Directorate General of Pharmacy and Drug Laboratories
REC or IRB responsible for ethical assessment of clinical trial applications?
Ethics Committee for Research in Health (ECRH)
Institution website address
Type of Organisation
What is the institutional affilliation of your Organisation
Government, State Ministry of Health
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?
National government, Fees for Services
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
Email of the CEO/DIRECTOR/HOD
Telephone number: (226) 50 32 46 60/61
Fax Number: Fax : (226) 50 31 44
Country: Burkina Faso
Court of the Trypano Department of Health
03 BP 7009 Ouagadougou 03, BURKINA FASO
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?
Approximately what is the time frame for response to an application?
Two (2) months
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?
Year of establishment of the organisation 0000
|Title||Initial||Family Name||Gender||Age||Specialty||Highest academic qualification||No of Years on MRA Board/Council|
|Professor||JB||NIKIEMA||F||41 - 50||Pharmacognosy||Doctoral|
|Professor||JB||NIKIEMA||F||41 - 50||Pharmacognosy||Doctorat|
|Professor||JB||NIKIEMA||F||41 - 50||Pharmacognosy||Doutorado|
|Professor||HB||TIENDREBEOGO||F||31 - 40||Pharmacy||Doctoral|
|Professor||HB||TIENDREBEOGO||F||31 - 40||Pharmacy||Doctorat|
|Professor||HB||TIENDREBEOGO||F||31 - 40||Pharmacy||Doutorado|
|Professor||R||SEMDE||F||41 - 50||Pharmacy (Dosage)||Doctoral|
|Professor||R||SEMDE||F||41 - 50||Pharmacy (Dosage)||Doctorat|
|Professor||R||SEMDE||F||41 - 50||Pharmacy (Dosage)||Doutorado|
|Professor||IP||TIENDREBEOGO||F||50 - 60||Pharmacology||Doctoral|
|Professor||IP||TIENDREBEOGO||F||50 - 60||Pharmacology||Doctorat|
|Professor||IP||TIENDREBEOGO||F||50 - 60||Pharmacology||Doutorado|
|Professor||IT||Pharmacologie||41 - 50||Analytic Chemistry|
|Dr||S||KOUANDA||F||Doctor of Public Health||Doctoral|
|Dr||S||KOUANDA||F||Doctor of Public Health||Doctorat|
|Dr||S||KOUANDA||F||Doctor of Public Health||Doutorado|
|CB||SOMBIE||F||Pharmacogists (Dosage)||Master’s Degree|
Does your MRA have a secretariat with a full-time administrator? Yes
Is your MRA autonomous or semi-autonomous? Semi-autonomous
If semi-autonomous, what is the host authority of the MRA?
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?
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
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
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)