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
Aspect |
PSMF |
PSSF |
---|---|---|
Scope |
Global/regional PV system |
Country-/site-specific PV system |
Regulatory Requirement |
Mandatory in EU, UK, etc. |
Required in specific countries (e.g., Middle East, India) |
Ownership |
MAH or global PV team |
Local PV responsible person |
Content |
Comprehensive PV system overview, including safety database and QPPV details |
Local processes, SOPs, and details of local responsible personnel |