摘要
文章从经济法的视角对我国近年来逐步推行的药品生产质量管理规范(GMP)认证制度进行评析,指出其本身具备的经济法性质,分析其作为一项经济法律手段所存在的问题。并以药品GMP认证为出发点,提出市场经济条件下完善我国现行药事法规体系的设想:改革药品生产准入法律制度、完善药品法法律责任、构建与GMP认证相配套的法律制度和定期修订GMP标准。
This study explored the economy-law effects of the good manufacturing practice （GMP） for drugs in China and presented the limitation of GMP as economic law. Based on the GMP certification for drugs,this study presented some methods to perfect the current pharmaceutical law systems, such as reforming the legal system for the entry of pharmaceutical industry, perfecting the legal duty of Chinese pharmaceutical law,constituting the legal system fit for the GMP certification and revising the GMP norm termly.
出处
《南京医科大学学报（社会科学版）》
2005年第4期309-312,共4页
Journal of Nanjing Medical University（Social Sciences）
关键词
药事法规
GMP
经济法
pharmaceutical law
GMP
economic law
