探究我国化学新药临床试验注册申请流程

To explore the application process for clinical trial registration of new chemical drugs in China

目的提高我国化学新药注册申请人进行临床试验注册申请时的效率。方法本文以文献研究法,阅读我国化学新药临床试验注册申请相关法规要求及参考文献,结合化学新药临床试验注册申请的实际情况,梳理我国化学新药临床试验注册申请流程。结果与结论申请人在化学新药临床试验注册申请前需要先了解NMPA、CDE发布的相关法规要求,提前了解CDE的注册审评部门和程序,做好资料提交的准备工作。在注册申请过程中,需要按照相关法规要求提交申报资料、缴纳注册费用,配合CDE等相关部门进行形式审查、技术审评等过程中的沟通交流、资料补充等工作。

Objective To improve the efficiency of applying for registration of new chemical drugs in China.Methods In this paper,the literature research method is used to read the relevant regulations and references of the application for clinical trial registration of new chemical drugs in China,and to comb the application process of clinical trial registration of new chemical drugs in China.Results and conclusions Applicants need to understand the relevant regulations and requirements issued by the NMPA、CDE before applying for registration of clinical trials of new chemical drugs,to understand the registration review departments and procedures of the CDE in advance,and to prepare for the submission of materials.During the process of registration application,it is necessary to submit the declaration materials according to the requirements of relevant regulations,pay the registration fee,cooperate with the relevant departments such as CDE to carry out formal examination,technical review and other communication and exchange,information supplement and so on.