Analysis on approval and declaration of new Chinese medicines from 2016 to 2022
Objective To discuss and analyze the current situation of the application and approval of new Chinese medicine in China;To provide a reference for the research and development of new Chinese medicines in the future.Methods The drug registration data were retrieved from Xanda database from January 1,2016 to December 31,2022,and the information of new approval and application of new Chinese medicines during this periods was systematically organized from the aspects of the number of registered varieties,registration categories,therapeutic areas,prescription sources,dosage form distribution,development cycle,clinical research and control drugs.Results From 2016 to 2022,the total number of application for new Chinese medicines was 265.The number of registration classification 1.1 of new compound drugs was the largest.The dosage forms of new drugs were mainly granules,capsules,and tablets.Indications mainly focused on respiratory,neuropsychiatric,digestion and cardio-cerebrovascular diseases,etc.From 2016 to 2022,the total number of approval for new Chinese medicines was 29,of these,19 from 2021 to 2022.The number of registration classification 1.1 of new Chinese medicines was the largest.The treatment fields are mainly respiratory system,gynecology and neuropsychiatric diseases,etc.The dosage forms of new drugs were mainly granules,capsules,and tablets.The number of drugs in prescriptions was 6-15.High-frequency drugs included Glycyrrhizae Radix et Rhizoma,Ephedrae Herba,Scutellariae Radix,Pinelliae Rhizoma,Poria and Gypsum Fibrosum.Phase Ⅱ and phase Ⅲ of the clinical trials had the largest number.The development period was approximately between 10-20 years.The most prescription source of new drugs was clinical experienced prescriptions and hospital pharmaceutics.Conclusion The results show that China has been gradually building-up a relatively complete ecosystem for research and development of new Chinese medicines,helping to develop more high-quality Chinese medicines.
New drug research and development(TCD)Review and approvalMarketing authorizationInvestigational new drugNew drug applicationData analysis
NETL
NSTL
万方数据
