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《药品生产许可证》是药品生产企业合法与否的证明文件,也是药品行政部门实施监督管理的重要手段。现行版《药品生产企业许可证》是国家药品监督管理局2000年印发并投入使用的,至今已经使用了近二年时间。与以往版本的许可证相比,现行版本更为客观、全面地反映了企业的信息,为药品监督管理部门了解企业情况提供了可靠的资料。但是,在具体操作过程中,同样反映出一些问题,特别是
“Drug production license” is the legal documents or drug-producing enterprises, but also the implementation of the administrative department of medicine an important means of supervision and management. The current version of the “Drug Manufacturer License” was issued and put into use by the State Drug Administration in 2000 and has been in use for nearly two years. Compared with the previous version of the permit, the current version is more objective and comprehensively reflecting the information of the enterprise, providing reliable information for the drug regulatory department to understand the situation of the enterprise. However, during the specific operation, some problems are also reflected, in particular