英文版gmp.doc

Contrast Research Report of Domestic and Foreign Drug GMP （5-6）
State Food and Drug Administration Center for Certification of Drug
Beijing 100061
Abstract:
Objective It was a reference for the realization of Chinese pharmaceutical GMP with advanced international standards. Methods After reviewing the implementation of GMP Chinese basic situation, the current situation and characteristics of the international drug GMP were analyzed. The difference of GMP general rule and appendix was compared between China with the European Union, WHO and the United States. The compared results point out the direction of the development and suggestion of the improvement. Results and Conclutions Along with the development of China, pharmaceutical production has been in the world the opportunity to play an important role, it is necessary to absorb and adopt management concept of the advanced country to achieve linking with the international drug GMP. Chinese medicine economy can truly integrated into the international market.[著者文摘]
Key words:
drug; GMP; EU; WHO; USA; contrast research