Pharmacovigilance (PV) is one of the most important parts of the drug product process. PV deals with the detection, assessment and revision of the adverse effects associated with the drugs.
However, after deep and detailed study analysis some adverse effects are only understood after its administration to the population for long term. So, for this it is necessary to keep track of the drug’s reaction in the population after its administration. So, for this we can make use of documents such as ICSR, PSMF, etc.
What is Pharmacovigilance System Master File (PSMF)?
Pharmacovigilance System Master File (PSMF) is a document required by the EU after the market approval of the drug which comprises of all the details of the pharmacovigilance aspect of the drug product.
If one desires to launch its drug product into the European market, he should apply for market authorization (MA) for its drug approval, after which the EMA which is the regulatory body of EU may ask for PSMF which should be submitted within 7 days or else your MA may be rejected.
Regulatory Basis of Pharmacovigilance System Master File
The legal framework mandating marketing authorization holders (MAHs) to maintain and provide a Pharmacovigilance System Master File (PSMF) finds its roots in:
- Directive 2010/84/EU and
- Regulation (EU) No 1235/2010
- Directive 2001/83/EC
- Implementing Regulation (EU) No 520/2012.
This regulatory framework, supplemented by guidance in the Good Pharmacovigilance Practices (GVP) Module, sets the stage for comprehensive and standardized pharmacovigilance practices across the EU.
Importance of PSMF In Pharmacovigilance Regulations
- PSMF is a document important for the safety of the drug.
- It helps to study and understand the safety of the drugs and adverse reactions associated with it and how to minimize them.
- It helps to achieve and fulfill the regulatory requirements.
- It is used as an evaluation document for the company’s pharmacovigilance parameter.
- It promotes patient safety.
- It is a healthy method of continuous improvement for drug safety.
PSMF Requirements:
- PSMF should follow Good Pharmacovigilance Practice (GVP) Module II requirements.
- The product for which PSMF is being submitted should be applicable to market authorization (MA).
- Details of the drug product if made any.
- The status of drug approval.
- It should be stated that how the PV system was implemented in the drug.
Also Read: Pharmaceutical Regulations in European Union
Structure & Content Of PSMF In Pharmacovigilance:
The structure of PSMF consists of three major parts namely cover page, main body, and annexes which are described below:
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- Cover Page: It consists of a brief abstract of the MA and all the information about the qualified person for pharmacovigilance.
- Main Body: It comprises of primary information about the MA and the main body is divided into 7 modules which are:
- QPPV Organizational Structure of the MAH Sources of Safety Data
- Computerized Systems and Databases
- PV Processes
- PV System Performance
- Quality System
Each module comprises of detailed information.
- Annexes: This part includes any supplementary information that gives more detailed information about any of the modules from the main body. There are overall 9 Annexes which are:
- QPPV Organizational Structure Sources of Safety Data
- Computerized Systems & Databases
- PV Processes
- PV System Performance
- Quality System
- List of Marketing Authorizations
- Document and Record Control
How To Prepare And Maintain A PSMF:
Getting a Pharmacovigilance System Master File (PSMF) ready isn’t just about copying regulations into a binder. Regulators want to see a file that actually reflects how your safety system runs in real life. Here’s a straightforward way to approach it:
1. Understand the rules first
Go through GVP Module II and any local requirements (EMA, MHRA, GCC, TGA, CDSCO in India, etc.). This helps you know exactly what must go in the file and avoids rework later.
2. Collect the core information
Start pulling together details such as:
- Who your QPPV is and their responsibilities.
- How safety data comes in (ICSRs, literature, partner companies).
- Systems and databases you use.
- Quality processes and audits in place.
3. Draft the structure
Use the standard PSMF layout:
- Cover Page (basic MA and QPPV info).
- Main Body with the 7 modules (organization, data sources, systems, processes, performance, quality).
- Annexes for the detailed lists (MA list, SOPs, contracts, record control, etc.).
4. Fill in with real examples
Don’t just write “we have a database.” Name the database, describe how it’s used, and who manages it. If you use Argus or ARISg, mention it. This makes the file audit-ready.
5. Review and cross-check
Have the QPPV and PV staff review the draft. Make sure what’s written actually matches what happens day to day. Regulators often catch inconsistencies between the PSMF and reality.
6. Train the team
The staff who handle safety reporting should know how their work ties back to the PSMF. This avoids gaps when inspectors ask questions.
7. Keep it alive
Update the PSMF whenever things change—new MA, new safety database, new partner, or even staff turnover. A stale PSMF is one of the most common findings in EMA inspections.
Location For Registration Of PSMF:
- While submission of the PSMF it should include a part called “Summary of the Pharmacovigilance System” and this summary should include the location where the PSMF is kept.
- This summary is needed tp submit with the marketing authorization application.
- The location for the EU PSMF should be where the QPVV operates or where all the PV activities take place.
- The EU PSMF has a unique code assigned by the EMA’s Eudravigilance system which should be attached to the PSMF location.
Also Read: Pharmacovigilance In Clinical Trials
Number Of PSMF Required:
Number of PSMF are decided according to the situation; which is explained below:
- For one Marketing Authorization Holder (MAH) and one PV system one PSMF is required.
- For one Marketing Authorization Holder (MAH) and multiple PV system one PSMF is required.
- For multiple Marketing Authorization Holder (MAH) and multiple PV system multiple PSMF are required; for which each system should be explained in different PSMF.
Who Maintains the PSMF?
The marketing authorization holder (MAH) is the one responsible for the Pharmacovigilance System Master File. It doesn’t matter if the product was approved through the centralized route or a national procedure—the obligation is the same. Usually, the QPPV is the person who looks after it on a daily basis.
- Herbal products: For traditional herbal medicines that go through the simplified registration process, companies don’t have to submit the summary of the pharmacovigilance system at the time of application. Even so, they must have a pharmacovigilance system in place and keep the PSMF available if inspectors ask for it. If the product isn’t in that simplified category, then the normal PSMF rules apply.
- Homeopathic medicines: The same principle applies here. When registered under the simplified route, the summary is not part of the application. But the MAH still has to maintain a PSMF and keep it updated. For homeopathic medicines outside the simplified registration, the full requirements apply.
Whether the medicine is herbal, homeopathic, or conventional, the MAH has to prepare and maintain the PSMF.
Also Read: What Is Drug Master File (DMF)
When Should a MAH Prepare a PSMF?
Work on the Pharmacovigilance System Master File (PSMF) usually starts early. A marketing authorization holder (MAH) can’t wait until after approval; parts of the file need to be ready during the application stage and then kept alive through the whole life of the product.
Pre-Authorization Phase:
- When an MAH is putting together the marketing authorization application, the pharmacovigilance system has to be outlined. That means the company should already have the basics in place—people, processes, databases, and the QPPV role. A short summary of the system also goes into the application dossier (Module 1.8.1). At this stage, regulators may also ask for the location of the PSMF.
- Submission of PSMF Information: As part of the marketing authorization application, the MAH must provide information about the location of the PSMF and demonstrate compliance with pharmacovigilance regulations. The Pharmacovigilance System Master File (PSMF) must be readily accessible for submission upon request during the evaluation of the application.
Post-Authorization Phase:
- Once the product is authorized, the PSMF has to be finalized and maintained. It’s not something you finish once and forget about. The file has to match the system as it actually works—who’s in the PV team, how reports come in, what risk management steps are in place, and the quality checks that keep it all running.
Ongoing updates:
- Whenever something changes—maybe new staff join, a process gets updated, or safety reporting shifts—the PSMF has to be adjusted. Leaving it outdated is a common mistake and one regulators don’t take lightly.
Global Regulatory Requirements for PSMF:
- In a study done recently it is revealed that now more than 30 countries have requirements for PSMF such as Australia, GCC, India, UK, Canada, Turkey, etc.
- GCC requires EU-PSMF with some additional documents.
- India requires MAH for PSMF maintenance.
- TGA Australia requires global PSMF with Australian PSMF.
Also Read: What Is Design History File (DHF)
PSMF Solutions for MAHs
For many Marketing Authorization Holders, the hardest part of pharmacovigilance compliance isn’t creating a PSMF once — it’s keeping it accurate and inspection-ready at all times. That’s why companies often look for practical PSMF solutions:
- Standard templates → Ready-to-use PSMF formats aligned with EMA GVP Module II save time and reduce errors.
- Technology tools → Safety databases and compliance platforms can link directly to annexes, keeping them automatically updated.
- Outsourced services → Many MAHs, especially small and mid-sized ones, rely on PV service providers or CROs to draft, maintain, and update their PSMFs.
- QPPV support → Having access to an experienced EU QPPV is essential. They not only sign off but also guide how the PSMF should reflect the actual PV system.
- Global alignment → For companies working beyond the EU, solutions also involve adapting the PSMF to local rules in India, GCC, UK, or Australia without duplicating effort.
Thus, we can conclude that PSMF is an essential document in getting your drug marketed in the EU market as it gives all the information related to the pharmacovigilance of the drug.
With Artixio we can help you meet all the regulatory requirements for PSMF and help you achieve a successful market authorization for your drug product.
FAQs:
Q: What is the PSMF full form?
Full form of PSMF is Pharmacovigilance System Master File.
Q: What is the MAH full form in pharmacovigilance?
MAH stands for Marketing Authorization Holder in pharmacovigilance.
Q: Who maintains PSMF?
Qualified Person Responsible for Pharmacovigilance (QPPV) maintains the PSMF up to date.
Q: What are some of the common challenges faced while preparing for a PSMF?
Some of challenges faced while preparing a PSMF are managing and confirming the accuracy of PSMF data, continuously updating the PSMF, meeting the global requirements, etc.
Q: What is the role of QPPV in PSMF documentation?
QPPV is responsible for monitoring the PSMF preparation and ensuring its accuracy and regulatory compliance.
