Nigeria - Apply for Clinical Trial in NAFDAC

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Procedure

Apply In-Person:

1. To apply for Clinical Trials in NAFDAC, the applicant has to make an application to the Drug Evaluation & Research Directorate of the National Agency for Food and Drug Administration and Control.
2. As the first step, the applicant needs to download the application form for Clinical Trials in NAFDAC (CTAF) which will be available in the official website of NAFDAC.
3. The applicant can also download the form by clicking the link below: application form
4. Complete the application form with required details under relevant sections. Attest it with your signature.
5. After completion of the application form, the applicant should visit anynearest NAFDAC office or theDrug Evaluation & Research Directoratewhich is present in the 1st floor of NAFDAC Office complex in Lagos and collect a payment advice for the inspection.
6. The contact link of NAFDAC can be found below: contact link
7. Address details of regional offices can be found in the following link: regional offices
8. Then, visit the following link to generate a Remita invoice: [www.remita.netremita website]
9. Follow the on-screen instructions and generate an invoice for making the payment. Make a hard copy of the invoice and visit the nearest commercial bank to make the payment.
10. Once the payment is made, the applicant should visit any nearest NAFDAC office or the Finance & Accounts Sectionwhich is in the 3rd floor of the NAFDAC office complex in Lagos and collect an official receipt of paymentthat you made by producing the transaction receipt given at the bank. (scroll up for address and contact links)
11. Now, attach the payment receipt issued by NAFDAC and other documents mentioned in the “Required documents” section of this page, with the completed application form.
12. Submit them altogether to theDrug Evaluation & Research Directorate in the NAFDAC office complex or any nearest NAFDAC office as applicable to you.
13. The application and other documents will be forwarded for required verification and examination processes.
14. On completion of all the necessary processes, the applicant will be notified through phone or email and informed about the approval.
15. Meanwhile, the applicant can also contact the office regarding the application status.
    

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Required Documents

• Completed CTAF form
• Proof of payment
• Study protocol
• Informed consent form
• Patient Information Leaflet
• Investigator’s brochure
• Proof of agreement between the Sponsor and the Investigator
• Accreditation proof of Ethics Committee (EC) by the National Health Research Ethics Committee (NHREC)
• Ethics Committee (EC) Approval from participating centres
• Minutes of the protocol approval meeting
• Informed Consent Form (ICF) from Ethics Committee (EC)
  

Refer the section 2.5 in the following document for more details and specifications: required documents

NOTE: Required documents check list is also found in the application form.

Office Locations & Contacts

National Agency for Food and Drugs Administration and Control - Head Office
Address: Plot 2032, Olusegun, Obasanjo Way, br> Zone 7, Wuse, Abuja,
Nigeria.
Tel: 0700-1-NAFDAC (0700-1-623322), +234(0)-1-4609750
Tel: 0800-1-NAFDAC (0800-1-623322) +234(0)909-763-0506, +234(0)909-763-0507
Email: [email protected]

Website: Link
NAFDAC Regional Contacts:Link

Eligibility

• Any person in Nigeria, who wishes to import, procure or manufacture a drug product, cosmetic or medical device in Nigeria for the purpose of a clinical test, can apply.
• The applying person should be aware that Clinical trial should be conducted in accordance with the approved Protocol, Good Clinical Practice (GCP) and Agency’s requirements.
  

Fees

Please refer ‘section C’ in the following document for fees details: fees details

Validity

The approval shall be valid through the test unless an amendment/modification is made.

Documents to Use

Application form

Sample Documents

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Processing Time

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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

• Note that all the correspondences should be addressed to the Director-General (NAFDAC) with an attention note to the Director of Drug Evaluation & Research Directorate. You can find the address in the “Office Locations & Contacts” section of this page.
• Ensure that all documents are submitted in triplicate with two electronic copies and additional copies of the application form may be requested by the Directorate.
• Applicant are advised to go through the following guidelines document before proceeding to the application lodgement process: guidelines
  

Required Information

• Title of the study and Protocol number
• Version number and date of protocol
• PACTR number
• NAFDAC Reg. Number
• NAFDAC Reg. Number(s) of comparator drug(s)
• NAFDAC Reg. Number(s) of concomitant drug(s)
• Date(s) of NAFDAC approval of previous protocol(s)
• Name of the sponsor
• Name of the applicant
• Name of the contact person
• Address and contact number
• Fax number and cell number
• Email address
• Banking particulars
  

Need for the Document

No person shall import, procure or manufacture a drug product, cosmetic or medical device in Nigeria for the purpose of a clinical test unless he is a holder of a valid clinical trial approval issued by NAFDAC.

Information which might help

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Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

• NAFDAC Good Clinical Practice Guidelines 2020
  
• CLINICAL TRIAL REGULATIONS 2019
  

Others

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