Nigeria - 2019 - Health

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, Nigeria

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.

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 Investigation of Medicinal Products in Paediatric Population Current Version

January 2022

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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