Gambia

  • Contact Info.
  • Organisation Info.
  • Resources
  • Supplementary Info.

Medicines Board

Medical Research Council, The Gambia

REC or IRB responsible for ethical assessment of clinical trial applications?
The Gambia Ethics Committee

Country
Gambia

Institution website address
http://www.mrc.gm/

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
Mrs Markieu Janneh Kaira

Gender of the CEO/DIRECTOR/HOD: F

Telephone of the CEO/DIRECTOR/HOD
Tel +220 9950777,

Email of the CEO/DIRECTOR/HOD
markieu@yahoo.co.uk

Administrator's name or contact person
None

Telephone number: Tel: (+220) 4495442/

Fax Number: Fax : Administration

Country: Gambia

Physical address
National Pharmaceutical Services, Near Kotu Power Station, Ministry of Health, The Gambia,

Postal address
Medical Research Council PO Box 273, Banjul The Gambia

 

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?: On demand

Stipulated deadlines for submission of applications?
None

Approximately what is the time frame for response to an application?
1-3 months

 

General Information

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

If so, please describe the process briefly
A fixed charge of $1500 is charged

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), Food supplements

Any other information that you would like to share about your MRA?
Application that do not involve use of medicinal products or investigational products (IP) may only need ethical approval

 

Organizational structure

Year of establishment of the organisation 0000

Does your MRA have units or sub-committees? Yes

If yes, please list the committees or sub-committees:
Licensing, Pharmacovigilance & Clinical Trial, Registration

 

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)
Registration of medicines, Inspection of premises, Licensing of persons and Premise, Pharmacovigilance activities, Clinical trials regulation

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

If yes, are the external reviewers local, regional or international?
We receive technical assistance from WHO in joint reviews

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

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)
Medical Research Council, The Gambia

 

Human resources development

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

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, Workshops

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? Electronically

Please list below in rank order the biggest resource constraints on the effective functioning of your MRA:
1. Human Resource 2.Lack of Autonomy hence 3. Lack of dedicated staff and budget. 4.The Head of the MRA is the Chief Pharmacist and Registrar for the MOH and also all other MRA staff are also Government_and playing a dual role. It is therefore difficult to follow timelines and also fully implement regulatory functions. 5. Fees are paid into the National budget and capacity building is not funded by it or supported. 6. The Legislation is also outdated and is presently under review to address gaps e.g regulation of Clinical Trials, creating autonomy, establishment of a QC lab and all regulatory functions

 

 

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