Regulatory note: This guide follows NAFDAC's Guidelines on Good Pharmacovigilance Practice (Doc. Ref. PV/PMS-GDL-017-01, effective 21 January 2021) and the Good Pharmacovigilance Practice Regulations 2021. Where it describes the detailed structure of the file, it also draws on NAFDAC's 2016 GVP guidelines, which set out the same master file model, and on the European Medicines Agency's GVP Module II, on which that model is based. The current NAFDAC edition takes precedence over any earlier text.
Quick answer: A Pharmacovigilance System Master File (PSMF) is the document that describes a company's pharmacovigilance system in full: who the Qualified Person for Pharmacovigilance (QPPV) is, how the organisation is structured, where safety data comes from, which systems and procedures are used, how well the system performs and how quality is controlled. In Nigeria, NAFDAC requires the file to be held in Nigeria and submitted with the product registration application. It must show reporting timeliness against the 15 day and 90 day reporting timelines, keep a logbook of changes, record audits, and remain available to the QPPV and NAFDAC at all times.
What Is a Pharmacovigilance System Master File?
The PSMF is a living description of how a company monitors the safety of its medicines. It is not a single procedure or report. It brings together everything an inspector needs to understand the pharmacovigilance system: the people, the processes, the data flows, the contracts and the evidence that the system works.
NAFDAC's guidelines describe the file as giving an overview of the pharmacovigilance system that helps the company and its QPPV confirm the system meets requirements, find deficiencies and non-compliance, and identify risks or failures. In practice, it is also the first document NAFDAC turns to in a pharmacovigilance inspection.
For the wider picture of safety obligations in Nigeria, see our complete guide to pharmacovigilance in Nigeria and our summary of NAFDAC pharmacovigilance requirements.
Who Needs a PSMF in Nigeria?
Every Certificate of Registration Holder (the marketing authorisation holder) for medicines in Nigeria needs a pharmacovigilance system described in a PSMF. NAFDAC's 2016 guidelines also extended the requirement to applicants for, and holders of, listings for traditional herbal medicinal products.
The file links directly to registration. The PSMF is submitted with the product registration application, so it has to exist, and be accurate, before a product reaches the market. Our guides on how to register a drug with NAFDAC and the NAPAMS online registration portal explain where it fits in the registration process.
Where the PSMF Must Be Held
NAFDAC requires the PSMF to be held in Nigeria. Its guidelines place the file at the site in Nigeria where the company's main pharmacovigilance activities are carried out, or where the QPPV operates. The address given should be an office address at that site, and it can differ from the company's registered address.
This ties the file to the QPPV, who under NAFDAC's guidelines should reside and operate in Nigeria. Our guide to the QPPV in Nigeria explains that role in detail.
One File per Pharmacovigilance System
The rule is one PSMF for each pharmacovigilance system, and each system has a single QPPV. Where companies share a system, each company must make sure a PSMF covers its products. Delegated activities must be set out in a written agreement, and the PSMF may cross refer to the file held by the party carrying out the delegated work.
What Goes into a PSMF: The Core Sections
NAFDAC's master file model is organised into core sections, each describing one part of the system:
| Section | What it describes |
|---|---|
| Qualified Person for Pharmacovigilance | The QPPV's identity, contact details, qualifications, responsibilities and back up arrangements |
| Organisational structure | How the company and its pharmacovigilance function are organised, including delegated activities and links with other organisations |
| Sources of safety data | Where adverse event information comes from: spontaneous reports, medical information, literature, studies, partners and other sources |
| Computerised systems and databases | The safety database and other systems used, with their validation status and controls |
| Pharmacovigilance processes | The written procedures for case handling, reporting, signal management, periodic reports and risk management |
| System performance | How the system is monitored, including reporting timeliness, quality measures and performance targets |
| Quality system | Document and record control, procedural documents, training, auditing, deviations and corrective actions |
Signal management is one of the processes inspectors look at closely. Our article on signal detection in Nigeria covers how it works in practice.
The PSMF Annexes
The core sections describe the system. The annexes hold the detail that changes more often, so the core text stays stable while the annexes are updated. NAFDAC's current guidelines organise the annexes under letters A to I. Across NAFDAC's master file model, the annexes cover:
- The list of products covered by the pharmacovigilance system
- The list of written procedures
- The list of contracts covering delegated activities
- Tasks the QPPV has delegated
- Scheduled and completed audits, covering a five-year period
- Performance indicators and their results
- A list of any other PSMFs held by the company
- The logbook of changes to the file
NAFDAC's 2016 guidelines added a practical rule on lettering: an annex that is not used keeps its letter and is marked as unused, rather than the other annexes being renumbered. This keeps the structure consistent for inspectors.
Showing the System Works: 15 and 90 Day Timeliness
A PSMF has to do more than describe the system. It has to show the system performs. NAFDAC's master file requirements ask companies to describe how correct reporting of individual case safety reports is assessed, and to include figures showing timeliness against the 15 day and 90 day reporting timelines over the past year.
Other performance measures the file should cover include:
- Measures of reporting quality
- Timeliness of periodic safety reports
- Timeliness of safety variations
- Adherence to risk management plan commitments
- The performance targets the company has set, and the actual results against them
If the figures show late reports, the file should also show what was done about them. An honest record of a deviation with a corrective action is stronger evidence of a working system than a file with no data.
The Logbook and Change Control
The PSMF is expected to change as the company changes, and every change must be traceable. NAFDAC's master file model requires:
- Changes to the file, including changes to its descriptive content, to be recorded in a logbook
- Each record to show at least the date, the person responsible and the nature of the change
- Changes to be notified to the QPPV, including changes to the file's location, new products, delegated services and corrective actions
- Records of notifications made to NAFDAC, the QPPV and third parties to be kept
- The history of changes to annex content to remain available to NAFDAC on request
NAFDAC may also ask for information on changes to safety databases, significant pharmacovigilance services, or the organisation and its sites.
Audits and the Quality System
The quality system section and its annex show how the company checks itself. Under NAFDAC's master file model, the file should:
- Describe how audits are planned and the timelines for reporting them
- Keep a list of scheduled and completed audits covering five years
- Record significant audit findings together with the corrective and preventive actions taken
- Remove a finding only once the corrective action has been shown to work or independently verified, with each change logged
- Include the results of audits of any party carrying out delegated pharmacovigilance work
Our guide to GVP compliance in Nigeria explains how audits fit into a wider quality system, and our comparison of ICH guidelines and NAFDAC requirements covers the international standards behind them.
Format and Accessibility
The PSMF can be kept electronically, as long as a clearly arranged printed copy can be made available to NAFDAC. The file should be indexed, and bookmarks and searchable text are recommended. It must stay legible and accessible throughout its life, with the archiving arrangements described, and it must be continuously accessible to both the QPPV and NAFDAC.
Outsourced Pharmacovigilance and the PSMF
Many companies in Nigeria contract out some or all of their pharmacovigilance. This is permitted, and a contract QPPV may be used, but the Certificate of Registration Holder keeps full responsibility for the PSMF and the system it describes. The file must list the contracts covering delegated activities, set out the service providers involved, and show how the company oversees them.
Our comparison of in-house and outsourced QPPV models explains how to resource the role and what oversight looks like in each model.
Common PSMF Gaps
- The file is held outside Nigeria, or the QPPV named in it does not reside and operate in Nigeria
- No timeliness data, or figures that have not been updated for the past year
- Changes made to the file with no logbook entry
- Contracts for delegated work missing from the annex, or expired
- An audit list that is incomplete, or findings closed without evidence of corrective action
- Product lists that do not match the products actually registered
- Procedures referenced in the file that are out of date or do not exist
PSMF Readiness Checklist
[ ] PSMF held at a site in Nigeria where pharmacovigilance activities take place or the QPPV operates
[ ] QPPV named, resident and operating in Nigeria, with back up arrangements
[ ] All core sections complete and current
[ ] Annexes organised under their letters, with unused annexes marked
[ ] Product list matches registered and pending products
[ ] 15 and 90 day timeliness figures for the past year included
[ ] Logbook in place, with date, person and nature of every change
[ ] Five year audit list, findings and corrective actions recorded
[ ] Contracts for all delegated activities listed and current
[ ] Electronic file indexed and searchable, with a printed copy available on request
[ ] File ready for submission with the next registration application
Frequently Asked Questions
What is a Pharmacovigilance System Master File?
A detailed description of a company's pharmacovigilance system, covering the QPPV, organisation, safety data sources, computerised systems, processes, performance and quality system, with supporting annexes.
Is a PSMF mandatory in Nigeria?
Yes. Certificate of Registration Holders must maintain a PSMF, and it is submitted with the product registration application.
Where must the PSMF be kept?
In Nigeria, at the site where the main pharmacovigilance activities take place or where the QPPV operates.
When is the PSMF submitted to NAFDAC?
With the product registration application. It then has to be kept up to date and available to NAFDAC.
What are the PSMF annexes?
Supporting lists that change more often than the main text, organised under letters A to I in NAFDAC's current guidelines. They cover products, procedures, contracts, delegated tasks, audits, performance indicators, other master files and the logbook.
What does the PSMF logbook record?
Every change to the file, with at least the date, the person responsible and the nature of the change.
What performance data must a PSMF show?
Timeliness of individual case safety reports against the 15 day and 90 day timelines over the past year, plus other quality and timeliness measures and the targets set for them.
Can a PSMF be kept electronically?
Yes, provided a clearly arranged printed copy can be made available to NAFDAC and the file is continuously accessible to the QPPV and NAFDAC.
Who is responsible for the PSMF when pharmacovigilance is outsourced?
The Certificate of Registration Holder. It can delegate activities under written contracts, but it keeps full responsibility for the file and the system.
How MedNova Supports Your PSMF
MedNova Lifesciences provides pharmacovigilance services in Nigeria, including PSMF preparation, gap assessments of existing files, annex and logbook maintenance, timeliness tracking, audit support and inspection readiness. We also provide local QPPV representation, so the person named in the file resides and operates in Nigeria, and regulatory affairs support for the registration applications the file goes with. See our capability statement.
Related reading: the complete guide to pharmacovigilance in Nigeria, our pharmacovigilance readiness guide, the compliance checklist, and the resources library.
Next step: contact our team for a PSMF gap assessment.
References
1. National Agency for Food and Drug Administration and Control. Guidelines on Good Pharmacovigilance Practice (PV/PMS-GDL-017-01), 2021.
2. National Agency for Food and Drug Administration and Control. Good Pharmacovigilance Practice Regulations 2021.
3. National Agency for Food and Drug Administration and Control. Good Pharmacovigilance Practice Guidelines, 2016.
4. European Medicines Agency. Guideline on Good Pharmacovigilance Practices, Module II: Pharmacovigilance System Master File (Rev 2).
5. National Agency for Food and Drug Administration and Control. Pharmacovigilance and Post Marketing Surveillance guidelines.
6. MedNova Lifesciences. Pharmacovigilance services, Nigeria and Africa.
7. MedNova Lifesciences. Regulatory affairs services, Nigeria and Africa