NAFDAC Registration & Regulatory Affairs (R & R) Director Guidelines for Registration of Imported Drugs, Vaccines and In-Vitro Diagnostics Under WHO collaborative Registration Procedure (CRP)
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 manufacturers/importers of drugs, vaccines and in-vitro diagnostics into the county which have been prequalified by the World Health Organization. This guideline is based on NAFDAC’s regulatory reliance policy on adoption regulatory reliance mechanisms to make regulatory decisions as it relates to the granting of marketing authorization. Clinical trial approval and conduct of Good Manufacturing Practice (GMP) Inspections.
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 for health ⬤
Federal Executive Council ⬤
Contacts
Monica Eimunjeze
Director
National Agency for Food and Drug Administration and Control (NAFDAC)
Moji Adeyeye
Director General
National Agency for Food and Drug Administration and Control (NAFDAC)
Mahmuda Mamman
Permanent Secretary
Ministry of Health
Adeleke O. Mamora
Honourable Minister of State
Ministry of Health
Osagie Ehanire
Honourable Minister
Ministry of Health
Muhammadu Buhari
President of the Federal Republic of Nigeria
NAFDAC Registration & Regulatory Affairs (R & R) Director Guidelines for Registration of Imported Drugs, Vaccines and In-Vitro Diagnostics Under WHO collaborative Registration Procedure (CRP) Current Version
January 2022
These guidelines are for the interest of the general public and in particular manufacturers/importers of drugs, vaccines and in-vitro diagnostics into the county which have been prequalified by the World Health Organization. This guideline is based on NAFDAC’s regulatory reliance policy on adoption regulatory reliance mechanisms to make regulatory decisions as it relates to the granting of marketing authorization. Clinical trial approval and conduct of Good Manufacturing Practice (GMP) Inspections.
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