Nigeria - 2019 - Health

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, Nigeria

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.

Process Flow

Department of Drug Evaluation and Research

Office of the Director General NAFDAC

Office of the Permanent Secretary, Ministry of Health

Office of the Minister of State for Health

Office of the minister for health

Federal Executive Council

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

January 2022

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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