简政放权环境下的社会性规制探析——以中国药品准入规制为例  

A Study on Social Regulation amid the Reform of Streamlining Administration and Delegating Government Powers——Taking China's Drug Review Regulation as A Typical Case

作　　者：薛澜[1] 郭薇[2] 乔雪[1] 

机构地区：[1]清华大学公共管理学院,北京海淀100084 [2]中共辽宁省委党校公共管理教研部,沈阳和平110004

出　　处：《中共中央党校学报》2016年第4期34-43,共10页Journal of The Party School of The Central Committee of The C.T.C

基　　金：国家自然科学基金重大项目"新时期中国特色应急管理体系的顶层设计和模式重构"(91224009);国家社会科学基金(青年项目)"政府监管与行业自律互动合作的实现机制研究"(12CZZ052)

摘　　要：简政放权等行政体制改革措施解决了束缚大众创业、万众创新和企业投资经营中的突出问题,大大释放和激发了企业和社会的创造力。但在简政放权过程中,如何保持在公共卫生、环境污染或生产安全等领域中的合理规制成为挑战。怎样适度规制,在激发创新活力与防范安全风险之间取得平衡,成为社会性规制顶层设计中的一个难题。破解这一难题的关键在于不断改进社会性规制,努力实现规制内容、目标、工具的三点均衡,继而通过规制环境的改善促进创新,实现"安全"与"创新"双赢的良性循环。对中国药品准入的具体实例分析也从一个侧面反映了社会性规制均衡的重要意义。Measures of administrative system reform like streamlining-administration and delegating powers have effectively solved the outstanding problems in the mass entrepreneurship and innovation and the enterprises＇ investment management, which helped greatly to release and stimulate the creativity of enterprises and the whole society. But we also see that in the decentralization process, it has become a challenge to maintain appropriate regulations in the area of public health, environmental pollution and production safety. Therefore, a major problem for the top design of social regulations is how to strike a balance between stimulating innovation vitality and prevent security risks with reasonable regulations. The key to solve this problem is to continue to improve social regulation so as to achieve regulation equilibrium of the following three aspects： regulatory contents, targets and regulatory tools. At the same time, continue to promote innovation by improving the regulatory environment to achieve a win- win virtuous circle of ＂security＂ and ＂innovation＂. Specific analysis of drug market access also reflected the great importance of social regulation equilibrium.

关 键 词：社会性规制 规制均衡 药品审评 技术创新 药品规制 

分 类 号：D63[政治法律—政治学]