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Policies / Policies from 2019

Policies from 2019

Policies with publication year 2019.

NAFDAC Guidelines for Importation and Release of Investigational Medicinal Products

Ministry of Health, National Agency for Food and Drug Administration and Control

Nigeria2019HealthOther

Investigational medicinal products, which are unregistered medicines, can only be brought into the country after a positive ethical opinion is obtained, the clinical trial application has been approved and a letter of authorization has been issued by NAFDAC. Therefore, this guideline applies to all investigational medicinal products, including vaccines, which do not have marketing authorization in the country of intended use. It provides information on the responsibilities of the sponsor, labelling and packaging, importation and documentation procedures.

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NAFDAC Drug Evaluation & Research (DER) Directorate Guidelines for Clinical Trials Protocol development

Ministry of Health, National Agency for Food and Drug Administration and Control

Nigeria2019HealthOther

This document defines the terms �objective� and �study endpoint�. It clearly states that for purposes of registration and reporting, the terms objectives and endpoints as used in this template provided in this document align with the terms primary purpose and outcome measures in clinicaltrials.gov, respectively. Individuals should provide a description of the study objectives and endpoints, as well as a justification for selecting the particular endpoints, in the table format included in the statement of compliance 3.0 of the document. This will provide clear articulation on how the selected primary and secondary endpoint(s) are linked to achieving the primary and secondary objectives and an explanation of why endpoint(s) were chosen. Data points collected in the study should support an objective or have a regulatory purpose. Therefore, careful consideration should be given prospectively to the amount of data needed to support the study�s objectives.

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NAFDAC Drug Evaluation & Research (DER) Directorate Guidelines for Submission of Clinical Trial Progress Report

Ministry of Health, National Agency for Food and Drug Administration and Control

Nigeria2019HealthOther

These guidelines are for the interest of the general public and in particular individuals and organizations intending to submit progress reports of ongoing clinical trials in Nigeria. The document emphasizes that progress reports on ongoing clinical trials in Nigeria should be submitted using the report template in This guideline.

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NAFDAC Drug Evaluation & Research (DER) Directorate Guidelines for Clinical Investigation of Medicinal Products in Paediatric Population

Ministry of Health, National Agency for Food and Drug Administration and Control

Nigeria2019HealthOther

The guideline has an overall objective to encourage and facilitate timely paediatric medicinal product development in Nigeria. It provides an outline of critical issues in paediatric drug development and the approaches to the safe, efficient and ethical study of medicinal products in the paediatric population.

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NAFDAC Drug Evaluation & Research (DER) Directorate Guidelines for Clinical trial Application in Nigeria

Ministry of Health, National Agency for Food and Drug Administration and Control

Nigeria2019HealthOther

These guidelines are for the interest of the general public and in particular individuals and organizations intending to conduct clinical trials in Nigeria. This document emphasizes that no person shall import, procure or manufacture a drug product, cosmetic or medical device for a clinical test in Nigeria unless he is a holder of a valid clinical trial approval and the trial is to be conducted under the terms of the approval and the provisions of any regulations in force.

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NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines for Renewal of certificate of registration for Imported Medical Devices in Nigeria

Ministry of Health, National Agency for Food and Drug Administration and Control

Nigeria2019HealthOther

These guidelines are intended to guide the technical and other general data requirements when applying for renewal of product licenses for imported medical devices. It outlines the process to be followed and the technical requirements to be met before a product can be placed on the Nigerian market.

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Guidance Document for Submission of Application in the Common Technical Document format - Vaccines for Human Use

Ministry of Health, National Agency for Food and Drug Administration and Control

Nigeria2019HealthOther

This guideline is technically and structurally inspired by Health Canada�s guidance document on harmonized requirements for the licensing of vaccines and guidelines for the preparation of an application and the World Health Organization (WHO) working document on vaccine prequalification dossier. This guideline document has been developed in pursuance of the National Agency for Food and Drug Administration and Control (NAFDAC) Act Cap. N1, LFN 2014 and made to provide guidance to applicants on the organization of information to be provided to the agency in seeking marketing authorization for Vaccines for human use. The document applies to all vaccines to be authorized for human use, regardless of where they are manufactured.

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Food Irradiation Regulations 2019

Ministry of Health, National Agency for Food and Drug Administration and Control

Nigeria2019HealthOther

These regulations apply to foods processed by ionizing radiation that is used in conjunction with applicable hygienic codes, food standards and transportation codes, manufactured, imported, exported, distributed, advertised, sold or used in Nigeria. The document provides information on the general requirement for food treatments, radiation sources, absorbed dose, facilities and control of the process, the wholesomeness of irradiated foods, packaging, quality assurance, inspection, re-irradiation, labelling, trade-in irradiated foods, importation, exportation, penalty, and forfeiture after conviction

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