The diagram describes the process flow for the registration, evaluation, quality control testing, lot release, and post-market surveillance of vaccines and other biological products by the National Agency for Food and Drug Administration and Control (NAFDAC).

The process begins with the client’s application submitted through the Vaccine and Biologicals Monitoring, Registration and Regulation (VBMR&R) unit on the NAFDAC Product Administration and Management System (NAPAMS). Following submission, permits for the importation of samples are issued where applicable. The submitted documents then undergo review and assessment for completeness and compliance. Where deficiencies are identified, a Compliance Directive (CD) is issued to the applicant for correction before the process can continue.

The Drug Evaluation and Research (DER) Directorate conducts cold chain facility inspection and clinical dossier review to ensure that storage facilities and clinical documentation meet regulatory requirements.

After successful inspection, dossier evaluation, and laboratory testing, the Vaccines, Biologics and Medical Devices Registration and Regulatory Affairs (VBMR&R) Directorate collates all evaluation reports, including inspection reports, laboratory reports, and dossier evaluation reports, and forwards them for approval by the National Advisory Committee on Vaccine and Biologicals (NACVB) and the Food and Drug Registration Committee (FDRC).

Upon satisfactory review and approval, market authorization or registration approval is granted to the importer or Marketing Authorization Holder (MAH).

Following market authorization, joint inspection and sampling activities are also conducted together with the Ports Inspection Directorate (PID) for imported vaccines for lot release purposes.  The Vaccine, Biologicals and Medical Devices Laboratory Services Directorate (VBM-LSD) also carries out laboratory quality control (QC) testing on sampled vaccine samples. For satisfactory samples, a lot release certificate is issued and dispatched to the importer or MAH through the Ports Inspection Directorate. Products that fail inspection or testing requirements are rejected, as evidenced by the issuance of a lot rejection certificate. Forfeiture and destruction procedures are initiated for unsatisfactory samples where necessary. After release into the market, continuous post-authorization surveillance is conducted through Pharmacovigilance (PV) and Post Market Surveillance (PMS) activities to monitor product safety, quality, and performance throughout the product lifecycle.