NDCT Rules 2019 · ICH E2C(R2) · ICH E2F · 21 CFR 314.81

Periodic Safety Reports That Regulators Accept First Time

Expert aggregate safety report writing for PSUR, PBRER, DSUR and PADER — aligned with Indian NDCT Rules 2019 and ICH guidelines.

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About Aggregate Reporting

What Are Aggregate Safety Reports and Why Are They Required?

Aggregate safety reports are periodic summaries that Marketing Authorization Holders submit to regulators, providing a comprehensive analysis of a product’s safety profile over a defined data lock point. Unlike individual ICSRs, aggregate reports synthesise all available safety data — clinical trial findings, spontaneous reports, literature, epidemiological data — to conduct a holistic benefit-risk evaluation.

In India, NDCT Rules 2019 and the IPC PV Guidance V2.0 mandate MAHs to submit Periodic Safety Update Reports (PSURs) for marketed products at intervals defined by CDSCO. Globally, the ICH E2C(R2) guideline governs the PBRER format, and ICH E2F covers DSURs for products in clinical development.

Reports We Prepare

Periodic Aggregate Safety Reports

PSUR — Periodic Safety Update Report

The standard aggregate safety report for marketed products in India. Required per NDCT Rules 2019 at intervals set by CDSCO — typically every 6 months for new products, then annually. Includes ICSR line listings, signal assessment, benefit-risk evaluation and PSUR summary in the IPC Guidance V2.0 format.

PBRER — Periodic Benefit-Risk Evaluation Report

The ICH E2C(R2) format replacing the PSUR for global filings. Required by EMA, WHO and accepted by CDSCO. Structured around the benefit-risk evaluation framework with reference information, clinical study summaries, cumulative summary tabulations, and signal and risk management assessments.

DSUR — Development Safety Update Report

Annual safety report for products in clinical development, per ICH E2F. Covers all clinical trials in the development programme, presenting cumulative exposure, line listings of deaths and SUSARs, aggregate analysis, and evaluation of the investigational product's benefit-risk profile.

PADER — Periodic Adverse Drug Experience Report

US FDA requirement (21 CFR 314.81) for approved NDAs and ANDAs. Submitted quarterly for the first 3 years post-approval, then annually. Includes 15-day Alert Reports, follow-up reports, and a narrative safety assessment.

What We Include in Every Report

✓ Comprehensive narrative safety assessment with clinical context
✓ Benefit-risk evaluation framework aligned with ICH E2C(R2) / EMA PBRER template
✓ Cumulative and interval ICSR line listings and summary tabulations
✓ Signal assessment and new safety findings section
✓ Literature review with reconciliation against ICSR database
✓ Reference information (IB, SmPC, SPL) review and labelling consistency assessment
✓ Risk management plan updates where applicable
✓ PSUR summary report per IPC Guidance V2.0 (India format)

Common Questions

Frequently Asked Questions

When must an MAH submit a PSUR to CDSCO?

Under NDCT Rules 2019, MAHs must submit PSURs at intervals specified by CDSCO — generally every 6 months for the first 2 years after approval, then annually for 2 years, and thereafter every 3 years or at CDSCO's request. Timelines may differ for new drugs vs. established products.

What is the difference between a PSUR and a PBRER?

Both are periodic aggregate safety reports, but PSUR is the traditional format used in India (and previously in Europe), while PBRER is the updated ICH E2C(R2) global format. The PBRER places greater emphasis on benefit-risk evaluation and is now the preferred format for EMA and many ICH regions.

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