When the coronavirus vaccine arrived at the end of 2020, many people were concerned about how a drug such as that was able to successfully make it to market in such a quick time. There were concerns that corners were cut in order to make this possible. Many people thought that this invalidated the efficacy of the drug. The truth is that, while the process was significantly sped up, it was able to happen due to the huge amounts of money that were poured into the process. It raises the wider question of how the drug approval actually works. If you are interested, then it is definitely worth reading the guide that has been created below.

It’s Highly Unlikely

It’s worth pointing out that the approval process can take up to 15 years and can cost a manufacturer around $2.6 billion to actually come to market. While developments in the drug development process have improved, only around 1 in 1000 drugs tested ever make it into commercial use.

It Must Be FDA-Approved

As the Theranos disaster showed, whereby the process went to market before any official FDAapproval, having that official, the government-mandated stamp is an absolute must. Standing for the Drug and Food Authority, they set out a key process all drugs must fulfill before they are given authorization for use.

Pre-Clinical Trials

Drug developers, usually working in hand with big Pharma, first have to develop a new compound. This is something that has been massively helped, along with thanks to the use of particle size analyzers courtesy of malvernpanalytical.com. Once it is created, then the drug has to be tested on animals. This data is then submitted to the FDA, which allows the process to move onto:

Clinical Trials

After animal trials, the trials move to humans. These are known as clinical trials. There are usually three phases to clinical trials. Phase one tests 100 healthy volunteers, phase two tests several hundred healthy volunteers, and phase three tests several thousand healthy volunteers. Each phase tests different parts of the drug for review. This usually takes around three years in total, although, for the coronavirus vaccines, the phases were allowed to overlap, speeding it up.

New Drug Application Review

Once the clinical trials have shown promise, then the drug creator is able to move on to the new drug application review. These three steps include labeling, which makes sure that the correct information is known and communicated about the drug, NDA review, which looks at research, data, and meets with the pharmaceutical sponsor, and facility inspection, which looks at the manufacturing facility itself to make sure that it’s compliant.

Once the drug is on the market, the post marketing and post approval risk assessment phase looks at the drug and sees how it is working in the real world. While most drugs have to follow every step in this way, the vaccines were able to use a fast-track program to significantly speed the process up. It’s likely there will be and already has been further analysis as the vaccines have been used around the world.