Guidelines for Pharmacovigilance Regulatory Reporting

1) Purpose

The purpose of this SOP is to outline procedures for the timely and accurate reporting of pharmacovigilance data to regulatory authorities in compliance with regulatory requirements.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in regulatory reporting activities, including pharmacovigilance managers, regulatory affairs specialists, and compliance officers.

3) Responsibilities

The Regulatory Reporting Team is responsible for ensuring that pharmacovigilance data is reported to regulatory authorities in accordance with applicable regulations and guidelines. The Pharmacovigilance (PV) Manager oversees regulatory reporting activities to ensure completeness, accuracy, and timeliness of submissions.

4) Procedure

4.1 Reporting Obligations

1. Identify regulatory reporting obligations based on regional requirements (e.g., FDA, EMA, Health Canada).
2. Understand specific reporting timelines, formats, and data requirements for different types of pharmacovigilance reports (e.g., expedited reports, periodic safety reports).
3. Establish communication channels with regulatory authorities for submission queries and updates.

4.2 Data Compilation and Analysis

1. Compile pharmacovigilance data from internal databases and external sources for regulatory reporting purposes.
2. Analyze collected data to ensure completeness, accuracy, and consistency in accordance with regulatory standards.
3. Prepare summary reports and analyses as required by regulatory authorities.

4.3 Report Preparation and Submission

1. Prepare pharmacovigilance reports (e.g., Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs)) according to regulatory guidelines and templates.
2. Ensure reports are reviewed and approved by designated personnel (e.g., PV Head, Regulatory Affairs).
3. Submit reports to regulatory authorities within specified timelines using authorized submission methods (e.g., EudraVigilance, FDA Electronic Submissions).

4.4 Compliance Monitoring

1. Monitor regulatory reporting metrics and key performance indicators (KPIs) to track compliance with reporting obligations.
2. Implement corrective actions to address any deviations or issues identified during compliance monitoring.
3. Conduct internal audits and inspections to ensure adherence to regulatory reporting requirements.

4.5 Record Keeping and Documentation

1. Maintain accurate records of all pharmacovigilance reports submitted to regulatory authorities.
2. Archive regulatory submission documents and correspondence for audit and inspection purposes.
3. Ensure documentation is organized and readily accessible for regulatory inquiries and internal reviews.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, ICSR – Individual Case Safety Report, PSUR – Periodic Safety Update Report

6) Documents, if any

Regulatory reporting templates, submission logs, compliance reports, audit findings.

7) Reference, if any

EU Good Pharmacovigilance Practices (GVP) Module VI – Management and Reporting of Adverse Reactions to Medicinal Products, FDA Guidance for Industry – Postmarketing Adverse Event Reporting for Human Drug and Biological Products Including Vaccines.

8) SOP Version

Version 1.0