NAFDAC Registration & Regulatory Affairs (R & R) Directorate Quality Guidelines for The Registration Of Pharmaceutical Products for Human Use In Nigeria
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
This document provides guidance for the preparation of regulatory submission for the registration of medicines for human use in Nigeria in line with the widely accepted format and common requirements achieved through the processes of the International Council for Harmonization (ICH) of regulatory requirement for the registration of medicinal products for human use. it provides guidance on the preparation of regulatory submission for pharmaceutical products by providing guidance on the organization and formatting of product dossier, The adoption of the Common Technical Document (CTD) as developed through the ICH processes and adopted by the World Health Organization in the WHO prequalification programme and the West African Health Organization in the promotion of the harmonization of regulatory requirement for the registration medicinal products for human use, elaborate on requirements for active pharmaceutical ingredients (API) and the finished pharmaceutical products, and promotion of a more transparent regulatory system.
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 ⬤
NAFDAC Registration & Regulatory Affairs (R & R) Directorate Quality Guidelines for The Registration Of Pharmaceutical Products for Human Use In Nigeria Current Version
January 2022
This document provides guidance for the preparation of regulatory submission for the registration of medicines for human use in Nigeria in line with the widely accepted format and common requirements achieved through the processes of the International Council for Harmonization (ICH) of regulatory requirement for the registration of medicinal products for human use. it provides guidance on the preparation of regulatory submission for pharmaceutical products by providing guidance on the organization and formatting of product dossier, The adoption of the Common Technical Document (CTD) as developed through the ICH processes and adopted by the World Health Organization in the WHO prequalification programme and the West African Health Organization in the promotion of the harmonization of regulatory requirement for the registration medicinal products for human use, elaborate on requirements for active pharmaceutical ingredients (API) and the finished pharmaceutical products, and promotion of a more transparent regulatory system.
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