Nigeria - 2019 - Health

NAFDAC Drug Evaluation & Research (DER) Directorate Guidelines for Labeling of Investigational Medicinal Products

Ministry of Health, Nigeria

Labelling is an important and integral part of the approval of a medicinal product. This also applies to the Investigational Medicinal Product (IMP) in Clinical Trials (CTs). The purpose of regulatory labelling requirements for investigational medicinal products (IMPs) in Clinical Trials (CTs) is to provide added value regarding protection of the subjects, Identification of the IMP, traceability of the IMP, proper use of the IMP, identification of trial and proper documentation of the trial.

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 Labeling of Investigational Medicinal Products Current Version

January 2022

Labelling is an important and integral part of the approval of a medicinal product. This also applies to the Investigational Medicinal Product (IMP) in Clinical Trials (CTs). The purpose of regulatory labelling requirements for investigational medicinal products (IMPs) in Clinical Trials (CTs) is to provide added value regarding protection of the subjects, Identification of the IMP, traceability of the IMP, proper use of the IMP, identification of trial and proper documentation of the trial.

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