QPPV.COM

GVP Module VII: PSUR Assessment, PRAC and Regulatory Follow-Up

A practical explanation of the EU PSUR assessment process, PRAC involvement, regulatory outcomes, MAH responses and follow-up activities after a periodic safety assessment.

Audio Lesson 18 min
Knowledge Assessment Test your understanding of this article. Take the assessment →

GVP Module VII: PSUR Assessment, PRAC and Regulatory Follow-Up

Introduction

Preparation and submission of a PSUR are only part of the periodic safety process. After submission, the information is independently assessed within the applicable EU regulatory procedure. The assessment may confirm the current safety profile, identify areas requiring further investigation, or lead to regulatory action.

This article focuses on what happens after the PSUR enters the regulatory assessment process and how the marketing authorisation holder should manage the resulting regulatory activity.

The terminology matters. The MAH prepares and submits the PSUR. The regulatory network assesses the information. Depending on the procedure and outcome, PRAC may adopt a recommendation, which can then be followed by a CHMP opinion, CMDh position or Commission decision where applicable.

The exact route depends on the products and regulatory procedure involved.

1. Why PSUR Assessment Is a Separate Activity

A PSUR is the MAH's scientific evaluation of the available evidence at a defined point in time. It is not the regulatory authority's final assessment.

The regulator may reach the same conclusion as the MAH, may identify additional uncertainties, or may conclude that the evidence supports a different action.

This independent assessment is important because the purpose of periodic reporting is not simply to allow an MAH to certify its own conclusion. It provides a structured opportunity for the EU regulatory network to review the cumulative safety and benefit-risk evidence.

EMA describes PSUR assessment as determining whether new risks have been identified or whether the benefit-risk balance has changed. An assessment can also determine whether further investigation or action is needed to protect public health. citeturn0search0

2. The Current EU Assessment Framework

PSURs submitted under the applicable EU reference-date framework are assessed through the EU PSUR single-assessment system where the relevant products fall within its scope.

EMA's current procedural guidance describes the assessment as involving a PRAC Rapporteur, or for nationally authorised products only the appointed Lead Member State, followed by the applicable PRAC and subsequent regulatory steps where action is recommended. citeturn0search0

The current published timetable provides an important practical framework:

Stage Current procedural milestone
Day 0 Start of procedure according to the published timetable
Day 60 Preliminary assessment report
Day 90 MAH and committee/member-state comments
Day 105 Updated assessment report, if necessary
Day 120 PRAC recommendation
Day 134 CHMP opinion / CMDh position where applicable

These are procedural milestones, not a substitute for checking the current EMA timetable applicable to the specific procedure. EMA's current procedural advice states that the assessment period can run to 134 days, followed by a 67-day Commission decision process where applicable. citeturn0search0

3. Technical Validation Versus Scientific Assessment

A useful distinction is between technical validation and scientific assessment.

Technical validation determines whether the submission meets the applicable technical and procedural submission requirements. It is not a scientific endorsement of the contents.

EMA's current procedural advice explicitly notes that there is no validation of the content of the PSUR as part of this process. citeturn0search0

Scientific assessment then considers the evidence and its implications for the safety profile and benefit-risk balance.

The distinction matters operationally because an MAH should not interpret successful technical submission as evidence that regulators agree with its scientific conclusions.

4. The Rapporteur's Role

The assessment is led by the designated assessor under the applicable procedure.

For PSUSA procedures involving relevant products, the PRAC Rapporteur or, for nationally authorised products only, the appointed Lead Member State performs the scientific assessment described in the current procedural framework. citeturn0search0

The preliminary assessment report provides the regulator's initial evaluation of the submitted evidence.

It may identify:

5. The Preliminary Assessment Report

The preliminary assessment report is a critical point in the procedure because it allows the MAH to understand how the assessor has interpreted the evidence before the recommendation is adopted.

The MAH should review it systematically rather than treating it as ordinary correspondence.

A structured review can identify:

  1. factual errors;
  2. missing information;
  3. differences in interpretation;
  4. scientific disagreements;
  5. proposed regulatory actions;
  6. proposed product-information wording;
  7. and questions requiring a formal response.

The review should involve the appropriate medical, pharmacovigilance and regulatory expertise.

6. Day 90: The MAH Response

The current EMA procedural advice provides for MAH comments during the assessment timetable, including responses to requests for supplementary information and comments on proposed recommendations. citeturn0search0

Depending on the circumstances, the MAH may need to:

The response should address the assessor's reasoning directly.

Simply reproducing the original PSUR conclusion is rarely an adequate response to a substantive scientific question.

7. Scientific Disagreement With the Assessor

A difference between the MAH and assessor does not necessarily mean that one side has acted improperly.

Safety evaluation often involves uncertainty, incomplete evidence and clinical judgement.

A scientifically defensible response should therefore distinguish:

The response should identify the evidence supporting the MAH's position and explain why it leads to a different conclusion.

8. The Updated Assessment Report

After comments and responses have been considered, the assessor may issue an updated assessment report.

This report is important because it shows whether the MAH's explanations changed the assessment and whether the proposed regulatory recommendation has changed.

The MAH should compare the preliminary and updated assessments systematically.

Important changes should be escalated to the appropriate governance level, particularly where they involve:

9. PRAC's Role

PRAC provides the central scientific pharmacovigilance assessment within its legal remit.

For applicable PSUSA procedures, PRAC considers the assessment and adopts a recommendation. EMA's current procedural advice distinguishes between a PRAC recommendation to maintain the marketing authorisation and recommendations involving regulatory action. citeturn0search0

The PRAC recommendation is therefore a major regulatory milestone, but it should still be distinguished from subsequent CHMP, CMDh or Commission steps where those apply.

10. Maintenance Recommendation

If PRAC recommends maintenance of the marketing authorisation, the current EMA procedure states that the recommendation is not transmitted to CHMP or CMDh and the procedure ends with adoption of the PRAC recommendation. citeturn0search0

A maintenance outcome should not be interpreted as evidence that no safety information was identified.

It means that, following assessment, the regulatory conclusion is that maintenance is appropriate under the applicable procedure.

The MAH should retain the outcome as part of the product's cumulative regulatory and safety history and consider it in subsequent pharmacovigilance activities.

11. Regulatory Action Recommendation

Where PRAC recommends a variation, suspension or revocation of a marketing authorisation, the current procedural framework provides for onward transmission to the applicable subsequent EU process.

For centrally authorised products, this can involve CHMP. For nationally authorised products, the applicable CMDh process can apply depending on the composition of the procedure and products involved. citeturn0search0

The precise legal route should always be confirmed against the current procedure rather than inferred from a generic diagram.

12. CHMP and CMDh

CHMP and CMDh have different regulatory roles.

CHMP is relevant to centrally authorised medicinal products within its remit. CMDh has a role concerning nationally authorised medicinal products within the mutual-recognition and decentralised framework.

A PSUSA can therefore involve different downstream regulatory pathways depending on which products are within scope.

This is one reason why a PSUSA outcome should not be described simply as an "EMA decision" without identifying the actual procedural stage.

13. Commission Decision

For centrally authorised products where the applicable process requires a Commission decision, the CHMP opinion is followed by the Commission decision within the relevant legal and procedural framework.

The Commission decision is therefore a distinct regulatory act from:

Maintaining this distinction is important when documenting regulatory history and determining when an obligation becomes legally applicable.

14. Regulatory Outcomes Seen in PSUSA

Published EMA PSUSA records illustrate that outcomes can include maintenance and variation, among other possible regulatory outcomes depending on the procedure. citeturn0search1turn0search8

The outcome should always be interpreted in the context of the specific procedure and affected products.

A database label such as "maintenance" or "variation" is only the starting point for determining what the MAH must actually do.

15. What the MAH Should Do When the Outcome Is Known

Once the applicable regulatory outcome is available, the MAH should perform a controlled impact assessment.

The assessment should determine:

The output should be a documented action plan with ownership and completion criteria.

16. Regulatory Follow-Up Is Not Administrative Closure

Closing the regulatory procedure does not necessarily close the pharmacovigilance issue.

An outcome may create continuing obligations, such as:

The organisation should therefore distinguish procedure closure from completion of all resulting actions.

17. Post-Outcome Monitoring

After implementation, the MAH should monitor whether the required action has been completed and, where applicable, whether it has achieved its intended purpose.

For example, if an additional risk-minimisation measure is introduced, implementation evidence does not automatically demonstrate effectiveness.

The subsequent evaluation may require specific effectiveness measures under the applicable risk-management framework.

18. QPPV Oversight

The QPPV should have appropriate oversight of significant PSUR assessment outcomes and resulting actions.

The QPPV should be able to understand:

The QPPV does not need to perform every operational task personally. The quality-system responsibility is to ensure that appropriate controls and escalation mechanisms exist.

Key Takeaways

PSUR assessment is an independent regulatory evaluation of the evidence submitted by the MAH.

The current EU process has defined assessment milestones, with the PRAC Rapporteur or applicable Lead Member State performing the scientific assessment and PRAC adopting a recommendation within the applicable procedure. citeturn0search0

The regulatory history should preserve the distinction between the PSUR, assessment reports, PRAC recommendation, CHMP/CMDh output and Commission decision where applicable.

Most importantly, the process does not end when the recommendation or decision is published. The MAH must translate the outcome into controlled product-level action and appropriate continuing pharmacovigilance.

References

  1. European Medicines Agency. Periodic safety update reports (PSURs), including current PSUSA procedural advice.
  2. European Medicines Agency. GVP Module VII — Periodic Safety Update Report.
  3. European Medicines Agency. Questions and answers on PSUR Single Assessment (PSUSA): Guidance document for assessors.
  4. European Medicines Agency. Procedural timetables — PSUR and PSUSA.
  5. European Medicines Agency. Pharmacovigilance Risk Assessment Committee (PRAC).
  6. European Commission. Commission Implementing Regulation (EU) No 520/2012, as amended.
  7. Directive 2001/83/EC, as amended.
  8. Regulation (EC) No 726/2004, as amended.

Regulatory Note

This article is an educational explanation of EU PSUR assessment and regulatory follow-up. It does not replace current EU legislation, GVP Module VII, EMA procedural guidance, the current PSUSA timetable, EURD information, PSUR Repository requirements or an organisation's approved procedures.

Regulatory procedures and guidance may change. Before responding to a PSUR assessment or implementing a regulatory outcome, the current applicable procedural documents and legal requirements should be verified.

Examples and inspection considerations are illustrative unless an authoritative source is specifically identified.

16. The Assessor's Core Question

The regulatory assessment asks whether the submitted evidence changes the understanding of the medicinal product's benefit-risk balance and, if so, what regulatory response is appropriate.

This is broader than checking whether the PSUR is complete.

An assessor may consider:

The assessment should therefore be understood as an independent scientific evaluation of the evidence rather than a quality-control review of the document alone.

17. Assessment of the MAH's Conclusions

The assessor does not have to accept the MAH's interpretation simply because the PSUR is internally coherent.

A conclusion can be challenged where, for example:

The regulatory assessment should make the scientific basis for a different conclusion understandable.

18. Requests for Additional Information

Where the submitted information is insufficient for a robust assessment, clarification or additional information may be required.

The MAH should treat such requests as part of the scientific assessment process rather than as purely administrative correspondence.

A controlled response process should identify:

  1. the exact question;
  2. the evidence needed to answer it;
  3. the responsible subject-matter experts;
  4. the source data and analyses used;
  5. the proposed answer;
  6. medical and regulatory review;
  7. submission approval;
  8. and the final submitted response.

The response should remain traceable to the question and supporting evidence.

19. Scientific Disagreement

Scientific disagreement between an MAH and an assessor is possible, particularly where evidence is incomplete or conflicting.

A useful distinction is between disagreement about:

The response should address the specific basis of disagreement rather than repeating the original conclusion without additional reasoning.

20. The Importance of Cumulative Evidence

The assessment should consider the reporting interval in the context of cumulative knowledge.

A new observation may be insignificant when viewed alone but important when combined with previous evidence. Conversely, a concerning observation may become less persuasive when cumulative evidence does not support it.

The assessor should therefore evaluate the trajectory of the evidence and not simply compare the latest case count with the previous PSUR.

21. Reference Product Information

Reference product information provides an important framework for assessing proposed changes to safety information.

The MAH should consider the implications of the cumulative safety evaluation for the authorised product information of the products within scope.

EMA's current procedural guidance emphasises that where EU product information differs between products, the proposed changes must be considered against the relevant product information rather than treated as a single generic wording exercise. citeturn1search0

This is particularly important in a PSUSA because products containing the same active substance may have different indications, wording and regulatory histories.

22. Proposed Product-Information Changes

A proposed product-information change should have a traceable scientific rationale.

The organisation should be able to show:

New / cumulative evidence
        ↓
Clinical assessment
        ↓
Change in safety understanding
        ↓
Proposed wording
        ↓
Product-specific impact assessment

The wording should accurately reflect the evidence and the applicable regulatory framework.

A PSUR should not propose a change merely because an event has been reported. The evidence must support the clinical and regulatory significance of the proposed change.

23. Assessment of Risk-Minimisation Measures

The assessment can consider whether existing risk-minimisation measures remain appropriate.

Important questions include:

Implementation and effectiveness are different questions.

A measure can be implemented completely while failing to achieve its intended clinical effect.

24. Benefit-Risk Assessment During Regulatory Review

The regulatory assessment should integrate safety findings with the therapeutic context.

The assessor may therefore consider whether:

The conclusion should be specific enough to explain why the evidence supports maintenance, modification or further regulatory action.

25. Possible PSUSA Conclusions

PSUSA outcomes are not limited to a binary choice between "safe" and "unsafe".

Depending on the evidence, the procedure can result in conclusions such as:

Current EMA PSUSA records illustrate both maintenance and variation outcomes. citeturn1search1turn1search5

The outcome should be read together with the underlying assessment report and implementation requirements.

26. Maintenance Does Not Mean No Assessment

A maintenance outcome means that the assessment did not identify a need for the relevant regulatory change at that point.

It should not be interpreted as a declaration that the medicine has no risks or that further pharmacovigilance is unnecessary.

For example, a PRAC outcome may maintain the current terms while requiring additional information to be presented in a subsequent PSUR or other follow-up activity. Current PRAC outcomes demonstrate this type of continuing monitoring. citeturn1search17

27. Variation Outcomes

A variation outcome indicates that the regulatory assessment supports a change to the marketing authorisation.

The precise implementation depends on the product and applicable procedure.

Possible changes can involve:

The MAH should translate the regulatory conclusion into a controlled implementation plan rather than treating publication of the recommendation as completion.

28. PRAC Recommendation and Subsequent Regulatory Steps

PRAC is the EU committee responsible for assessing and monitoring safety issues for human medicines within its remit.

In PSUSA procedures, PRAC's recommendation is an important regulatory step, but the subsequent pathway depends on whether the products concerned include centrally authorised products and on the applicable legal procedure.

The organisation should therefore distinguish clearly between:

The historical GVP Module VII flowchart illustrates these different pathways, including the distinction between procedures involving centrally authorised products and those involving nationally authorised products. citeturn0search12

29. CAP and NAP Consequences

A PSUSA can involve centrally authorised products (CAPs), nationally authorised products (NAPs), or both.

The regulatory path following the PRAC recommendation differs according to the authorisation situation.

For an organisation with both CAPs and NAPs, the implementation assessment should therefore map the outcome to each affected authorisation rather than applying one generic instruction to every product.

30. Products Outside the PSUSA Scope

An important current EMA clarification concerns products that are not included in the scope of the particular single assessment.

The PRAC recommendation is directly applicable to products within the scope of that PSUSA. MAHs whose products are outside the scope nevertheless have an obligation to keep their product information up to date with current scientific knowledge and should consider whether the recommendation is relevant to their products. In exceptional circumstances, the assessment report may indicate that the recommendation can be extrapolated to products outside the procedure. citeturn1search0

This is a particularly important distinction between:

31. Regulatory Follow-Up Is a Controlled Process

Once an assessment produces an action, the MAH should establish a controlled implementation pathway.

A practical sequence is:

Regulatory recommendation / decision
            ↓
Impact assessment
            ↓
Affected products identified
            ↓
Required actions defined
            ↓
Regulatory pathway determined
            ↓
Submission / implementation
            ↓
Verification
            ↓
Closure and evidence retention

The exact workflow depends on the action and applicable procedure.

32. Impact Assessment After a PSUSA

The impact assessment should determine, at minimum where relevant:

The assessment should document the rationale for both action and no-action conclusions.

33. Practical Scenario: PRAC Recommends a Variation

Suppose PRAC concludes that a known adverse reaction should be added to the product information.

The MAH should not simply change the text in its internal database.

It should identify the affected authorisations, determine the applicable regulatory route, prepare the required submission or implementation, update controlled safety information and verify that the final authorised wording is reflected in the relevant systems.

The PSUSA assessment, regulatory outcome and implementation records should remain linked.

34. Practical Scenario: PRAC Maintains the Current Terms

Suppose the assessment concludes that the benefit-risk balance remains favourable and no variation is required.

The organisation should record the conclusion and determine whether any continuing monitoring, data-generation or next-PSUR commitments remain.

A maintenance outcome is therefore a regulatory conclusion, not permission to stop ordinary pharmacovigilance.

35. Practical Scenario: Additional Data Requested

Suppose the assessment identifies an important uncertainty but considers the evidence insufficient for a regulatory change.

The outcome may require further information or analysis.

The organisation should convert the requirement into a controlled commitment with:

The next PSUR may then need to demonstrate what was learned from that additional work.

36. Practical Scenario: Conflicting MAH Conclusions

Where several MAHs submit PSURs for the same active substance, their conclusions may not initially be identical.

The single-assessment process provides a common regulatory evaluation of the relevant evidence.

Each MAH should nevertheless preserve the scientific rationale for its own submission and maintain the regulatory history showing how the final conclusion was reached.

37. Inspection Questions

An inspector may ask:

A mature system should answer these questions using contemporaneous records.

38. Key Takeaways

The PSUR assessment is an independent scientific evaluation of the evidence and the MAH's conclusions.

PRAC recommendation, CHMP opinion, CMDh position, Commission decision and MAH implementation are distinct stages that should not be collapsed into a generic "regulatory decision".

The regulatory outcome can require variation, maintenance, additional information, further monitoring or other action. Even a maintenance outcome may contain follow-up expectations.

The current EMA guidance also makes clear that a PSUSA recommendation is directly applicable to products within the procedure's scope; products outside the scope require a separate assessment of relevance rather than automatic extrapolation. citeturn1search0

The strongest systems maintain a continuous evidence chain from assessment through implementation and subsequent pharmacovigilance.

References

  1. European Medicines Agency. Periodic safety update reports (PSURs) and PSUR Single Assessment (PSUSA).
  2. European Medicines Agency. GVP Module VII — Periodic Safety Update Report.
  3. European Medicines Agency. Questions and answers on PSUSA: Guidance document for assessors.
  4. European Medicines Agency. Explanatory note to GVP Module VII.
  5. European Medicines Agency. Pharmacovigilance Risk Assessment Committee (PRAC).
  6. European Commission. Commission Implementing Regulation (EU) No 520/2012, as amended.
  7. Directive 2001/83/EC, as amended.
  8. Regulation (EC) No 726/2004, as amended.

Regulatory Note

This article is an educational explanation of PSUR assessment, PRAC involvement and regulatory follow-up in the EU. It does not replace current EU legislation, GVP Module VII, the current EMA PSUSA assessor guidance, procedural advice, applicable regulatory decisions or an organisation's approved procedures.

The GVP framework is undergoing revision following amendments to Commission Implementing Regulation (EU) 2025/1466. Current EMA guidance should therefore be checked before applying a procedural statement operationally. citeturn0search1

Examples and inspection considerations are illustrative unless an authoritative source is specifically identified.

39. Maintaining the Regulatory Evidence Trail

A PSUSA-related activity should remain reconstructable after the procedure has closed.

The evidence trail should connect, as applicable:

The objective is not to create documents for their own sake. The objective is to demonstrate what the organisation knew, what it concluded, what it was required to do and how it verified completion.

40. Regulatory Intelligence and Change Control

PSUSA governance depends on current regulatory information.

The organisation should monitor relevant changes to:

Changes should be assessed for operational impact rather than simply stored in a regulatory-intelligence repository.

This is particularly important because EMA continues to update PSUR procedural guidance and related PSUSA documents. The current EMA PSUR page records updates to the explanatory note and assessor Q&A in May 2026. citeturn0search0turn1search4

41. What the QPPV Should Know

The QPPV does not need to personally perform every PSUR assessment-response activity.

However, for significant procedures the QPPV should have sufficient oversight to understand:

This is particularly important where a PSUSA outcome changes the organisation's understanding of an important risk.

42. Common Failure: Treating the Assessment Report as a Formality

An assessment report can contain important scientific reasoning that is not captured in a simple regulatory-action tracker.

If the organisation records only "variation required" and does not evaluate the underlying assessment, it can miss:

The assessment report should therefore be reviewed as a substantive pharmacovigilance document.

43. Common Failure: Closing the Action When the Submission Is Made

Submitting a variation or safety-related regulatory response is not necessarily equivalent to completing the regulatory action.

Depending on the applicable process, completion may require:

The organisation should define completion criteria before closing the action.

44. Common Failure: Assuming a PRAC Recommendation Applies Everywhere

A recommendation can have a defined scope.

The organisation should establish whether its products are within the relevant PSUSA procedure and determine the appropriate regulatory pathway.

For products outside the procedure, the current EMA clarification requires the MAH to consider the scientific relevance rather than assuming automatic application. citeturn1search0

This distinction is particularly important for companies with broad product portfolios containing the same active substance.

A significant PSUSA action may require follow-up in a subsequent PSUR.

If the commitment is not transferred into the next reporting-cycle plan, the organisation can lose continuity between regulatory procedures.

A useful control is to maintain explicit links between:

PSUSA outcome
      ↓
Commitment / follow-up requirement
      ↓
Owner and due date
      ↓
Next PSUR or other deliverable
      ↓
Evidence of completion

46. Practical Scenario: A Regulatory Action Is Implemented but Not Verified

Suppose a product-information change is submitted and approved, but no one verifies that the final authorised wording is reflected in the safety database, reference information and controlled internal materials.

The regulatory submission may have been completed correctly, but the pharmacovigilance implementation is incomplete.

The organisation should define verification activities appropriate to the change and retain evidence of the check.

47. Practical Scenario: A Follow-Up Requirement Is Not Due Until the Next PSUR

A PSUSA may require additional information to be presented in a future PSUR.

The requirement should not remain only in the closed procedure file.

It should enter the appropriate ongoing PV planning process so that the next reporting cycle can demonstrate:

48. Practical Scenario: A New Safety Issue Emerges Before Implementation Is Complete

A new important safety concern can emerge after a PSUSA outcome but before implementation of the previous action is complete.

The organisation should not assume that the open PSUSA action automatically covers the new concern.

The new information should be assessed through the applicable ongoing signal-management and regulatory processes.

The PSUSA implementation and the new safety issue should remain separately traceable while being considered together where scientifically relevant.

49. Interaction With Signal Management

PSUSA assessment and signal management are complementary.

A signal may be identified before, during or after a PSUSA procedure.

The organisation should therefore maintain clear interfaces so that:

EMA's current signal-management guidance illustrates that regulatory recommendations can require additional information, a subsequent PSUR or ad-hoc PSUR, PASS or direct regulatory action. citeturn0search6

50. Interaction With Risk Management

A PSUSA outcome can change the risk-management strategy without necessarily changing every part of the RMP.

The organisation should assess whether the outcome affects:

The impact assessment should be documented.

51. Interaction With Product Information

Product-information implementation should remain connected to the regulatory conclusion.

Where several EU products have different authorised wording, the organisation should map the regulatory outcome to the actual product information rather than relying on a single generic text.

EMA specifically advises MAHs to consider proposed changes against the relevant EU product information when products covered by a single assessment have different authorised information. citeturn0search0

52. Regulatory Outcome as Future Safety Knowledge

A PSUSA conclusion becomes part of the cumulative evidence base.

Future PSURs, signal assessments and RMP updates should be able to take account of what the regulatory network previously concluded and what evidence subsequently became available.

This is particularly important for risks that remain under monitoring after a maintenance outcome.

The regulatory history should therefore be treated as a source of pharmacovigilance knowledge, not merely as a closed administrative record.

53. Inspection Scenario: The Organisation Cannot Explain a Disagreement

An inspector may compare the MAH's PSUR conclusion with the final assessment and ask why the regulator reached a different conclusion.

The organisation should be able to explain:

A difference in conclusion is not automatically a system failure. Inability to reconstruct the scientific reasoning is the greater concern.

54. Inspection Scenario: The Organisation Cannot Identify the Affected Products

If the regulatory outcome applies to several products, the organisation should be able to identify the complete affected population.

A controlled product-authorisation inventory should support this determination.

This is especially important where the same active substance exists across:

55. Inspection Scenario: The Organisation Relies on Individual Memory

PSUSA governance should not depend on one regulatory-affairs or pharmacovigilance employee remembering the procedural history.

The evidence should reside in controlled systems and records.

If the responsible employee is unavailable, another qualified person should be able to determine:

This is a practical test of process maturity.

56. Final Governance Checklist

For each significant PSUSA procedure, confirm that the organisation can demonstrate:

57. Key Takeaways

PSUR assessment is where the periodic safety report becomes part of the EU regulatory decision-making system.

The critical skill for an MAH is not merely knowing the procedural timetable. It is maintaining the connection between scientific evidence, regulatory reasoning, product-specific impact and implementation.

PRAC recommendations should be understood in their proper scope and regulatory context. Current EMA guidance also requires careful consideration of products outside a PSUSA procedure rather than assuming automatic extrapolation. citeturn1search0

A mature pharmacovigilance system treats the assessment report and regulatory outcome as active inputs into ongoing safety management, rather than as documents that can simply be filed after the procedure closes.

References

  1. European Medicines Agency. Periodic safety update reports (PSURs) and PSUR Single Assessment (PSUSA).
  2. European Medicines Agency. GVP Module VII — Periodic Safety Update Report.
  3. European Medicines Agency. Questions and answers on PSUSA: Guidance document for assessors.
  4. European Medicines Agency. Explanatory note to GVP Module VII.
  5. European Medicines Agency. Pharmacovigilance Risk Assessment Committee (PRAC).
  6. European Medicines Agency. Signal management.
  7. European Commission. Commission Implementing Regulation (EU) No 520/2012, as amended.
  8. Directive 2001/83/EC, as amended.
  9. Regulation (EC) No 726/2004, as amended.

Regulatory Note

This article is an educational explanation of PSUR assessment, PRAC involvement and regulatory follow-up in the EU. It does not replace current EU legislation, GVP Module VII, current EMA PSUSA assessor guidance, procedural advice, applicable regulatory decisions or an organisation's approved procedures.

The GVP framework is undergoing revision following amendments to Commission Implementing Regulation (EU) 2025/1466. Current EMA guidance should therefore be checked before applying a procedural statement operationally. citeturn0search1

Examples and inspection considerations are illustrative unless an authoritative source is specifically identified.

Revision History

Related Articles

GVP Module VII Explained: The EU PSUR

A textbook-style introduction to the EU PSUR: what it is, why it exists, how it fits into pharmacovigilance, and how MAHs should govern its preparation and submission.

GVP Module VII: Multiple Products, Substances and Marketing Authorisation Holders

A practical explanation of how PSUR scope is coordinated across products and marketing authorisation holders, including single PSUR principles, active-substance scope, product differences and EU single assessment.

GVP Module VII: PSUR Single Assessment and EU Procedures

A practical explanation of PSUR single assessment, the EU regulatory procedure, the roles of MAHs and authorities, and how periodic safety evaluation can lead to coordinated regulatory action.

Last reviewed: 2026-08-24