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New Drugs Marketed: 26 MAH approvals approved for 26 exclusive varieties

Release date: 2020-01-10 Views: 0

Source: Yaozhi  

Aspects:

The total number of new approvals of the Drug Administration in December was 59.

New approvals for 44 varieties were added in December.

In December, 45 domestic drug approvals and 14 import approvals were added.

According to the latest statistics of PharmacoData Enterprise Edition, 59 new approvals were issued in December 2019.

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Figure 1 New Approvals in September-December 2019

In December, 45 new approvals were for domestic medicines and 14 were for imported medicines. See below for a detailed analysis of the new approvals.

I. Drug Types

In December, the CFDA added 46 approvals for chemical drugs, 8 approvals for biological products, and 5 approvals for traditional Chinese medicine.

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Figure 2 The situation of various drug types of the China Food and Drug Administration in September-December 2019

Second, the dosage form

In December, the FDA added 23 injections, 19 tablets, 10 capsules, 2 aerosols, 2 in vitro diagnostic reagents, and 1 granule, ointment, and powder each.

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Figure III The dosage form of the FDA in September-December 2019

Third, the type of medical insurance

Among the new approvals in December, 9 approvals belong to Class A drugs in the new version of the National Medical Insurance Catalogue in 2019, and 23 approvals belong to Class B drugs in the new version of the National Healthcare Insurance Catalog in 2019.

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Figure IV Situation of each medical insurance category of the Drug Administration of China from September to December 2019

4. Number of approvals in each province

In December, the number of newly-approved manufacturing enterprises registered in Jiangsu was the most, with seven.

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Figure V Number of approvals in each province in December 2019

V. Exclusive situation

There are 16 approvals exclusively for the same variety.

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Figure 6 The number of exclusive categories of the same breed in December 2019

Table 1.Exclusive drugs of the same species in December 2019

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Data as of January 2, 2020

There are 26 approvals for the same product exclusive (the same product exclusive includes the same variety exclusive).

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Figure VII Number of exclusive categories of same product regulations in December 2019

Table 2: Exclusive drugs with same product regulations in December 2019

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Data as of January 2, 2020

Table III Newly approved drugs in December 2019

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Data as of January 2, 2020

Data source: Pharmachi China's listed drug database

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