仿制药研发趋势及中美仿制药申报注册要求对比--.ppt

Generic Drug Review The drug company must show the generic drug is “bioequivalent” to the brand-name drug. active ingredient works in the same way active ingredient works in the same amount of time Generic Drug Review The generic drug’s labeling must be basically the same as that of the approved brand-name drug. Generic Drug Review 4. The drug company must: fully document the generic drug’s chemistry, manufacturing steps, and quality control measures detail each step of the process Generic Drug Review 5. The raw materials and the finished product must meet USP specifications, if these have been set. USP-United States Pharmacopeia Generic Drug Review The drug company must: show that its generic drug maintains stability as labeled before it can be sold continue to monitor drug’s stability Generic Drug Review The drug company must: comply with federal regulations for current good manufacturing practices give a full description of the facilities it uses to manufacture, process, test, package, label, and control the drug Generic Drug Review 8. Inspection at the proposed manufacturing site ensures that the firm: is capable of meeting commitments of the application can manufacture the product consistently 问卷式评审- FDA仿制药评审模式 问卷式评审模式（Question-based-Review，QbR） 1) 在于帮助仿制药评审部门有效地评估制剂的关键属性，有效控制配方，生产工艺及参数，并建立与临床疗效相关的产品质量标准，准备完整统一的评审报告。 2) 帮助制药企业了解仿制药评审部门的评审标准和程序。 3) 指导制药企业把药品质量源于设计的理念用于仿制药开发，也有助于提高仿制药开发的效率以及产品的质量。 QBR: Drug Substance QBR: Drug Product QBR: Drug Substance QBR: Drug Product QBR: Drug Product QBR: Process Development Report QBR: Process Development Report QBR: Process Development Report QbD 质量源于设计 Quality by Design is a scientific approach where systematic study of product development is undertaken based up on predefined objectives with emphasis on product and process understanding and process control based on sound science and quality risk management QbD 质量源于设计 早期的理念是“药品质量是通过检验来控制的”，后来过渡到“药品质量是通过生产过程控制来实现的”，进而又发展到“药品质量是通过良好的设计来达到的”。这就意味着药品从研