Guidelines for Periodic Pharmacovigilance Reporting

1) Purpose

The purpose of this SOP is to establish standardized procedures for the preparation and submission of periodic safety reports to regulatory authorities to ensure ongoing assessment of the benefit-risk profile of medicinal products.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the creation, review, and submission of periodic safety reports, including safety specialists, data analysts, and managers.

3) Responsibilities

The Reporting Team is responsible for the preparation and submission of periodic safety reports. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Preparation for Periodic Reporting

1. Identify the schedule and frequency of periodic safety reports as required by regulatory authorities (e.g., PSURs, PBRERs).
2. Gather all relevant data, including adverse event reports, literature reviews, and risk management activities.
3. Organize and prioritize the data to be included in the periodic safety report.

4.2 Drafting the Periodic Safety Report

1. Access the pharmacovigilance database and other relevant sources of information.
2. Compile and summarize the safety data, including individual case safety reports (ICSRs), aggregate data, and significant findings.
3. Analyze the data to identify any new safety signals or changes in the benefit-risk profile of the product.
4. Document the methodology and results of the data analysis in the periodic safety report.
5. Include sections on the product’s safety profile, benefit-risk assessment, and any necessary risk minimization measures.
6. Review the draft report for accuracy, completeness, and clarity before finalizing it.

4.3 Review and Approval

1. Submit the draft periodic safety report to the PV Manager and other relevant stakeholders for review.
2. Incorporate any feedback or revisions from the review process into the final report.
3. Obtain formal approval of the final periodic safety report from the PV Manager or authorized signatory.

4.4 Submission of the Periodic Safety Report

1. Submit the finalized periodic safety report to the relevant regulatory authorities within the required timeframe.
2. Use the appropriate submission method (e.g., electronic submission, postal mail) as specified by the regulatory authority.
3. Confirm receipt of the report by the regulatory authority and document the submission details.

4.5 Quality Control

1. Conduct regular quality control checks on periodic safety reports to ensure accuracy and compliance with regulatory requirements.
2. Address any discrepancies or errors identified during quality control checks promptly.
3. Document all quality control activities and any corrective actions taken.

4.6 Documentation and Record Keeping

1. Maintain detailed records of all periodic safety reports, including initial drafts, revisions, and final submissions.
2. Ensure all documentation is securely stored and easily accessible for audits and inspections.
3. Keep a log of all periodic safety reports submitted and their corresponding regulatory timelines.

4.7 Training and Communication

1. Communicate periodic reporting procedures and updates to all relevant staff members.
2. Provide training on reporting tools and techniques to ensure consistency and quality.
3. Report any issues or challenges encountered during the periodic reporting process to the PV Manager.

5) Abbreviations, if any

PV – Pharmacovigilance
PSUR – Periodic Safety Update Report
PBRER – Periodic Benefit-Risk Evaluation Report

6) Documents, if any

Case reports, literature reviews, data analysis reports, draft and final periodic safety reports, quality control reports.

7) Reference, if any

ICH E2E Pharmacovigilance Planning, EU Good Pharmacovigilance Practices (GVP) Module VII.

8) SOP Version

Version 1.0