Nigeria Drug Registration and Approval Process

Nigeria Drug Registration and Approval Process – Overview

The Nigeria Drug Registration and Approval Process is governed by the National Agency for Food and Drug Administration and Control (NAFDAC), the key drug Regulatory Authority responsible for overseeing pharmaceutical product registration in Nigeria.

Established under Decree No. 15 of 1993 and amended by Decree No. 19 of 1999, NAFDAC operates under the National Agency for Food and Drug Administration and Control Act Cap N1, Laws of the Federation of Nigeria (LFN), 2004. This body regulates and controls the manufacture, importation, exportation, distribution, advertisement, sale, and use of drugs in Nigeria, by implementing a rigorous NAFDAC product registration procedure to ensure compliance. The national agency for food and drug administration and control (NAFDAC)  works closely with local pharmaceutical stakeholders to strengthen compliance and safety in the drug approval process.

In addition to NAFDAC, the Pharmaceutical Council of Nigeria also plays a supporting role in regulating the professional practices of pharmacists involved in drug distribution and pharmaceutical regulatory affairs in Nigeria. Their combined efforts help maintain the integrity of the Nigerian pharmaceutical industry.

Medicinal Product Classification in Nigeria 

For the NAFDAC product registration procedure, medicines in Nigeria are classified as follows:

• Prescription-only Medicines
• Over the Counter (OTC) Medicines

Nigeria Drug Registration and Approval Process: Step-by-Step 

The Pharmaceutical Regulatory Affairs in Nigeria covers a detailed process for drug registration and approval. Submitting a new Marketing Authorization Application (MAA) involves the following steps:

A) Six-Step Market Authorization Procedure 

Step 1: Trademark Registration and Approval

 It is mandatory to get a trademark registration done before pharmaceutical product registration in Nigeria. The Ministry of Industry Trade and Investment’s Commercial Law Department is responsible for this step, following the NAFDAC product registration requirement.

Step 2: Dossier Submission & Screening Process

 The application must be submitted along with all the documentation to the NAFDAC for screening, in accordance with NAFDAC product registration guidelines.

Step 3: Import Permit and Label Vetting

 An import permit is issued upon successful screening of documentation and review of supporting documents. Post this, the products are submitted for vetting, a key part of the Nigeria Drug Registration and Approval Process.

Step 4: Submission of Samples for Laboratory Analysis

 After label vetting, samples are submitted for laboratory analysis.

Step 5: Product Approval Meeting

 The products are presented for ‘Approval Meetings’ after the satisfactory review of the dossier, GMP of the production facility, and laboratory analysis, which are essential steps in the Drug Approval Process in Nigeria.

Step 6: Issuance of Notification

 For products approved at the Annual Meeting, a notification of registration is issued. This completes the process of drug registration in Nigeria, and a compliance directive is provided to the applicant.

B) Collaborative Registration Procedure  

It is an accelerated Nigeria drug registration and approval process (for pharmaceutical product registration in Nigeria) under programs such as:

• WHO Prequalification of Medicines Program (PQP)
• West African Health Organization’s joint drug product assessment
• Stringent Regulatory Agencies (SRAs) recognized by WHO

This is achieved through improved information sharing and ensures quicker access to the Nigerian market.

C) Importance of a Local Entity for a Foreign Manufacturer 

The NAFDAC drug registration guidelines mandate the appointment of a local agent/legal representative in Nigeria for foreign manufacturers. This representative plays a critical role in pharmaceutical regulatory affairs in Nigeria, managing all communications with NAFDAC to ensure compliance with local laws and a smooth drug product registration process.

Product Maintenance & Compliance

Pharmaceutical Product Registration in Nigeria – Freyr Expertise 

• Trademark Registration Process
• End-to-end pharmaceutical product registration in Nigeria
• Authorized Local Agent Support
• Nigeria Drug Registration and Approval
• Manufacturing Site Approval Support
• Import License Support
• Regulatory Affairs Consulting
• Pharmaceutical Dossier Preparation and Submission for the NAFDAC registration
• Preparation of Gap Analysis Report and Remediation Plan
• Dossier Compilation and Submission to NAFDAC
• Accelerated Market Entry for Nigeria Pharmaceutical Registration
• NAFDAC product registration & query management till approval
• Pharmaceutical Lifecycle Management Support
• Ad-hoc regulatory affairs consultation

Conclusion 

Understanding the Nigeria Drug Registration and Approval Process is crucial for achieving timely market access in one of Africa’s largest pharmaceutical markets. Whether you're a domestic company or a foreign manufacturer, strict compliance with NAFDAC product registration guidelines and classification requirements ensures regulatory success.

With the right local representation and end-to-end support, companies can effectively navigate pharmaceutical regulatory affairs in Nigeria and accelerate entry into this growing market. Freyr’s extensive expertise in drug registration process helps ensure smooth and compliant product launches.