Pharmacovigilance CE Course
17 self-paced modules on drug safety and NAFDAC requirements, with a final assessment and a verifiable certificate.
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Resources & Insights
MedNova shares practical regulatory, pharmacovigilance, clinical development, and scientific knowledge for life sciences organizations working across Nigeria and Africa.
Browse practical guides, glossary definitions, and the NAFDAC QPPV Compliance Checklist — or download the checklist PDF — to connect safety, regulatory, and trial readiness. See glossary definitions for adverse drug reaction, Good Pharmacovigilance Practice, and Risk Management Plan. If you want help applying these insights, explore our training and consulting services.
Practical, field-based knowledge
Our resources are designed to support teams with clear guidance, real-world examples, and actionable insight.
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Explore resources by topic
How to Choose a Regulatory Consulting Company in Nigeria
Ten criteria to assess, red flags to avoid, a side-by-side scorecard and the questions to ask before you appoint a regulatory consultant for NAFDAC registration.
New · Oct 22, 2026Read Article
Pharmacovigilance
Practical perspectives on drug safety, signal management, and post-marketing oversight.
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Medical Writing
Support for scientific, clinical, and regulatory content development.
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Clinical Development
Guidance on trial readiness, operations, and regional delivery.
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Regulatory Affairs
Insights on strategy, registration readiness, and regulatory planning.
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Change Briefs
A practical framework for turning regulatory changes into controlled implementation steps and evidence-based follow-through.
Drug Safety
Articles and practical guidance on safety operations and reporting readiness.
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NAFDAC
Local market insight and guidance for registration and compliance planning.
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Clinical Research
Approaches to readiness, documentation, and operational execution.
2 ArticlesBrowse Articles
QPPV Support Essentials
Practical guidance for QPPV oversight, documentation, vendor control, and strong pharmacovigilance accountability.
Clinical Research: Site Readiness
A practical guide to feasibility, delegation, facilities, documentation, and activation readiness for clinical trial sites.
PV Readiness Guide
An operational guide to governance, case handling, signal review, and inspection preparedness for PV teams.
NAFDAC PV Requirements
A complete breakdown of NAFDAC's Good Pharmacovigilance Practice guideline: QPPV rules, the master file, reporting duties, and a compliance checklist.
After You Report to NAFDAC
What happens to an adverse event report after submission: ICSR validation, follow-up requests, signal detection, and what triggers regulatory action.
GVP Compliance in Nigeria
A plain guide to what GVP compliance actually means: the pharmacovigilance system, the resident QPPV, qualified personnel, and a full compliance checklist.
WHO Prequalification vs NAFDAC
Understand the difference between WHO prequalification and Nigeria's local registration pathways, and what each requires from companies operating in the market.
ICH vs NAFDAC
A side-by-side comparison of ICH E2 pharmacovigilance standards and NAFDAC's Nigerian requirements: where they align, and where NAFDAC's governance layer diverges.
Signal Detection in PV
What a safety signal is, what NAFDAC requires, and why standard statistical methods underperform on small Nigerian datasets, with a practical detection design.
AMA vs NAFDAC
What the African Medicines Agency means for companies already registered with NAFDAC: what changes, what doesn't, and a readiness checklist.
5 PV Compliance Mistakes
The five pharmacovigilance compliance mistakes Nigerian pharma companies make most often, what NAFDAC requires, how to fix each one, and a 30-day readiness plan.
Pharmacovigilance in Nigeria
The complete 2026 guide for pharmaceutical companies: NAFDAC's requirements, the QPPV, the master file, reporting, signal detection, risk management and how to resource the function.
In-House or Outsourced QPPV
Should you employ a QPPV in Nigeria or outsource the role? Responsibility, cover, cost drivers, NAFDAC's contract rules and a QPPV service agreement checklist.
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NAFDAC Online Registration Portal: NAPAMS
A practical guide to preparing for a NAPAMS application, organising product documents, and understanding the steps after online submission.
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NAFDAC Registration Documents Checklist
Every document NAFDAC asks for on an imported drug: corporate and legal papers, COPP and GMP certificates, CTD Modules 1 to 5, labels, samples and validity dates.
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How to Register a Drug with NAFDAC
The six stages from NAPAMS application to Certificate of Registration, realistic timelines, the 60-day reliance routes and a readiness checklist.
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Selling Medicines in Nigeria
Why foreign manufacturers need a Nigerian registration holder, what local regulatory representation covers after approval, and how to choose the right partner.
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Glossary
Search a growing reference library of life sciences terminology for pharmacovigilance, regulatory affairs, clinical development, and medical writing.
Includes glossary definitions for Medical Information and Medical Writing.
QPPV in Nigeria
What NAFDAC requires of a QPPV in Nigeria: residency, deputy cover, authority, qualifications and inspection expectations, plus when foreign companies need local QPPV support.
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Latest Resources
Current articles and updates
NAFDAC Online Registration Portal: A Practical Guide to NAPAMS for 2026
Who applies through NAPAMS, what to prepare before starting, and how an online application progresses through review, sampling, GMP assessment, and decision.
NAFDAC Registration Requirements: The Complete Documents Checklist for Imported Drugs (2026)
The legal and corporate documents uploaded on NAPAMS, authenticated COPP and GMP certificates, the GMP invitation letter, CTD Modules 1 to 5, labelling and sample documents, validity dates and a full checklist.
How to Register a Drug with NAFDAC: Step by Step Process for 2026
Who can apply, the six stages from NAPAMS to the Certificate of Registration, the 240 working day timeline, faster reliance routes, labelling rules and a registration readiness checklist.
Can You Sell Medicines in Nigeria Without Local Regulatory Support?
NAFDAC requires a Nigerian entity to hold every product registration. What that local role covers, the market-entry risks foreign manufacturers face, and the questions to ask a local partner.
In-House or Outsourced QPPV in Nigeria: How to Choose the Right Model
What NAFDAC allows, how the in-house, outsourced and hybrid QPPV models compare, what an outsourcing contract must contain, and the questions to ask a QPPV provider.
Pharmacovigilance in Nigeria: The Complete 2026 Guide for Pharmaceutical Companies
Everything pharmaceutical companies need to know about pharmacovigilance in Nigeria, from NAFDAC's legal framework and the eight building blocks of a compliant system to reporting, resourcing and a starting checklist.
5 Pharmacovigilance Compliance Mistakes Nigerian Pharma Companies Make
The five mistakes behind most pharmacovigilance inspection findings in Nigeria, what NAFDAC's guidelines require for each, and the evidence that proves the fix.
What the African Medicines Agency Means for NAFDAC-Registered Companies
AMA layers on top of NAFDAC registration rather than replacing it. What's changed as of September 2026, and a readiness checklist for the years ahead.
Signal Detection in Pharmacovigilance
How safety signals are found, what NAFDAC requires, and why standard statistical methods underperform on Nigerian data, with a practical design for small datasets.
ICH Guidelines vs NAFDAC Requirements
A side-by-side comparison of ICH E2 pharmacovigilance standards and NAFDAC's Nigerian requirements, including a full comparison table and what NAFDAC's ICH membership means going forward.
What Is GVP Compliance?
A plain guide to what GVP compliance actually means for Nigerian pharma companies: the pharmacovigilance system, the resident QPPV, qualified personnel, and a full checklist.
What Happens After You Report an Adverse Event to NAFDAC?
A step-by-step walkthrough of NAFDAC's adverse event review process: ICSR validation, follow-up requests, signal detection, and what triggers regulatory action.
NAFDAC Pharmacovigilance Requirements
A plain language breakdown of NAFDAC's pharmacovigilance guideline, covering the QPPV, the master file, reporting duties, common compliance gaps, and a full checklist.
Clinical Development
A practical guide to clinical development concepts, study design, feasibility, ethics, and operational execution.
Clinical Development Readiness
A practical article on regional trial readiness and the realities of executing clinical programs in Nigeria and West Africa.
Regulatory Affairs
A practical primer on regulatory strategy, dossier quality, labelling, lifecycle control, and governance for pharmaceutical companies operating in Nigeria and Africa.
Regulatory Change Briefs
A practical guide to assessing new regulatory developments, prioritising risk, and implementing controlled action across local and regional teams.
NAFDAC Product Registration
A practical guide to product registration in Nigeria, including classification, local representation, dossiers, timelines, inspections, and post-registration obligations.
Registration Preparation Guide
A practical overview of dossier readiness, reliance pathways, timelines, labelling, and submission coordination for NAFDAC market-entry programmes.
Pharmacovigilance System Master File in Nigeria: What NAFDAC Expects in 2026
What NAFDAC expects from a Pharmacovigilance System Master File in Nigeria: who needs one, where it is held, the core sections and annexes, the logbook, 15 and 90 day timeliness, audits and common gaps.
How to Choose a Regulatory Consulting Company in Nigeria: A Practical Guide for 2026
How to choose a regulatory consulting company in Nigeria: what a consultant should handle, ten criteria to assess, red flags, the questions to ask, and how to set up the engagement with NAFDAC requirements in mind.
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Future content we are preparing
Medical Writing
Writing Effective Clinical Study Reports