论文部分内容阅读
目的阐释变更药品有效期和变更生产场地的新要求与规定。方法参阅《药品注册管理办法》(局令第28号)(简称“办法”),讨论该“办法”对国内生产药品的“变更有效期”和“变更生产场地”的新规定。结果与结论新药或仿制药申请经批准后,改变、增加或者取消原批准事项或者内容的注册申请,应在《药品注册管理办法》要求的基础上,按照《已上市化学药品变更研究的技术指导原则》中的要求开展研究工作,进行相应的补充申请注册,经批准后方可执行。
Purpose To explain new requirements and regulations for changing the validity of a drug and changing a manufacturing site. Methods refer to the Measures for the Administration of Drug Registration (Bureau Order No. 28) (referred to as the “Measures”), discussing the “effective period” and “changing the manufacturing site” of domestically produced drugs, The new rules RESULTS AND CONCLUSION After the application for new drug or generic drug is approved, the application for changing, adding or canceling the original approval matter or content registration should be based on the requirements of the Administrative Measures for the Registration of Pharmaceuticals and in accordance with the Technical Guidance for Listed Chemical Drug Change Research Principle "in the research work carried out, the corresponding supplementary application for registration, after approval before implementation.