Kenya

Pharmarcy and Poisons Board

Ministry of Health

REC or IRB responsible for ethical assessment of clinical trial applications?
Experts Committee on Clinical Trials

Country
Kenya

Institution website address
http://www.pharmacyboardkenya.org

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, Other

Finances

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

From what sources does the research budget come?
National government, Fees for Services

Medicines Regulatory Authority

Name of the CEO/DIRECTOR/HOD
Dr. C.K. Koskei

Gender of the CEO/DIRECTOR/HOD: M

Age of group of the CEO/DIRECTOR/HOD: 50 - 60

Telephone of the CEO/DIRECTOR/HOD
+254 20 3562107

Email of the CEO/DIRECTOR/HOD
enquiries@pharmacyboardkenya.org

Administrator's name or contact person
Dr. Edward Abwao

Administrator's name or contact person E-mail
pv@pharmacyboardkenya.org or ct@pharmacyboardkenya.org

Telephone number: +254 20 3562107

Fax Number: +254 20 2413538

Physical address
LENANA ROAD, KILIMANI AREA, NAIROBI

Postal address
P.O BOX 27663, 00506

MRA - Protocols

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

If you have a timetable, please provide this information here
Meetings are held monthly on every first Wednesday of the month

Application fee is required?: Yes

How often are the review meetings?: monthly

Stipulated deadlines for submission of applications?
Three weeks before the scheduled meeting

Approximately what is the time frame for response to an application?
Thirty (30) working days

General Information

Is the review fee fixed for all applicants or is it negotiable? Yes

If so, please describe the process briefly
A fixed fee equivalent USD 1,000 is charged depending on the exchange rates in Kenya

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)
PROTOCOLS SUBMITTED TO PPB, REVIEWED BY ECCT

Organizational structure

Year of establishment of the organisation 1957

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

Does your MRA have units or sub-committees? Yes

Functions

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

If semi-autonomous, what is the host authority of the MRA?
Kenya 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)
RECEIVE, REVIEW AND APPROVE ALL CLINICAL TRIALS APPLICATIONS, MONITOR ALREADY APPROVED PROTOCOLS.

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 external reviewers from across Kenya

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? No

Human resources development

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

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

From what sources does the research budget come?: National government, Fees for Services

MRA Information management System

Does your MRA have a comprehensive electronic Information Management System for creation, storage and retrieval of document? Yes

How is the information you gather stored? Manually,Electronically