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GMP是药品生产管理规范条例的英文缩写,鉴于药品生产的特殊性、安全性、高效性和优质性,世界各国都把GMP的建设和完善作为本国药品生产管理现代化、科学比的重要内容。我国自1985年《药品管理法》诞生以来,GMP建设得到了一定的发展,其间吸收和借鉴了许多国外有益的东西。但是GMP建设是一个长期的、动态的过程,GMP建设不仅要在内容上,而且更应该在整体上、机制上注重其自我完善和效率的发挥。日本等发达国家在这方面的经验很值得我们借鉴。
GMP is the abbreviation of the Regulations for the Administration of Pharmaceutical Production. Due to the particularity, safety, efficiency, and quality of pharmaceutical production, countries all over the world regard the construction and improvement of GMP as an important part of the modernization and scientific comparison of pharmaceutical production management in the country. Since China’s Drug Administration Law was born in 1985, GMP construction has achieved certain development. During this period, it has absorbed and learned many useful things from abroad. However, GMP construction is a long-term and dynamic process. GMP construction should not only focus on content, but also should focus on its self-improvement and efficiency in its overall and mechanism. The experience of Japan and other developed countries in this area is worth our reference.