Periodic and lifecycle safety documents do more than summarise data. They show regulators how the available evidence changes the product's benefit-risk profile and what action the sponsor or marketing authorisation holder will take.
In the EU, the applicable document, data lock point, submission route and timetable depend on the product's development stage, authorisations and regulatory commitments. PSUR is the EU regulatory term for periodic post-authorisation reporting; PBRER is the ICH format and content standard used for periodic benefit-risk evaluation. A DSUR covers an investigational product in clinical development, while an RMP defines safety concerns and the activities used to characterise and minimise risk.
Which safety document do you need?
| Document | Lifecycle stage | Primary purpose | Key scheduling reference |
|---|---|---|---|
| PSUR | Post-authorisation | Periodic evaluation of new safety information in the context of benefits and cumulative product knowledge | EU Reference Dates list, marketing authorisation conditions or applicable national requirements |
| PBRER | Post-authorisation | ICH structure for an integrated periodic benefit-risk evaluation | International Birth Date and the reporting interval defined for the report |
| DSUR | Clinical development | Annual review of cumulative safety information for an investigational product across the development programme | Development International Birth Date |
| RMP | Initial authorisation and throughout the product lifecycle | Describe important safety concerns, pharmacovigilance activities and risk-minimisation measures | Initial MAA and subsequent regulatory or safety-driven updates |
| Addendum to the Clinical Overview | Late development or MAA preparation, when applicable | Present relevant new clinical information arising after the main dossier data cut-off | Submission strategy and authority expectations for the application |
The table is a starting point, not a submission calendar. The final requirement must be confirmed against the product's authorisation status, the current EURD list, applicable procedures and authority correspondence.
PSUR and PBRER: periodic benefit-risk evaluation after authorisation
A PSUR should evaluate relevant new safety information against the product's existing safety profile and authorised use. It is not an ICSR listing or a collection of disconnected departmental summaries.
The report should bring together the information needed to answer three questions:
- What relevant safety and use information became available during the reporting interval?
- Does that information change the understanding of identified risks, potential risks, missing information or the overall benefit-risk balance?
- Is any regulatory, pharmacovigilance or risk-minimisation action required?
Inputs commonly include:
- worldwide marketing-authorisation status;
- actions taken for safety reasons;
- changes to reference safety information;
- estimated patient exposure and use patterns;
- interval and cumulative ICSR summaries;
- findings from clinical studies, literature and non-interventional data;
- completed, ongoing and closed signals;
- risk evaluation and effectiveness of risk-minimisation measures;
- relevant effectiveness or benefit information;
- an integrated benefit-risk analysis;
- conclusions and proposed actions.
The EURD list determines more than frequency
For active substances included in the EU Reference Dates list, the list specifies the data lock point, submission frequency and submission date. It is legally binding and can override a standard cycle or frequency stated in individual marketing authorisations.
The EURD list is updated regularly. The responsible team should confirm the current entry before planning each report rather than relying on the previous cycle.
View EMA's current PSUR and EURD guidance
DSUR: cumulative safety during clinical development
The DSUR provides an annual review of safety information for an investigational product. Its focus is the protection of clinical-trial participants and the continuing assessment of whether the development programme remains appropriately managed from a safety perspective.
A DSUR brings together information across the sponsor's relevant clinical development programme, including:
- the status of ongoing and completed trials;
- cumulative subject exposure;
- interval and cumulative serious adverse reaction information;
- important findings from clinical and non-clinical sources;
- new or ongoing safety signals;
- changes to the Investigator's Brochure or reference safety information;
- actions taken for safety reasons;
- an overall safety assessment and proposed actions.
The DSUR is generally annual and is anchored to the Development International Birth Date. The submission route and recipient authorities depend on the applicable clinical-trial framework and territories.
View the ICH E2F DSUR guideline
RMP: connect safety concerns with planned action
An EU Risk Management Plan describes what is known and not yet known about the medicine's safety profile and how risks will be further characterised or minimised.
An RMP may include:
- the safety specification;
- routine and additional pharmacovigilance activities;
- routine and additional risk-minimisation measures;
- plans for evaluating the effectiveness of risk-minimisation measures;
- product-specific milestones and commitments.
RMP content should remain consistent with the clinical dossier, product information, signal evaluations and other safety documents. An update may be needed when new information materially changes the safety profile, when the risk-management system changes or when requested by a competent authority.
The reporting process needs named owners
| Activity | Accountable or contributing function |
|---|---|
| Confirm requirement, data lock point and submission route | Regulatory affairs with pharmacovigilance input |
| Define the report strategy and source-data plan | Pharmacovigilance report lead and medical reviewer |
| Provide ICSR, signal and compliance data | PV operations, signal management and quality |
| Provide exposure, clinical and benefit information | Clinical, medical, epidemiology, commercial or data functions as applicable |
| Draft and reconcile the report | Qualified pharmacovigilance medical writer |
| Perform medical and benefit-risk review | Appropriately qualified medical reviewer |
| Perform quality-control and consistency checks | Independent quality reviewer |
| Approve and submit | Sponsor or MAH according to the approved governance model |
Outsourcing authoring does not outsource sponsor or MAH accountability. The organisation should approve the data sources, review model, conclusions and final submission.
A practical reporting-readiness check
Before drafting starts, confirm that:
- the current regulatory requirement and data lock point are documented;
- the reporting period is consistent across all source functions;
- reference safety information and product information versions are controlled;
- exposure methodology and data owners are agreed;
- signal records are current and reconciled;
- important risks and missing information use consistent terminology across the PSUR, RMP and product information;
- clinical, literature, ICSR and regulatory data owners understand their deadlines;
- medical review, quality review, approval and submission responsibilities are named;
- the final report and working records will be archived with a traceable audit trail.
How NextPV can support the reporting lifecycle
NextPV can support a complete report or a defined part of the process, including:
- requirement and submission-planning review;
- source-data and contributor planning;
- PSUR/PBRER and DSUR authoring;
- RMP preparation and updates;
- Addendum to the Clinical Overview support;
- medical and benefit-risk review;
- quality-control and cross-document consistency review;
- response support during authority assessment;
- process, template and SOP development.
Our role is to make the document scientifically coherent, operationally traceable and consistent with the product's wider safety story.
Related NextPV guidance
- PSUR, PBRER and DSUR explained
- EU Market Entry pharmacovigilance
- PV systems, PSMF and quality management
- All NextPV pharmacovigilance services
Discuss your reporting needs
Share the product stage, required document, expected data lock point and current authoring model. We will help identify the inputs, reviewers and decisions needed for a controlled reporting process.
Prepared and reviewed by the NextPV Pharmacovigilance Team · Updated July 2026