- Contact Info.
- Organisation Info.
- Resources
- Publications
- Supplementary Info.
Directorate General of Pharmacy and Drug Laboratories (DGPML)
Government- Ministère de la santé
Ministère de la santé
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
What is the operational language(s) of your MRA/DRA?
Français
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: (226) 50 31 44 76
Country: Burkina Faso
Physical address
cour de la Trypano face à la DEP/Santé
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, E-mail submission
How often are the review meetings?: monthly
Stipulated deadlines for submission of applications?
Tous les mardis (Every Tuesday)
Approximately what is the time frame for response to an application?
Deux mois (Two months)
General Information
If so, please describe the process briefly
Charge is fixed at 500 000 FCFA
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
If the responsibility for approval of applications is done by another body, please indicate (you can comment)
DGPML et CTEC (Comité technique d?examen des demandes d?autorisation d?essais cliniques) (Technical Committee for Review of Applications for Clinical Trials)
Organizational structure
| Title | Initial | Family Name | Gender | Age | Specialty | Highest academic qualification | No of Years on MRA Board/Council |
|---|
| Professor | JB | NIKIEMA | F | 41 - 50 | Pharmacien, Pharmacognosie, DGPML | Doctoral |
| Professor | JB | NIKIEMA | F | 41 - 50 | Pharmacien, Pharmacognosie, DGPML | Doctorat |
| Professor | JB | NIKIEMA | F | 41 - 50 | Pharmacien, Pharmacognosie, DGPML | Doutorado |
Does your MRA have units or sub-committees? Yes
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