A study on evaluation duration and insurance admission of new traditional Chinese medicine drug approvals from 2014-2022
Objective To explore the changes in the number and duration of approvals for new traditional Chinese medi-cine drugs,and provide references for the implementation of policies and related systems for the innovation and development of traditional Chinese medicine,this article focuses on the study of new traditional Chinese medicine drugs in China in the past decade.Methods The annual drug review reports issued by the National Drug Administration were searched and the varieties of new Chinese medicine listed from 2014 to 2022 were analyzed.The acceptance and review approval time of each new Chi-nese medicine were searched through the drug review center's acceptance variety query system and the drug intelligence web-site.Results From 2014 to 2022,the median time required for the review and approval of 40 new Chinese medicine drugs in-cluded in the study was 38 months.The review and approval time for new Chinese medicine drugs launched after 2019 has sig-nificantly shortened,with the median duration dropping to 11 months.Meanwhile,after 2019,the duration of new traditional Chinese medicine drugs entering the medical insurance catalog has significantly shortened,with the median duration dropping to 14 months.And the proportion of new Chinese medicine drugs included in the medical insurance catalog has significantly increased to 59.09%of the approved new Chinese medicine drugs.Conclusion The Opinions on Promoting the Inheritance,Innovation,and Development of Traditional Chinese Medicine issued by the China State Council and related policies have to some extent promoted the improvement of the efficiency of the review and approval of new Chinese medicine,accelerated the listing of new Chinese medicine,and played a positive role in promoting the research and development of new traditional Chi-nese medicine drugs.
new traditional Chinese medicinereview and approveinsurance admission
NETL
NSTL
万方数据
