2018年山东省药品生产和GMP认证许可分析

License analysis of drug production and GMP certification in Shandong Province in 2018

目的对山东省药品生产和药品生产质量管理规范(GMP)认证许可情况进行分析,探讨山东省药品生产企业发展现状和趋势特点,助推产业新旧动能转换。方法对2018年度山东省药品生产和药品生产质量管理规范认证事项的申报、受理和许可数据进行统计分析。结果与结论药品生产申报基本保持稳定,行业保持良好发展态势。企业药品生产质量管理规范申报量增长较大,实质性变更和新认证占有较大比例。新开办企业同比增多,创新药品、重点项目较多。

Objective To analyze the drug production and GMP certification license in Shandong Province,to discuss the current situation and trend characteristics of drug production enterprises,and promote the transformation of new and old kinetic energy of the pharmaceutical industry.Methods Data of declaration,acceptance and licensing of drug production and GMP certification in 2018 were statistically analyzed.Results and Conclusion Declaration of drug production remained basically stable,and the industry was developing well.GMP declaration increased considerably,among which,fundamental changes and new certifications accounted for a large proportion.More enterprises were established than the previous year,and considerable number of innovative drugs and key projects were performed in 2018.