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** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-623322) ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-623322) ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-623322)

Clinical Trial Guidelines

Drugs Section

NAFDAC Good Clinical Trial Guideline documents for regulated product application, progress report, progress timeliness, etc. Click on the links below to download

TitleProduct TypeCategoryStatus
Guidelines for Registration of Drug Products Made in Nigeria Human and Veterinary DrugDrugsLocal Registration (DR&R)Published21-Mar-30
Guidelines for Registration of Imported Drug Products in Nigeria Human and Veterinary DrugsDrugsImport Registration (DR&R)Published21-Mar-30
Revised Guidelines for Risk Categorization of Product Dossiers for the Registration of Drug Products for Human UseDrugsGuidance Document (DR&R)Published7-Dec-29
Guidelines for Renewal of Certificate of Registration for Drug Products Human and VetDrugsCertificate Renewal (DR&R)Published7-Dec-29
NAFDAC Good Storage and Distribution Practices Guidelines for Pharmaceutical ProductsDrugsGuidance Document (PMS)Published25-Nov-29
NAFDAC Good Storage and Distribution Practices Guidelines for Pharmaceutical ProductsDrugsGuidance Document (PMS)Published25-Nov-29
Guidelines and Requirement for inspection of Food Storage Facilities Warehouse and Issuance of e-Permit for Bulk Raw Materials in NigeriaRegulated ProductsGMP Inspection (FSAN)Published01-Oct-29
NAFDAC Good Manufacturing Practice For Pharmaceutical Products Guidelines 2024 - DER-GDL-019-03DrugsGMP InspectionPublished25-Nov-29
NAFDAC Inspectors Guide 2023 Regulated ProductsInspectionPublished24-Sep-24
NAFDAC Guidelines for Conformity Assessment of IVD Medical DevicesRegulated ProductsGuidance Document (VBM-R&R)Published
NAFDAC Guidelines for Conformity Assessment of Non-IVD Medical DevicesRegulated ProductsGuidance Document (VBM-R&R)Published
Guidelines for Compilation of a Product Dossier for Registration of In Vitro Diagnostics - IMDRF ToCRegulated ProductsRegistration Requirement (VBM-R&R)Published
Guidelines On Variations To Registered Medical Devices Including In Vitro Diagnostics And Related ProductsRegulated ProductsRegistration Requirement (VBM-R&R)Published
Guidelines on the Role of Standards in the Assessment of Medical DevicesMedical DevicesGuidance Document (VBM-R&R)Published
Guidelines For Renewal Of Certificate Of Product Registration For Medical Devices In NigeriaMedical DevicesCertificate Renewal (VBM-R&R)Published
Guidelines For Registration Of Medical Devices In NigeriaMedical DevicesRegistration Requirement (VBM-R&R)Published
Guidelines for Good Refurbishment Practice of Medical Devices (NGRPMD)Medical DevicesGuidance Document (VBM-R&R)Published
Guidelines for Compilation of a Product Dossier for Registration of Non-In Vitro Diagnostic (nIVD ToC)Regulated ProductsRegistration Requirement (VBM-R&R)Published
Guidelines for Conduct of Clinical Trials During EmergenciesDrugsClinical Trial (DER)Published
Guidelines for Clinical Trial Application in NigeriaDrugsClinical Trial (DER)Published
NAFDAC Guidelines for the Recall of Defective Medical ProductsRegulated ProductsGuidance Document (PMS)Published
NAFDAC GMP For Medical Devices, IVDs, Related Products Guidelines 2024Regulated ProductsGuidance Document (DER)Published
NAFDAC Good Clinical Practice Guidelines 2020Drugs Clinical Trial (DER)Published
Guidelines For Submission Of Clinical Trial Progress ReportDrugs Clinical Trial (DER)Published
Guidelines For Labelling Of Investigational Medicinal ProductsDrugs Clinical Trial (DER)Published
Guidelines For Importation & Release Of Investigational Medicinal ProductsDrugs Clinical Trial (DER)Published
Guidelines For Clinical Trial Protocol DevelopmentDrugs Clinical Trial (DER)Published
Guidelines For Clinical Trials Process TimelinesDrugs Clinical Trial (DER)Published
Guidelines For Clinical Trials In Paediatric PopulationsDrugs Clinical Trial (DER)Published
Guidelines for Registration of Software as a Medical Device (SaMD) in NigeriaMedical DevicesRegistration Requirement (DR&R)Published
Guideline for Risk Categorization of Narcotics and Controlled SubstancesRegulated ProductsGuidance Document (NCS)Published
Guidance Document on Chemistry, Manufacturing, Control (CMC) and Lot Release for Finished Vaccine or Biological Medicinal ProductVaccines, Biologics & Medical DevicesLot release (VBM-LSD)Published
Guidelines For Production Inspection Of Small Scale Food Enterprises In Nigeria (New Applicants)Food GMP Inspection Requirement (FSAN)Uncontrolled
Guidelines For Production Inspection Of Micro Scale Food Manufacturing Facilities In Nigeria (New Applicants)FoodGMP Inspection Requirement (FSAN)Uncontrolled
Guidelines for Registration of Packaged Edible Vegetable Oil by Dispensers Under Micro Scale in NigeriaFoodGMP Inspection Requirement (FSAN)Uncontrolled
Guidelines for Issuance of Export E-Licenses for NAFDAC Regulated Products General Export Permit (PID)Published
Guidelines for Listing of Exporters of NAFDAC Regulated Products in Nigeria General GMP Requirement (PID)Published
Guidelines on the Investigation of Bioequivalence 2024DrugsGMP Inspection (DER)Published
Guidelines For UMC Review Nigeria Industry E-Reporting Manual VersionRegulated ProductsGuidance Document (PV)Published
Nigerian Guidelines for Detecting and Reporting of Adverse Reactions for Pharmaceutical Products and Medical DevicesRegulated ProductsGVP Requirement (PV)Published
Pharmacovigilance Inspection Guidelines For Nigeria Regulated DrugsDrugsGVP Inspection (PV)Published
Guidance Manual for Pharmacovigilance Focal Points in Nigerian Healthcare FacilitiesRegulated ProductsGuidance Document (PV)Published
Guidelines For Qualified Person For PharmacovigilanceRegulated ProductsGVP Inspection (PV)Published
NAFDAC Guidelines on Post-Marketing Surveillance of Medical ProductsRegulated ProductsGuidance Document (PMS)Published
Guidance on Emergency Use Authorization for Medical ProductsRegulated ProductsGuidance Document (DR&R)Published
NAFDAC Laboratory Sampling Guide 2023Regulated ProductsSampling PlanPublished
Guidelines For Issuance Of Additional Permit (New Items Or Quantities) To Import Industrial And Laboratory ChemicalsChemicalImport Permit (CER)Published
Guidelines For Issuance Of Permit To Import Severely Restricted Chemicals (Pesticides, Agrochemicals And Fertilizers)ChemicalImport Permit (CER)Published
Guidelines For Labeling Of Chemicals Manufactured In NigeriaChemicalGMP Requirement Labeling (CER)Published
Guidelines For Obtaining Listing Certificate For Chemical Marketers (New Applicants)ChemicalListing Certificate New Applicants (CER)Published
Guidelines For Obtaining Permit To Import Industrial And Laboratory Chemicals (New Applicants)ChemicalImport Permit New Applicants (CER)Published
Guidelines For Renewal Of Listing Certificate For Chemical MarketersChemicalListing Certificate Renewal (CER)Published
Guidelines For Renewal Of Permit To Import Industrial And Laboratory ChemicalsChemicalImport Permit Renewal (CER)Published
Guidelines For Warehouse InspectionChemicalWarehouse Inspection Requirement (CER)Published
Permit For Clearance Of Imported Severely Restricted Chemicals (Pesticides, Agrochemicals And Fertilizers)ChemicalImport Permit (CER)Published
Guidelines for the Preparation of Summary of Product Characteristics (SmPC) for Drug Products in Nigeria (Human Drugs)DrugsSMPC Guidelines (DR&R)Published
NAFDAC Guidance Document And Guideline For Lot Release Of HumanVaccines, Biologics & Medical DevicesLot release (VBM-LSD)Published
Guidelines For Change In Formulation Of Food And Feed ProductsFoodGMP Requirement (FR&R)
Guideline For Production Inspection Of Chemical Manf Facilities.pdfChemicalGuidance Document (CER)Published
GMP Guidelines For Chemical And Chemical Products.pdfChemicalGMP Requirement (CER)Published
Guidelines For Pre-Production Inspection Of Pharmaceutical Manufacturing Facilities In NigeriaDrugsGMP Requirement (DER)Published
Guidelines For Pre- Registration Inspection Of Pharmaceutical Manufacturing Facilities In NigeriaDrugsGMP Requirement (DER)Published
Guidelines for Registration of Animal Feed Made in NigeriaVeterinaryLocal Registration (R&R)Published
Guidelines for Advertisement Control of Food Products in NigeriaFoodAdvert Guidelines (R&R)Published
Guidelines for Registration of Imported Animal Feed in NigeriaVeterinaryImport Registration (R&R)Published
NAFDAC Guidelines For Contract Manufacturing Of Finished Pharmaceutical Products In NigeriaDrugsGMP Requirement (DER)Published
NAFDAC Good Pharmacovigilance Practice GuidelinesDrugsGVP Requirement (PV)Published
Guidance on Regulatory Preparedness for Licensing or Access to COVID-19 VaccinesDrugsLicensing Access to Covid-19 Vaccines(DR&R)Published
Current Good Manufacturing Practice Guidelines For Food And Food Products (Revised).pdfFoodGMP Requirement (FSAN)Uncontrolled
Food Hygienic Practices Guidelines NGFHP.pdfFoodGuidance Document (FSAN)Uncontrolled
Guidelines For Importation Of Active Pharmaceutical Ingredients (APIs)DrugsAPI Requirement (DER)
Guidelines For Complaints And Appeals Against Regulatory Decisions QMS -GLD-001-01-1GeneralConsumer Complaints (QMS)Published
Guidance Document for the Registration of Alcohol-based Hand Sanitizers Made in NigeriaGeneralGuidance Document (DR&R)
Guidance to Applicants for Registration of Herbal Medicines Made in NigeriaHerbalGuidance Document (DR&R)
NAFDAC Guidelines on Good Review PracticeRegulated ProductsQuality Guidelines (DR&R)Published
Guidelines For Listing Of Chemical Manufacturers In Nigeria (New Applicants)ChemicalListing Requirement (CER)Published
Guidance Document for Submission of Application in the CTD Format Vaccines for Human UseDrugsGuidance Document (DR&R)Published
Guideline for Approval to Import Donated Items by Non-Governmental OrganizationsGeneral Import Permit (PID)Published
Guidelines for Approval To Import Raw Material for Machine Trial or Research Purpose General Import Permit (PID)Published
Guidelines for Approval of Authorization to Open Form M General GMP Requirement (PID)Published
Guidelines for Approval for Letter of Non-Objection General GMP Requirement (PID)Published
Guidelines For Complaints ResolutionGeneral Consumer Complaints (Reforms)Published
NAFDAC Good Cold Chain Management For Vaccines & Biopharm. Products Guidelines 2021General GMP Requirement (DER)Published
Guidelines on Variations to a Registered Vaccine for HumansGeneral Variation Guidelines (DR&R)Published12-Dec-26
Guidelines for Renewal of Herbal Medicines and Dietary Supplements Made in NigeriaHerbalRenewal Registration Requirement (DR&R)Published12-Dec-26
Guidelines for Renewal of Certificate of Registration for Imported Herbal Remedies, Dietary Supplements in NigeriaHerbalRenewal Registration Requirement (DR&R)Published12-Dec-26
Guidelines For Registration of Imported Drugs Vaccines IVDs Under Collaborative Registration ProcedureDrugsRegistration Requirement (DR&R)Published12-Dec-26
Guidelines For Labeling Of Investigational Medicinal ProductsDrugsGMP Labeling (DER)Published28-Oct-26
Guidelines For Importation And Release Of Investigational Medicinal ProductsDrugsQuality Guidelines (DER)Published15-Nov-28
NAFDAC Guidelines on Variation to Registered Pharmaceutical ProductDrugsVariation Guidelines (DR&R)Published28-Sep-29
Guidelines for Approval to Import Products by Government Agencies, Multinationals Organization General Guidance Document (PID)Published23-Sep-27
Guideline for Form M Online Application 2019General Guidance Document (PID)Published
Guideline for NOC Online Application 2019General Guidance Document (PID)Published
Biosimilar Guidance DocumentDrugsQuality Guidance Document (DR&R)Published12-Dec-26
Guidelines for Registration of Biosimilars in NigeriaDrugs Local Registration (DR&R)Published
Guidelines for Issuance of Listing Certificate for Chemical Marketers (New applicants)ChemicalListing Certificate (CER)Published
Guidelines for Issuance of Permit to Clear for Restricted and Agro ChemicalsChemicalClearance Permit (CER)Published
Guidelines for Issuance of Permit to Import Laboratory and Industrial ChemicalsChemical Import Permit (CER)Published
Guidelines for Renewal of Import Permit for Laboratory and Industrial ChemicalsChemical Import Permit Renewal (CER) Published
Guidelines for the Issuance of Import Permit for Restricted and Agro ChemicalsChemical Import Permit (CER)Published
Guidelines for the Renewal of Listing Certificate for Chemical MarketersChemicalListing Certificate Renewal (CER)Published
Guidelines for Obtaining Permit to Clear Narcotic Drugs, Psychotropic Substances and Drug Precursors 2025NarcoticClearance Permit (NCS)Published
Guidelines for Obtaining Permit to Clear Precursor ChemicalsNarcoticClearance Permit (NCS)Published
Guidelines for Obtaining Permit for Importation of Narcotic Drugs, Psychotropic Substances and Drug Precursors 2025NarcoticImport Permit (NCS)Published
Guidelines for Obtaining Permit to Import Precursor ChemicalsNarcoticImport Permit (NCS)Published
Guidelines for Obtaining Permit for Importation of Schedule 1 Narcotic DrugsNarcotic Import Permit (NCS)Published
Guidelines for Warehouse InspectionNarcoticWarehouse Inspection Requirement (NCS)Published
Guidelines for the Registration of Imported Animal FeedsGeneral Import Registration (R&R)Published
Guidelines for Registration of Imported Cosmetics in NigeriaCosmeticsImport Registration (DR&R)Published
Guidelines for Registration of Imported Food Products in NigeriaFoodImport Registration (R&R)Published
Guidelines for Registration of Imported Herbal Remedies And Dietary Supplements in NigeriaHerbalImport Registration (DR&R)Published
Guidelines for Registration of Imported Pesticides in NigeriaChemicalImport Registration (DR&R)Published
Guidelines for Registration of Herbal Medicines and Dietary Supplements Made in NigeriaHerbalLocal Registration (DR&R)Published
Guidelines for Registration of Cosmetics Made in NigeriaCosmeticsLocal Registration (DR&R)Published
Guidelines for Registration of Food Products and Packaged Water Made in NigeriaFoodLocal Registration (R&R)Published
Guidelines for the Registration of Pesticides made in NigeriaChemicalLocal Registration (DR&R)Published
Guidelines for the Inspection of WarehousesVeterinaryWarehouse Inspection Requirement (VMAP)Published
Guidelines for the Inspection of Facilities for Manufacture of Veterinary DrugsVeterinaryGMP Requirement (Inspection)Published
Guidelines for Listing of Animal Feed Toll Millers Requirements for the Toll Milling Facility RenewalVeterinaryListing Requirement (Renewal)Published
Guidelines for Listing of Animal Feeds Toll Millers Requirements for Toll Milling FacilityVeterinaryGMP Requirement Published
Guideline for Listing of Pesticides Agrochemicals Fertilizers Bio Fertilizer and Bio Pesticides Marketer RenewalVeterinaryListing Requirement Published
Guidelines for Issuance of Permit to Import Field Trial SamplesVeterinaryImport PermitPublished
Guidelines for Issuance of Permit to Import Feed Supplements Feed Concentrates Feed Additives Premixes Fish Meal RenewalVeterinaryImport PermitPublished
Guidelines for Issuance of Permit to Import Feed Supplements Feed Concentrate Feed Additives Premixes Fish Meal New ApplicantVeterinaryImport PermitPublished
Guidelines for Issuance of Permit to Import Bulk Pesticides Agrochemicals and FertilizersVeterinaryImport PermitPublished
Guidelines for Issuance of Permit to Import Bulk Pesticides Agrochemicals and Fertilizers RenewalVeterinaryImport PermitPublished
Guidelines for Inspection of Local Manufactured Animal Feed Pet Food PremixesVeterinaryGMP Requirement (Inspection)Published
Guidelines for Inspection of Facility for the Manufacture of Veterinary Medicinal Cosmetics in NigeriaVeterinaryGMP Requirement (Inspection)Published
Guidelines for Inspection of Facilities for the Manufacture of Medicated FeedVeterinaryGMP Requirement (Inspection)Published
Guidelines for Inspection of Facilities for Manufacture of Veterinary CosmeticsVeterinaryGMP Requirement (Inspection)Published
Guideline for Listing of Pesticides Agrochemicals Fertilizers Bio Fertilizer and Bio Pesticides Marketer RenewalVeterinaryListing Requirement Published
Guidelines for Handling and Disposal of Unwholesome Medicines and Other NAFDAC Regulated ProductsDrugsListing Requirement (I&E)Published
Guidelines for Inspection & Requirements for Pre-Packaged Food Manufacturing Packaging Facilities in Nigeria.pdfFoodGMP Inspection Requirement (FSAN)Uncontrolled
Guidelines for Inspection and Requirements for Bread Manufacturing FacilityFoodGMP Inspection Requirement (FSAN)Uncontrolled
Guidelines for Inspection and Requirements for Packaged Water Facility in Nigeria.pdfFoodGMP Inspection Requirement (FSAN)Uncontrolled
Guidelines for Clearing of Imported Donated Items in Nigeria General Import Clearance Permit (PID)Published
Guidelines for Clearing Imported Bulk Food Animal Feed and Food Raw Materials and Animal Feeds at Ports of Entry in Nigeria FoodImport Clearance Permit (PID)Published
Guidelines for Clearing imported Narcotic & Controlled Substances, Pharm Raw Materials NarcoticsImport Clearance Permit (PID)Published
Guidelines For Clearing Imported Finished Pharmaceutical (Human And Veterinary) Products at Ports of Entry in Nigeria HerbalImport Clearance Permit (PID)Published
Guidelines for Clearing Imported Regulated Food Supermarket Items Restaurant Operators at Ports of Entry in Nigeria Food Import Clearance Permit (PID)Published
Guidelines for Clearing of Cosmetics and Medical Device Cosmetic, Medical DevicesImport Clearance Permit (PID)Published
Guidelines for Clearing of Imported General Chemicals and Raw Materials ChemicalImport Clearance Permit (PID)Published
Guidelines for Fast Track Clearing of Imported NAFDAC Regulated Products & Bulk Raw Materials General Import Clearance Permit (PID)Published
Guidelines for Export Approval for NAFDAC Regulated Products and Food Stuff not Pre-packaged for Personal Use Food, Other Regulated ProductsExport Permit (PID)Published
NAFDAC MAS GuidelinesGeneral Mobile Authentication Service (PMS)Published
Label Guidance For Pharmaceutical ProductsGeneral GMP Labelling (DR&R)Published
NAFDAC Guideline on Registration Requirements to Establish Interchangeability of Generic Pharmaceutical ProductsDrugsRegistration Requirement (DR&R)Published
NAFDAC GMP Guidelines For Cosmetics Products 2021 CosmeticsGMP Requirement (DER)Published
Guidelines For Production Inspection Of Large And Medium Scale Cosmetics Manufacturing FacilitiesCosmeticsGMP Inspection (DER) Published
Guidelines For Production Inspection Of Herbal Medicines And Nutraceuticals Manufacturing FacilitiesHerbalGMP Inspection (DER)Published
Guidelines For Inspection Of Premises For Global Listing Of Cosmetics ProductsCosmeticsGMP Inspection (DER)Published
Guidelines For Good Storage Practice (GSP) And Good Distribution Practice (GDP) Inspection Of Cold Chain Facilities For Storage Of Vaccines & BiologicsVaccines & BiologicsGSP & GDP Inspection (DER)Published
Label Guidance For Herbal Medicines And Dietary SupplementHerbal GMP Labelling (DR&R)Published
Guidelines for the Global Listing of Supermarket Items (GLSI)Regulated ProductsGlobal Listing (DR&R)Published
Dossier Submission GuideGeneralGuidance Document (DR&R)Published
Guidelines For Advertisement Of Medical Products, Cosmetics, Veterinary Products And Finished ChemicalsRegulated ProductsGMP Advertisement (DR&R)Published
Guideline for Donated Medical Products in NigeriaRegulated ProductsGuidance Document (DR&R)Published
Guideline for Operation of Service Drugs and Orphan Drug SchemeDrugsOperation Guidelines (DR&R)Published
Guidelines For The Preparation of Product Dossiers in the Common Technical Document (CTD) FormGeneralQuality Guidance Document (DR&R)Published
Guidance on Master Data Attributes for Pharmaceutical Products DGO-GDL-001-00DrugsTraceabilityPublished

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  • Content Current as of October 29, 2024

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NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL (NAFDAC)

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