Egypt - Obtain Clinical Trials Letter of Approval

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Procedure

Apply In-Person:

1. To Obtain Clinical Trials Letter of Approval in person, the applicant has to approach the Ministry of Health and Population.
2. Information related to the respective office and License authority can be obtained from the “Office locations and contacts” section of this page.
3. Applicant must obtain the application form from the relevant department.
4. Documents that are needed for this procedure are mentioned under “Required Documents” section of this page.
5. Payment of appropriate fees should be made and that can be found under the "Fees" section of this page.
6. Submit the completed forms along with the supporting documents at the respective office.
7. Submit the payment receipt to the respective offices for processing of the licensing application process to begin.
8. Applications will be reviewed according to Standard Operating Procedures of the Unit.
9. 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.
10. 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
11. Confidentiality will be maintained at all times during review.
12. The decision will communicate to the applicant within 30 working days of the receipt of a complete and valid application
13. When an application for a Clinical Trial is accepted, an acknowledgement of receipt will be issued with a reference number for each application.
14. In the case of rejection, the applicant may appeal and provide additional information to satisfy requirements.
15. 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

• Application to the registrar
• 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
• 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 Health and Population
Address: 3 Magless El Shaabst
Phone no: 27951821
Fax: 27953966 - 27922904
E-mail: [email protected]
Website 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

• The whole process is usually completed after a period of 30 days.

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.gIn 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-coordinating investigator (for multicentre trials in Egypt)
• Principal investigator (for multicentre trial)
• Organizations 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 MOHP Board 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.

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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