD list can set legally binding data lock points, frequencies, and submission dates that override default ICH intervals for listed substances. Always compare planner output with the current EURD entry and GVP Module VII obligations before locking the project schedule.

Can DSUR and PBRER data lock points be synchronized?

Yes, when a product is both marketed and in development, sponsors may align DSUR and PBRER reporting periods—often requiring regulatory approval or waiver. ICH E2F notes that synchronized DSUR periods should not exceed one year. See PROMETRIKA and ICH references for harmonization options.

What is the difference between PBRER and PSUR?

PBRER (Periodic Benefit-Risk Evaluation Report) under ICH E2C(R2) replaced the PSUR format in ICH regions while retaining similar periodic safety reporting intent. Many teams still say PSUR colloquially; regional submission systems and templates may use either label.

When is an ad hoc PBRER required?

Regulators or internal safety governance may request an ad hoc PBRER outside the routine cycle—for example after a new safety signal, label change, or referral procedure. This planner applies a 90-day DLP + interval for ad hoc planning; confirm the authority request letter for exact deadlines.

Does FDA use the same 70-day rule as EMA?

FDA postmarketing periodic reporting follows 21 CFR 314.80 and product-specific commitments—not a universal 70-day PSUR rule. FDA DSUR expectations for IND annual reporting commonly reference submission within 60 days of the DSUR data lock point. Use jurisdiction-specific rules for US submissions.

How does aggregate reporting relate to case processing?

Cases received after the DLP belong to the next reporting interval. PV operations freeze intake processing, literature cutoffs, and signal outputs to the DLP before authoring. Use the ICSR Case Processing Guide and Signal Detection tools upstream of this calendar.