The Drug Approval Process: How a Drug Becomes a Drug

December 21, 2016

For most of us, if we need a medicine, we head to the doctor and pick up a prescription to take to our local pharmacist. We wait for a while, pick up our medicine, and go on about our day. It’s a simple task, and most of us don’t take the time to think about how our medicines made it onto the market in the first place.

So how do medications make it from conception to research to your medicine cabinet?

Step 1 – The Idea

No medicine or treatment plan ever made it onto the market without first starting as an idea, a concept or a problem that needs to be solved. The first step in the drug approval process is to find the problem that needs to be solved or the need that must be addressed.

Once that starting point has been discovered, the next steps can begin.

Step 2 – The Preclinical Phase

This is technically Stage 1 of the drug approval process. The preclinical phase consists of finding promising solutions to the problem that was discovered in Step 1. Much of this phase is completed by standing on the shoulders of those who came before and relying on advances that were already made in order to address a specific need. By breaking down the target, whether that target is disease, virus, cancer or other ailment into its individual parts, it’s easier to determine the next step toward creating an effective drug.

This stage often takes 3-4 years and is the longest stage in the drug approval process. It’s also the stage that will include animal tests, if applicable. This is all dependent on the type of drug being developed and in some cases will not require any testing on animals.

Once a promising solution is found, the next step can begin.

Step 3 – IND Applications

Applying for approval as an IND is the next step in the approval process. IND stands for Investigational New Drug, meaning the drug shows promise but has not yet been approved for full scale clinical trials and tests. There are usually three parties involved in the approval of an IND:

  • The Food and Drug Administration, or FDA
  • The drug’s sponsors and/or investigators
  • An institutional review board

All drugs must be cleared by the FDA before they can be approved for use in human trials. The FDA is in charge of making sure the trial drugs are as safe and effective as can be determined without the use of human subjects. Sponsors and investigators are the individuals and researchers responsible for the initial study. Finally, the institutional review board — an external group — reviews and monitors any research that takes place using human trial subjects.

Once a drug has received its IND application approval, it can move into the clinical trial phases. This is essentially the last step before the drug is approved. In this stage, the drug will be tested to determine if it has the ability to

Step 4 – The Clinical Phases

Clinical trials are split into three phases, each one taking one or more years to complete.

Phase 1 is designed to study the safety of the new drug, as well as the overall pharmacology of the drug itself. Starting with very low doses, the drug is administered to healthy test subjects to determine if it’s safe for human consumption. In some cases, as with drugs being tested to treat a specific illness or ailment, patients who suffer from the target disease may be enrolled in the trial instead of healthy subjects.

If a drug is considered safe enough, it will progress to phase 2.

Phase 2 will determine the overall efficacy of the drug. This phase will almost always include patients suffering from the target ailment to enable researchers to determine the most effective dose, the best delivery method, and then monitor and treat any potential side effects.

Drugs that prove effective without too many side effects will proceed to Phase 3.

Phase 3 allows the researchers to confirm the findings from the previous two phases while utilizing a larger subset of trial subjects. This is the last step required before the researchers seek final approval from the FDA.

Step 5 – Approval

Even after success in the previous 4 steps, the FDA might reject an application. If rejected, the FDA will inform the researchers and explain why.

If the application is approved, the drug can be marketed to the public. Depending on the type and classification of the medication, it will either be marketed as an over-the-counter medication or restricted to prescription only.

The drug approval process is a lengthy one that involves years of dedication to bring an idea or treatment concept to fruition, and it is designed to make sure your medications are safe and effective.

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