Study on the innovation of working mechanism of registration and inspection for overseas production of chemical drugs

LI Wenlong; WANG Xuelei; TAN Liyuan; WEI Jingjing; WU Zhaoyang; YAO Shangchen; HUANG Haiwei; SUN Huimin

doi:10.13506/j.cnki.jpr.2025.03.014

Abstract：Objective To carry out scientific research on drug regulation,innovative working mechanism for the com-pletion of high-quality registration and inspection of overseas production of chemical drugs.Methods According to the document review,quality standard review,standard audit three stages,sorting and summarizing the common problems high-lighted in the registration and inspection work,to adapt to the new vision of"Provisions for Drug Registration"work require-ments,put forward an innovative working mechanism for practical exploration,comparison of working mechanisms before and after the operation of the variety of registration and inspection time and efficiency.Results Compared with the new"Provi-sions for Drug Registration"before the implementation of the new mechanism,the new mechanism after the operation of the data review phase of the data received from 11.2 natural days to shorten the time to 1.4 natural days,62％shorter than the standard review stage,the standard review stage audit waiting time from 20.5 working days to 1 working day.Conclusion By carrying out parallel review of information,optimize the allocation of species,the report that is the review of innovative in-itiatives to establish a new working mechanism,effectively improve the efficiency of the registration and inspection of over-seas production of chemical drugs,streamline the procedures and steps to shorten the test time,has become an important cornerstone of the high-quality completion of the registration and inspection of overseas production of chemical drugs,can be extended to the full range of innovative working mechanisms to promote the registration and inspection of innovative medi-cines.The innovative working mechanism can be extended and applied to the registration and inspection of all varieties,thus promoting the accelerated listing of innovative drugs.