Nigeria: Drugs

Clinical Trial Data Requirements

Clinical trial documentation requirements are listed in NAFDAC's Regulatory and Registration Directorate: Documentation Guidelines for Clinical Trials in Nigeria. Clinical trial approval is required to import, procure, or manufacture a drug product or device for the purpose of a clinical trial.

The following documents should also be supplied:
-Study protocol.
-Informed Consent Form (ICF).
-Patient Information Leaflet (PIL).
-Investigator's Brochure.
-Evidence of agreement between the Sponsor and the Investigator.
-Evidence of Registration of Institutional Review Boards (IRBs) with the National Health Research Ethics Committee (NHREC).
-Institutional Review Board's (IRB's) approval from participating centers.
-List of members of the IRB.
-Minutes of meeting held to approve the protocol and ICF.
-Evidence to show that the Investigator(s) have undergone basic Good Clinical Practices (GCP) trainings in the last two years.
-Curriculum Vitae of Investigators.
-Sample of all Case Report Forms (CRFs) or Electronic Case Report Forms (e-CRFs) for the study.
-Evidence of insurance coverage for trial participants.
-Name and qualification of the trial monitor.
-List and Charter of the Data Safety Monitoring Board (DSMB).

Additional clinical trial guidelines:
-The sponsor must notify NAFDAC two weeks before a trial begins. 
-Clinical trial studies should be conducted in accordance with the approved trial protocol, NAFDAC-GCP Guidelines, and the Declaration of Helsinki.
-Any changes to the study protocol require approval from the NAFDAC, and must be in line with the Clinical Trial Regulations. 
-NAFDAC GCP inspectors will inspect approved trial sites to ensure the trial is following GCP, and revalidate data obtained from the study.
-Within seven working days of notification, a trial sponsor is required to submit all Serious Adverse Events to NAFDAC. 
-Investigators are required to submit quarterly progress reports on the trial to NAFDAC.
-Investigators must submit a Final Report of the clinical trial for review and comments.
-At the trial's conclusion an announcement will be made whether the product is adequate for market authorization. The Drug Registration Division is formally advised to process the registration application if found adequate.
-NAFDAC will give marketing authorization after a Phase III study or bridging study, but with a directive to conduct a Phase IV trial if there is justification for further review.

 NAFDAC encourages registration of clinical trials on the Pan African Clinical Trials Registry (PACTR). 

Clinical Trial Import Authorization

If a clinical trial application is approved, NAFDAC issues a permit to import the investigational product.

Clinical Trial Timelines

~90 working days.

Clinical Trial Costs

Academic trials (Initiator-sponsored trials):

Imported Drugs, Locally Developed Drugs, Herbal/Natural Medicines (Both Imported and Locally Made)
Application fee: 5,000 NGN
Approval authorization fee: 100,000 NGN

Industrial trials (Industry-sponsored trials):

Imported Drugs
Application fee: 5,000 NGN
Approval authorization fee: 750,000 NGN

Imported Herbal/Natural Medicines
Application fee: 5,000 NGN
Approval authorization fee: 500,000 NGN

Locally Developed Drugs
Application fee: 5,000 NGN
Approval authorization fee: 250,000 NGN

Herbal/Natural Medicines (Both Imported and Locally Made)
Application fee: 5,000 NGN
Approval authorization fee: 50,000 NGN

In-Country Manufacturing Requirements

NAFDAC Guidelines for Establishment of Pharmaceutical Plants in Nigeria are available here.

 

Good clinical practices regulations 2009 found here.

Insurance Requirements

As part of the application to conduct a clinical trial, the applicant must provide evidence of insurance coverage for trial participants.

Liability Policy

According to NAFDAC's Good Clinical Practice Regulations 2009, the institutional ethics committee assesses indemnity or compensation provisions of a trial in the event of death or injury due to the trial.

Precedent (Clinical Trials Approved/Denied in Last 2 Years)

18 clinical trials approved from June 2012 to June 2014.

Product Registration Data Requirements

There are seven primary steps in the product registration process: filing/submission of documents, authentication, issuance of import permit (if imported), submission of samples and dossier, dossier review and vetting labelling, laboratory evaluation, and approval.

"Guidelines for Registration of Imported Drug Products in Nigeria NAFDAC/RR/002/00" outline all requirements related to product registration of imported drugs 

Imported Drugs:

A manufacturer can initiate an application to register a drug. If the manufacturer is foreign, the manufacturer should be represented in Nigeria by a duly registered pharmaceutical company. The representative must submit to the NAFDAC a Power of Attorney or Contract Manufacturing Agreement. The representative will be held responsible for informing any serious hazards newly associated with a product imported or of any criminal abuse of the certificate (which includes importation of falsely labeled, spurious, counterfeited or sub-standard medical products).

The applicant must submit to the Office of the Director (Registration and Regulatory Affairs) a written application that states the name of the manufacturer, generic name of the product, brand name of the product (when applicable), strength, indications, and the application form. Each drug formulation (and dosage) requires a separate application. If the drug product is imported from India or China, the manufacturer must submit evidence that they are licensed to manufacturer drugs for sale in the country of origin (a Manufacturer's Certificate).

Other requirements:
-Evidence that the drug is manufactured according to Good Manufacturing Practices (GMP)
-Evidence the sale of the product is not a contravention of drug laws in that country (i.e. Certificate of Pharmaceutical Product in WHO's format)
-Evidence of trademark approval for the brand name from the Federal Ministry of Commerce in Nigeria
-Copy of current Annual License to Practice as a Pharmacist for the Superintendent Pharmacist issued by the Pharmacists Council of Nigeria
-Copy of current Certificate of Registration Retention of Premises issued by Pharmacists Council of Nigeria
-Comprehensive Certificate of Analysis of the batch of product submitted for registration processing

"Guidelines for Registration of Drug Products and Related Products Manufactured in Nigeria NAFDAC/RR/003/00" outline all requirements related to product registration of drugs and other products manufactured in Nigeria. 

Drugs Manufactured in Nigeria:

An application should be submitted for each drug product and different dosages to the Director (Registration and Regulatory Affairs) stating the manufacturer name, generic name of the product brand name (when applicable), product strength, and indications. Products of limited therapeutic value will not be considered for registration.

Documents required include:
-Evidence of pre-production inspection/Certificate of Recognition issued by NAFDAC.
-Current Certificate of Registration/Retention Premises, issued by the Pharmacists' Council of Nigeria (drugs only).
-Current Annual License to Practice as a Pharmacist issued by the Pharmacists' Council of Nigeria to the Superintendent Pharmacist (drugs only).
-Evidence of PMG-MAN membership (drugs only).
-Two copies of product dossiers in the NAFDAC format.
-Evidence of Approval for brand name from Federal Ministry of Commerce.
-Certificate of Incorporation of the company issued by the Corporate Affairs Commission (except for drugs).
-Comprehensive Certificate of Analysis on the batch of the product for registration from the manufacturer stating name and signature of the analyst.

Product registration does not confer permission to advertise, this requires a seperate approval.

Product Registration Estimated Timeline

~90 working days.

Product Registration Costs

Imported:

Over the Counter Medicines
1,000,000 N + 5% VAT per product

Prescription Medicines
250,000 N + 5% VAT per product

Orphan Drugs
80,000 N + 5% VAT per product

Drug form labeled "FORM D-REG/001"
500 N

Locally produced product:

70,000 N + 5% VAT per product

All fees made payable to the NAFDAC.

Post Registration Labeling Requirements

Outlined by Drug Labelling Regulations 2005, which is available here.

Post Registration Pharmacovigilance Requirements

Information on pharmacovigilance is available on the NAFDAC website here. The National Pharmacovigilance Center (NPC) oversees pharmacovigilance in Nigeria. The pharmacovigilance system in Nigeria is built within the National Medicines Policy (2005). There is also a draft of Good Pharmacovigilance Practice Regulation available here. The government also drafted a Pharmacovigilance Policy, but it is not available and it is unclear if the policy is operationalized.

Adverse Drug Reaction (ADR) forms can be requested from the NPC and completed forms shold be sent to the NPC, the nearest NAFDAC state office, or to a National Advisory Committee member.

More information on pharmacovigilance in Nigeria is available here.

Last Updated

October 20, 2015.