Ethiopia - Apply for Drug Clinical Trial

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Procedure

Apply In Person

1. To Apply for Drug Clinical Trial, the applicant has to approach the Ministry of Food Drug Administration link
2. The applicant has to get the form from the administration office.
3. The applicant has to fill-in all the necessary details in the form.
4. When an application for a Clinical Trial is accepted, an acknowledgement of receipt will be issued with a reference number for application.
5. Applications will be reviewed according to Standard Operating Procedures of the Unit.
6. Each member prior to reviewing the application will declare conflict of interest in the study and should have no financial or personal interests, which could affect their impartiality.
7. The office will investigate the clinical trial site.
8. Confidentiality will be maintained at all times during review.
9. The decision will communicate to the applicant within 30 working days of the receipt of a complete and valid application.
10. In the case of rejection, the applicant may appeal and provide additional information to satisfy requirements.
11. Confidentiality will be maintained at all times during review.
12. All decisions will be communicated to the applicant in writing stating whether the trial has been approved as it is, or if it requires certain corrections or if it has been rejected within 1 Month.

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Required Documents

• Cover letter
• Completed application form
• The Study Protocol
• Patient Information leaflet and Informed consent form
• Investigators Brochure/Package inserts or Investigational Medicinal Product Dossier (IMPD)
• Adequate data and information on previous studies and phases
• Stability data of the investigational product
• GMP certificate of the investigational product from the site of manufacture
• Certificate of Analysis of the investigational product
• Pictorial Sample of the investigational products. This sample should include the text of the labelling to be used
• Signed investigator(s) CV(s) including that of study Pharmacist
• Evidence of recent GCP training of the core study staff
• DSMB Charter including the composition and meeting schedule
• Detailed budget of the study
• Financial declaration by Sponsor and/or PI
• Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to protocol and applicable laws and regulations.
• Indemnity cover for PI and investigators
• Insurance Certificate for the participants
• Copy of favourable opinion letter from the local Ethics Review Committee (ERC).
• Copy of current Practice Licenses for the Investigators and study Pharmacist
• Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable
• Where the trial is part of an international study, sufficient information regarding the other participating countries and the scope of the study in these countries.
• For multicentre/multi-site studies, an addendum for each of the proposed sites including among other things the sites capacity to carry out the study i.e personnel, equipment, laboratory etc.
• Registration at the clinical trial registry at www.ctr. [pharmacyboardkenya.org Link]
• A signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading.
• Payment of fees
• Four bound hard copies of all the above documents
• Signed checklist

Office Locations & Contacts

MINISTRY OF FOOD DRUG ADMINISTRATION
P.O.BOX - 5681
Africa Avenue, near wolosefer, Kirkos sub city,
02/03 kebelle, 02
Airport Rd, Addis Ababa, Ethiopia
Contact - +251-11-552-41-22
Fax: +251115521392 & +25111552411
Business hours:
Mon - Fri: 9AM - 7PM
Email - [email protected]
Contact link
Location link

Eligibility

• Any person Having the disease or health condition being studied are eligible to carry out Drug Clinical Trial.

Fees

• Fee for this procedure has to be paid as per the authority request.

Validity

• The validity for clinical trial is for 1 year.

Documents to Use

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Sample Documents

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Processing Time

• The processing time for this procedure is within one month.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• Applicant must complete the application form before submitting. Incomplete applications will not be accepted.
• Applicant must provide genuine information while applying for this procedure.

Required Information

• Number of sites
• Participants (subjects)
• Age span
• Group of trial subjects
• Gender
• Co-ordinating investigator
• Principal investigator (for multicentre trial)
• Organisations to whom the sponsor has transferred trial related duties and functions
• Principal inclusion criteria
• Scope of the trial
• Trial type and phase
• Design of the trial

Need for the Document

• The most important purpose of source documentation in a clinical trial is to reconstruct the trial as it done for medical health.
• Applicant has to get the document from the clinical trial in food and drug administration.

Information which might help

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Other uses of the Document/Certificate

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e.g. Birth Certificate can be used as proof of identity.

External Links

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Others

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