November 24, 2025
DSURs, RMPs, and PSURs – The Harmonization of Pharmacovigilance Documents
To learn how harmonizing Development Safety Update Reports (DSURs), Risk Management Plans (RMPs), and Periodic Safety Update Reports (PSURs) can transform your pharmacovigilance efforts, read our white paper.
References
ICH guideline E2F on development safety update report Step 5. European Medicines Agency. September 2011. EMA/CHMP/ICH/309348/2008.
Food and Drug Administration 21 CFR Part 312, [Docket No. FDA–2020–N–0258], RIN 0910–AI37 Investigational New Drug Application Annual Reporting
Associate Director | Service Line Head (Safety/PV)
Dr. Mary Pilkington, PhD brings two decades of regulatory writing excellence to every client partnership. As a recognized authority in pharmacovigilance documentation, she specializes in crafting development safety update reports, periodic benefit-risk evaluation reports, periodic adverse drug experience reports, and comprehensive risk management plans that drive successful outcomes.
As Associate Director and Service Line Head for Safety/PV at Certara, she’s transformed junior writers into pharmacovigilance subject matter experts through her proven training methodologies. Her vision extends beyond individual projects to shape the future of regulatory writing excellence.
Frequently asked questions
What exactly is a DSUR, and how does it differ from the FDA’s current IND annual report?
A Development Safety Update Report (DSUR) is a harmonized format (defined under ICH E2F) for periodic safety reporting that integrates cumulative safety data from ongoing and completed clinical trials worldwide. Under the FDA’s proposed rule, the DSUR would replace the current IND annual report requirement (21 CFR 312.33) with a richer, more comprehensive safety evaluation. (Federal Register)
Compared to the existing annual IND report, the proposed FDA DSUR would demand additional content, such as global clinical data, cumulative subject exposure, global interval and cumulative safety data, a listing of all known important risks, and integrated safety assessments that are not required today.
When would the FDA DSUR need to be submitted (i.e. what is the Data Lock Point)?
Under the proposal, the Data Lock Point (DLP) would default to the calendar day before the anniversary of when the IND went into effect (i.e. 1 day before that anniversary). (GovInfo)
Sponsors may instead use the Development International Birth Date (DIBD) (i.e. the date of first authorization to conduct trials anywhere) as an alternate driver of the DLP, but only if the FDA grants a waiver.
The final DSUR must be submitted within 60 calendar days of the DLP.
How will these changes affect sponsors already preparing E2F DSURs for other regulatory regions?
Sponsors already preparing E2F DSURs may see a smoother transition, since the FDA’s proposal aligns with many elements of the ICH E2F standard. (U.S. Food and Drug Administration)
The benefit is that sponsors could submit a single DSUR format to multiple regulators (rather than multiple heterogeneous reports), reducing redundancy.
However, because the proposed U.S. DSUR includes some U.S.-specific requirements (e.g., inclusion of IND safety report reference numbers, certain trial demographics, DLP rules), sponsors will need to maintain flexibility in their authoring process to accommodate those extra data fields in U.S. submissions.
Delivering high-quality, timely responses to EMA safety queries
A pharmaceutical company needed to answer eight safety-related queries from the European Medicines Agency (EMA) with a tight deadline. This case study explains how Certara pharmacovigilance writers worked with the client to deliver on-time, high-quality responses to the EMA’s safety queries.
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