Zambia

Pharmaceutical Regulatory Authority

Ministry of Health Zambia

Country
Zambia

Institution website address
http://www.pra.gov.zm

Organisation Info.

Type of Organisation
National

What is the institutional affilliation of your Organisation
Government, State Ministry of Health

What is the operational language(s) of your MRA/DRA?
English

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, Institutional Grant

Medicines Regulatory Authority

Name of the CEO/DIRECTOR/HOD
Dr. E. Mwape

Gender of the CEO/DIRECTOR/HOD: F

Telephone of the CEO/DIRECTOR/HOD
+260 211 220429

Email of the CEO/DIRECTOR/HOD
pharmacy@pra.gov.zm

Fax Number: +260 211 238458

Physical address
Tuleleka Rd off Makushi Rd, Lusaka, Zambia

Postal address
P.o. Box 31890, Lusaka, Zambia

MRA - Protocols

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

Application fee is required?: Yes

General Information

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

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

Any other information that you would like to share about your MRA?
Visit:http://www.

Organizational structure

Year of establishment of the organisation 2004

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?
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. Authorize the importation of medicinal investigational products 2.Evaluation clinical trial applications 3.Supposed to conduct GCP inspections but we are still building capacity in this area, will start soon. 4. Liase with the Ethics Committee

Does your MRA sometimes rely on external reviewers to review clinical trials protocols? Yes

If yes, are the external reviewers local, regional or international?
Currently reviewers are from within MRA. The Medicines Committee approves.

Which of the following pharmaceutical products require your MRAÂ’s authorization for use in clinical trials?
Drugs, Therapy protocols

Does your MRA conduct clinical trial audits and monitoring? No

If not, who is responsible for this function?
Still building capacity, hoping to start clinical trial audits soon

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)
1. Dr J .Munthali, Chairperson of UNZA, Ethics Committee- email:jmunthali@yahoo.com 2. Dr Mwanza, Deputy Chairperson, National Ethics Committee. E-mail: ammwanza@unza.zm

Human resources development

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

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

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

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