Pharmacovigilance System Master File (PSMF) Development and Maintenance

Postmarketing Know-how for Pharmacovigilance Systems

The EU requires each application for Marketing Authorization (MA) to have a Pharmacovigilance System Master File (PSMF) in place, including the named Qualified Person responsible for Pharmacovigilance within the EEA.

The PSMF is a document containing all of the details regarding the pharmacovigilance system and processes for a companies medicinal product(s). It is important to note that it must be made available to a Competent Authority on request, within 7 calendar days.

Why would a company need help to develop or update their PSMF?

A PSMF is absolutely required to be in place for all marketing authorization holders who hold Marketing Authorizations (MA) within the EEA. The configuration of the PSMF is firmly controlled by the guidelines of the GVP, Module II. It is important to note that it is required to be in place at the time of submission of all new applications for Marketing Authorisations (MAs). The PSMF must contain precise sections with details of the pharmacovigilance system and processes in place. It is expected that:

The PSMF exists as a real time and dynamic document with Annexes kept meticulously up to date at all times
The PSMF forms the basis of the pharmacovigilance system, as it describes the system and processes as a whole
Therefore, the PSMF is to be regarded as a key reference document for the company’s personnel, on all aspects of day-to-day drug safety operations. The PSMF should contain all of the details of the pharmacovigilance system for the MAH and its product(s). It is therefore a vital tool for providing full disclosure of the pharmacovigilance system and can be used by the EEA QPPV to assist with their oversight.
The PSMF and the standard operating procedures (SOPs) form the cornerstone of all pharmacovigilance activities

Consequently, the PSMF plays a fundamental role and requires expert knowledge to meet all of the regulator’s requirements.

PSMF Guidelines, Processes, and Maintenance

It is crucial to monitor and methodically document in the PSMF, all aspects of the PV system in harmony with company procedures and regulatory requirements. The PSMF is part of the registration dossier and must be prepared within the required timelines for the Marketing Authorization Application (MAA). It is important to note, that it is signed off by the EU Qualified Person for Pharmacovigilance (EU QPPV).

Our experts understand the involvedness of the PSMF and follow the regulatory guidelines on Good Pharmacovigilance Practice (GVP) specific to each PV system.

PSMF Content

The content of the file is defined in GVP Module II. There is no typical template, however, Gemini Group has an established template in place. The following sections of the PSMF are provided as generalized guidelines to stipulate the comprehensive nature of the required content:

Details of the qualified person responsible for pharmacovigilance (QPPV)
Details of the organizational structure of the company that holds the Marketing Authorization or that applies for the Marketing Authorization
Details of all relevant sources of safety data
Details of all electronic (computerized) systems and databases
Details of all pharmacovigilance processes
Details of the implementation and performance of all drug safety systems
Details of all quality control systems

Additional annexes are required to provide comprehensive information to fully explain the PV system in place. It is important to note that in all cases, the content must be accurately and meticulously documented for compliance. All biotech and/or pharmaceutical companies are recommended to seek advice from specialized pharmacovigilance service providers to ensure that the content of the Pharmacovigilance System Master File complies with the regulatory requirements. We would be delighted to chat with you, talk to our team today on 973-348-5838.