How long does it take to develop a new medication?

How long does it take to develop a new medication?  The answer is 12 years, from when the medicine is in the experimental stage to when you can actually purchase the medication at a pharmacy.

Only 1 in 5000 medications that is ever invented progresses to the point of being tested on humans.

In the United States, the FDA (Food and Drug Administration) is in charge of the approval process.

Before a medication can be in a Clinical Trial, the first step is an application with the FDA.  This information has to include the chemical structure of the new medicine, how it is thought to work, any toxic effects found on animal studies, and how the medication will be manufactured.

The medication then enters into Phase I Clinical Trial, where it is tested on between 20 to 80 healthy volunteers.  This process takes about a year.

Next is Phase II Clinical Trials.  This is where the medication is used for testing on patients who have the actual disease the medicine is going to be used for.   This testing is done on 100-300 volunteer patients and takes about 2 years.

Next is Phase III Clinical Trials, and includes 1000 to 3000 patients in clinics and hospitals.  Patients are watched closely for any side effects.  Some patients are put on a sugar pill, or placebo, to compare the effects compared to the study medication.  This stage takes up to three years.

Then, all of this information is submitted to the FDA in a New Drug Application.  This consists of all of the results of all of the Trials.  If the FDA then approves the drug it can go to marketing.  The approval process can take over two years.

In Phase IV, continued information is collected from patients who are on the medication.

In the United States, the average cost of getting a single new medication to market during this process is $2.5 billion dollars.


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