National Agency for Food and Drug Administration and Control (NAFDAC).
National Drug Regulatory Authority
Clinical Trial Unit of Regulatory Affairs Directorate
REC or IRB responsible for ethical assessment of clinical trial applications?
Local Institutional Ethics Committee (IEC)
Institution website address
Type of Organisation
What is the institutional affilliation of your Organisation
What is the operational language(s) of your MRA/DRA?
Does your organisation have a dedicated budget for research for health?
From what sources does the research budget come?
Name of the CEO/DIRECTOR/HOD
DR. PAUL ORHII
Gender of the CEO/DIRECTOR/HOD: M
Age of group of the CEO/DIRECTOR/HOD: 50 - 60
Telephone of the CEO/DIRECTOR/HOD
Email of the CEO/DIRECTOR/HOD
Administrator's name or contact person
DR. PAUL ORHII
Administrator's name or contact person E-mail
Telephone number: +234-9-6718008,
NAFDAC , PLOT 2032, OLUSEGUN OBASANJO WAY, WUSE ZONE
LAGOS HEAD-OFFICE 3/5 OSHODI EXPRESSWAY, OSHODI LAGOS Telephone : 01-4524259, 01-4524270, 01-4731018
What is your preferred manner to receive protocols: Hard copy by mail or by hand
Application fee is required?: Yes
How often are the review meetings?: quarterly
Stipulated deadlines for submission of applications?
No stipulated deadlines, applications are reviewed as they come in.
Approximately what is the time frame for response to an application?
Is the review fee fixed for all applicants or is it negotiable? Yes
If so, please describe the process briefly
An application fee of $ 1350 is charged
Which categories of medicines need approval before conducting a clinical trial?: Registered medicines - Indications(s) and clinical use, Registered medicines - Target patient population(s), Registered medicines - Route(s) of administration, Registered medicines - Dosage regimen(s)
If the responsibility for approval of applications is done by another body, please indicate (you can comment)
Clinical Trial Unit of NAFDAC
Any other information that you would like to share about your MRA?
All clinical trial application are only approved when they meet NAFDAC regulatory requirements and have evidence of favorable opinion from the IRB of the institution that is hosting the trial as well as evidence that such IRB has been accredited by the National Ethics Committee called National Health Research Ethics Committee(NHREC) in Nigeria.
Year of establishment of the organisation 1996
Does your MRA have a secretariat with a full-time administrator? Yes
Does your MRA have units or sub-committees? Yes
Please briefly summarize the major functions of your MRA regarding the regulation and control of the conduct of clinical trials in your country (Expand space as required)
NAFDAC is mandated by law to regulate the conduct of all clinical trials in Nigeria for drugs, vaccines and new chemicals The Agency reviews protocols, authorize the trial and conduct Good Clinical Practice Inspection visits to the approved sites in Nigeria.
Does your MRA sometimes rely on external reviewers to review clinical trials protocols? Yes
If yes, are the external reviewers local, regional or international?
Which of the following pharmaceutical products require your MRAs authorization for use in clinical trials?
Drugs, Traditional & Complimentary Medicines
Does your MRA conduct clinical trial audits and monitoring? Yes
Does your MRA collaborate/coordinate reviews with any local Research Ethics Committees? Yes
If yes, please provide name and email address of the Research Ethics Committee(s)
National Health Research Ethics Committee (NHREC) which is the National Ethics Committee in Nigeria
Do any of your MRA members have specialist training and experience in any of the following?: Clinical Trials, Research Ethics, Epidemiology
Please indicate if your staff members are given the opportunity to attend the following capacity building trainings regarding the review of clinical trial protocols?: Short courses, Conferences, Workshops
Does your organisation have a dedicated budget for research for health? No
From what sources does the research budget come?: National government
Does your MRA have a comprehensive electronic Information Management System for creation, storage and retrieval of document? Yes
How is the information you gather stored? Manually,Electronically
Please list below in rank order the biggest resource constraints on the effective functioning of your MRA:
The staff of the clinical trial unit need to be exposed to latest scientific information in clinical research of new entities especially of Biologics . Exposures can be through internships with a well developed regulatory authorities.