Botswana

Drug Regulatory Unit (DRU)

Botswana Ministry of Health

Drug Regulatory Unit

REC or IRB responsible for ethical assessment of clinical trial applications?
Health Research & Development Committee (HRDC)

Country
Botswana

Institution website address
http:www.moh.gov.bw

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

From what sources does the research budget come?
National government

Medicines Regulatory Authority

Name of the CEO/DIRECTOR/HOD
Dr. Sinah Selelo

Gender of the CEO/DIRECTOR/HOD: F

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

Telephone of the CEO/DIRECTOR/HOD
+267 363-2064

Email of the CEO/DIRECTOR/HOD
sselelo@gov.bw

Administrator's name or contact person
Dr. Sinah Selelo

Administrator's name or contact person E-mail
sselelo@gov.bw

Telephone number: +267 363-2064

Country: Botswana

Physical address
Government Enclave, Plot No 54609 Gaborone- Botswana

Postal address
P/Bag 0038 Gaborone Botswana

MRA - Protocols

What is your preferred manner to receive protocols: Hard copy by mail or by hand, by courier

Application fee is required?: No

How often are the review meetings?: On demand

Stipulated deadlines for submission of applications?
Not stipulated

Approximately what is the time frame for response to an application?
Not stipulated

General Information

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)

If the responsibility for approval of applications is done by another body, please indicate (you can comment)
Botswana medicines Board

Organizational structure

Year of establishment of the organisation 1992

Does your MRA have a secretariat with a full-time administrator? No

Does your MRA have units or sub-committees? No

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)
Visit:http://www.sapraa.org.za

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, Therapy protocols

Does your MRA conduct clinical trial audits and monitoring? No

If not, who is responsible for this function?
Food and Drug Regulation (FDA)

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)
Mr. P. Khulumani Email: pkhulumani@gov.bw

Human resources development

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

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

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? No

How is the information you gather stored? Manually,Electronically