국내 개발 신약의 기술개발 소요기간 분석

Analysis of Development Time of New Drugs Developed by Korean Domestic Companies

There are more than 30 new drugs developed by Korean companies, but empirical research on the new drug development process is insufficient. This study aimed to compare the development time for new drugs developed by Korean companies with previous studies on foreign companies. This study defined and analyzed each milestone of the drug development process through a public data source for new drugs approved from 1999 to 2019. The development time before initial human testing was 2.8 years and the time for each clinical development phase were 1.4 year, 2.4 year and 3.1 year, respectively. The result was similar with the previous studies in other countries. In addition, as in the case of previous research, the development time has increased in recent years.