中药新药申请临床药学研究综述资料的撰写要点

Writing Points of Review Data for Clinical Pharmaceutical Research of Investigational New Drug Application in TCM

药学研究是中药新药研发的重要组成部分,是进行药物安全性、有效性研究和评价的基础。药学研究综述资料是对药学研究工作的总结、分析与评价,对于申请人和审评者全面了解药学研究情况具有重要的意义。随着对新药研究认识的不断提高,结合审评体会,本文对申请临床试验注册阶段药学研究综述资料的撰写要点提出建议,供研究和评价者参考,以提高注册申请的质量和效率。

Pharmaceutical research is the important component of the research and development of new drug in TCM and is the foundation of drug safety and effectiveness study as well as evaluation.The re-view data of pharmaceutical research is the summary,analysis and evaluation of the study work,which is sig-nificant for the applicants and reviewers to completely understand the situation of pharmaceutical research. With the constant improvements on the recognition of new drug study,in association of the review experi-ences,the writing points were introduced on the review data for the application of pharmaceutical research on clinical trial registration stage so as to provide the reference for the researchers and reviewers and improve the quality and efficiency of registration application.