美国新药技术成熟度评价研究

目的研究提出适合我国新药研发和药品安全管理的技术成熟度评价机制。方法借鉴美国新药研发技术成熟度等级(biomedical technology readiness level,BTRL)评价标准与方法,结合我国新药研发、监管和产业化特点,提出我国成熟度评价等级和指标,并在重大新药创制科技重大专项研发管理中开展探索分析。结果与结论探索建立我国化学药和生物制品技术成熟度评价等级标准,将为我国新药研发科研项目和保障药品安全提供管理与评估工具,为其他行业领域提供参考借鉴。

Research on the Evaluation Method of New Drug Technology Readiness Level in the United States

Objective To generate a technology readiness evaluation mechanism suitable for drug R&D and safety management in China.Methods The evaluation standards and methods of biomedical technology readiness level(BTRL)in the United States are studied and analyzed.Combined with the characteristics of drug discovery,supervision and industrialization in China,the technology readiness level and indicators in China are put forward,and an empirical analysis in the major R&D project of new drug discovery are performed.Results and Conclusion Through the research,the evaluation method of technology readiness level of chemical drugs and biological drugs in China are established.The evaluation method provides management and evaluation tools of scientific research projects,R&D and safety control in China,which also provides reference for other industries.