The short version
What teams need to understand
- Safety Data Exchange Agreements must require routine reconciliation of safety data between the parties.
- Reconciliation processes must confirm that valid cases, follow-up information, and key case attributes are aligned between systems.
- Discrepancies such as missing cases, duplicate cases, inconsistent receipt dates, or mismatched case details must be investigated and resolved.
- Reconciliation controls must support complete and accurate downstream regulatory reporting.
- Duplicate prevention and case matching logic must be defined and operationally workable.
- Inspection-ready evidence should demonstrate that reconciliation is performed, discrepancies are investigated, and data consistency is actively maintained.
Regulatory expectation
What regulators expect
Each expectation should be supported by controlled documentation, traceable records, clear ownership, and evidence that the process works in practice.
- Safety data exchanged between parties must be complete and consistent.
- Routine reconciliation must be performed to detect missing or mismatched cases.
- Discrepancies must be investigated and resolved in a documented manner.
- Duplicate controls must prevent double counting or duplicate reporting.
- Reconciliation outcomes must support the MAH's ability to maintain a complete pharmacovigilance system.
Why it matters
What this means in practice
Inspectors assess whether Safety Data Exchange Agreements include effective reconciliation and data consistency controls. They typically review case list matching, duplicate handling, discrepancy logs, and evidence that missing or inconsistent safety data is identified, investigated, and resolved promptly.
Questions this page answers
Inspection evidence
Evidence teams should be able to show
Reconciliation Procedure or SDEA Clause
- Defined reconciliation frequency such as monthly or quarterly
- Defined scope of reconciliation including initial cases and follow-up information
- Rules for matching cases between party systems
- Escalation requirements for unresolved discrepancies
Reconciliation Outputs
- Case lists exchanged between parties
- Matched and unmatched case records
- Identification of missing cases or delayed transmissions
- Evidence of completed reconciliation cycles
Discrepancy Logs and Investigation Records
- Logs of missing, duplicate, or inconsistent cases
- Investigation notes explaining root cause
- Corrective actions taken to resolve case mismatches
- Closure evidence for reconciled discrepancies
Duplicate Management Controls
- Duplicate search expectations before case creation
- Rules for handling the same case received through multiple parties
- Documentation linking follow-up information to the correct original case
- Prevention of duplicate reporting to authorities
Data Consistency Checks
- Alignment of day zero and receipt dates between systems
- Consistency of seriousness, expectedness, and causality fields where applicable
- Matching of case identifiers and source details
- Consistency between exchanged follow-up data and local case records
Regulatory Basis (Primary Sources)
- GVP Module I - pharmacovigilance systems must include quality controls and oversight processes
- GVP Module VI - ICSR collection, exchange, follow-up, and reporting must be complete and traceable
- ICH E2D - post-approval safety data management requires complete and timely case handling
- MHRA GPvP guidance - expectations for data integrity and compliant pharmacovigilance processes
- FDA postmarketing safety reporting guidance - safety data must be accurate, complete, and consistently maintained
Typical Inspection Questions (What Inspectors Ask)
- How often do you reconcile cases with your partner or vendor?
- Show me the output from your last reconciliation exercise.
- What happens when a case is present in one system but not the other?
- How do you manage duplicate cases across parties?
- How do you ensure both parties hold the same day zero and follow-up information?
Common failure patterns
What good looks like
- Routine reconciliation is performed on a defined cadence and fully documented.
- Missing or inconsistent cases are identified quickly and investigated to closure.
- Duplicate controls are effective and understood by both parties.
- Key case data such as day zero, seriousness, and follow-up status remain aligned across systems.
- Reconciliation findings feed into governance, escalation, and process improvement.
How teams operationalise it
- Define reconciliation scope, frequency, and ownership in the SDEA.
- Exchange structured case lists that allow reliable matching across systems.
- Investigate all missing, duplicate, or inconsistent cases promptly.
- Document discrepancy resolution and confirm correction in both party records.
- Use reconciliation findings to strengthen data quality and partner oversight.
- Trend repeated mismatch types and implement CAPA where necessary.
From expectation to working control
Find the documentation that supports this work
Review the related toolkit to understand its purpose, included files, and how it supports this regulatory expectation.
Frequently asked questions
What is reconciliation in a Safety Data Exchange Agreement?
Reconciliation is the process of comparing safety data held by both parties to confirm that the same cases, follow-up information, and key case details are present and aligned.
What is case reconciliation in pharmacovigilance?
Case reconciliation is the process of comparing safety data between parties to ensure that all valid cases, follow-up information, and key case details are present, consistent, and correctly aligned across systems.
Why is reconciliation important in pharmacovigilance agreements?
Reconciliation is important because missing, duplicate, or inconsistent cases can lead to incomplete safety oversight, late reporting, or duplicate regulatory submissions.
How often should safety data be reconciled between parties?
The frequency should be defined in the agreement, but reconciliation is commonly performed monthly for active safety exchanges.
What should happen if the two parties' case lists do not match?
The discrepancy should be investigated promptly, root cause identified, the missing or incorrect data corrected, and the issue documented to closure.
Do inspectors review reconciliation outputs in pharmacovigilance inspections?
Yes. Inspectors frequently review reconciliation records to confirm that both parties maintain complete and consistent safety data.
How are duplicate cases handled in safety data exchange?
Duplicate controls should be defined in the agreement and operational process so that repeated or overlapping case reports are linked correctly and not reported twice.
Source boundary
Regulatory sources
These primary sources inform this structured interpretation. Always confirm current requirements against the original source and the requirements applicable to your organisation, product, and jurisdiction.
European Medicines Agency (EMA)
Guideline on good pharmacovigilance practices (GVP) - Module I
View sourceGuideline on good pharmacovigilance practices (GVP) - Module VI
View source
International Council for Harmonisation (ICH)
Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting (E2D)
View source
U.S. Food and Drug Administration (FDA)
Postmarketing Safety Reporting for Human Drug and Biological Products
View source
UK MHRA
Good Pharmacovigilance Practice (GPvP)
View source