Guidelines for Pharmacovigilance Aggregate Report Submission

1) Purpose

The purpose of this SOP is to outline procedures for the preparation, review, and submission of pharmacovigilance aggregate reports to regulatory authorities.

2) Scope

This SOP applies to pharmacovigilance personnel responsible for compiling, verifying, and submitting aggregate reports within the organization.

3) Responsibilities

The Pharmacovigilance (PV) Manager is responsible for overseeing the Aggregate Report Submission process. PV staff involved in aggregate reporting are responsible for adhering to this SOP.

4) Procedure

4.1 Aggregate Report Preparation

1. Identify the type of aggregate report required (e.g., Periodic Safety Update Report (PSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Development Safety Update Report (DSUR)).
2. Collect and compile safety data, including adverse events, product complaints, and safety-related findings, for inclusion in the aggregate report.

4.2 Aggregate Report Structure

1. Define the structure and content requirements for the aggregate report, including sections on product information, safety data updates, benefit-risk assessment, and risk minimization measures.
2. Ensure compliance with regional regulatory requirements and guidelines (e.g., ICH guidelines, EU Pharmacovigilance legislation) for aggregate reporting.

4.3 Aggregate Report Review

1. Conduct internal review and quality assurance checks to ensure accuracy, completeness, and consistency of the aggregate report content.
2. Seek input and approval from relevant stakeholders, including medical affairs, regulatory affairs, and marketing authorization holders.

4.4 Aggregate Report Submission

1. Prepare the aggregate report for submission to regulatory authorities according to specified timelines and submission requirements.
2. Document the submission process, including tracking and confirmation of receipt by regulatory agencies.

4.5 Post-Submission Activities

1. Respond promptly to requests for additional information or clarification from regulatory authorities regarding submitted aggregate reports.
2. Monitor regulatory updates and guidelines related to aggregate reporting and incorporate changes into future report preparations.

4.6 Documentation and Record Keeping

1. Maintain comprehensive records of aggregate report preparation, review, submission, and correspondence with regulatory agencies.
2. Ensure that all aggregate report documentation is stored securely and is accessible for regulatory inspections and audits.

4.7 Training and Education

1. Provide training to PV staff on aggregate report requirements, preparation processes, and regulatory expectations.
2. Ensure that PV team members are knowledgeable about pharmacovigilance guidelines and best practices related to aggregate report preparation and submission.

4.8 Continuous Improvement

1. Regularly review aggregate report procedures and templates based on feedback, regulatory changes, and inspection findings.
2. Implement improvements to streamline report preparation, enhance data quality, and ensure compliance with evolving regulatory requirements.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, PSUR – Periodic Safety Update Report, PBRER – Periodic Benefit-Risk Evaluation Report, DSUR – Development Safety Update Report

6) Documents, if any

Aggregate report templates, safety data summaries, regulatory guidelines, training materials.

7) Reference, if any

ICH Guideline for Good Clinical Practice, FDA Guidance for Industry – Pharmacovigilance Responsibilities of Marketing Authorization Holders (MAHs), EU Guidelines on Good Pharmacovigilance Practices (GVP) Module VII – Periodic Safety Update Reports (PSURs).

8) SOP Version

Version 1.0