1.中欧药品质量受权人制度比较研究.pdf

中、欧药品质量受权人制度比较研究 ＊ 段文海 （广东食品药品职业学院，广州市 510520） 中图分类号 R95 文献标识码 C 文章编号 1001-0408（2011）29-2701-03 摘 要 目的：为完善我国药品质量受权人（QP ）制度提供参考。方法：运用比较法，从QP 的人员模式、资质要求、职责和法律责 任方面对比我国与欧盟的QP 制度，进而提出完善建议。结果与结论：在QP 的人员模式方面，我国为企业负责人本人或下属，而在 欧盟是独立于质量管理者；在资质要求方面，我国由省级药监部门备案，对资质只有原则性要求，而欧盟由国家药监部门授权专业 团体评审，对资质作出了详细规定；在职责方面，我国易与质量管理职责混淆，而欧盟其对药品质量负总责；在法律责任方面，我国 无明确规定，欧盟有明确规定。我国QP 制度的完善方向是改善QP 人员模式，逐步实现QP 职业化；进一步细化QP 资质要求；缩小 质量负责人职责范围，充实QP 职责；建立QP 责任追究制度，引入资格罚。 关键词 中国；欧盟；药品；质量受权人；制度；比较 Comparative Study of the Drug Qualified Person System between China and EU DUAN Wen-hai （Guangdong Food and Drug Vocational College ，Guangzhou 510520，China ） ABSTRACT OBJECTIVE ：To provide reference for the improvement of the drug qualified person （QP ）system in China. METH- ODS ：Using the horizontal comparison ，the QP system was compared between China and European Union （EU ）in respects of the staff model ，qualification requirements and legal responsibilities in order to put forward suggestions. RESULTS CONCLU- SIONS ：In staff model ，QP is enterprise administrator or subordinateness in China while independent of quality administrator in EU. In qualification requirements ，provincial drug administration put on record and set up principle requirement in China ，while state drug administration authorize professional organization to evaluate qualification in detail. In responsibilities ，the responsibilities of QP are easily confused with that of quality management in China ，while QP is responsible for drug quality completely. In legal responsibilities ，there is no definite regulation of QP in China ，while EU has it. The trend of improving the QP system of China is to improve the staff mode of QP in the enterprise ，realize progressively the QP professionalization ；further refine the QP qualifica- tion requirements ；reduce the responsibilities of quality manager ，fill t