Analysis of development trends in overseas produced of chemical drugs in China from the perspective of registration and inspection testing
LI Wenlong
YAO Shangchen
ZHANG Yu
WU Zhaoyang
WEI Jingjing
HUANG Haiwei
SUN Huimin
Abstract：Objective To provide reference for the policy formulation of drug regulatory agencies and the R&D and production of domestic drug manufacturers.Methods Combing and counting the data of registration inspection of overseas produced of chemical drugs in China from 2015 to 2023,we analyze the changes,reasons and development trend of the information of the number of registration inspections,varieties,indications,production countries,and agents in the territory from the perspectives of APIs and preparations,combined with the issuance of complementary inspections.Results The number of registration inspection of overseas produced of chemical drugs showed a trend of first decrease and then increase with 2018 as the inflection point.The number and proportion of APIs and preparations issued with supplementary inspection increased year by year from 2020,and the most items issued with supplementary inspection were related substances.Conclusion The adjustment of regulatory policies has a significant impact on the amount of registered tests of APIs,which in turn affects the total amount of registered tests.Domestic manufacturers could differentiate their competition from multiple perspectives such as innovation and encouraging imitation.Regulatory authorities could further strengthen the post-marketing regulation and verification supervision of overseas produced of chemical drugs to ensure the safety of the quality.Registration applicants could establish perfect quality standards by combining domestic and foreign guidelines,and agents could continuously strengthen policy learning,improve the quality of registration and inspection materials,and guarantee the timeliness of registration and inspection.
Keywords：Overseas production of chemical drugsImport drugsActive pharmaceutical ingredientsRegistration testingIssuance of replacement inspectionRegulatory science
Publication Date：2025-08-30
Online Publishing Date：2025-09-30(First online date of this platform, not the publication date of the document)
Pages：7( 767-773 )