OVERVIEW OF THE DIRECTORATE

The Vaccines, Biologics, and Medical Devices Registration and Regulatory Affairs (VBMR&R) Directorate was created out of the Drug Registration and Regulatory Affairs (DR & R) Directorate. The Directorate has the responsibility for the registration of human and veterinary vaccines, biologics, and medical devices including in vitro diagnostics. 

Core functions of the Directorate include: 

1. Undertake the registration of vaccines, biologics, and medical devices including In Vitro Diagnostics.
2. Develop regulations, and guidelines for the regulation and control of vaccines, biologics, and medical devices including In Vitro Diagnostics.
3. Issue guidelines, grant approvals, and monitor the advertisement of vaccines, biologics & medical devices including In Vitro Diagnostics in approved media.
4. Acts as the lead for the NAFDAC Committee for Vaccines and Biologics.
5. Grant market authorizations such as permits for service medical devices and Emergency Use Authorization for vaccines and In Vitro Diagnostics in exceptional circumstances in the interest of public health
6. Organize stakeholder engagements and training for relevant stakeholders to enable regulatory compliance. 

The Directorate comprises the following three (3) Divisions and the Office of the Director: 

1. Vaccines and Biologics Registration Division.
2. Medical Devices and In Vitro Diagnostics Registration Division
3. Vaccines, Biologics and Medical Devices Regulatory Affairs and Advert Control Division

Vaccines & Biologics Registration Division – is responsible for processing registration applications and variations of all imported and locally manufactured biologics and human and veterinary vaccines. The Division is made up of the following two (2) units; 

1. Vaccines Registration Unit
2. Biologics Registration Unit 

The Division also processes applications for Emergency Use Authorization for vaccines and biologics during health emergencies. 

Medical Devices and In Vitro Diagnostics Registration Division – is responsible for processing applications and variations of all imported and locally manufactured medical devices and in vitro diagnostics. The Division is made up of two units viz:

1. Medical Devices Registration unit
2. In Vitro Diagnostics Registration unit.

The Division also processes applications for Emergency Use Authorization for medical devices and in vitro diagnostics for public health emergencies.

Vaccines, Biologics and Medical Devices (VBM) Regulatory Affairs and Advert Control Division – is responsible for regulation and control of advertisement of vaccines, biologics & medical devices as well as responsibility for drafting and processing of regulations and guidelines for approval.

The Units in the Division are: 

1. VBM Regulatory Affairs Unit
2. VBM Advert Control Unit 

VBM Regulatory Affairs Unit – has the responsibility for drafting and processing regulations and guidelines in collaboration with the Divisions of the Directorate. The Unit is also responsible for drafting Regulatory Directives as applicable to the Directorate.  

Advert Control Unit performs the under-listed functions:

1. Evaluation of advertisement applications. 
2. Assessment of advertisement materials.
3. Monitoring of approved advertisements in the media.  

The Office of the Director has the following Units: 

Technical Office of the Director (TOD) 
This office serves as the interphase between the Directorate and clients, ensuring that all the activities of the directorate are kept running smoothly and seamlessly.

The TOD collaborates with the Divisions of the Directorate to facilitate communication, coordinate activities, provide operational support, and ensure seamless execution of responsibilities. 

Liaison Office of the Directorate (LOD)

The LOD is the gateway for all registration applications submitted via the NAFDAC Product Administration and Monitoring System (NAPAMS) portal where the applications are checked for correctness, completeness, and adequacy before they are subsequently moved to the appropriate Division(s) for further processing.

The LOD also supports the Directorate with the provision of technical write-ups, development of briefs, presentations, and communication with both internal and external interested parties. 

In line with the Agency’s mantra of being customer-focused, the LOD maintains excellent customer service relations through the Directorate online channel (bvmregistration@nafdac.gov.ng)  to attend to all inquiries, applications, and requests; ensure prompt and timely resolution of complaints and communication of necessary approvals and documents.

Quality Management System (QMS) Office:

This office is responsible for the establishment, maintenance, and improvement of the quality management system of the Directorate. The office is also charged with coordination of reports of activities of the Directorate and ensuring operational compliance with approved procedures.