| 蒋雨琦，房雨彤，李秋桐，何瑞欣，王琪，刘陶世，陈仁寿，程建明.古代经典名方制剂免药效及临床研究的合理性探讨[J].南京中医药大学学报(社会科学版),2020,36(5):710-714. |
| 古代经典名方制剂免药效及临床研究的合理性探讨 |
| Discussion on the Rationality of the Clinical Research and the Immune Efficacy of the Ancient Classical Prescription |
| |
| DOI： |
| 中文关键词: 关键词：经典名方 新药审批 临床试验 |
| 英文关键词: classical prescription new drug approval clinical trial |
| 基金项目: |
|
| 摘要点击次数: 549 |
| 全文下载次数: 688 |
| 中文摘要: |
| 国家食品药品监督管理总局于2018年发布《古代经典名方中药复方制剂简化注册审批管理规定》，明确经典名方制剂申请上市，可仅提供药学及非临床安全性研究资料，免报药效学研究及临床试验资料。该规定出台后引起热烈讨论，就经典名方制剂免药效及临床研究的合理性进行探讨，为明确相关政策内涵、推动经典名方研发和审批上市提供参考。 |
| 英文摘要: |
| In 2018， the State Food and Drug Administration issued the administrative provisions on simplified registration and approval of ancient classical prescription， which made it clear that the application for listing of classical prescription could only provide pharmaceutical and non-clinical safety research data. The pharmacodynamic research and clinical trial data were not required to be provided. The regulation caused a heated discussion after its promulgation. In this paper， we briefly discussed the rationality of the drug efficacy and clinical research free of classical prescription， so as to provide a reference for clarifying the connotation of relevant policies， promoting the R&D and approval of classic famous prescription. |
|
查看全文
查看/发表评论 下载PDF阅读器 |
| 关闭 |
