DSUR in pharmacovigilance is the yearly Development Safety Update Report for investigational drugs. It grew from CIOMS work in 2006 and an ICH E2F draft in 2008, reaching Step 4 in 2010. FDA and other ICH regulators accept one DSUR every 12 months instead of separate IND Annual Reports and EU Annual Safety Reports, which streamlines global clinical trial safety oversight.
In pharmacovigilance, the DSUR summarises serious adverse events, benefit–risk updates, and key safety signals. It follows ICH E2F and has guided FDA implementation since 2011, supporting continuous regulatory safety protection of trial participants worldwide.
Table of Contents
What Is DSUR in Pharmacovigilance? (ICH E2F Definition)
A development safety update report gives regulators a yearly view of clinical trial safety. DSUR guidelines define format, timing, and content for these reports. First, sponsors compile data from all ongoing trials into one global safety document.
They explain new safety findings from the last 12 months clearly and concisely. Sponsors reassess overall benefit–risk balance using clinical results, literature, and other sources. Moreover, DSUR guidelines help teams coordinate decisions, update risk plans, and support timely actions.
Finally, three comparisons show why this report matters for global oversight:
• 1 report vs 3 reports: sponsors reduce duplication across FDA, EMA, and other agencies
• 12 months vs 24 months: teams spot trends earlier and react before risks escalate
• 2008 draft vs 2010 final: DSUR guidelines moved from proposal to widely adopted standard
Why DSUR Is Required During Clinical Development
ICH E2F DSUR describes how sponsors report clinical trial safety reporting to regulators. Authorities expect one yearly report for each investigational product. First, sponsors align the data lock point and submission date for all studies.
The report explains new risks, benefits, and signals from the last 12 months. Sponsors compare emerging information with data and reassess benefit–risk balance. Moreover, they document decisions about protocol changes, additional monitoring, or stopping recruitment.
Regulators request this report because it supports oversight and timely decisions. DSUR vs PSUR comparisons show its focus on development, not marketed products. Key expectations include:
Clear annual timeline for clinical trial safety reporting and authority review
Transparent reasoning for benefit–risk conclusions and any required risk minimisation steps
Who Prepares DSUR? Roles in PV & Clinical Teams
Pharmacovigilance teams lead the Development Safety Update Report for each product. Clinical operations and medical writing support data collection and clear summaries.
Pharmacovigilance: collect cases, analyse signals
Clinical operations: track sites, enrolment
Medical writing: organise text, check consistency
Moreover, regulatory affairs and safety physicians review and sign off reports. They align clinical trial safety reporting with ICH E2F DSUR guidance.
Regulatory affairs: manage timelines, submit documents
Safety physicians: judge risks, propose actions
Key Sections of a DSUR (Based on ICH E2F)
DSUR in pharmacovigilance works as the annual safety report clinical trials require for regulators. It supports drug development safety reporting with one harmonised overview for each investigational product. Moreover, ICH E2F describes standard sections so teams follow the same clear structure.
Key sections appear in every report and answer specific safety questions.
Introduction and worldwide status: outlines product, trials, and exposure
Safety findings: summarises adverse events, new signals, and risk changes
Benefit–risk evaluation: summarises conclusions overall
DSUR vs PSUR: What’s the Difference?
A DSUR reviews safety during clinical trials, before approval. A PSUR reviews safety after approval, with real-world data. Moreover, DSUR supports development decisions, while PSUR supports ongoing market authorisation decisions. Both reports guide safe use.
| Aspect | DSUR (Development Safety Update Report) | PSUR / PBRER (Periodic Safety Update / Benefit-Risk Evaluation Report) |
|---|---|---|
|
Main purpose |
Annual safety report for clinical trials during drug development |
Periodic safety and benefit–risk report for marketed products |
|
Development vs post-marketing |
Focuses on drug development safety reporting |
Focuses on post-marketing pharmacovigilance |
|
Regulatory guideline |
Defined in ICH E2F DSUR |
Defined in ICH E2C(R2) PBRER guideline |
|
Product status |
Investigational medicinal products in ongoing trials |
Authorised / licensed products on the market |
|
Typical interval |
Every 12 months from the Development International Birth Date (DIBD) |
Interval depends on product age and region (e.g., 6–12 months, then longer) |
Final words
Experts recognise the importance of DSURs for global patient protection. WHO works with 194 member states to strengthen medicine safety. DSURs link local trials with global expectations and support PV reporting requirements.
Each report can cover 10–25 studies and thousands across WHO regions. Teams review serious events, new signals, and changing exposure patterns. This safety surveillance in clinical development helps detect issues early.
Professionals who master DSURs strengthen their pharmacovigilance career path. They align risk reviews with WHO guidance and national centres in 170 countries. Strong DSUR work supports smarter PV reporting and cross-functional decisions.
FAQs:
1️⃣ What are DSUR guidelines and why do they matter?
DSUR guidelines (ICH E2F) explain how sponsors should write Development Safety Update Reports. They matter because they standardise clinical trial safety reporting and help protect trial participants worldwide.
2️⃣ How often do DSUR guidelines say we should submit a report?
Sponsors usually submit one Development Safety Update Report every 12 months per investigational product. This fixed yearly cycle helps regulators compare safety trends and make consistent decisions.
3️⃣ What information do DSUR guidelines expect in the report?
They expect data on exposure, serious adverse events, safety signals, and benefit–risk evaluation. The report should also describe planned or completed risk-minimisation actions and important protocol changes.
References
Ershad Moradi, a Content Marketing Specialist at Zamann Pharma Support, brings 6 years of experience in the pharmaceutical industry. Specializing in pharmaceutical and medical technologies, Ershad is currently focused on expanding his knowledge in marketing and improving communication in the field. Outside of work, Ershad enjoys reading and attending industry related networks to stay up-to-date on the latest advancements. With a passion for continuous learning and growth, Ershad is always looking for new opportunities to enhance his skills and contribute to pharmaceutical industry. Connect with Ershad on Facebook for more information.
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