国内外药品GMP对比调研报告(四)

Contrast Research Report of Domestic and Foreign Drug GMP (4)

目的为实现我国药品GMP与国际先进水平接轨提供参考。方法在回顾我国实施GMP的基本情况,分析国际药品GMP的现状与特点,对比我国与欧盟、WHO、美国GMP通则之间存在的差异的基础上,进一步选择无菌药品、原料药和中药制剂研究其GMP附录存在的主要差距。结果与结论对比的结果为探索改进我国GMP附录指明了努力方向。

Objective It was a reference for the realization of Chinese drug GMP with advanced international standards. Methods After reviewing the implementation of the basic situation of Chinese GMP, the current situation and characteristics of the international drug GMP were analyzed. The difference of GMP general rule was compared between China with the European Union, WHO and the United States. In further study to choose drugs Sterile, raw materials and Chinese medicine preparation, the major shortcomings of GMP appendix were studied. Results and Conclutions The compared results point out the direction of the exploration for the improvement of Chinese GMP appendix.