What are the steps of New Drug Development (NDA)?

Sat. 3 Apr 2021

In this article, we try to expand on “steps of New Drug Development” in general to give you an idea of the steps involved in this process and its importance.

In France, six out of 90 volunteers to try a new drug went to the hospital after undergoing clinical trials, and three died of brain death. Indeed, the clinical trial of the drug has now stopped, and the drug company has called all the volunteers to let them know. Also, the French prosecutor’s office has announced that it has started an investigation.

But let’s expand on a few questions here:

  • What are the steps of New Drug Development?
  • What is a clinical trial?”
  • How dangerous can a new drug test be on humans?
  • What laws exist in this field?
  • What basis have they been enacted?
  • Are there ethical issues that can occur during human trials?

Until the twentieth century, there was little control over drugs and treatments.  In 1906, then-President, Theodore Roosevelt, signed the Food and Drug Administration Act.  This newly developed law focused more on chemicals used in food and medicine, such as food coloring.

About thirty years later, the law expanded to regulate food, medicine, and cosmetics.  On the other hand, the discovery of radioactive substances in some cosmetics and the deaths of about 100 people from a toxic substance (sulfanilamide) increased surveillance. In the 1950s and 1960s, the “thalidomide catastrophe” drew the international community’s attention to the importance of monitoring new drugs.  The medical community prescribed Thalidomide to relieve nausea in pregnant women.  Unfortunately, the result of this drug was the birth of thousands of children with disabilities.  After the catastrophe, they banned thalidomide in most countries.

As a result, they strictly monitored any new medicine and treatment supply from the second half of the twentieth century.  Each country has its own rules; of course, the strictest rules apply in the United States (FDA) and the European Union (EMA).

In general, the steps of New Drug Development (clinical trial phases) must be followed for each drug to enter the market:

  • Basic research:

Typically, pharmaceutical companies, universities, and research centers perform basic research with pharmaceutical scientists’ help from various disciplines. These can include pharmaceutical chemistry, biology, pharmacology, and medicine. Notably, they should follow Good laboratory practice (GLP) regulations in this stage.

  • Pharmaceutical drug discovery:

Once the basic research has found its way, the result will be new pharmaceutical research.  With the introduction of the study drug to other researchers, the new study drug enters the following stages of research.

  • Preclinical testing:

In this stage, the active pharmaceutical ingredient is subjected to pharmacodynamics ([PD]; study of the physiological effects of drugs on the body), pharmacokinetics ([PK]; study of the impact of drugs on cells and biological molecules of the body), toxicology tests, and other studies are performed to measure its effectiveness and safety. They perform this research stage on cells cultured in the laboratory or laboratory animals. Of course, it is necessary to carefully examine and obtain the necessary permits to comply with ethical principles.  On average, out of every five thousand drugs that enter this stage, only one drug reaches the final production and licensing stage.

  • First stage clinical trial (Phase I):

At this stage, scientists will test this drug on volunteers.  Candidates must be adults over 18 years of age and in good physical and mental health. Usually, the number of participants in this stage is between twenty and one hundred. Also, they should strictly follow Good Laboratory Practice (GLP) regulations should be from this stage onward.

  • Second stage clinical trial (Phase II):

Scientists will test this drug on patients at this stage to evaluate its effectiveness (Efficacy) and safety.  They will test a total of one hundred to three hundred people at this stage.

  • Third stage clinical trial (Phase III):

Scientists will test this drug on more patients to ensure greater efficacy and safety.  One thousand to two thousand volunteers will participate in the stage.  Scientists usually administer this drug to adults in relatively good health.  They will not admit children, the elderly, the critically ill, and pregnant mothers to trials except in rare and exceptional cases.

After the above steps of New Drug Development, if the results are satisfactory, the drug can enter the market by applying to the regulatory bodies  (FDA, EMA, …) for a Marketing Authorization permit and to be prescribed by doctors. The above steps take about ten years, from the beginning of basic research to the completion of clinical trials.

Once the drug enters the market, the fourth phase of the clinical trial (Phase IV) begins.  At this stage, patients who have used the drug are being followed-up and asked to volunteer with research centers to understand better the side effects (Adverse drug reactions [ADRs] of the drug. Discovering a new drug on the market is very complex and requires strict monitoring, so most drugs that reach the clinical trial stage are relatively safe. Although what happened in France is sad, like any other innovation, research and clinical trials have a percentage of error.


[11:37 a.m., 2021-05-03] Dr. Afsaneh Motamed Khorasani: “داروی جدید چه مراحلی را باید طی کند تا به بازار برسد؟ – BBC News فارسی” https://www.bbc.com/persian/science/2016/01/160117_me_france_failed_drug_clinical_trial.amp




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