Ethiopia - Obtain Clinical Trials Letter of Approval

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Procedure

Apply In-Person:

1. To obtain a Clinical Trials Letter of Approval the applicant has to approach Ethiopian Food and Drug Authority contact link
2. Application form will be provided, the Applicant has to fill-in all the necessary details in the application form.
3. Applicant must make sure to carry documents that are listed under “Required Documents” section of this page (Both photocopies and originals).
4. When an application for a Clinical Trial is accepted, an acknowledgement of receipt will be issued with a reference number for each 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 reviewers shall be independent of the sponsor, of the clinical trial site and the investigators involved and of persons financing the clinical trial, as well as free of any other undue influence
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. 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 labeling 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

Ethiopian Food and Drug Authority
Africa Avenue, near Wolosefer,
Kirkos sub city, 02/03 kebelle, 02
Tel: +25111-5-524122
Fax: +251115521392 & +25111552411
Contact details link

Eligibility

Any person wishing to carry out a clinical trial in the country should apply to the Board for approval before engaging in such study involving investigational products.

Fees

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Validity

The clinical-trails letter of approval is valid for 1 year.

Documents to Use

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Sample Documents

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Processing Time

Processing time for this procedure is 1 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

An application to conduct a clinical trial is required for any study that intends to use human subjects for the testing of:

• Unregistered medicines, vaccines or medical devices
• Registered medicines where the proposed clinical trials are outside the conditions of approval for registration.
• Indications and clinical use
• Target patient population(s)
• Routes of administration
• Dosage regimens
• Comparative bioavailability trials
• Studies intended to generate data on a product that is registered in Kenya based on foreign generated data.
• Studies to establish Bioequivalence for registration of generic products
• Studies to identify any adverse reactions to one or more medicinal products
• Studies to generate information on the absorption, distribution, metabolism and excretion of one or more medicinal products;
• Or any study that is going to use an investigational product/medicine/device on human beings.
• Post- Marketing clinical trials of registered medicines
  

Required Information

• Number of sites
• Participants (subjects)
• Age span
• Group of trial subjects
• Gender
• Co-ordinating investigator (for multicentre trials in kenya)
• 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 Ethiopian Food and Drug Authority recognizes the importance of Research and Development of new medicines, medical devices or procedures in the attainment of national health, social and economic goals. Clinical research must nonetheless be conducted under conditions that satisfy ethical and scientific quality standards.
• Ethiopian Food and Drug Authority will endeavour to provide a regulatory environment that avoids unnecessary delays in the clinical trial authorization process while providing safeguards for quality, efficacy, and public health.
  

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

Link

Others

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