企业界与CDE在新药研发中的有效沟通  

Efficient Communication of Industry and CDE in New Drug Development

作　　者：杨志敏 

机构地区：[1]国家食品监督管理局药物审评中心(CDE)审评三部

出　　处：《中国处方药》2010年第6期27-29,共3页Journal of China Prescription Drug

摘　　要：国家食品药品监督管理局(SFDA)药品审评中心(CDE)作为药品审评机构,一直在思索如何与企业界以及各方机构携手,共同推动国内新药临床试验的发展。对CDE以往的工作进行分析发现,如果企业在新药研发过程中能及早发现问题,或者及时与CDE进行交流和沟通,能调整的进行调整,根本不具备研发潜力的可以提早终止研究,对于企业来说可以避免更多的损失,也能从中汲取经验与教训。As the drug review institution, Center for Drug Evaluation (CDE) of State Food and Drug Administration (SFDA), has been thinking about how to work with the industry and various organizations to jointly promote the development of clinical trials of new drug in China. Analysis of the working of CDE in the past shows that, if companies could find problems as early as possible, or exchange and communicate with CDE as soon as possible, modify the trial protocol as soon as possible, terminate those lacking R&D potential, the companies can avoid more losses and learn experiences and lessons.

关 键 词：新药研发 企业界 有效沟通 国家食品药品监督管理局 CDE 药品审评机构 药物创新 新药临床试验 

分 类 号：F203[经济管理—国民经济] F426.72