Ghana

Food and Drugs Authority Ghana

Ghana Ministry of Health

Drugs Division

REC or IRB responsible for ethical assessment of clinical trial applications?
Ghana Health Service Ethics Committee & other Institutional Riview Boards (IRBs)

Country
Ghana

Institution website address
http://www.fdaghana.gov.gh/

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

Medicines Regulatory Authority

Name of the CEO/DIRECTOR/HOD
Dr.Stephen K. Opuni

Gender of the CEO/DIRECTOR/HOD: M

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

Telephone of the CEO/DIRECTOR/HOD
+233-302-233200/2351

Email of the CEO/DIRECTOR/HOD
skopuni@fdaghana.gov.gh

Administrator's name or contact person
Mrs. Delese Darko or Mr. Jones Ofosu

Administrator's name or contact person E-mail
mimidarko66@yahoo.co.uk or Jsofosu@yahoo.com or fda@fdaghana.gov.gh

Telephone number: +233-302-233200/2351

Fax Number: Fax: +233-0302-22979

Country: Ghana

Physical address
Independence Avenue Adjacent Latter Days Saint Church, Next to Agric Developement Bank, Ridge Accra, Ghana

Postal address
P. O. Box CT 2783 Cantonments, Accra, Ghana

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?: every two months

Stipulated deadlines for submission of applications?
Not stipulated

Approximately what is the time frame for response to an application?
60 days after the review meeting

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?
The Head of Department on Safety Monitoring-Mrs. Delese Darko is the contact person for Clinical Trial issues. Her e-mail address is: mimidarko66@yahoo.co.uk

Organizational structure

Year of establishment of the organisation 1997

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

Does your MRA have units or sub-committees? Yes