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 the importance of it.

In France, six out of 90 volunteers to try a new drug went to the hospital after undergoing clinical trials, and three of them died of brain death. Naturally, 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 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, the Food and Drug Administration Act was signed by then-President, Theodore Roosevelt.  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, as well as the deaths of about 100 people from a toxic substance called sulfanilamide, which was claimed to be used as a medical solution, increased surveillance. In the 1950s and 1960s, the “thalidomide catastrophe” drew the attention of the international community to the importance of monitoring new drugs.  Thalidomide was a drug prescribed to relieve nausea in pregnant women.  Unfortunately, the result of this drug was the birth of thousands of children with disabilities.  After the catastrophe, thalidomide was banned in most countries.

From the second half of the twentieth century onwards, the supply of any new medicine and treatment was strictly monitored.  Each country has its own rules, and 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:

Basic research is done by pharmaceutical companies, universities, and pharmaceutical research centers with the help of pharmaceutical scientists from a variety of disciplines. These can include: pharmaceutical chemistry, biology, pharmacology, and medicine. Of note, Good laboratory practice (GLP) regulations should be followed 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 next stages of research.

  • Preclinical testing:

In this stage, the active pharmaceutical ingredient is subjected to pharmodynamics ([PD]; study of the physiological effects of drugs on the body), pharmacokinetics ([PK]; study of the effect of drugs on cells and biological molecules of the body), toxicology tests, and other studies are performed to measure its effectiveness and safety. This stage of research is performed 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, the drug is tested on volunteers.  Candidates must be adults over 18 years of age and in good physical and mental health.  Normally, the number of participants in this stage is between twenty and one hundred. From this stage onward, Good Laboratory Practice (GLP) regulations should be strictly followed.

  • Second stage clinical trial (Phase II):

At this stage, the drug is tested on patients to evaluate its effectiveness (Efficacy) and safety.  At this stage, the drug is tested on one hundred to three hundred people.

  • Third stage clinical trial (Phase III):

The drug is being tested on more patients to ensure greater efficacy and safety.  One thousand to two thousand volunteers will participate in the stage.  Clinical trials are usually performed on adults in relatively good health.  Children, the elderly, the critically ill, and pregnant mothers will not be admitted 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, from the beginning of basic research to the completion of clinical trials, take about ten years.

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 better understand 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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