【摘要】 开展仿制药质量和疗效一致性评价对于提升我国制药行业整体水平,保障药品安全性和有效性,增强国际竞争能力,具有十分重要的意义。通过汇总国家食品药品监督管理总局(CFDA)政府网站基础数据库、中国食品药品监管数据中心信息平台数据,对2018年底前通过一致性评价的品种目录的总体情况、药品品种数量构成情况、涉及生产企业构成情况、药品剂型情况、符合有关鼓励政策的生产企业情况等药品行政许可数据进行分析,为相关医药行业和监管部门提供借鉴和参考。更多还原

【Abstract】 It is of great significance to carry out the evaluation of the quality and efficacy of generic drugs to improve the overall level of the pharmaceutical industry in our country,to ensure the safety and effectiveness of drugs,and to enhance the international competitiveness. Through the summary of CFDA foundation database,and China’s Food & Drug Administration Data Center platform data,those administrative license data were analyzed that the catalog past the consistency of the overall situation of the evaluation by the end of 2018,and the drugs composition,enterprise production composition,drug dosage forms,the enterprises compliance with the relevant policies to encourage. We wish the analysis results will provide some reference for the relevant pharmaceutical industry and regulatory authorities.更多还原