PSUR Writing — A Step-by-Step Guide for Indian Pharma Teams

A PSUR is not a template exercise. It is a structured scientific document with defined sections, evidence requirements, and regulatory expectations. This guide walks through the full ICH E2C(R2) structure as practised in 2026 — with the specific considerations Indian pharma teams need for CDSCO submissions and multi-market authorisations.

Before writing begins: scoping

Every PSUR engagement starts with three scoping decisions. Getting these wrong creates downstream rework that no amount of careful writing can recover.

1. Data Lock Point (DLP)

The DLP is the cutoff date for safety data inclusion. All cases up to the DLP go into this PSUR; later cases hold for the next reporting period. The DLP must be confirmed before any other scoping decision.

2. Submission deadline and regulatory market(s)

Each regulator has different submission timelines. EMA follows EURD list dates. CDSCO has product-specific submission requirements. FDA has its own periodic safety reporting structure. Multi-market submissions typically require a core PSUR plus market-specific addenda.

3. Reference safety information

The Company Core Safety Information (CCSI) or the most recent approved SmPC is the reference document against which the PSUR evaluates safety. Using an outdated reference triggers regulatory queries. Confirming the right reference document is part of scoping — not part of writing.

The ICH E2C(R2) PSUR structure

Section 1: Introduction

The introduction sets DLP, reporting period, and the product's reporting history. Brief — typically half a page to one page. Common error: making this section longer than necessary. The introduction is not where to summarise the report's conclusions.

Section 2: Worldwide Marketing Authorisation Status

A comprehensive list of authorised indications, dosage forms, and territories. Includes pending applications, recent variations, and any withdrawals. This section is purely factual but commonly contains errors — especially around recent variations not yet captured in central databases.

Section 3: Actions Taken in the Reporting Period for Safety Reasons

Any regulatory or sponsor action taken because of safety in the reporting period. SmPC updates. Class labelling changes. Risk minimisation measures implemented. The honest version of "what we did about safety in the last six months." Common error: under-reporting because the team isn't aware of all global actions.

Section 4: Changes to Reference Safety Information

Specific delta between the CCSI/SmPC at start of period and end of period. Frequently a short section but inspectors check it carefully against actual approved updates.

Section 5: Estimated Patient Exposure and Use Patterns

Sales data converted to patient exposure estimates. Use patterns including off-label use where data exists. The exposure estimation method must be documented — not just the result. Common error: presenting an exposure number without explaining the calculation. Inspectors ask: "How did you arrive at this number?"

Section 6: Data in Summary Tabulations

The signature ICH E2C(R2) tabulation: SOC/PT breakdowns of cases, with cumulative and interval columns, by seriousness and report source. Standard format. Common error: tabulation inconsistencies between cumulative and interval columns (math doesn't add up).

Section 7: Summaries of Significant Findings from Clinical Trials During the Reporting Period

Where clinical trial data is part of the safety picture for a marketed product (e.g., post-marketing studies, label expansion trials). Brief summaries with reference to full study reports.

Section 8: Findings from Non-Interventional Studies

Real-world data from registries, observational studies, post-authorisation safety studies. Increasingly important as RWE evidence bases grow.

Section 9: Information from Other Clinical Trials and Sources

Any safety information from sources not covered above — including academic publications, signal detection alerts, MedDRA-coded case reviews.

Section 10: Non-Clinical Data

New non-clinical findings relevant to safety. Typically brief or absent unless new toxicology or pharmacology data emerged in the period.

Section 11: Literature

The literature monitoring section. Search methodology must be reproducible. This is the most common audit-finding section in PSURs. Powered by Pharos Scout at ICG.

Section 12: Other Periodic Reports

Cross-reference to DSURs, REMS reports, or other safety reports submitted in the period.

Section 13: Lack of Efficacy in Controlled Clinical Trials

Any signals of efficacy attenuation observed in clinical trials during the period.

Section 14: Late-Breaking Information

Information received after DLP but before submission that materially affects the safety picture. Typically empty.

Section 15: Overview of Signals

Structured presentation of all signals identified, evaluated, or carried forward. Each signal characterised with current status. The audit trail for each signal evaluation must be documented separately.

Section 16: Signal and Risk Evaluation

Detailed evaluation of each signal. This section requires the most scientific writing skill and the most rigorous evidence sourcing.

Section 17: Benefit Evaluation

Updated benefit characterisation based on accumulated evidence. Often references original approval data plus any new efficacy/effectiveness evidence.

Section 18: Integrated Benefit-Risk Analysis for Authorised Indications

The integration section that PBRER format makes explicit. Benefits and risks brought together with a defensible conclusion.

Section 19: Conclusions and Actions

What the company recommends as a result of the safety evaluation in this PSUR. Specific. Defensible. Tied to the analysis above.

CDSCO-specific considerations

For products with Indian marketing authorisations, CDSCO follows the ICH E2C(R2) structure but expects specific India-relevant content:

• Indian patient exposure — separate exposure estimation for the Indian market, where data permits
• India-specific safety actions — any actions taken by CDSCO or the company for Indian patients in the reporting period
• Indian SmPC consistency — the reference safety document must be the currently approved Indian SmPC
• India-specific literature — relevant Indian publications on the product, where they exist

The 8 most common PSUR writing errors

1. Literature search not reproducible
2. Patient exposure period misaligned with safety data DLP
3. Signal evaluation conclusions without supporting evidence
4. Reference safety information out of date
5. Cumulative/interval tabulation math inconsistencies
6. Benefit-risk section drafted last (and therefore inconsistent with sections above)
7. Worldwide marketing authorisation status missing recent variations
8. Signal documentation incomplete for inspector reproducibility

The Publication Readiness System™ for PSUR writing

ICG's PSUR engagements run on the same Publication Readiness System™ that governs scientific writing — adapted for periodic safety reporting. Five phases, sequential sign-off, complete audit trail:

1. Pre-Writing — DLP confirmed, regulatory markets confirmed, reference document confirmed
2. Outline — Section-by-section structure with data sources mapped
3. Drafting — Full first draft with version control
4. 4-Layer QC — Scientific → Editorial → Compliance → Technical
5. Submission — Submission-ready document plus audit-trail report