Malawi

Pharmacy, Medicines and Poisons Board (PMPB)

Ministry of Health, Government of Malawi

Research council of Malawi

REC or IRB responsible for ethical assessment of clinical trial applications?
National Health Science Research Committee (NHSRC)

Country
Malawi

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?

From what sources does the research budget come?
National government

Medicines Regulatory Authority

Name of the CEO/DIRECTOR/HOD
Mr. Aaron Glyn Sosola

Gender of the CEO/DIRECTOR/HOD: M

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

Telephone of the CEO/DIRECTOR/HOD
(265) 01 755 634

Email of the CEO/DIRECTOR/HOD
sosola@malawi.net or agsosola63@gmail.com

Administrator's name or contact person
Mrs Mary Mkali

Telephone number: (265) 01 755 634

Physical address
Off Chilambula Road- Lilongwe, Malawi

Postal address
P.O. BOX 30241, LILONGWE 3, MALAWI

MRA - Protocols

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

Application fee is required?: Yes

How often are the review meetings?: quarterly

Stipulated deadlines for submission of applications?
At Least seven weeks before the scheduled meeting

Approximately what is the time frame for response to an application?
At least three months to get a final decision (approval, pending or rejected)

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)

If the responsibility for approval of applications is done by another body, please indicate (you can comment)
The Clinical Trial Review Committe after approval byy the National Health Science Research Committee

Any other information that you would like to share about your MRA?
Medical devices, medical supplies, traditional medicines and diagnostics are authorized although they are not spelt out in legislation

Organizational structure

Year of establishment of the organisation 1988

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:
1. Pharmacy committee 2. Medicines Committee 3. Inspectorate committee 4. GMP Evaluation committee 5. Education Committee 6. Poisons committee 7. Illegal Drug Handling Committee 8. Clinical Trial Review Committee 9. Finance and Administration Committee

Functions

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

If semi-autonomous, what is the host authority of the MRA?
Ministry of Health; Office of President and Cabinet

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)
Regulation and control of Clinical trials both in human beings and animals (Section 42,43 and 44 of PMPB Act

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 MRA’s authorization for use in clinical trials?
Drugs, Therapy protocols

Does your MRA conduct clinical trial audits and monitoring? Yes

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)
National Health Science Research Committee (dkathyola@gmail.com); College of Medicine Research and Ethics Committee (fmasiye@medcol.mw)

Human resources development

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

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

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