ICH guidelines are international technical standards. NAFDAC requirements are Nigerian law. The two overlap heavily in substance and diverge sharply in structure. ICH sets out how safety data should be defined, coded, transmitted and periodically evaluated. NAFDAC builds on that foundation but adds a governance layer ICH does not address at all — most importantly a Qualified Person for Pharmacovigilance who must reside in Nigeria, and a Pharmacovigilance System Master File that must be held in country. Since November 2025 the relationship has changed materially: NAFDAC moved from ICH observer to full Regulatory Member, which brings a defined implementation obligation for the ICH E2 series. This article sets out where the two frameworks align, where they diverge, and what a company operating in Nigeria should do about it.
The short version
If you take nothing else from this article, take these six points.
- ICH is a standards body, not a regulator. It has no enforcement power anywhere. NAFDAC does.
- Complying with ICH E2 does not make you compliant in Nigeria. Complying with NAFDAC does not automatically make you ICH aligned either.
- The substance of case handling, coding, periodic reporting and pharmacovigilance planning is broadly common to both.
- The governance requirements that most often catch companies out in Nigeria — the resident QPPV and the in-country master file — have no ICH equivalent. They come from a European regulatory tradition, not from ICH.
- NAFDAC's pharmacovigilance guidelines exclude clinical trial safety reporting, which is the exact territory ICH E2A governs. The two documents are answering different questions.
- NAFDAC became a full ICH Regulatory Member in November 2025, which triggers a defined implementation pathway for E2A, E2B, E2D, M4 and M1 over the following five years.
What is ICH, and what authority does it actually have?
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use is an association that brings regulators and industry together to develop harmonised technical guidelines. Its output is guidance, not legislation. An ICH guideline has legal force in a country only once that country's regulator adopts it into its own framework.
This matters for Nigeria because the relationship has recently changed. NAFDAC announced its transition from observer status to full membership of the International Council for Harmonisation, joining as a Regulatory Member. NAFDAC had previously attained World Health Organization Maturity Level 3 in 2022, a classification indicating a stable, well functioning and integrated regulatory system, and has sustained that status through re-benchmarking. Our regulatory change briefs track how developments of this kind translate into operational requirements.
ICH membership is not ceremonial. Under the ICH Assembly Rules of Procedure, guidelines are grouped into three tiers for implementation purposes, and Regulatory Members carry obligations against each tier.
A membership criterion
Q1 on stability testing, Q7 on Good Manufacturing Practice for active pharmaceutical ingredients, and E6 on Good Clinical Practice. Adequate implementation of these is itself a membership criterion.
A five-year implementation pathway
E2A on clinical safety data management, E2B on electronic transmission of Individual Case Safety Reports, E2D on post-approval safety data management, M4 on the Common Technical Document, and M1 on MedDRA. A Regulatory Member is expected to submit specific plans with identified milestones and timeframes for implementing these within five years after its membership is approved.
Near-term implementation
All remaining ICH guidelines, which a Regulatory Member is expected to implement in the near term.
What the ICH E2 series actually covers
The E2 series is the pharmacovigilance backbone of ICH. Each document answers a narrow question.
Clinical Safety Data Management, Definitions and Standards for Expedited Reporting
Reached Step 4 in October 1994 and has never been reopened. E2A is the origin of the vocabulary the entire discipline uses. It defines what makes an adverse event serious, and establishes that seriousness, not severity, is what determines regulatory reporting obligations. Its serious criteria are death, life threatening, requiring inpatient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or incapacity, and congenital anomaly or birth defect, plus important medical events. E2A also sets the expedited reporting standard for the clinical trial setting: fatal or life threatening unexpected serious adverse drug reactions reported as soon as possible and no later than seven calendar days, with follow up within a further eight days, and all other serious unexpected reactions within fifteen calendar days.
Electronic Transmission of Individual Case Safety Reports
Defines the data elements and the message specification for transmitting an ICSR electronically. This is what makes a safety case machine readable and transferable between a company, a national regulator and the World Health Organization global database. E2B is the reason a case processed in Lagos can be read without reinterpretation in Uppsala.
Periodic Benefit-Risk Evaluation Report
Sets the format and content for the periodic evaluation of an authorised product's benefit to risk balance. It replaced the older Periodic Safety Update Report concept with a document structured around the benefit to risk question rather than around a list of cases.
Post-Approval Safety Data Management
The post-marketing counterpart to E2A. It addresses spontaneous reports, solicited sources, literature, special situations, and the expedited reporting standard after approval, conventionally fifteen calendar days for serious unexpected reactions. E2D is also the source of the day zero convention: the reporting clock starts on the day any personnel of the marketing authorisation holder first receives the minimum information, not the day the safety department sees it. E2D is currently under revision through an ICH working group.
Pharmacovigilance Planning
Guidance on planning pharmacovigilance activities, particularly around the early post-marketing period for a new product. E2E introduces the two-part structure of a safety specification — summarising identified risks, potential risks and missing information — followed by a pharmacovigilance plan describing what will be done about them.
Development Safety Update Report
The annual safety report for products under clinical development, sitting alongside E2A in the trial space rather than the post-marketing space.
MedDRA
Not part of the E series, but inseparable from it in practice. MedDRA is the standardised medical terminology used to code safety data. Without a common terminology, aggregated safety analysis across companies and countries is not possible.
What NAFDAC's pharmacovigilance framework actually covers
Nigeria's requirements sit in NAFDAC's Good Pharmacovigilance Practice Regulations, made under the NAFDAC Act, Cap N1, Laws of the Federation of Nigeria 2004, and are elaborated in the NAFDAC Good Pharmacovigilance Practice Guidelines, which run to more than 160 pages across eight chapters. Our companion article on what GVP compliance means in Nigeria sets out the framework in full, and the NAFDAC pharmacovigilance requirements guide covers the obligations chapter by chapter.
In outline, NAFDAC requires the Certificate of Registration Holder to:
- Operate a pharmacovigilance system covering organisational structure, responsibilities, procedures, processes, resources, resource management, compliance management and record management
- Have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance who resides in Nigeria
- Employ a sufficient number of competent and appropriately qualified pharmacovigilance personnel
- Establish and maintain a quality system documented in written policies and procedures, with training delivered, effectiveness verified and records kept
- Maintain a Pharmacovigilance System Master File, located in Nigeria and submitted during application for a Certificate of Registration
- Collect, validate, follow up, assess and report suspected adverse reactions from unsolicited and solicited sources
- Operate a risk management system, including a risk management plan where applicable, and monitor the outcome of risk minimisation measures
- Run documented signal detection and cumulative case review
- Conduct post-authorisation safety studies where required
- Communicate safety information under the Agency's framework
- Audit the pharmacovigilance system and implement corrective and preventive actions
- Govern any subcontracted pharmacovigilance activity by written contract while retaining full responsibility
Read that list against the E2 series and the shape of the difference becomes visible immediately. ICH tells you what a safety case is and how to move it. NAFDAC tells you who in Nigeria is answerable for it, where the evidence must physically sit, and what happens when the Agency comes to look.
Side by side: ICH E2 compared with NAFDAC requirements
The following comparison covers the areas where regulatory teams most often need to know which framework governs.
| Area | ICH position | NAFDAC position |
|---|---|---|
| Legal status | Guidance. Binding only once adopted by a national regulator. | Regulations made under the NAFDAC Act, Cap N1 LFN 2004, enforceable in Nigeria. |
| Named accountable person | No QPPV concept anywhere in the E2 series. | A Qualified Person for Pharmacovigilance who resides and operates in Nigeria, permanently and continuously at the holder's disposal. |
| System description document | No master file concept. | A Pharmacovigilance System Master File, maintained, available at the holder's premises and located at the Nigerian site of main pharmacovigilance activity or where the QPPV operates. |
| Clinical trial safety reporting | Governed by E2A and E2F. | Expressly outside the scope of the GVP guidelines. Governed instead by NAFDAC Good Clinical Practice Regulations. |
| Seriousness definition | Defined in E2A: death, life threatening, hospitalisation or its prolongation, persistent or significant disability, congenital anomaly, plus important medical events. | Substantively aligned with the ICH criteria. |
| Seriousness vs. severity | E2A is explicit that seriousness, not severity, determines reporting obligations. | Aligned in substance. |
| Case validity criteria | Identifiable patient, identifiable reporter, suspect product, suspected reaction. | Aligned. Reports are validated before progressing. |
| Expedited reporting after approval | E2D convention of fifteen calendar days for serious unexpected reactions, with day zero at first receipt by any company personnel. | Timeframes set in the NAFDAC regulations. The master file must evidence measured timeliness of 15-day and 90-day reporting. |
| Electronic case format | E2B(R3) data elements and message specification. | Not yet mandated in the published guidelines. E2B sits in ICH Tier 2 with a five-year implementation pathway. |
| Medical terminology | M1, MedDRA. | Not yet mandated in the published guidelines. M1 sits in ICH Tier 2. |
| Periodic reporting | E2C(R2), the Periodic Benefit-Risk Evaluation Report. | PSUR and PBRER required, with periodicity and format specified by the Agency. |
| Pharmacovigilance planning | E2E: safety specification plus pharmacovigilance plan. | Risk Management Plan in seven parts with an eight-element safety specification, including the epidemiology of the indication in Nigeria specifically. |
| Audit | Not addressed in the E2 series. | A dedicated chapter. Risk-based audits, a five-year list of completed audits in the master file, and findings held open until corrective action is verified. |
| Outsourcing | Not addressed in the E2 series. | Written contract required, delegated services described in the master file, subcontract list in the annex, and the vendor may itself be inspected. |
| Herbal and traditional products | Outside ICH scope. | Applicants for and holders of listings for traditional herbal medicinal products must also submit a master file. |
| Regulatory inspection | Not addressed in the E2 series. | The Agency may inspect at any time it deems fit, and the holder must permit access to, copying and verification of pharmacovigilance records. |
Where ICH and NAFDAC align
The alignment is deeper than the divergence, and it is worth stating clearly because it means a company with a mature global pharmacovigilance system is not starting from zero in Nigeria.
Shared vocabulary
The definitions of adverse event, adverse drug reaction, serious, unexpected and Individual Case Safety Report are substantively common. A Nigerian case file and a European one describe the same objects. This is not accidental — NAFDAC's framework was built on the international consensus that ICH codified.
The same four validity criteria
An identifiable patient, an identifiable reporter, a suspect product and a suspected reaction. This is the universal threshold, and NAFDAC applies it.
The same conceptual pipeline
Collect, validate, assess, follow up, code, detect duplicates, report within the applicable timeframe, archive, then review in aggregate. Both frameworks describe this sequence, and neither treats individual case processing as the end of the obligation.
Benefit to risk as the organising question
E2C(R2) reframed periodic reporting around the benefit to risk balance rather than around a case listing. NAFDAC's definition of a pharmacovigilance system is a system designed to monitor the safety of authorised products and to detect any change to their benefit to risk balance. Same question, same organising logic.
Planning rather than reacting
ICH E2E asks a company to state what it knows, what it does not know, and what it intends to do about the gap. NAFDAC's Risk Management Plan asks the same question in a more prescriptive format. See MedNova's glossary entry on the Risk Management Plan for the Nigerian structure.
Where NAFDAC diverges from ICH
These are the points at which a globally compliant company can still fail a Nigerian inspection.
NAFDAC requires a QPPV. ICH does not have the concept.
Search the entire E2 series and you will not find a Qualified Person for Pharmacovigilance. The role is a European regulatory construct that NAFDAC adopted and then localised by requiring residency. Each pharmacovigilance system can have only one QPPV. The role carries authority over the master file, acts as the single Agency contact point on a 24-hour basis and as the contact point for inspections, and must be backed by documented deputy arrangements. It may be outsourced, but the holder retains ultimate responsibility. This is the requirement multinational companies most frequently misjudge, because nothing in their ICH aligned global system flags it. MedNova provides local QPPV representation in Nigeria, with the governance expectations set out in our QPPV Support Essentials guidance.
NAFDAC requires a master file, held in Nigeria.
ICH has no master file concept. NAFDAC requires the Pharmacovigilance System Master File to be maintained, made available to the Agency on request, available at the holder's premises, and located either at the Nigerian site of main pharmacovigilance activity or where the QPPV operates. It must also be submitted during application for a Certificate of Registration. A global master file sitting on a server in another jurisdiction, describing a system operated from a regional hub, does not discharge this. Our PV Readiness Guide covers how the master file connects to governance and inspection readiness.
The scope boundary runs in a different place.
ICH E2A and E2F govern the clinical trial setting. NAFDAC's Good Pharmacovigilance Practice Guidelines expressly exclude adverse reactions occurring in clinical trials, which fall instead under NAFDAC's Good Clinical Practice Regulations. A company running trials and marketing products in Nigeria therefore operates two parallel safety reporting pathways under two different Nigerian instruments, and needs an internal rule determining which pathway a given case follows. Companies frequently assume one framework covers both. It does not.
NAFDAC names Nigeria-specific active monitoring categories.
The guidelines identify product categories expected to be under active safety monitoring, including products developed wholly or largely outside Nigeria, products with under ten years of post-marketing experience elsewhere or under five years in Nigeria, advanced therapeutic products, products subject to a risk management plan in any other country, orphan products, products granted accelerated or conditional approval anywhere, products for special populations, immunologically active products, and central nervous system products. ICH sets no equivalent national risk stratification. The under-five-years-in-Nigeria criterion in particular catches products that are mature and unremarkable everywhere else.
NAFDAC wants Nigerian epidemiology.
The safety specification within NAFDAC's Risk Management Plan structure requires the epidemiology of the indication in Nigeria specifically. A safety specification populated with European or North American incidence data does not meet this, and it is a common finding. ICH E2E asks for epidemiology, but it does not ask for your epidemiology.
NAFDAC extends pharmacovigilance into product categories ICH does not touch.
Traditional herbal medicinal product listings carry a master file obligation in Nigeria. NAFDAC's framework also addresses vigilance of other regulated product categories. ICH's remit is pharmaceuticals for human use as conventionally defined. A company whose Nigerian portfolio includes herbal listings has obligations that its global standard operating procedures will not describe.
Audit is an explicit NAFDAC chapter.
The E2 series does not address pharmacovigilance audit. NAFDAC devotes a chapter to it, requires risk-based audits of the quality system and the pharmacovigilance system including delegated organisations, requires a five-year list of completed audits and the audit schedule in the master file, and requires findings to remain noted until corrective action is demonstrably complete or independently verified.
NAFDAC asks you to measure your own compliance.
The master file must explain how correct ICSR reporting is assessed and present figures showing the timeliness of 15-day and 90-day reporting across the previous year, alongside submission quality metrics. This is a self-monitoring obligation with an evidential output. ICH sets reporting standards; it does not require you to instrument and publish your own performance against them.
Electronic standards are not yet mandated in Nigeria.
E2B(R3) and MedDRA are the international defaults, but neither is mandated in NAFDAC's published pharmacovigilance guidelines. This is a divergence that runs in the opposite direction to the others, and it is the one most likely to close. Both sit in ICH Tier 2.
What NAFDAC's ICH membership means over the next five years
Full Regulatory Membership carries an implementation expectation. Under the ICH Assembly Rules of Procedure, a Regulatory Member is expected to submit specific plans with identified milestones and timeframes for implementing the Tier 2 guidelines within five years of membership approval, and to implement the remaining guidelines in the near term.
Three of the five Tier 2 guidelines are directly relevant to pharmacovigilance:
- E2A. Clinical safety data management and expedited reporting definitions in the trial setting.
- E2B. Electronic transmission of Individual Case Safety Reports. Implementation would mean structured electronic submission in a defined format rather than form-based or narrative submission.
- E2D. Post-approval safety data management, including the day zero convention and the treatment of special situations and solicited sources.
The remaining two, M4 on the Common Technical Document and M1 on MedDRA, affect registration dossiers and safety coding respectively. Together with E2B, M1 implementation would move Nigerian safety data onto the same technical footing as the major regulated markets.
What a prudent company does with that information:
- Assume the direction of travel is towards ICH alignment, not away from it, and build accordingly
- Do not wait for a mandate to code in MedDRA if your global system already does. Retro-coding a legacy case archive is far more expensive than coding correctly from the start
- Ensure your safety database can produce an E2B compliant output, even if Nigeria does not yet require one
- Apply the E2D day zero convention internally now. It is the stricter interpretation, so a company that applies it is compliant under either reading
- Watch for NAFDAC's published implementation plan and treat each milestone as a change control trigger
- Keep the Nigerian-specific requirements separate in your documentation, because they will not be superseded by ICH implementation. The QPPV and master file obligations are national and will remain so
Practical implications for companies operating in Nigeria
If you are a multinational with a global pharmacovigilance system
Your case processing, coding, aggregate reporting and signal detection are probably fine. Your exposure is concentrated in the governance layer.
- Is your QPPV for Nigeria resident in Nigeria, or is a regional contact named on the file?
- Is there a documented, trained deputy inside Nigeria?
- Does a Nigeria-specific master file exist, or only a global one?
- Where is that master file physically or electronically located, and can the Agency access it at your Nigerian premises?
- Does your safety specification carry Nigerian epidemiology?
- Are your Nigerian herbal or traditional product listings, if any, covered by a master file?
- Can you produce measured 15-day and 90-day timeliness figures for Nigeria as a separate dataset, rather than as part of a global aggregate?
- Have you audited your Nigerian distributor or local partner, and is there a signed pharmacovigilance agreement in place?
If you are a Nigerian company
Your governance layer is probably closer to correct, because the QPPV and premises requirements are natural to a domestic operation. Your exposure is concentrated in the technical layer.
- Are cases coded using a standardised medical terminology, or in free text?
- Can your safety database export in a structured, transferable format?
- Is seriousness assessed against the ICH criteria, or judged informally?
- Is the seriousness and severity distinction correctly applied, given that it determines the reporting clock?
- Is day zero recorded as the date any employee first received the information, or the date the safety team opened it?
- Does aggregate reporting follow a benefit to risk structure, or is it a case listing?
- Is there a written signal detection procedure with documented roles, methods and outcomes?
- Does your safety specification distinguish identified risks, potential risks and missing information?
Use the NAFDAC QPPV Compliance Checklist alongside these questions to build a complete self-assessment.
Download the Checklist PDFIf you are preparing to enter the Nigerian market
Build both layers at once. The pharmacovigilance obligation attaches to the product being on the market, not to the company feeling ready, so pharmaceutical registration in Nigeria and pharmacovigilance readiness belong on the same project plan. Our NAFDAC product registration guide and market entry and compliance overview set out the registration side, and the registration preparation guide covers dossier assembly. Note that the master file is submitted during application for a Certificate of Registration, which means pharmacovigilance is a registration deliverable in Nigeria, not a post-approval one.
A common misreading worth correcting
Regulatory teams sometimes describe NAFDAC's framework as being modelled on ICH. That is only half right, and the half that is wrong causes real problems.
NAFDAC's technical content — the definitions, the case handling logic, the benefit to risk framing — does descend from the international consensus that ICH codified. But NAFDAC's structural content — the QPPV, the master file, the audit chapter, the subcontracting rules, the system description components — tracks the European Union's Good Pharmacovigilance Practice modules far more closely than it tracks ICH. Nigeria's framework is best understood as international technical standards fitted inside a European-style governance architecture, then localised with Nigerian-specific requirements on residency, location, epidemiology and product categories.
Key takeaways
- ICH sets technical standards. NAFDAC sets enforceable Nigerian obligations. Meeting one does not mean meeting the other.
- The substance of case handling is largely common. The governance layer is where Nigeria diverges.
- The QPPV resident in Nigeria and the master file held in Nigeria have no ICH equivalent, and they are the most common points of failure for globally compliant companies.
- NAFDAC's GVP guidelines exclude clinical trials, which is exactly the territory ICH E2A governs.
- NAFDAC's ICH Regulatory Membership brings a defined five-year implementation pathway for E2A, E2B, E2D, M4 and M1, which will close technical gaps but not governance ones.
How MedNova supports ICH and NAFDAC alignment
MedNova Lifesciences provides pharmacovigilance services in Nigeria covering pharmacovigilance system setup and SOP development, gap analysis against both NAFDAC requirements and ICH standards, ICSR intake and case processing, aggregate reporting, signal detection and risk management, literature surveillance, inspection readiness and CAPA management, and local QPPV representation for Marketing Authorisation Holders. On the regulatory side we provide regulatory affairs support in Nigeria spanning NAFDAC product registration, dossier preparation, import permits, variations, renewals and lifecycle management, alongside clinical development services and training and consulting for pharmacovigilance and regulatory teams.
Related reading: our guide to NAFDAC pharmacovigilance requirements, the breakdown of what GVP compliance means in Nigeria, the walkthrough of what happens after you report an adverse event to NAFDAC, and the regulatory affairs primer. For our full scope of work, see the MedNova capability statement or browse the complete resources library.
Next step: download the NAFDAC QPPV Compliance Checklist, or contact our team to discuss a combined ICH and NAFDAC gap analysis.
Need a combined ICH and NAFDAC gap analysis?
MedNova Lifesciences helps companies close both the technical gap and the governance gap: pharmacovigilance system builds, QPPV representation, and inspection-ready compliance in Nigeria and across Africa.
Contact MedNova LifesciencesRelated resources
Frequently asked questions
What is the difference between ICH guidelines and NAFDAC requirements?
ICH guidelines are international technical standards developed by an association of regulators and industry, and they carry legal force only once a national regulator adopts them. NAFDAC requirements are Nigerian regulations made under the NAFDAC Act and are directly enforceable in Nigeria. The two align closely on case definitions and handling, and diverge on governance, where NAFDAC requires a QPPV resident in Nigeria and a Pharmacovigilance System Master File held in country, neither of which appears anywhere in the ICH E2 series.
Does ICH compliance mean NAFDAC compliance?
No. A company can be fully ICH aligned and still be non-compliant in Nigeria, because the ICH E2 series does not address the QPPV, the master file, pharmacovigilance audit, subcontracting or regulatory inspection. Those obligations exist only in the Nigerian framework.
Is NAFDAC a member of ICH?
Yes. NAFDAC announced its transition from observer status to full membership of the International Council for Harmonisation, joining as a Regulatory Member in November 2025.
What are the ICH E2 guidelines?
E2A covers clinical safety data management and expedited reporting definitions, E2B covers electronic transmission of Individual Case Safety Reports, E2C(R2) covers the Periodic Benefit-Risk Evaluation Report, E2D covers post approval safety data management, E2E covers pharmacovigilance planning, and E2F covers the Development Safety Update Report.
Which ICH guidelines must NAFDAC implement?
Under the ICH Assembly Rules of Procedure, Tier 1 guidelines Q1, Q7 and E6 are a membership criterion. Tier 2 guidelines E2A, E2B, E2D, M4 and M1 are subject to specific implementation plans with milestones and timeframes within five years of membership approval. Remaining guidelines are to be implemented in the near term.
Does NAFDAC require MedDRA coding?
MedDRA is not mandated in NAFDAC's published pharmacovigilance guidelines. It sits in ICH Tier 2 as guideline M1, so it falls within the implementation pathway that follows NAFDAC's ICH membership. Companies with global systems already coding in MedDRA should continue to do so.
Does NAFDAC require E2B electronic reporting?
E2B(R3) is not mandated in NAFDAC's published pharmacovigilance guidelines. It is an ICH Tier 2 guideline and therefore within the implementation pathway. Companies should ensure their safety database is capable of producing an E2B compliant output in anticipation.
Does NAFDAC's GVP guideline cover clinical trial safety reporting?
No. NAFDAC's Good Pharmacovigilance Practice Guidelines expressly exclude adverse reactions occurring in clinical trials. Those obligations sit under NAFDAC's Good Clinical Practice Regulations, which means companies running trials and marketing products in Nigeria operate two parallel pathways.
Is the ICH definition of a serious adverse event the same as NAFDAC's?
They are substantively aligned. Both treat an adverse reaction as serious where it results in death, is life threatening, requires inpatient hospitalisation or prolongs an existing one, results in persistent or significant disability or incapacity, or causes a congenital anomaly or birth defect.
Does ICH require a QPPV?
No. The Qualified Person for Pharmacovigilance is not an ICH concept. It originates in European pharmacovigilance legislation and was adopted into the Nigerian framework, with the additional Nigerian requirement that the QPPV resides in Nigeria.
What is day zero in adverse event reporting?
Under the ICH E2D convention, the reporting clock starts on the day any personnel of the marketing authorisation holder first receives the minimum information for a valid case, not the day the safety department processes it. Applying this convention internally is the stricter and safer interpretation.
Will NAFDAC requirements be replaced by ICH guidelines?
No. ICH implementation will close technical gaps such as electronic reporting formats and terminology, but the Nigerian governance requirements, notably the resident QPPV, the in-country master file, the audit obligations and the inspection powers, are national requirements and will remain in force alongside any ICH aligned standards.
Regulatory sources and references
- National Agency for Food and Drug Administration and Control. NAFDAC Good Pharmacovigilance Practice Guidelines (Doc. Ref. PV/PMS-GDL-017-01). https://www.nafdac.gov.ng/wp-content/uploads/Files/Resources/Guidelines/PVG_GUIDELINES/NAFDAC-Guidelines-on-Good-Pharmacovigilance-2021.pdf
- National Agency for Food and Drug Administration and Control. Good Pharmacovigilance Practice Regulations, 2021.
- National Agency for Food and Drug Administration and Control. Pharmacovigilance and Post Market Surveillance Guidelines index. Use this page to confirm the current edition of any NAFDAC document referenced above.
- National Agency for Food and Drug Administration and Control. NAFDAC Announces a Transition from Observer Status to Full Membership of the International Council for Harmonisation.
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Assembly Rules of Procedure, approved version 17, 13 May 2025.
- International Council for Harmonisation. ICH E2E Pharmacovigilance Planning Guideline.
- International Council for Harmonisation. ICH E2B(R3) Individual Case Safety Report Implementation Guide.
- International Council for Harmonisation. ICH Association 2026 Annual Work Plan.
- European Medicines Agency. ICH guidelines: efficacy, including the E2A to E2F pharmacovigilance series.
- World Health Organization. Egypt and Nigeria medicines regulators achieve high maturity level in WHO classification, 30 March 2022.
- National Agency for Food and Drug Administration and Control. NAFDAC's WHO ML3 Re-Benchmarking Success: Sustaining Regulatory Excellence.
- MedNova Lifesciences. Pharmacovigilance services, Nigeria and Africa. mednovalife.com/pv.html
- MedNova Lifesciences. Regulatory services, Nigeria and Africa. mednovalife.com/regulatory.html