Analysis Report of China's Listed Drugs in 2019

Attention: 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 In 2019, 5391 new approvals were issued for domestic drugs and 690 for 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 2、 Medical insurance category Among the new approvals in 2019, 1270 belong to class a drugs in 2019 new national medical insurance catalog, and 1959 belong to class B drugs in 2019 new national medical insurance catalog 3、 Number of approvals in each province In 2019, the largest number of newly added approval production enterprises registered in Guangdong was 1165, followed by Hunan Province, 392, and Chongqing only received 68 approvals, ranking 22nd (for details, please refer to the pharmaceutical intelligence data enterprise version of China's listed drug database) 4、 Exclusivity There are 933 approvals for the same variety There are 1570 approvals for the same product specification (the same product specification includes the same product specification) 5、 Evaluate varieties by consistency In 2019, SFDA added 30 new approvals that passed the consistency evaluation Table 1 consistency evaluation varieties approved in 2019 6、 Deemed to pass consistency evaluation of varieties In 2019, the SFDA added 109 approvals deemed to have passed the consistency evaluation Table II deemed approved varieties in 2019 7、 Varieties of listing license holders In 2019, CFDA added 165 approval documents with listing license holders, and Guangdong Province has the largest number of approval documents, which is 56 (for details, please refer to the drug intelligence data enterprise version of China listing drug database) Table 3 types of listing license holders approved in 2019