How to Apply for Clinical Trial in NAFDAC in Nigeria

Apply for Clinical Trial in NAFDAC in Nigeria by yourself

  • To be eligible to participate in Clinical Trials in NAFDAC, applicants must submit an inquiry to Drug Evaluation & Research Directorate of the National Agency for Food and Drug Administration and Control.
  • In the initial step, the applicant must fill out the Application Form to apply for Clinical Trials in NAFDAC (CTAF) which is available on NAFDAC’s official site. NAFDAC.
  • The applicant may also download the application form by clicking on the below link: application form
  • Fill out the application form and provide specific information in the appropriate sections. Sign it and sign it.
  • After completing your application, the candidate must go to any nearby NAFDAC office or Drug Evaluation and Research Directorate which is located on the 1st floor of the NAFDAC Office complex in Lagos and get a payment recommendation to be inspected.
  • Contact information for NAFDAC is available here: contact link
  • Contact information for regional offices are available on the following link: regional offices
  • Then, visit the following link to generate a Remita invoice: [www.remita.netremita website]
  • Follow the instructions on screen and generate an invoice for the payment. Take a printout of the invoice and then visit the closest commercial bank to pay the amount.
  • After the payment has been made after the payment has been made, the person who paid should go to the closest NAFDAC Office or Finance and Accounts Section located on third floor in the NAFDAC Office Complex in Lagos and obtain an official receipt for the payment you made, by showing the receipt of transaction issued by the bank. (scroll up to find the directions and contact information)
  • Then, attach the receipt for payment issued by NAFDAC along with other documents listed under the “Required documents” section on this page, along with the application form that you have completed.
  • Send them all to the Drug Evaluation and Research Directorate within the NAFDAC office complex, or to the closest NAFDAC office, if appropriate to your situation.
  • The application as well as the other supporting documents will be sent to be examined and verified in the necessary procedures.
  • After completing all required steps The applicant will then be notified by email or by phone of the approval.
  • The applicant may contact the office to inquire about the status of their application.

Required Documents For Clinical Trial in NAFDAC

  • Completed CTAF form
  • Documentation of payment
  • Study protocol 
  • Informed consent form
  • Patient Information Leaflet
  • Investigator’s brochure
  • The evidence of agreement between the Investigator and the Sponsor.
  • Accreditation evidence from the Ethics Committee (EC) by the National Health Research Ethics Committee (NHREC)
  • Ethics Committee (EC) Approval from the participating centers
  • Protocol approval minutes
  • Informative Consent Form (ICF) from the Ethics Committee (EC)

Check out the Section 2.5 in the document that follows for further details and specifics: required documents

Note: The required documents checklist is also available on the form for application.

Office Locations and Contacts

NAFDAC Corporate Headquarters,Plot 2032,
Olusegun,
Obasanjo Way, Zone 7,
Wuse, Abuja,
Nigeria.
For inquiries:
0700-1-NAFDAC (0700-1-623322), +234(0)-1-4609750
Email: nafdac@nafdac.gov.ng
Site: homepage link

Lagos Operation Office:
Plot 1, Industrial Estate,
Lagos– OshodiApapa Expressway,
Isolo,
Lagos, Nigeria.

Drug Evaluation & Research Directorate,
1st Floor NAFDAC Office Complex,
Isolo Industrial Estate,
Apapa-Oshodi Express Way,
Isolo, Lagos
E-mail address: der.headquarters@nafdac.gov.ng

Finance & Accounts Section,
3rd Floor,
NAFDAC Office Complex,
Isolo, Lagos.
Regional Offices

What are all the Eligibility

  • Anyone living from Nigeria who wants to purchase, import or produce a drug or cosmetic device in Nigeria to conduct conducting a clinical test, is eligible to apply.
  • The applicant should be aware that a clinical trials should be conducted according to guidelines of the accepted Protocol, Good Clinical Practice (GCP) and the Agency’s requirements.

Fees

Please refer to’section C’ of the document for details on fees: fees details

Validity

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

Documents to Utilize

Application form

Instructions

  • Be aware that all correspondence should be addressed to Director General (NAFDAC) with a to the Director of the Drug Evaluation & Research Directorate. The address is on the “Office Locations & Contacts” section on this page.
  • Make sure that all documents are provided in triplicate along and with 2 electronic copies. extra copies of your application can be required from the Directorate.
  • Candidates are advised to read through the guidelines document prior to proceeding with the application submission process: guidelines

Requirements Information

  • The title of the study as well as Protocol number
  • Version number and the date of the protocol
  • The PACTR number
  • NAFDAC Reg. Number
  • NAFDAC Reg. Number(s) of the comparator drug(s)
  • NAFDAC Reg. Number(s) for concomitant drug(s)
  • Date(s) (s) of NAFDAC approval of the prior protocol(s)
  • The name of the person who sponsored
  • Name of the person who is applying
  • Name of contact person
  • Contact number and address
  • Fax number and cell phone number
  • Email address
  • Information about banks

Documentation is needed

A person is not allowed to purchase, import or manufacture cosmetics, drugs or other medical instrument in Nigeria to conduct an experiment in clinical research in the absence of an approval for a clinical trial granted by NAFDAC.

External Links

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