Namibia

Namibia Medicines Regulatory Council (NMRC)

Government of Namibia

REC or IRB responsible for ethical assessment of clinical trial applications?
Ministry of Health

Country
Namibia

Institution website address
http:www.nmrc.na/Portals/15/NMRC%20....

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

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

Medicines Regulatory Authority

Name of the CEO/DIRECTOR/HOD
Dr. Johannes Gaeseb

Gender of the CEO/DIRECTOR/HOD: M

Age of group of the CEO/DIRECTOR/HOD: 31 - 40

Telephone of the CEO/DIRECTOR/HOD
+264 61 203 2403

Email of the CEO/DIRECTOR/HOD
regmeds@nmrc.com.na

Administrator's name or contact person
None

Physical address
Ministry of Health and Sociak Services Namibia Medicines Regulatory Council Harvey Street Windhoek North Windhoek NAMIBIA

Postal address
PRIVATE BAG 13366 WINDHOEK NAMIBIA

MRA - Protocols

What is your preferred manner to receive protocols: All the above

If you have a timetable, please provide this information here
The Medicines Regulatory Authority does not review clinical trial proposals

Application fee is required?: No

Stipulated deadlines for submission of applications?
None

General Information

Which categories of medicines need approval before conducting a clinical trial?: Unregistered medicines, Medical devices and appliances/prosthetics, Food supplements

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

Organizational structure

Year of establishment of the organisation 0000

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

Does your MRA have units or sub-committees? Yes

If yes, please list the committees or sub-committees:
Therapeutics Information and Pharmacovigilance Center. Visit:http://www.nmrc.com.na

Functions

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

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

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. Registration of Drugs, Inspection for Good Manufacturing Practice Standards (GMPS)and Good Distribution Practice Standards (GDPS) 2. Quality Surveillance (Quality Surveillance Laboratory). 3. Registration of Drugs

Does your MRA conduct clinical trial audits and monitoring? No

If not, who is responsible for this function?
The National Research Ethics Committee

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)
Ms. Hilma Nangombe Tel: +264 61 2032562 E-mail: hnangombe@gmail.com

Human resources development

Does your organisation have a dedicated budget for research for health? No

Clinical Trials oversight and review are not under the jurisdiction of the Medicines Regulatory Authority (MRA). This function is performed by the Permanent Secretary Ministry of Health , assisted by the Research Unit.