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)
Type of Organisation
What is the institutional affilliation of your Organisation
What is the operational language(s) of your MRA/DRA?
Does your organisation have a dedicated budget for research for health?
From what sources does the research budget come?
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
firstname.lastname@example.org or email@example.com
Administrator's name or contact person
Mrs Mary Mkali
Telephone number: (265) 01 755 634
Off Chilambula Road- Lilongwe, Malawi
P.O. BOX 30241, LILONGWE 3, MALAWI
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)
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
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
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?
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? 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 (firstname.lastname@example.org); College of Medicine Research and Ethics Committee (email@example.com)
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
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
* Regional pages of relevance for your country: Africa