Overview of Registration and Regulatory Affairs Directorate.
The Registration and Regulatory Affairs (R & R) Directorate is one of the 13 Directorates in NAFDAC with the responsibility for the registration of all NAFDAC regulated products.
The Directorate comprises of nine (9) Divisions and the Office of the Director.
The Divisions are:
- Regulatory Affairs (RA) Division.
- Imported Drugs (ID) Division.
- Advert Control (AC) Division.
- Drugs and Herbal (DH) Division.
- Biologics, Vaccines and Medical Devices (BVM) Division
- Cosmetics and Household Products (CHP) Division.
- Animal Health and Finished Chemical (AHFC) Division.
- Imported Food and Packaged Water (IFPW) Division.
- Food Products and Others (FPO) Division.
The Regulatory Affairs (RA) Division has the statutory function of drafting and processing the Regulations. The Quality Management System (QMS), Thematic Working Group (TWG) and Immersion activities are domiciled here. The Division comprises of two (2) Units; Regulations (RU) and Good Regulatory Practice (GRP) Units.
The Advertisement Control (AC) Division is responsible for the regulation and control of advertisements of foods, drugs, cosmetics, medical devices, packaged water, chemicals and detergents. There are three (3) Units in the Division namely; Drugs, Biologics, Vaccine and Medical Devices Unit, Food Unit and the Cosmetics Unit.
Imported Drugs (ID) Division is responsible for the registration of all imported Drugs. It comprises of two Units; Unit 1 (China, Europe, Other Asian countries and Africa), Unit II (India, The Americas and Australia).
Drugs and Herbal (DH) Division is responsible for the registration of all drugs made in Nigeria and all Herbal products. The two Units in this Division are; Nigeria Drugs and Herbal Units.
Biologics, Vaccines and Medical Device (BVM) Division is responsible for the registration of all Biologics, Vaccines and Medical Device that are imported or locally manufactured. The three (3) Units in this Division are Biologics, Vaccines Medical Devices Units.
Cosmetics and Household Products (CHP) is responsible for processing all registration for cosmetics and household products. These include the imported and locally manufactured products. The two Units in the Division are Cosmetics and Household Products Units.
Animal Health Products and Finished Chemicals Products Division (AHFC) is responsible for Registration of Animal Health Products, Pesticides, Bio-pesticides, and Finished chemicals. The Units here include Animal Health Products Unit and Pesticide & Finished Chemicals Unit.
Imported Food and Packaged Water (IFPW) Division is responsible for the registration of all imported foods and locally packaged water. It comprises of two Units; Imported Food Unit and Packaged Water Unit.
Food Products and Others (FPO) Division is responsible for the registration of all food products produced in the country. It comprises of three Units to handle applications nationwide.
Office of the Director R & R
The Office of the Director R & R comprises of the following Desks and Unit;
- Small Business Support Desk (SBSD)
- International Desk
- Regulatory Intelligence Desk
- Technical service/Service Drugs Desk
- Global Listing Desk
- Liaison to the Director (LOD)
- NAFDAC Registered Products Automated Database (NARPAD)
Small Business Support Desk (SBSD):
The Desk was created to liaise with Small Businesses (Micro Small and Medium Enterprise; MSMEs) to foster a greater understanding of our procedures and also serve as an enquiry point for clients on regulatory issues. The functions of the Desk include;
- Improving access to information on product registration,
- Promoting productive interaction with stakeholders,
- Providing timely feedback to stakeholders and sectoral groups,
- Clarifying NAFDAC laws and regulations to the regulated industry with a view to bridge the gap between the Directorate and the regulated industry whilst fostering greater collaboration and understanding.
The Desk is also charged with the responsibility of organizing R & R Open days and the NAFDAC Product Registration Outreach (NaPRO) program.
The R & R Open Days provide an opportunity for closer interaction with stakeholder groups to allow for feedback and dissemination of further information.
The NAPRO provides a free advisory service on documentation, labelling, and other requirements to facilitate prompt processing of applications and registration of products with the Agency.
International Desk
The aim of this desk is to build strong, sustained partnerships and to, support regional and international collaboration. It serves as a portal for R & R to leverage on global best practises in the discharge of its regulatory functions whilst driving international collaboration and harmonization.
Regulatory Intelligence Desk
The Desk was created to keep the Directorate informed about regulatory decisions in other jurisdictions that may have the potential to impact public health. The desk gathers and analyses publicly available regulatory information and communicates the implications of the information on our regulatory processes.
Liaison to the Director (LOD)
The LOD is responsible for receiving all applications for registration of regulated products and forwarding to relevant Divisions for further processing.
NAFDAC Registered Products Automated Database (NARPAD)
The functions of NARPAD include;
- Collating and keeping data on all registered products in an automated database accessible electronically to designated users,
- Printing and issuing registration certificate,
- Attending to issues involving registration status and other enquiries from stakeholder.
