The Phases of Developing Pharmaceutical Drugs

With the outbreak of COVID-19 and the need for a vaccine, many people are curious as to why the process takes so long. The reason is that the FDA requires pharmaceutical companies to go through a five-phase process before a drug can go to market. If you’d like to learn more about the phases of developing pharmaceutical drugs, we encourage you to continue reading

Discovery and development

For a real-world example, this first phase of discovery and development is where most labs currently stand in the process of developing a vaccination for COVID-19. In general, this first phase is where preliminary research takes place. Pharmaceutical companies see a need for medicine, and they begin their R&D processes to reach a solution.

Preclinical research

Once a lab has potentially developed a new drug, pharmaceutical companies must begin preclinical research, like tablet hardness testing. The preclinical research phase involves several different testing methods. The FDA requires companies to use what’s called “good laboratory practices” (GLP), which include meeting basic standards such as operating procedures, personnel, clean facilities, equipment, and more. This usually entails working with a pharmaceutical machinery manufacturer to ensure all the equipment is up to standard. The pharmaceutical industry relies on chromatography for development as well as preclinical and clinical research. With lab management software, chromatography workflows work faster, and it’s easier to meet GLP standards and more available for collaboration. Plus, a good lab management system also automates data analysis.

Clinical research

Once the pharmaceutical company feels they’ve developed adequate data and findings, the FDA will decide whether the company can proceed with clinical research. At the clinical research phase, companies will begin testing on individuals, both to ensure safety and to collect further data. Clinical research involves three phases of its own. The first phase includes 20 to 100 volunteers who are healthy, and the study will last several months. As companies collect data, make adjustments to their drug, and test further, each phase involves more participants and longer study durations.

FDA review

After collecting data and going through rigorous studies, companies will submit their findings and proposals to the FDA. At this phase, the FDA will review all the data the company found, safety details, and patent information, and then they’ll decide whether to approve the drug or not. If they do approve the drug, the FDA will work with the company to begin the labeling process. Labeling simply involves stating why the drug was approved and how to use it. If the FDA rejects the information, the company must go back to the drawing board and re-evaluate.

FDA post-market safety monitoring

There are several factors involved in this final phase, but one of the most important is that the FDA will monitor advertising to ensure accuracy. Furthermore, the FDA continues to analyze data and research any complaints involving the drug. If the FDA has any reason to believe the drug is being abused, or companies are price gouging, they have every right to limit drug sales and issue warnings.

From Lab to Production

While the phases above cover research, clinical trials, and FDA review, the production stage is equally critical. High-quality manufacturing—such as capsule filling—must adhere to rigorous regulatory standards to ensure safety and consistency. For example, detailed capsule filling compliance guidelines illustrate how these standards are applied in production.

The first three phases of developing pharmaceutical drugs can take over ten years. Consequently, it only makes sense that the FDA didn’t approve the first submission from a company that claimed to have a vaccination for COVID-19. The FDA takes its job very seriously, and rightfully so—even with the pressure of a pandemic, they won’t rush their process.

See: How To Easily Stay Healthy During COVID