The Directorate comprises of five (5) Divisions and the Office of the Director.
The Divisions are:
- Drug Registration Division.
- Drug Advert Control Division.
- Animal Health & Finished Chemicals Division.
- Cosmetics & Household Items Division.
- Biologics, Vaccines & Medical Devices Division
Some offices under the office of the Director are;
- Regulatory Affairs Unit.
- E-Registration & Data Management Office (ERDM).
- Dossier Review Team (DRT)
The Regulatory Affairs (RA) Unit has the statutory function of drafting and processing the Regulations. The Division comprises of two (2) Units; Regulations (RU) and Good Regulatory Practice (GRP) Units. RA provides regulatory support to Divisions, Directorates in the Agency as well as the product approval meetings. RA is responsible for compilation of Regulatory Directives.
Email: regulatoryaffairs@nafdac.gov.ng
The eRegistration and Data Management Office has the following responsibilities:
- Handling of Post Registration Documentation.
- Updating of Data of Registered Products on the Database.
- Printing of Certificates for Registered Products.
- Issuance of Certificates to Certificates of Products Registration Holders (CPRHs).
- Customer helpdesk: Responding to all enquiries on Status and data on Registered Products.
- Serve as SERVICOM Nodal office by liaising with the reforms unit in DG’s office to handle customer concerns.
- Coordinate Directorate’s Periodic Reports- Monthly, Quarterly & Annual Reports.
- Managing activities on NAFDAC Automated Products Administration and Monitoring System for Product Registration.
- Serve as super user for R&R Single Window for Trade Portal activities: Clearing Ancillary Approvals, coordinating clearance of all other applications and respond to enquiries on the trade portal.
Email: certificate@nafdac.gov.ng
The Dossier Review Team is the unit responsible for analyzing new drug applications (NDAs) and biologic licensing applications (BLAs) submitted for Market Authorization applications processing.
