GMP stands for Good Manufacturing Practice, and it is that part of quality assurance that ensures that products are consistently manufactured and controlled to the standards appropriate for their use and as required by their marketing authorization.

A GMP Inspection of manufacturing facilities is conducted to assess compliance with the requirements of Good Manufacturing Practice (GMP) as prescribed in the relevant regulations and guidelines. For DER Directorate, GMP inspections are conducted to assess compliance with the requirements of the Good Manufacturing Practice for Medicinal Products Regulations 2021, NAFDAC GMP Guidelines for Pharmaceutical Products 2021, NAFDAC GMP Guidelines for Cosmetics Products 2021 and NAFDAC GMP Guidelines for Herbal Medicinal Products 2022.

DER Directorate regulates the manufacture of human drugs, human biologics, herbal medicines, nutraceuticals, cosmetics, and medical devices.

Manufacture of both orthodox pharmaceuticals and herbal medicines can only be manufactured in premises that meet the minimum GMP requirements for the type of product intended. Residential buildings do not meet these requirements.

A newly established pharmaceutical manufacturing facility will require a Pre-Production inspection followed by a Pre-Registration inspection.

A Pre-Production inspection is an inspection performed before commencement of production activities to assess adequacy and compliance of intended facilities, equipment, personnel, and systems with requirements for the manufacture of the product line of interest. A satisfactory outcome of a Pre-Production Inspection leads to issuance of an Authority to Manufacture or manufacturing authorization for the intended product line e.g. oral solid dosage form, oral liquid dosage form, small volume parenteral and external semi-solid product lines.

A Pre-Registration Inspection is conducted after issuance of the Authority to Manufacture. The manufacturing lines are expected to be operational during this inspection and all aspects of GMP are assessed. This inspection is a prerequisite before product registration and applies only pharmaceutical products. The outcome of the inspection leads to recommendation for issuance of marketing authorization for the products of interest.

According to the NAFDAC policy on establishment of new pharmaceutical manufacturing facilities in Nigeria, it is mandatory for the layout of every new, retrofitted or remodeled pharmaceutical manufacturing plant to be submitted for review and approval to ensure that proper guidance is provided before the intending pharmaceutical manufacturer proceeds with the construction of a permanent structure and therefore ensure compliance with GMP principles.

It is mandatory for existing manufacturers to notify NAFDAC of their intention to start a new product line. The process requires submission of the layout of new product line for review and a satisfactory review of the submission would necessitate a Pre-production Inspection followed by a Pre-Registration Inspection if the outcome of the former is satisfactory.

According to the NAFDAC Act (Cap N1 LFN 2004), officers of the Agency can enter any premises where regulated products are being manufactured or packaged to carry out their regulatory functions without prior notification of the occupants of the premises. This is usually done by the DER Directorate through unannounced routine inspections.

The contract manufacturing arrangement requires only the intending manufacturer (contract acceptor) to hold a valid manufacturing authorization for the product line of interest.

Deionization removes ions from water to prevent interaction between the ions and ingredients in the product, thereby ensuring consistency and stability of the product.

Permits to import APIs that are narcotics or controlled substances (e.g. psychotropics) are issued by the Narcotics and Controlled Substances Directorate while permits for restricted chemicals and excipients are issued by the Chemical Evaluation and Research Directorate of the Agency. DER Directorate issues permits to import all other APIs.

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.

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.

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.

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.

Clinical trial application can be made by completing the NAFDAC Clinical Trial Application Form on the Electronic Clinical Trial Application Platform (e-CTAP) at this link https://nafdac.smapply.io/ on the NAFDAC website and attaching other relevant documents as reflected in the form.

The processing fees for both Industry sponsored, and Academic sponsored trials can be found on the NAFDAC website.

These are clinical trials sponsored for commercial purposes or any study that the sponsorship is not from the investigator.

Any clinical trial that is sponsored by the trial investigator.

It takes a maximum of sixty (60) working days to review a clinical trial application.

Clinical Trial approval last one year from the date of approval, however, it can be renewed.

Yes, positive Ethical Clearance must be obtained from either your institutional Ethics Review Board (IRB)/Independent Ethics Committee (IEC) or from the National Health Research Ethics Committee (NHREC); where applicable before NAFDAC can grant an approval for CTA. However, the applicant can submit CTA at the same tine to both NAFDAC and Ethics Committee.

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.

Randomized is used to describe a research study that hopes to compare two or more different treatments or procedures. Randomized means that you will be assigned to a study group by chance, like flipping a coin.

A treatment arm is any of the treatment groups in a randomized trial. Most randomized trials have two “arms,” but some have three “arms,” or even more.

A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment’s effectiveness.

To ensure the strongest results, researchers want trial participants to be alike in keyways. Therefore, each study has its own entry criteria that will be clearly stated in the description of the trial.

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.

Before volunteering to participate in the clinical research you should fully understand the research through the inform consent process and endorsed (signature or thumb printing) the informed consent form.

Each clinical study is different because each trial tries to find answers to a specific question. Researchers must follow strict rules to decide who may take part in research. Not everyone with the disease or problem that is being studied can take part in a clinical trial. If your doctor thinks that you might qualify for a study, he or she may ask if you want to take part or you can be approached on a visit to a hospital to participate in a clinical trial.

To be included in a trial, you must agree to take part. You may drop out of a trial at any time, even if you already agreed to participate. Saying no to participating in a clinical trial will not change your standard medical care at the hospital.

If you have questions about participating, you may talk to your doctor or to another doctor who is not a member of the research team about your other choices.

Yes. Whether you are eligible depends on the criteria set for each trial. In some cases, the treatment you had in a prior trial may exclude you from being in a later one using the same or a related treatment. However, being in one clinical trial will not necessarily keep you from being in another one later.

NAFDAC carefully monitor the actual conduct and safety of participants during the trial as well as monitor the careful implementation of the protocols. The Ethical Committees also monitor the conduct of the trial at the site.

Physicians, nurses, sponsors, auditors, and statisticians also monitor clinical trial. This means that different groups are reviewing the safety and progress of each protocol on a regular basis. If any of these groups determine that there is a concern with how the study is conducted, the study will stop.

• You have the right to not take part in a clinical
• You have the right to drop out at any
• You have the right to be given new information about the
• You have the right to ask questions at any time and have them answered as soon as

You also have the responsibility to stay informed during your participation in a study. You should ask questions about anything you do not understand or simply want to know.

You may consider taking part in a study because:

• You may benefit from the best possible treatment or an experimental treatment that would otherwise not be available to
• The physicians and nurses will closely monitor your progress throughout the trial.
• You would be helping researchers to improve the treatments for future patients.

You might consider not taking part in a study because:

• The experimental treatment may not work for you, or it could make your condition
• The experimental treatment may cause side effects that no one
• Your health insurance may not cover research
• If the trial is randomized and includes a placebo (an inactive, dummy pill), you may not be given the experimental
• The amount of testing for efficacy and safety purposes may involve too many trips to the research office and take too much

When deciding whether to participate, you should ask the following questions and you should feel comfortable with the answers:

• If I am ill, will this research help me?
• What are the risks?
• What is involved? What will I have to do?
• Will I be charged anything or compensated for my participation?
• How can I end my participation if I change my mind?
• What will happen when the study is over? Will I be told the results?
• Is the study controversial?
• Whom do I contact to express concerns or obtain information?

Clinical trials test new drugs, devices, or treatments. In many cases, taking part will not cost you anything.

The study informed consent form will describe any costs to you in detail when it is applicable. If the information in the consent form is not clear, you should ask the research team to explain any costs before you sign the consent form.

You are protected first by being told honestly and without bias, what the known and potential risks are for participating in the trial. This information will be submitted to you in a language you will be able to understand. There is an Institutional Review Board (IRB) requirement that every participant in a clinical trial be informed about the possible risks, benefits and available alternatives. All of the information necessary to assist you in determining whether to participate in a clinical trial is provided in a document called the “informed consent document.” This document informs you of how to let the investigator know if you think you are experiencing a problem with the research and what resources are available to help you. You should ask any questions you may have about a clinical trial before signing the informed consent document.

Even after you have signed the informed consent document to participate in a clinical trial, you should always speak to the investigator if you have questions or problems.

In some clinical trials, insurance are provided to cover participants in case of any trial related injury that may be sustain by any participant.

Some studies compensate participants for the time they spent participating in a trial; generally, this amount is given to cover expenses for transportation, meals, and possibly, for lost work time; however, payment may not be substantial enough to constitute inducement to participate for monetary gain.

At the end of a study, the researchers analyse the data that were collected from all participants throughout the study. Findings and data collected about you will be compared to other participants. In clinical trials, doctors and specialists in biostatistics would conduct the analysis and report the findings to scientific meetings and medical journals. Data will also be shared with NAFDAC (responsible for the approval of new drugs, biologics and devices), Ethics Committee and experts. Not all experimental treatments receive final NAFDAC approval in the end.

What happens when the study is over also varies from study to study. Sometimes patients can remain on the study drug if they are responding to the new treatment; however, this is the exception rather than the rule.

Generally, participation ends when the study ends because it might not be safe or effective to continue treatment based on what is known at the time. Clinical trial participants can withdraw from the study at any time without jeopardizing the rest of their standard medical care.

A clinical trial registry is an official platform and catalogue 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 WHO primary registry.