《药品定点生产相关制度研究》（2016）：国家卫计委研究课题

Policy Research on Drug Production Funded by The National Health and Family Planning Commission

该课题旨在研究国外对短缺药品的供应保障机制，为完善中国药品定点生产的相关政策提供参考。本课题主要包括三个部分，第一，探讨药品定点生产的合理性和必要性；第二，梳理国际上对短缺药品的管理模式，包括这些药品的生产、定价、供应、质量等；第三，分析中国当前环境下，如何借鉴国际做法和经验，保障短缺药品的供给；以及探讨药品定点生产的相关法理问题。

This project studies international policies on the supply of shortage drugs, aiming to provide policy references for China in dealing with the matter of shortage drugs. This project includes three parts. First, it explores the rationality and necessities of designating manufactures for the supply of shortage drugs. Second, it conducts a comprehensive review of the management models for shortage drugs globally, including production, pricing, supply and quality control. Third, based on international practices and experience, it offers policy recommendations on supply of shortage drugs and legal issues in China.