Burkina Faso

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)

Pays
Burkina Faso

URL de l'institution
http://www.dgpml.sante.gov.bf

Informations sur l'organisation

Type d'organisation
National

Quelle est l'affiliation institutionnelle de votre 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

Numéro de téléphone: (226) 50 32 46 60/61

Numéro de fax: (226) 50 31 44 76

Pays: Burkina Faso

Adresse postale
cour de la Trypano face à la DEP/Santé

Adresse physique
03 BP 7009 Ouagadougou 03, BURKINA FASO

MRA - Protocols

Quel est votre mode de réception préféré pour des protocoles: 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

Does your MRA have units or sub-committees? Yes