2019 China Market Drug Analysis Report

The total number of new approvals from the FDA in 2019 was 6091added 30 approvals for the variety through consistency evaluation in 2019, and 109 varieties were evaluated through consistencyadded 5,391 domestic drug approvals and 427 import approvals in 2019According to the latest statistics of the Enterprise Edition of Pharmaceutical Intelligence Data, a total of 6,091 new approvals were added in 2019, with a peak of 809 approvals in JulyFigure 1 New approval for January-December 2019
2019 new approval 5,391 for domestic drugs, 690 for imported drugsBelow and see the details of the new approvals, the drug typein 2019 the FDA added 3,839 approved chemical drugs, 181 biological products approvals and 2046 Chinese medicine approvalsFigure II, January-December 2019, the drug types of the Drug Administration
II, the medical insurance categorythe 2019 new approval of 1270 of which belong to the 2019 new version of the National Health Insurance Directory of Class A drugs, 1959 approvals belong to the 2019 new version of the National Medical Insurance Directory of Class B drugsFigure 3 January-December 2019 The Fda Administration's medical insurance categoriesthree, the provinces have the number of approvals
in 2019 the number of new batch production enterprises registered address for Guangdong, there are 1165, followed by Hunan Province, there are 392, Chongqing received only 68 approvals, ranked 22nd (specifically check the pharmaceutical data enterprise version of China listed drug database)Figure 4 2019 provinces have the number of approvalsfour, exclusive situation
with the same varieties exclusive 933 approvals Figure V 2019 with the same variety exclusive number of various categories the same product rules exclusive 1570 approvals (the same product rules exclusive contain the same variety exclusive) Figure VI The number of exclusive categories of the same product rules in 2019 5, through consistency evaluation of varieties the FDA in 2019 to add 30 approved through consistency evaluation Table I 2019 to obtain the approval of the consistency evaluation varieties note: data as of January 8, 2020 Saturday, as if through the consistency evaluation varieties
2019 FDA added 109 approved as a consistency evaluation Form II 2019 approved by the same as through the consistency evaluation of the variety note: data as of January 8, 2020
7, listed license holders varieties
2019 FDA has added 165 approvals with listed license holders, Guangdong Province has the largest, 56 (specifically check the pharmaceutical data enterprise version of China listed drug database) Form III List 3 2019 Approval of the Listed License holders Note: Data as of January 8, 2020
Data Source: - China Listed Drug Database