Analysis Report of China's Listed Drugs in 2019

Highlights: in 2019, the total number of new approvals issued by SFDA is 6091 In 2019, 30 approval documents of consistency evaluation varieties were added, and 109 were deemed to have passed the consistency evaluation In 2019, 5391 domestic drug approvals and 427 import approvals will be added According to the latest statistics of pharmaceutical intelligence data Enterprise Edition, there are 6091 new approvals in 2019, with a peak of July and 809 new approvals Figure 1 new approvals from January to December 2019 5391 new approvals in 2019 are domestic drugs and 690 imported drugs See the detailed analysis of new approvals below 1、 Drug type: in 2019, SFDA added 3839 chemical drug approvals, 181 biological product approvals and 2046 traditional Chinese medicine approvals Figure 2: the situation of each drug type of drug administration from January to December 2019 2 The situation of medical insurance category Among the new approvals in 2019, 1270 belong to category A of national medical insurance catalog 2019, and 1959 belong to category B of national medical insurance catalog 2019 Figure 3: the medical insurance categories of the drug administration from January to December 2019 3 The number of approvals in each province In 2019, the registered address of the new approved production enterprises is the largest in Guangdong, with 1165, followed by Hunan, with 392 Chongqing has only 68 approvals, ranking 22nd (for details, please refer to the drug intelligence data enterprise version of China's listed drug database) Figure 4 The number of approvals in each province in 2019 4 The number of exclusive approvals for the same variety is 933 Figure 5: in 2019, there are 1570 approvals for the same type, quantity and specification (including the same type and specification) Figure 6: the number of exclusive categories of the same product specification in 2019 5 30 new approval documents passed the consistency evaluation by drug administration in 2019 Table 1: consistency evaluation varieties approved in 2019 note: as of January 8, 2020, the data is 6 There are 109 new approval documents deemed to have passed the consistency evaluation in 2019 Table II deemed approved varieties in 2019 note: data as of January 8, 2020 7, new 165 approvals of listing license holders' varieties added by drug regulatory bureau in 2019, with the largest number in Guangdong Province, being 56 (please refer to China's listing drug database of enterprise version of drug intelligence data for details) Table 3 list of approved holders in 2019 note: data as of January 8, 2020