Pharmacovigilance System Master File (PSMF)

The PSMF is a comprehensive document that delineates the structure and functionality of a company's global or regional PV system.

Key aspects include:

• Mandatory Nature: For Marketing Authorization Holders (MAHs) operating within the European Union (EU), United Kingdom (UK), and numerous other regulated markets, maintaining a PSMF is obligatory. This requirement was instituted by the European Medicines Agency in July 2012 to enhance oversight and transparency in PV practices.

• Content Overview: The PSMF encompasses detailed descriptions of the PV system's organizational structure, processes, and responsibilities. It provides insights into safety data sources, computerized systems, and databases relevant to PV activities. Additionally, it outlines the role and qualifications of the Qualified Person Responsible for Pharmacovigilance (QPPV).

• Maintenance and Accessibility: This dynamic document requires regular updates to reflect any changes in the PV system. It must be readily accessible for regulatory inspections, underscoring its critical role in demonstrating a company's commitment to drug safety.

Pharmacovigilance Site Master File (PSSF)

The PSSF serves as a localized counterpart to the PSMF, focusing on PV activities at a specific affiliate, country, or site level.

Its primary characteristics are:

• Regional Specificity: The PSSF provides detailed information about local PV activities, including personnel roles, Standard Operating Procedures (SOPs), and reporting timelines. It ensures that regional nuances and regulatory requirements are adequately addressed.

• Regulatory Requirements: Unlike the globally mandated PSMF, the necessity for a PSSF varies by region. Countries such as those in the Middle East, India, and parts of Africa may require a PSSF to ensure that local PV practices align with national regulations. For instance, in Lebanon, multinational MAHs are required to maintain a National Pharmacovigilance Sub-System File (PSSF) alongside their global PSMF to address local PV activities and compliance.

Key Differences Between PSMF and PSSF

Global Adoption and Compliance

Since its inception in 2012, the requirement for maintaining a PSMF has expanded beyond the EU. As of today, regulatory agencies in over 60 countries mandate the maintenance of a PSMF, reflecting its significance in global pharmacovigilance practices.

In regions like the Middle East, the PSSF has emerged as a crucial document to ensure that local PV activities are conducted in compliance with national regulations. For example, the Saudi Food and Drug Authority (SFDA) requires the PSSF to include all necessary information related to PV activities within the Saudi market, with the local Qualified Person for Pharmacovigilance (QPPV) bearing full responsibility for its maintenance.

Conclusion

Both the PSMF and PSSF are integral to a company's pharmacovigilance framework. While the PSMF offers a macro perspective of global or regional PV systems, the PSSF provides a micro view, detailing site-specific activities. Understanding their distinct roles and requirements is essential for MAHs to ensure compliance and uphold drug safety standards across diverse regulatory landscapes.