EMA ICSR Submission

Need for this

ICSR submission to EMA is a two-way process — cases are sent, and an acknowledgement is received from the regulatory authority. 
 When done manually, this process faces several challenges: 

  • Manual Masking Errors – Under the new EMA GVP Module VI Addendum II, specific personal data fields (e.g., reporter’s name, patient medical record numbers) must be masked. Manual masking is prone to oversight, risking non-compliance.
  • Time-Intensive Acknowledgement Handling – Professionals have to manually attach EMA acknowledgement files to the correct case record, a repetitive and time-consuming task.
  • Risk of Misplacement or Omission – Due to heavy workloads, acknowledgements can be missed or attached to the wrong case, compromising compliance traceability.
  • Regulatory Compliance Pressure – The masking rules are extensive and require precise application to avoid exposure of personal identifiers while retaining all required pharmacovigilance data.

How it Benefits

Our automated approach removes these bottlenecks by: 

Saving Time & Reducing Manual Effort

No need for case processors to manually handle acknowledgement files.

Boosting Productivity

Staff focus on case quality assessment, not repetitive admin work.

Ensuring Full Regulatory Compliance

Automatically applies EMA’s required masking for personal identifiers before submission, reducing the risk of non-compliance.

Error-Proof Linking

Acknowledgement files are auto-attached to the correct case, ensuring an unbroken compliance trail.


How We Are Using This in Existing Products

We have developed PvEdge to: 

  • Auto-Mask Personal Data – Our system ensures that fields requiring masking are transmitted exactly as specified.
  • Preserve Essential Data – Non-personal but pharmacovigilance-critical fields remain intact for EMA processing and signal management.
  • Integrated EMA Gateway Submission –Directly submits ICSRs to EMA through an integrated gateway.
  • Automated Acknowledgement Attachment –Instantly links regulatory acknowledgements to the correct case, eliminating missed files and misplacements.
  • Multi-Source Intake – Handles case creation from MICC, literature, regulatory sources, and web intake in a single streamlined workflow.

Result of Implementation

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100% compliance

with EMA Addendum II masking requirements.

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Zero missed acknowledgements

due to automation.

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Improved staff efficiency

by freeing up PV experts from repetitive admin tasks.

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Higher data accuracy

and audit readiness.

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Up to 40% reduction

in case processing time.

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Enhanced traceability

for inspections and audits.

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