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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
NAFDAC Guidelines on the Investigation of Bioequivalence 2025DrugsClinical Trial (DER)Published4-May-30
Guidelines for Registration of Drug Products Made in Nigeria Human and Veterinary Drug 2025DrugsLocal Registration (DR&R)Published21-Mar-30
Guidelines for Registration of Imported Drug Products in Nigeria Human and Veterinary Drugs 2025DrugsImport Registration (DR&R)Published21-Mar-30
Guidelines on Labelling Requirements for Semi-Processed Food Products for Export from Nigeria 2025FoodGMP Labelling (FR&R)Published17-Jan-30
Revised Guidelines for Risk Categorization of Product Dossiers for the Registration of Drug Products for Human Use 2024DrugsGuidance Document (DR&R)Published7-Dec-29
Guidelines for Renewal of Certificate of Registration for Drug Products Human and Vet 2024DrugsCertificate Renewal (DR&R)Published7-Dec-29
NAFDAC Good Storage and Distribution Practices Guidelines for Pharmaceutical Products 2024DrugsGuidance Document (PMS)Published25-Nov-29
NAFDAC Good Storage and Distribution Practices Guidelines for Pharmaceutical Products 2024DrugsGuidance 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 Nigeria 2024Regulated ProductsGMP Inspection (FSAN)Published1-Oct-29
NAFDAC Good Manufacturing Practice For Pharmaceutical Products Guidelines 2024DrugsGMP InspectionPublished25-Nov-29
Guidelines For Registration And Related Activities Of Drugs, Vaccines And In-Vitro Diagnostics Using The Reliance Procedure 2024DrugsRegistration Requirement (DR&R)Published9-Sept-29
NAFDAC Inspectors Guide 2023 Regulated ProductsInspectionPublished24-Sep-24
NAFDAC Guidelines for Conformity Assessment of IVD Medical Devices 2024Regulated ProductsGuidance Document (VBM-R&R)Published18-Nov-29
NAFDAC Guidelines for Conformity Assessment of Non-IVD Medical Devices 2024Regulated ProductsGuidance Document (VBM-R&R)Published18-Nov-29
Guidelines for Compilation of a Product Dossier for Registration of In Vitro Diagnostics - IMDRF ToC 2024Regulated ProductsRegistration Requirement (VBM-R&R)Published6-Nov-29
Guidelines On Variations To Registered Medical Devices Including In Vitro Diagnostics And Related Products 2024Regulated ProductsRegistration Requirement (VBM-R&R)Published6-Nov-29
Guidelines on the Role of Standards in the Assessment of Medical Devices 2024Medical DevicesGuidance Document (VBM-R&R)Published6-Nov-29
Guidelines For Renewal Of Certificate Of Product Registration For Medical Devices In Nigeria 2024Medical DevicesCertificate Renewal (VBM-R&R)Published10-Nov-29
Guidelines For Registration Of Medical Devices In Nigeria 2024Medical DevicesRegistration Requirement (VBM-R&R)Published3-Nov-29
Guidelines for Good Refurbishment Practice of Medical Devices (NGRPMD) 2024Medical DevicesGuidance Document (VBM-R&R)Published6-Nov-29
Guidelines for Compilation of a Product Dossier for Registration of Non-In Vitro Diagnostic (nIVD ToC) 2024Regulated ProductsRegistration Requirement (VBM-R&R)Published6-Nov-29
Guidelines for Conduct of Clinical Trials During Emergencies 2024DrugsClinical Trial (DER)Published18-Nov-29
Guidelines for Clinical Trial Application in Nigeria 2024DrugsClinical Trial (DER)Published18-Nov-29
NAFDAC Guidelines for the Recall of Defective Medical Products 2024Regulated ProductsGuidance Document (PMS)Published29-Sep-29
NAFDAC Good Manufacturing Practice (GMP) for Medical Devices, IVDs, and Related Products Guidelines 2024Regulated ProductsGuidance Document (DER)Published10-Nov-29
NAFDAC Good Clinical Practice (GCP) Guidelines 2025Drugs Clinical Trial (DER)Published4-May-30
Guidelines For Submission Of Clinical Trial Progress Report 2024Drugs Clinical Trial (DER)Published2-Sep-29
Guidelines For Labelling Of Investigational Medicinal Products 2024Drugs Clinical Trial (DER)Published4-Sep-29
Guidelines For Importation & Release Of Investigational Medicinal Products 2024Drugs Clinical Trial (DER)Published5-Sep-29
Guidelines For Clinical Trial Protocol Development 2024Drugs Clinical Trial (DER)Published4-Sep-29
Guidelines For Clinical Trials Process Timelines 2024Drugs Clinical Trial (DER)Published5-Sep-29
Guidelines For Clinical Trials In Paediatric Populations 2021Drugs Clinical Trial (DER)Published21-Oct-26
Guidelines for Registration of Software as a Medical Device (SaMD) in Nigeria 2024Medical DevicesRegistration Requirement (DR&R)Published30-Jun-26
Guideline for Risk Categorization of Narcotics and Controlled Substances 2024Regulated ProductsGuidance Document (NCS)Published29-Jul-29
Guidance Document on Chemistry, Manufacturing, Control (CMC) and Lot Release for Finished Vaccine or Biological Medicinal Product 2024Vaccines, Biologics & Medical DevicesLot release (VBM-LSD)Published7-Aug-29
Guidelines For Production Inspection Of Small Scale Food Enterprises In Nigeria (New Applicants) 2024Food GMP Inspection Requirement (FSAN)Uncontrolled18-Apr-29
Guidelines For Production Inspection Of Micro Scale Food Manufacturing Facilities In Nigeria (New Applicants) 2024FoodGMP Inspection Requirement (FSAN)Uncontrolled18-Apr-29
Guidelines for Registration of Packaged Edible Vegetable Oil by Dispensers Under Micro Scale in Nigeria 2023FoodGMP Inspection Requirement (FSAN)Uncontrolled17-Oct-28
Guidelines for Issuance of Export E-Licenses for NAFDAC Regulated Products 2022General Export Permit (PID)Published23-Sep-27
Guidelines for Listing of Exporters of NAFDAC Regulated Products in Nigeria 2023General GMP Requirement (PID)Published8-May-28
Guidelines on the Investigation of Bioequivalence 2024DrugsGMP Inspection (DER)Published27-Oct-29
Guidelines For UMC Review Nigeria Industry E-Reporting Manual Version 2024Regulated ProductsGuidance Document (PV)Published14-Oct-29
Nigerian Guidelines for Detecting and Reporting of Adverse Reactions for Pharmaceutical Products and Medical Devices 2024Regulated ProductsGVP Requirement (PV)Published13-Oct-29
Pharmacovigilance Inspection Guidelines For Nigeria Regulated Drugs 2024DrugsGVP Inspection (PV)Published14-Oct-29
Guidance Manual for Pharmacovigilance Focal Points in Nigerian Healthcare Facilities 2024Regulated ProductsGuidance Document (PV)Published9-Oct-29
Guidelines For Qualified Person For Pharmacovigilance 2024Regulated ProductsGVP Inspection (PV)Published14-Oct-29
NAFDAC Guidelines on Post-Marketing Surveillance of Medical Products 2024Regulated ProductsGuidance Document (PMS)Published26-Sep-29
Guidance on Emergency Use Authorization for Medical Products 2024Regulated ProductsGuidance Document (DR&R)Published9-Sep-29
NAFDAC Laboratory Sampling Guide 2023Regulated ProductsSampling PlanPublished27-Feb-28
Guidelines For Issuance Of Additional Permit (New Items Or Quantities) To Import Industrial And Laboratory Chemicals 2023ChemicalImport Permit (CER)Published15-Nov-28
Guidelines For Issuance Of Permit To Import Severely Restricted Chemicals (Pesticides, Agrochemicals And Fertilizers) 2023ChemicalImport Permit (CER)Published15-Nov-28
Guidelines For Labeling Of Chemicals Manufactured In Nigeria 2023ChemicalGMP Requirement Labeling (CER)Published15-Nov-28
Guidelines For Obtaining Listing Certificate For Chemical Marketers (New Applicants) 2023ChemicalListing Certificate New Applicants (CER)Published15-Nov-28
Guidelines For Obtaining Permit To Import Industrial And Laboratory Chemicals (New Applicants) 2023ChemicalImport Permit New Applicants (CER)Published15-Nov-28
Guidelines For Renewal Of Listing Certificate For Chemical Marketers 2023ChemicalListing Certificate Renewal (CER)Published15-Nov-28
Guidelines For Renewal Of Permit To Import Industrial And Laboratory Chemicals 2023ChemicalImport Permit Renewal (CER)Published15-Nov-28
Guidelines For Warehouse Inspection 2023ChemicalWarehouse Inspection Requirement (CER)Published15-Nov-28
Permit For Clearance Of Imported Severely Restricted Chemicals (Pesticides, Agrochemicals And Fertilizers) 2023ChemicalImport Permit (CER)Published15-Nov-28
Guidelines for the Preparation of Summary of Product Characteristics (SmPC) for Drug Products in Nigeria (Human Drugs) 2024DrugsSMPC Guidelines (DR&R)Published12-Sep-29
NAFDAC Guidance Document And Guideline For Lot Release Of Human 2024Vaccines, Biologics & Medical DevicesLot release (VBM-LSD)Published7-Aug-29
Guidelines For Change In Formulation Of Food And Feed Products 2023FoodGMP Requirement (FR&R)Published29-Mar-28
Guideline For Production Inspection Of Chemical Manufacturing Facilities 2023ChemicalGuidance Document (CER)Published18-Jan-28
GMP Guidelines For Chemical And Chemical Products 2023ChemicalGMP Requirement (CER)Published18-Jan-28
Guidelines for Pre-Production Inspection of Pharmaceutical Manufacturing Facilities in NigeriaDrugsGMP Requirement (DER)Published6-Dec-29
Guidelines for Pre- Registration Inspection of Pharmaceutical Manufacturing Facilities in NigeriaDrugsGMP Requirement (DER)Published6-Dec-29
Guidelines for Registration of Animal Feed Made in Nigeria 2021VeterinaryLocal Registration (R&R)Published28-Feb-26
Guidelines for Advertisement Control of Food Products in Nigeria 2021FoodAdvert Guidelines (R&R)Published28-Feb-26
Guidelines for Registration of Imported Animal Feed in Nigeria 2021VeterinaryImport Registration (R&R)Published28-Feb-26
NAFDAC Guidelines For Contract Manufacturing Of Finished Pharmaceutical Products In Nigeria 2021DrugsGMP Requirement (DER)Published2-Feb-26
NAFDAC Good Pharmacovigilance Practice Guidelines 2021DrugsGVP Requirement (PV)Published20-Jan-26
Guidance on Regulatory Preparedness for Licensing or Access to COVID-19 Vaccines 2020DrugsLicensing Access to Covid-19 Vaccines(DR&R)Published27-Oct-25
Current Good Manufacturing Practice Guidelines For Food And Food Products 2024FoodGMP Requirement (FSAN)Uncontrolled27-Mar-29
Food Hygienic Practices Guidelines NGFHP 2024FoodGuidance Document (FSAN)Uncontrolled27-Mar-29
Guidelines For Importation Of Active Pharmaceutical Ingredients (APIs) 2020DrugsAPI Requirement (DER)Published23-Aug-25
Guidelines For Complaints And Appeals Against Regulatory Decisions 2020GeneralConsumer Complaints (QMS)Published21-Jun-25
Guidance Document for the Registration of Alcohol-based Hand Sanitizers Made in Nigeria 2020GeneralGuidance Document (DR&R)Published21-Jun-25
Guidance to Applicants for Registration of Herbal Medicines Made in Nigeria 2020HerbalGuidance Document (DR&R)Published20-May-25
NAFDAC Guidelines on Good Review Practice 2021Regulated ProductsQuality Guidelines (DR&R)Published12-Dec-26
Guidance Document for Submission of Application in the CTD Format Vaccines for Human Use 2021DrugsGuidance Document (DR&R)Published12-Dec-26
Guideline for Approval to Import Donated Items by Non-Governmental Organizations 2022General Import Permit (PID)Published6-Jun-27
Guidelines for Approval To Import Raw Material for Machine Trial or Research Purpose 2022General Import Permit (PID)Published6-Jun-27
Guidelines for Approval of Authorization to Open Form M 2022General GMP Requirement (PID)Published23-Sept-27
Guidelines for Approval for Letter of Non-Objection 2022General GMP Requirement (PID)Published23-Sept-27
Guidelines For Complaints Resolution 2020General Consumer Complaints (Reforms)Published21-Jun-25
NAFDAC Good Cold Chain Management For Vaccines & Biopharm. Products Guidelines 2021General GMP Requirement (DER)Published21-Oct-26
Guidelines on Variations to a Registered Vaccine for Humans 2021General Variation Guidelines (DR&R)Published12-Dec-26
Guidelines for Renewal of Herbal Medicines and Dietary Supplements Made in Nigeria 2021HerbalRenewal Registration Requirement (DR&R)Published12-Dec-26
Guidelines for Renewal of Certificate of Registration for Imported Herbal Remedies, Dietary Supplements in Nigeria 2021HerbalRenewal Registration Requirement (DR&R)Published12-Dec-26
Guidelines For Registration of Imported Drugs Vaccines IVDs Under Collaborative Registration Procedure 2021DrugsRegistration Requirement (DR&R)Published12-Dec-26
Guidelines For Labeling Of Investigational Medicinal Products 2021DrugsGMP Labeling (DER)Published28-Oct-26
Guidelines For Importation And Release Of Investigational Medicinal Products 2021DrugsQuality Guidelines (DER)Published15-Nov-28
NAFDAC Guidelines on Variation to Registered Pharmaceutical Product 2024DrugsVariation Guidelines (DR&R)Published28-Sep-29
Guidelines for Approval to Import Products by Government Agencies, Multinationals Organization 2022General Guidance Document (PID)Published23-Sep-27
Biosimilar Guidance Document 2021DrugsQuality Guidance Document (DR&R)Published12-Dec-26
Guidelines for Registration of Biosimilars in Nigeria 2021Drugs Local Registration (DR&R)Published12-Dec-26
Guidelines for Obtaining Permit to Clear Narcotic Drugs, Psychotropic Substances and Drug Precursors 2024NarcoticClearance Permit (NCS)Published4-Aug-29
Guidelines for Obtaining Permit for Importation of Schedule 1 Narcotic Drugs 2024Narcotic Import Permit (NCS)Published29-Jul-29
Guidelines for Warehouse Inspection 2024NarcoticWarehouse Inspection Requirement (NCS)Published04-Aug-29
Guidelines for Registration of Imported Cosmetics in Nigeria 2021CosmeticsImport Registration (DR&R)Published12-Dec-26
Guidelines for Registration of Imported Food Products in Nigeria 2021FoodImport Registration (R&R)Published28-Feb-26
Guidelines for Registration of Imported Herbal Remedies And Dietary Supplements in Nigeria 2021HerbalImport Registration (DR&R)Published12-Dec-26
Guidelines for Registration of Imported Pesticides in Nigeria 2021ChemicalImport Registration (DR&R)Published12-Dec-26
Guidelines for Registration of Herbal Medicines and Dietary Supplements Made in Nigeria 2021HerbalLocal Registration (DR&R)Published12-Dec-26
Guidelines for Registration of Cosmetics Made in Nigeria 2021CosmeticsLocal Registration (DR&R)Published12-Dec-26
Guidelines for Registration of Food Products and Packaged Water Made in Nigeria 2021FoodLocal Registration (R&R)Published28-Feb-26
Guidelines for the Registration of Pesticides made in Nigeria2021ChemicalLocal Registration (DR&R)Published12-Dec-26
Guidelines for the Inspection of Warehouses 2021VeterinaryWarehouse Inspection Requirement (VMAP)Published31-Oct-26
Guidelines for the Inspection of Facilities for Manufacture of Veterinary Drugs 2021VeterinaryGMP Requirement (Inspection)Published31-Oct-26
Guidelines for Listing of Animal Feeds Toll Millers Requirements for Toll Milling Facility 2021VeterinaryGMP Requirement Published31-Oct-26
Guideline for Listing of Pesticides Agrochemicals Fertilizers Bio Fertilizer and Bio Pesticides Marketer Renewal 2021VeterinaryListing Requirement Published31-Oct-26
Guidelines for Issuance of Permit to Import Field Trial Samples 2021VeterinaryImport PermitPublished31-Oct-26
Guidelines for Issuance of Permit to Import Feed Supplements Feed Concentrates Feed Additives Premixes Fish Meal Renewal 2021VeterinaryImport PermitPublished31-Oct-26
Guidelines for Issuance of Permit to Import Feed Supplements Feed Concentrate Feed Additives Premixes Fish Meal New Applicant 2021VeterinaryImport PermitPublished31-Oct-26
Guidelines for Issuance of Permit to Import Bulk Pesticides Agrochemicals and Fertilizers 2021VeterinaryImport PermitPublished31-Oct-26
Guidelines for Issuance of Permit to Import Bulk Pesticides Agrochemicals and Fertilizers Renewal 2021VeterinaryImport PermitPublished31-Oct-26
Guidelines for Inspection of Local Manufactured Animal Feed Pet Food Premixes 2021VeterinaryGMP Requirement (Inspection)Published31-Oct-26
Guidelines for Inspection of Facility for the Manufacture of Veterinary Medicinal Cosmetics in Nigeria 2021VeterinaryGMP Requirement (Inspection)Published31-Oct-26
Guidelines for Inspection of Facilities for the Manufacture of Medicated Feed 2021VeterinaryGMP Requirement (Inspection)Published31-Oct-26
Guidelines for Inspection of Facilities for Manufacture of Veterinary Cosmetics 2021VeterinaryGMP Requirement (Inspection)Published31-Oct-26
Guideline for Listing of Pesticides Agrochemicals Fertilizers Bio Fertilizer and Bio Pesticides Marketer Renewal 2021VeterinaryListing Requirement Published31-Oct-26
Guidelines for Handling and Disposal of Unwholesome Medicines and Other NAFDAC Regulated Products 2024DrugsListing Requirement (I&E)Published25-Nov-29
Guidelines for Inspection & Requirements for Pre-Packaged Food Manufacturing Packaging Facilities in Nigeria 2023FoodGMP Inspection Requirement (FSAN)Uncontrolled17-Oct-28
Guidelines for Inspection and Requirements for Bread Manufacturing Facility 2023FoodGMP Inspection Requirement (FSAN)Uncontrolled08-Nov-28
Guidelines for Inspection and Requirements for Packaged Water Facility in Nigeria 2023FoodGMP Inspection Requirement (FSAN)Uncontrolled08-Nov-28
Guidelines for Clearing of Imported Donated Items in Nigeria 2022General Import Clearance Permit (PID)Published06-Jun-27
Guidelines for Clearing Imported Bulk Food Animal Feed and Food Raw Materials and Animal Feeds at Ports of Entry in Nigeria 2022FoodImport Clearance Permit (PID)Published23-Sep-27
Guidelines for Clearing imported Narcotic & Controlled Substances, Pharm Raw Materials 2022NarcoticsImport Clearance Permit (PID)Published23-Sep-27
Guidelines For Clearing Imported Finished Pharmaceutical (Human And Veterinary) Products at Ports of Entry in Nigeria 2022HerbalImport Clearance Permit (PID)Published23-Sep-27
Guidelines for Clearing Imported Regulated Food Supermarket Items Restaurant Operators at Ports of Entry in Nigeria 2022Food Import Clearance Permit (PID)Published23-Sep-27
Guidelines for Clearing of Cosmetics and Medical Device 2022Cosmetic, Medical DevicesImport Clearance Permit (PID)Published06-Jun-27
Guidelines for Clearing of Imported General Chemicals and Raw Materials 2022ChemicalImport Clearance Permit (PID)Published06-Jun-27
Guidelines for Fast Track Clearing of Imported NAFDAC Regulated Products & Bulk Raw Materials 2022General Import Clearance Permit (PID)Published06-Jun-27
Guidelines for Export Approval for NAFDAC Regulated Products and Food Stuff not Pre-packaged for Personal Use 2023Food, Other Regulated ProductsExport Permit (PID)Published08-May-28
Label Guidance For Pharmaceutical Products 2024General GMP Labelling (DR&R)Published07-Oct-29
NAFDAC Guideline on Registration Requirements to Establish Interchangeability of Generic Pharmaceutical Products 2021DrugsRegistration Requirement (DR&R)Published12-Dec-26
Guidelines For Production Inspection Of Large And Medium Scale Cosmetics Manufacturing Facilities 2021CosmeticsGMP Inspection (DER) Published28-Apr-26
Guidelines For Production Inspection Of Herbal Medicines And Nutraceuticals Manufacturing Facilities 2021HerbalGMP Inspection (DER)Published03-Oct-26
Guidelines For Inspection Of Premises For Global Listing Of Cosmetics Products 2021CosmeticsGMP Inspection (DER)Published02-May-26
Guidelines For Good Storage Practice (GSP) And Good Distribution Practice (GDP) Inspection Of Cold Chain Facilities For Storage Of Vaccines & Biologics 2021Vaccines & BiologicsGSP & GDP Inspection (DER)Published21-Oct-26
Label Guidance For Herbal Medicines And Dietary Supplement 2021Herbal GMP Labelling (DR&R)Published12-Dec-26
Guidelines for the Global Listing of Supermarket Items (GLSI) 2021Regulated ProductsGlobal Listing (DR&R)Published12-Dec-26
Dossier Submission Guide 2022GeneralGuidance Document (DR&R)Published18-Jan-27
Guidelines For Advertisement Of Medical Products, Cosmetics, Veterinary Products And Finished Chemicals 2021Regulated ProductsGMP Advertisement (DR&R)Published12-Dec-26
Guideline for Donated Medical Products in Nigeria 2021Regulated ProductsGuidance Document (DR&R)Published12-Dec-26
Guideline for Operation of Service Drugs and Orphan Drug Scheme 2021DrugsOperation Guidelines (DR&R)Published12-Dec-26
Guidelines For The Preparation of Product Dossiers in the Common Technical Document (CTD) Form 2021GeneralQuality Guidance Document (DR&R)Published12-Dec-26
Guidance on Master Data Attributes for Pharmaceutical Products 2022DrugsTraceabilityPublished (Uncontrolled)19-Apr-27

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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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