Nigeria

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)

Country
Nigeria

Institution website address
http:www.nafdac.gov.ng

Organisation Info.

Type of Organisation
National

What is the institutional affilliation of your Organisation
Government

What is the operational language(s) of your MRA/DRA?
English

Finances

Does your organisation have a dedicated budget for research for health?

From what sources does the research budget come?
National government

Medicines Regulatory Authority

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
+234-9-6718008,

Email of the CEO/DIRECTOR/HOD
nafdac@nafdac.gov.ng

Administrator's name or contact person
DR. PAUL ORHII

Administrator's name or contact person E-mail
nafdac@nafdac.gov.ng

Telephone number: +234-9-6718008,

Physical address
NAFDAC , PLOT 2032, OLUSEGUN OBASANJO WAY, WUSE ZONE

Postal address
LAGOS HEAD-OFFICE 3/5 OSHODI EXPRESSWAY, OSHODI LAGOS Telephone : 01-4524259, 01-4524270, 01-4731018

MRA - Protocols

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?
Three months

General Information

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.

Organizational structure

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

Functions

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?
Local

Which of the following pharmaceutical products require your MRAÂ’s 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

Human resources development

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

MRA Information management System

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.