Guideline for Renewal of Certificate of Registration for Drug Products (Human and Veterinary Drugs) DR&R-GDL-025-02 | Regulated Product | Renewal Registration Requirement (DR&R) | Published |
Guidelines for the Preparation of Summary of Product Characteristics (SmPC) for drug products in Nigeria | Drugs | SMPC Guidelines | Published |
Patient Information Listing (PIL) Review Checklist | Drugs | PIL Checklist | Published |
SMPC Review Checklist | Drugs | SMPC Checklist | Published |
Guideline For Lot Release Of Human Vaccines And Other Biologicals 2023 | Vaccines, Biologics & Medical Devices | Lot release (VBM-LSD) | Published |
Guidance Document on Chemistry, Manufacturing, Control (CMC) And Lot Release For Finished Vaccine Or Biological Medicinal Product | Vaccines, Biologics & Medical Devices | Lot release (VBM-LSD) | Published |
Guidelines For Pre-Production Inspection Of Pharmaceutical Manufacturing Facilities In Nigeria | Drugs | GMP Requirement (DER) | Published |
Guidelines For Pre- Registration Inspection Of Pharmaceutical Manufacturing Facilities In Nigeria | Drugs | GMP Requirement (DER) | Published |
Guidelines For Clinical Trial Process Timelines | Drugs | Clinical Trial (DER) | Published |
Guidelines For Submission Of Clinical Trial Progress Report | Drugs | Clinical Trial (DER) | Published |
NAFDAC Good Manufacturing Practice (GMP) For Pharm. Products Guidelines 2021 | Drugs | GMP Requirement (DER) | Published |
NAFDAC Guidelines For Contract Manufacturing Of Finished Pharmaceutical Products In Nigeria | Drugs | GMP Requirement (DER) | Published |
Guidance on Regulatory Preparedness for Licensing or Access to COVID-19 Vaccines | Drugs | Licensing Access to Covid-19 Vaccines(DR&R) | Published |
Guidelines For Importation Of Active Pharmaceutical Ingredients (APIs) | Drugs | API Requirement (DER) | |
Guidance Document for Submission of Application in the CTD Format – Vaccines for Human Use | Drugs | Guidance Document (DR&R) | Published |
Guidelines for Renewal of Certificate of Registration for Medical Devices Made in Nigeria | Medical Devices | Renewal Registration Requirement (DR&R) | Published |
Guideline for the Renewal of the Certificate of Registration License for Imported Medical Devices | Medical Devices | Renewal Registration Requirement (R&R) | Published |
Guidelines For Registration of Imported Drugs Vaccines IVDs Under Collaborative Registration Procedure | Drugs | Registration Requirement (DR&R) | Published |
Guidelines For Labeling Of Investigational Medicinal Products | Drugs | GMP Labeling (DER) | Published |
Guidelines For Importation And Release Of Investigational Medicinal Products | Drugs | Quality Guidelines (DER) | Published |
Guidelines For Conduct Of Clinical Trials During Emergencies | Drugs | Clinical Trial (DER) | Published |
Guidelines For Clinical Trials Protocol Development | Drugs | Clinical Trial(DER) | Published |
NAFDAC Guidelines on Variations to a Registered Pharmaceutical Product | Drugs | Variation Guidelines (DR&R) | Published |
Guidelines For Clinical Investigation Of Medicinal Products In Paediatric Population | Drugs | Clinical Trial(DER) | Published |
Biosimilar Guidance Document | Drugs | Quality Guidance Document (DR&R) | Published |
Guidelines for Registration of Biosimilars in Nigeria | Drugs | Local Registration (DR&R) | Published |
Quality Guidelines for Registration of Pharmaceutical Products26381 | Drugs | Quality Guidelines (R&R) | Published |
Guidelines for Obtaining Permit to Clear Narcotic drugs, Psychotropic Substances and Drug Precursors_ | Narcotic | Clearance Permit (NCS) | Published |
Guidelines for Obtaining Permit to Import Narcotics, Drugs, Psychotropic Substances and Drug Precursor | Narcotic | Import Permit (NCS) | Published |
Guidelines for Obtaining Permit to Import Schedule 1 Narcotic Drugs | Narcotic | Import Permit (NCS) | Published |
Guidelines for Registration of Imported Drug Products in Nigeria (Human and Veterinary Drugs) | Drugs | Import Registration (DR&R) | Published |
Guidelines for Registration of Imported Medical Devices in Nigeria | Medical Device | Import Registration (DR&R) | Published |
Guidelines for Registration of Medical Devices made in Nigeria | Medical Device | Local Registration (DR&R) | Published |
Guidelines for Registration of Drug Products Made in Nigeria (Human and Veterinary Drugs) | Drugs | Local Registration (DR&R) | Published |
Guidelines for the Inspection of Facilities for Manufacture of Veterinary Drugs | Veterinary | GMP Requirement (Inspection) | Published |
Guidelines for Handling and Disposal of Unwholesome Medicines and Other NAFDAC Regulated Products | Drugs | Listing Requirement (I&E) | Published |
Guidelines for Clearing of Cosmetics and Medical Devices | Cosmetic, Medical Devices | Import Clearance Permit (PID) | Published |
NAFDAC Guideline on Registration Requirements to Establish Interchangeability of Generic Pharmaceutical Products | Drugs | Registration Requirement (DR&R) | Published |
NAFDAC Good Manufacturing Practice (GMP) For Pharm. Products Guidelines 2021 | Drugs | GMP Inspection (DER) | Published |
Guidelines For Clinical Trial Application In Nigeria | Drugs | Clinical Trial (DER) | Published
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Guideline for Operation of Service Drugs and Orphan Drug Scheme | Drugs | Operation Guidelines (DR&R) | Published |
Guidelines for Renewal of Certificate of Registration for Imported Drug Products in Nigeria (Human & Veterinary Drugs) | Regulated Products | Renewal Registration Requirement (DR&R) | Published |