Guidelines for Pharmacovigilance Regulatory Intelligence Monitoring

1) Purpose

The purpose of this SOP is to outline procedures for monitoring regulatory developments related to pharmacovigilance to ensure compliance with evolving regulations and guidelines.

2) Scope

This SOP applies to all pharmacovigilance personnel responsible for monitoring and interpreting regulatory intelligence, including changes in legislation, guidelines, and best practices.

3) Responsibilities

The Regulatory Affairs Manager is responsible for overseeing regulatory intelligence monitoring activities. Pharmacovigilance (PV) personnel are responsible for implementing and adhering to this SOP.

4) Procedure

4.1 Identification of Regulatory Sources

1. Identify relevant regulatory authorities and sources of regulatory information, including health authorities, industry associations, and regulatory publications.
2. Establish a systematic approach for monitoring updates and changes from these sources.

4.2 Regulatory Intelligence Collection

1. Regularly monitor regulatory websites, publications, newsletters, and announcements for updates related to pharmacovigilance.
2. Subscribe to regulatory alerts and updates provided by relevant authorities and organizations.

4.3 Information Assessment and Interpretation

1. Review and analyze regulatory updates to assess their potential impact on pharmacovigilance activities and obligations.
2. Interpret regulatory changes in the context of company operations and pharmacovigilance practices.

4.4 Communication of Regulatory Updates

1. Disseminate key regulatory updates and interpretations to relevant stakeholders within the organization, including PV teams, regulatory affairs, and senior management.
2. Ensure that stakeholders understand the implications of regulatory changes and their responsibilities for compliance.

4.5 Response and Action Planning

1. Develop response strategies and action plans to address new regulatory requirements or changes in pharmacovigilance practices.
2. Assign responsibilities for implementing necessary changes or updates to SOPs, processes, or systems.

4.6 Documentation and Record Keeping

1. Maintain comprehensive records of regulatory intelligence monitoring activities, including sources monitored, updates received, assessments conducted, and actions taken.
2. Ensure all documentation is stored securely and is accessible only to authorized personnel.

4.7 Training and Awareness

1. Provide training to PV personnel on the importance of regulatory intelligence monitoring and the procedures outlined in this SOP.
2. Ensure that PV staff are updated on changes to regulatory requirements through regular training sessions and updates.

4.8 Continuous Improvement

1. Regularly review and update the regulatory intelligence monitoring process based on feedback, regulatory changes, and emerging best practices.
2. Implement improvements to enhance the effectiveness and efficiency of regulatory intelligence monitoring activities.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure

6) Documents, if any

Regulatory monitoring logs, update summaries, action plans, training materials.

7) Reference, if any

ICH Guideline for Good Clinical Practice, FDA Guidance for Industry – Risk Evaluation and Mitigation Strategies (REMS): Modifications and Revisions, EU Guidelines on Good Pharmacovigilance Practices (GVP) Module I – Pharmacovigilance Systems and their Quality Management Systems.

8) SOP Version

Version 1.0