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 the purpose of a clinical test in Nigeria unless he is a holder of a valid clinical trial approval and the trial is to be conducted in accordance with 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 ⬤

Contacts

Approver

Ijeoma U. Nwankwo

Director

National Agency for Food and Drug Administration and Control (NAFDAC)

Approver

Moji Adeyeye

Director General

National Agency for Food and Drug Administration and Control (NAFDAC)

Approver

Mahmuda Mamman

Permanent Secretary

Ministry of Health

Approver

Adeleke O. Mamora

Honourable Minister of State

Ministry of Health

Approver

Osagie Ehanire

Honourable Minister

Ministry of Health

Approver

Muhammadu Buhari

President of the Federal Republic of Nigeria

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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 the purpose of a clinical test in Nigeria unless he is a holder of a valid clinical trial approval and the trial is to be conducted in accordance with the terms of the approval and the provisions of any regulations in force.

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