Drug Evaluation & Research FAQs
1. What is the fee to be paid for obtaining market authorization for a locally manufactured herbal medicinal product?
The amount payable for obtaining market authorization for a locally manufactured herbal medicine is available in the NAFDAC Approved tariffs. All fees attract 5% value added tax (VAT). This fee includes payment for a Production Inspection.
2. What do I do if the outcome of my factory inspection is unsatisfactory?
You are expected to correct all the non-conformance observations made during the inspection and then apply for a Follow-up Inspection on payment of the appropriate fees which are available in the NAFDAC Approved tariffs. All fees attract 5% value added tax (VAT).
3 What is the procedure for renewal of expired market authorization?
Apply to the Registration & Regulatory Affairs Directorate for renewal of the market authorization. Processing of this application would include payment of the appropriate fees which are available in the NAFDAC Approved tariffs and a GMP Reassessment Inspection. All fees attract 5% value added tax (VAT).
4. What are the requirements for GMP inspection prior to registration of herbal medicines or nutraceutical products?
The minimum requirements are as outlined in the guidance on Requirements for GMP Inspection of Herbal Medicines & Nutraceutical Manufacturing Facilities available here.
5. What is the minimum qualification for a Production Manager in a herbal medicine manufacturing facility?
Persons in charge of production should have a minimum of National Diploma (ND) in a relevant science discipline or provide evidence of licensure by the state or national Traditional Medicines Board.
6. Why do we need to write a disclaimer on our product?
The disclaimer is required by law as provided in the Herbal Medicines and Related Products Labelling Regulations when a manufacturer makes a claim which indicates that the product will affect the function of the body based on historical use. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims as they are not evaluated by NAFDAC.
7. What type of inspections are conducted for pharmaceutical products?
- Pre-Production Inspection
- Pre-Registration Inspection
- GMP Re-assessment Inspection
- Special (Advisory) Inspection
- Follow-Up Inspection
- Routine Inspection
8. What are the tariffs for the different types of regulatory inspections /Audit carried out for pharmaceutical products?
The applicable fees for the different types of inspections are available in the NAFDAC Approved tariffs. All fees attract 5% value added tax (VAT).
9. What is the minimum duration for each of NAFDAC’s Regulatory inspections /audit?
- Pre-Production Inspection (local Manufacturers) – 1-2 days per site
- Pre-Registration Inspection (local & foreign manufacturers) – 1- 3 days per site
- Special (Advisory) Inspection (local manufacturers) – 1- 2 days per site
- Follow-Up Inspection (local manufacturers) – 1-2 days per site
- Routine Inspection (local manufacturers) – 1- 3 days per site
10. What are the requirements for GMP Inspection for pharmaceutical products
The minimum requirements are as outlined in the Requirements for Pre-Production Inspection of Pharmaceutical Manufacturing Facilities available here and Requirements for Pre-Registration Inspection of Pharmaceutical Manufacturing Facilities available here.
11. What is the structural layout for a typical pharmaceutical manufacturing plant?
The requirements for the structural layout of pharmaceutical manufacturing plants are as specified in the Current Good Manufacturing Practice for Medicinal Products Regulations 2009 sections 9 – 10 and as described in the NAFDAC Good Manufacturing Practice Guidelines for Pharmaceutical Products 2016 (Chapter 3). An intending manufacturer may request for a Special (Advisory) inspection through a written application to the Director, Drug Evaluation and Research on payment of appropriate fees for DER Inspectors to visit the proposed site and advise on how to ensure compliance of the site with applicable regulations.
12. What is a GMP Certificate and how is it obtained?
It is a document issued by NAFDAC which attests to the conformity of the manufacturing line(s) used for pharmaceutical or cosmetic products with the relevant GMP standard. It is issued only when the manufacturer is operating at an acceptable level of compliance with NAFDAC GMP requirements on payment of required fees.
13. What is the validity of a GMP Certificate?
The GMP certificate is valid for 2 years.
14. What is required for submission of laboratory samples?
The requirements for submission of laboratory samples are:
- Certificate of Analysis for the product batch
- Product Dossier in CTD format (e-copy)
- Satisfactory GMP status of the manufacturing facility
15. What is clinical research?
Clinical research is research conducted with human subjects, or material of human origin, in which the researcher directly interacts with human subjects. Clinical research helps doctors and researchers to find new and better ways to understand, detect, control, and treat illness. A clinical research study is a way to find answers to difficult scientific or health questions.
16. What is a clinical trial?
If a clinical research study involves testing or studying a drug or medical device to see if it is a safe and effective treatment for people, it is called a “trial.” For example, a clinical trial may test the effectiveness of a new drug for treating Parkinson’s disease.
Many new medicines and drugs are found to work in the researcher’s lab, and to be safe and effective in animal tests. But drugs and devices must be proven to be safe and effective for people before NAFDAC can approve them and doctors can prescribe them to patients. NAFDAC has strict rules that govern how clinical trials are conducted. These rules are designed to ensure the safety of those who participate.
17. What is a protocol?
All clinical studies are based on a set of rules or directions called a protocol. A protocol describes what types of people are eligible to participate in the study; determines the schedule of tests, procedures, medications, and dosages; and sets the length of the study.
18. What are clinical trial “phases?”
Clinical trials of experimental drugs proceed through four phases:
In Phase I clinical trials, researchers test a new drug or treatment for the first time in a small group of normal, healthy volunteers (about 20 to 80) to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II clinical trials, the study drug or treatment is given to a larger group of people (about 100 to 300), including patients with the particular disease, to see if the drug or treatment is effective, and to further evaluate its safety.
In Phase III clinical trials, the study drug or treatment is given to large groups of people (from 1,000 to 3,000), including patients, to confirm its effectiveness, monitor side effects, compare it to other commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV clinical trials are done after the drug or treatment has been approved by the NAFDAC and marketed for public use. These studies continue testing the drug or treatment to collect information about its effect in various populations and gather data on any side effects associated with long-term use.
19. How can I apply for clinical trial in NAFDAC?
Clinical trial application can be made by completing the NAFDAC Clinical Trial Application Form (found on NAFDAC website), writing an application letter to the DG-NAFDAC and attaching other relevant documents (see documentation guidelines on NAFDAC website).
20. What are the Documentation Requirements for Clinical Trial Application (CTA)?
The documentation requirements for a CTA are available here.
21. What are the Processing Fees for CTA?
Please refer to the NAFDAC Approved Tariffs available here
22. What is an Industry sponsor clinical trials?
These are clinical trials sponsored for commercial purposes or any study that the sponsorship is not from the investigator.
23. What is an Academic or Investigator Initiated Clinical trial?
Any clinical trial that is sponsored by the trial investigator.
24. How long does it take to review a Clinical Trial Application in NAFDAC?
It takes a maximum of sixty (60) working days to review a clinical trial application.
25. How long does clinical trial approval last?
Clinical Trial approval last one year from the date of approval, however, it can be renewed.
26. Must I receive Ethical clearance before getting NAFDAC approval of a CTA?
Yes, positive Ethical Clearance must be obtained before NAFDAC can grant an approval for CTA. However, the applicant can submit CTA at the same tine to both NAFDAC and Ethics Committee.
27. What are “blind” or “masked” studies?
In many clinical trials, one group of patients will be given an experimental drug or treatment, while a control group is given either a standard treatment for the illness, or a placebo (a harmless “fake” drug), or no treatment at all.
In a “blinded” or “masked” study, participants do not know whether they are getting the drug being tested, or whether they are in the control group. The goal is to prevent the so-called “placebo effect” from influencing the results of the experiment. The placebo effect is the phenomenon of patients feeling better simply because they think they are receiving a helpful drug or treatment.
Sometimes, clinical trials are “double-blind” or “double-masked.” That means that neither the participants, nor the study staff members, know who is receiving the experimental drug and who is in the control group. Studies are performed in this way so that neither the patients’ nor the doctors’ expectations about the experimental drug can influence the observations and results.
28. Should I volunteer for clinical research?
Clinical research is a vital part of finding new treatments and cures for diseases. Carefully conducted clinical studies are the fastest way to find treatments that are safe and effective. By volunteering for a clinical study, you would be participating in research that may result in a new treatment for a deadly or debilitating disease.
Before you agree to participate in a study, you must be given complete information about the study, known as “informed consent.” Informed consent involves two essential components: a document and a process. The informed consent document gives a summary of the research project (including the study’s purpose, research procedures, potential benefits and risks, etc.) and explains the individual’s rights as a research participant. This document is part of an informed consent process, which consists of conversations between the research team and the participant, and may include other supporting material such as study brochures. The informed consent process provides research participants with ongoing explanations that will help them make informed decisions about whether to begin or continue participating in the research project
29. What is a Clinical Trial Registry?
A clinical trial registry is an official platform and catalog for registering a clinical trial.
NAFDAC requires that all clinical trials conducted in Nigeria must be registered on the Pan African Clinical Trial Registry (PACTR) at www.pactr.org – which is a World Health Organization (WHO) primary registry.
30. How much does it cost to carry out a production inspection for a cosmetic product?
The amount payable for a Production Inspection for a cosmetic product is available in the NAFDAC Approved tariffs. All fees attract 5% value added tax (VAT).Q2.
31. Can water from a borewell be used in the production of cosmetic products?
Only water sourced from a borehole of at least 150ft depth or public mains can be used in production of cosmetics.
32. Why is water treatment plant necessary in the production of cosmetic products?
A water treatment plant is necessary to provide water of the desired quality as the risk of product contamination and product instability is increased when untreated water is used for production.
33. Why must I install a deionizer since the water source I intend to use for cosmetic products manufacture is potable and suitable for drinking?
A deionizer is needed because potable water still contains ions which affect the stability of finished cosmetics products.
34. Must NAFDAC be notified any time a client wishes to manufacture a new pack size of an already registered product?
An application for a pack size extension should be made and approval obtained from NAFDAC before the new pack size is manufactured.
35. Can production of cosmetics products be carried out in a one room facility?
This is permitted for certain categories of products under the Kitchen/Micro Scale Cosmetic Products Manufacturing Scheme. Refer to the guidance document on requirements for the scheme available here.
36. What are the requirements for storage of a product that entails maintenance of a cold chain?
A cold store with adequate facilities for storage of the products at the recommended temperature under the supervision of a competent cold chain officer.
37. What are the requirements for inspection of a cold chain storage facility?
The minimum requirements are as outlined in the guidance on Requirements for Pre-Registration Inspection of Cold Chain Facilities for Storage of Vaccines/Biologics available here.
38. What are the relevant documents that must be in place at a cold chain storage facility?
The following documents should be available at a cold chain storage facility:
- Standard Operating Procedures for the following activities:
- Cleaning of the cold store
- Handling of vaccines
- Product recall
- Product distribution
- Personnel gowning and;
- Preventive maintenance of equipment
- Daily temperature monitoring charts.
- Current certificate of fumigation of the premises.
- Evidence of qualification of the cold store