OVERVIEW OF THE DIRECTORATE

The Drug Registration and Regulatory Affairs (DRR) Directorate was created out of the defunct Registration and Regulatory Affairs (R & R) Directorate. It has the responsibility for registration of human and veterinary drugs & vaccines, biologics, medical devices, cosmetics, household products and agrochemicals. 

Core functions of the Directorate include: 

1. Undertake the registration of drugs, biologics, vaccines, medical devices, cosmetics, chemicals and detergent (regulated products).
2. Draft Regulations, and guidelines for the regulation and control of regulated products.
3. Issue guidelines, grant approvals and monitor the advertisement of drugs, cosmetics, medical devices, chemicals and detergents (regulated products). 
4. Acts as national advisory board for vaccines and biologicals. 
5. Grant Marketing Authorization (Permit for Service Drugs, Emergency use Authorization for Covid-19 Vaccine, Listing Certificate, Certificate of Registration) to Applicants. 
6. Stakeholder engagements/Trainings 

The Directorate comprises of five (5) Divisions and the Office of the Director. The Divisions are: 

1. Drug Registration Division.
2. Drug Advert Control Division.
3. Animal Health & Finished Chemicals Division.
4. Cosmetics & Household Items Division.
5. Biologics, Vaccines & Medical Devices Division. 

Some offices under the office of the Director are; 

1. Regulatory Affairs Unit.
2. E-Registration & Data Management Office (ERDM).
3. 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: 

1. Handling of Post Registration Documentation.
2. Updating of Data of Registered Products on the Database.
3. Printing of Certificates for Registered Products.
4. Issuance of Certificates to Certificates of Products Registration Holders (CPRHs).
5. Customer helpdesk: Responding to all enquiries on Status and data on Registered Products.
6. Serve as SERVICOM Nodal office by liaising with the reforms unit in DG’s office to handle customer concerns.
7. Coordinate Directorate’s Periodic Reports- Monthly, Quarterly & Annual Reports.
8. Managing activities on NAFDAC Automated Products Administration and Monitoring System for Product Registration.
9. 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. 

Liaison Office of the Director (LOD) 
This office serves as the interphase for the Director with staff and clients respectively, ensuring that all the activities of the directorate are kept running smoothly and seamlessly. The LOD comprises of different parts saddled with the responsibilities of ensuring that the wheels of the Directorate are kept lubricated for efficient and effective discharge of her responsibilities. 

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

Global Listing and Service Drug schemes are also operated through this office for ancillary approvals to deserving applications. 

The office also supports the Director through technical write ups, development of briefs, presentations, communications both internally and externally.  

In line with the Agency’s mantra of Customer focused, Agency Minded, this office maintains an excellent customer service relations through her online channels (registration@nafdac.gov.ng or nafdacrr@gmail.com) to all enquiries, applications and requests received, ensure prompt and timely resolutions and communication of necessary approvals and documents. The Administrative office receives and processes all physical documents submission to the Directorate. 

Drug Registration Division is responsible for the registration, issuance of Marketing Authorization (MA) and approvals for post registration variations for both locally manufactured and imported drugs and herbal & nutraceuticals. The Division is made up of 5 units as stated below; 

1. Imported Drugs New Registration Unit.
2. Imported Drugs Renewal Unit.
3. Imported Drugs Variation Unit.
4. Nigeria Drugs Unit.
5. Herbal & Nutraceuticals Unit 

In addition to the core activities, the Division also engages in the following; 

1. Formulation Review
2. Regulatory Review
3. Stakeholders’ engagement
4. Local and International collaboration 

Email: drugregistration@nafdac.gov.ng  

Drug Advertisement Control Division is responsible for regulation and control of advertisement of drugs, herbal medicines, cosmetics, medical devices, agro-allied chemicals, and detergents. 

Units in the division are: 

1. Drugs Unit
2. Cosmetics/Medical devices Unit 

Functions of the division are: 

1. evaluation of advertisement application. 
2. assessment of advertisement materials.
3. monitoring of approved advertisement in the media.  

Different types of regulated advertisement medium are: 

1. Electronic: television, radio, online etc.
2. Print: newspaper, magazine, medical journal etc.
3. Out of home: billboard, T-shirt, buses, hand bills, roll–up banner, leave behind etc. 

Email: advertcontrol@nafdac.gov.ng  

Biologics, Vaccines & Medical Devices Division is responsible for processing registration applications and variations of all imported vaccines and Biologics, imported and locally manufactured medical devices. The Division is made up of 2 units viz; 

1. Biologics and Vaccines unit.
2. Medical Devices Unit 

The Division also process applications for Emergency Use Authorization for vaccines and medical devices during health emergencies. 

For more enquiries kindly send an email to  bvmregistration@nafdac.gov.ng 

Cosmetics and Household Products Division is responsible for the registration, issuance of Marketing Authorization (MA) and approvals for post registration variations for both locally manufactured and imported cosmetics and household products. The Division is made up of two (2) units as stated below; 

1. Personal Care Products Unit (Personal Care products include but not limited to; Oral care products, skin care products, Hair care products, makeup products, Perfumes and fragrances).
2. Household Products Unit (Household products include but not limited to; Detergents, Laundry Soaps, Bleach, Surface cleaners, Toilet wash, Air fresheners, Liquid soaps, cleaning agents)  

In addition to the core activities, the Division also engages in in regulatory reviews, in-house capacity building of personnel, formulation review , stakeholders engagement, local and international collaboration. 
Email: cosmeticsregistration@nafdac.gov.ng  

Animal Health Products and Finished Chemicals Products (AHFC) Division is responsible for Registration of Animal Health Products, Pesticides, Bio-pesticides, Fertilisers and Finished chemicals. The Units here are: 

1. Veterinary Drug Unit 
2. Pesticides & Finished Chemicals Unit. 

The division ensures that formulations presented for registration are appropriate and safe to animals, humans and their shared environment in tandem with global best practices. 
Email: animalhealthfc@nafdac.gov.ng  

Service Offerings: Describe the process step-by-step (e.g Registration, permit to import etc).

Registering a pharmaceutical product with the National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria involves several steps. Here’s an overview of the process: 

Application Submission: 

• Prepare all necessary documents for registration, including an application letter following NAFDAC guidelines. 
• Create a profile on Dossier Management System (DMS) and on NAFDAC Automated Product Administration and Management (NAPAMS).  
• Submit Product dossier for pre-submission validation (For Drugs only) on DMS. 
• Submit a completed online application form for accepted Product dossier on NAPAMS. 

Document Verification: 

• NAFDAC verifies the submitted documents within 10 days. 

Facility Inspection and Sampling: 

• Provide relevant information about the facility (for inspection) related to registration and importation of NAFDAC-regulated products. 
• For drug products, this process takes up to 20 days. 

Laboratory Analysis: 

• Submit samples of the product for laboratory analysis when notified by NAFDAC. 
• Laboratory analysis is conducted within 30 days for drug products. 

Dossier Review 

• NAFDAC reviews technical data and information provided in the product dossier within 20 days.  

Final Vetting: 

• NAFDAC reviews all information and data. 

Approval Meeting and Issuance of NAFDAC Registration Number: 

• Within 20 days, NAFDAC holds an approval meeting and issues the Certificate of Registration.