Nigeria - 2016 - Health

NAFDAC Good Clinical Practice Guidelines 2016

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

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of humans. It provides unified standards for the conduct of clinical data in Nigeria. The guidelines describe the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and ethics committees.

Process Flow

Department of Registration and Regulatory Affairs

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 of Health

Federal Executive Council

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NAFDAC Good Clinical Practice Guidelines 2016 Current Version

January 2022

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of humans. It provides unified standards for the conduct of clinical data in Nigeria. The guidelines describe the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and ethics committees.

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