Burkina Faso

Directorate General of Pharmacy and Drug Laboratories

Government

REC or IRB responsible for ethical assessment of clinical trial applications?
Ethics Committee for Research in Health (ECRH)

Country
Burkina Faso

Institution website address
http://www.dgpml.sante.gov.bf

Organisation Info.

Type of Organisation
National

What is the institutional affilliation of your Organisation
Government, State Ministry of Health

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

Finances

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

From what sources does the research budget come?
National government, Fees for Services

Medicines Regulatory Authority

Name of the CEO/DIRECTOR/HOD
Prof Jean Baptiste NIKIEMA

Gender of the CEO/DIRECTOR/HOD: M

Age of group of the CEO/DIRECTOR/HOD: 41 - 50

Telephone of the CEO/DIRECTOR/HOD
+22670259201

Email of the CEO/DIRECTOR/HOD
jb-nikiema@yahoo.fr

Telephone number: (226) 50 32 46 60/61

Fax Number: Fax : (226) 50 31 44

Country: Burkina Faso

Physical address
Court of the Trypano Department of Health

Postal address
03 BP 7009 Ouagadougou 03, BURKINA FASO

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?: every two months

Stipulated deadlines for submission of applications?
Every Tuesday

Approximately what is the time frame for response to an application?
Two (2) months

General Information

Is the review fee fixed for all applicants or is it negotiable? Yes

If so, please describe the process briefly
A fixed fee of 500,000 FCFA is charged for the review.

Which categories of medicines need approval before conducting a clinical trial?: Unregistered medicines, Registered medicines - Indications(s) and clinical use, Registered medicines - Target patient population(s), Registered medicines - Route(s) of administration, Registered medicines - Dosage regimen(s), Medical devices and appliances/prosthetics, Food supplements

Any other information that you would like to share about your MRA?
Nil

Organizational structure

Year of establishment of the organisation 0000

Does your MRA have a secretariat with a full-time administrator? Yes

Functions

Is your MRA autonomous or semi-autonomous? Semi-autonomous

If semi-autonomous, what is the host authority of the MRA?
Government

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)
1. Clinical trial registry update 2.Clinical trial reviews 3. Inspections 4. Management of notifications for clinical trials

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, Diagnostics, Medical devices, Therapy protocols, 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)
Dr. Bocar Kouyate, Head of the Research Ethics Committee in Burkina Faso

Human resources development

Do any of your MRA members have specialist training and experience in any of the following?: Clinical Trials, Research Ethics, Epidemiology, Statistics

Please indicate if your staff members are given the opportunity to attend the following capacity building trainings regarding the review of clinical trial protocols?: Conferences, Workshops

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

From what sources does the research budget come?: National government, Fees for Services

MRA Information management System

Does your MRA have a comprehensive electronic Information Management System for creation, storage and retrieval of document? No

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:
1. Inadequate financial resources 2. Lack of a computerized system for information mangement 3. Inadquate trianing of staff and MRA mmebers

 Medicines Regulatory Authority Documents
Medicines Regulatory Authority that guide the review scientific and ethical review of clinical trials in Burkina Faso  - (docx, 14.9 Kb)