Drug Information Q&A Q33. How many years does it take to develop a single drug?
Answer
It is said that it takes 9 to 17 years to develop a single drug. It is very difficult to develop a drug successfully, as most of the candidate substances studied are abandoned at some stage in the development process.
Explanation
Drugs are developed through the following stages
(1) Basic research (2-3 years)
Research is conducted to create candidate compounds and investigate their potential by extracting them from natural materials (plants, animals, minerals, etc.) and using various scientific technologies such as chemical synthesis and biotechnology. The chemical structures of new candidate substances are investigated, and screening tests are conducted repeatedly to select the best candidates. Recently, genome information is also being utilized.
(2) Non-clinical trials (3-5 years)
The efficacy and safety of new substances that have the potential to become drugs are confirmed using animals and artificially grown cells for testing.
We also observe how the substances are absorbed and distributed in the body, what effects they have on the body and how they are excreted outside the body, and conduct tests on the quality and stability of the substances themselves.
(3) Clinical trials (3-7 years)
Clinical trials are conducted to determine whether a drug candidate that has passed preclinical trials is effective and safe for humans (see Q34).
Clinical trials are divided into three stages.
(4) Application for approval and review (1-2 years)
Once the efficacy, safety, and quality of the drug have been proven, an application is filed with the Ministry of Health, Labour and Welfare (MHLW) for approval.
The MHLW requests the Pharmaceuticals and Medical Devices Agency (PMDA) to review the application, and once the application has passed the review, the Pharmaceutical Affairs and Food Sanitation Council, composed of academic experts and others, deliberates on the application, and once the MHLW grants approval, the drug can be manufactured and sold as a pharmaceutical product.
As described above, it takes a long time and costs a lot of money to develop a drug, from basic research to manufacturing and marketing. Compared to the past, the time required for research and development tends to get longer every year.
Chart/Column
33｜Process and Duration of New Drug Development
The development of a new drug requires 9 to 17 years and a large amount of R&D expenses.
Source: "Tekisutobukku Pharmaceutical Industry 2012.
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