Connected Systems: Fastest Path to an Inspection-Ready PSMF

Nov 26, 2025 | Christina Kim and Celine Ghafari

This edition of Veeva’s safety newsletter highlights global pharmacovigilance system master file (PSMF) management and easier inspection readiness. Explore how pharmacovigilance (PV) teams can use connected regulatory and safety systems to reduce manual updates and increase PSMF accuracy.

Global PSMF and Cross-Functional Data Challenges

The PSMF is required by EU Good Pharmacovigilance Practices (GVP) Module II and is a comprehensive collection of documents that describe the entire PV system and demonstrate its performance. With many countries mandating a PSMF or equivalent documentation and different regional guidance, marketing authorization holders (MAHs) often struggle managing multiple PSMFs.

Adding to the complexity, the PSMF also includes data originating outside of safety teams. For example, information in Annex H — which lists the authorized products monitored by the PV system and included in the PSMF — is typically managed by regulatory teams within the regulatory information management (RIM) system.

PSMF Annexes

Key information in Annex H

Annex H is one of the most frequently updated sections of the PSMF, containing key information on authorized medicinal products:

• List of Medicinal Products: Complete list of all product names and active ingredients managed by the PV system, including where authorized
• Marketing Status: Whether the product is being marketed in those locations or is authorized but not available
• Regulatory Details: Specific information like the procedure type (e.g., centralized or national procedure), authorization number, and additional safety monitoring requirements

The PSMF requires prompt updates to Annex H for new drug approvals, product or market expansion, or product withdrawals from the market. With manual update processes such as emailing the regulatory team, obtaining a current list of authorized products and related information, and uploading it into the applicable PSMF(s), it is difficult to keep Annex H current with every product or authorization change.

Streamlining Annex H generation and oversight with connected systems

With connected RIM and safety systems on a common platform, PSMF contributors can seamlessly share information to enable automatic generation of Annex H.

A connected approach:

• Reduces the amount of time spent gathering product information
• Increases reliability of Annex H information, as RIM is the single source of truth
• Automatically generates real-time information and improves inspection readiness

Learn how Veeva SafetyDocs streamlines global PSMF management and improves inspection readiness.

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