Asian Journal Of Social Pharmacy

Abstract: Objective To identify technical risks in the process of innovative drug development, and to provide reference for technical risk management so as to reduce the uncertainties and improve the efficiency of research and development. Methods The initial risk index was investigated by literature research. Then, the Likert scale was used to design a questionnaire, and the experts’ opinion was used to analyze the risk factors affecting the different stages of the development of innovative drugs in China. Results and Conclusion Based on the analysis of questionnaire, 31 risk indicators of five key stages in the development of innovative drugs from drug discovery to marketing authorization were established. The key risk indicators constructed in this study can provide reference for technology-related risk management in the process of innovative drug development.

Key words: innovative drug development, technology risk, risk management