Chinese medicine standard word
Release time:
2019-05-05
"Chinese medicine standard word"
It is the drug production approval number obtained by the drug production unit after strict approval by the State Food and Drug Administration before the production of new drugs, which is equivalent to a person's ID card. Its format is: Chinese medicine standard word 1 letter 8 digits, of which the letter used in chemicals is "H", the letter used in traditional Chinese medicine is "Z" and so on. Only with this approval number can drugs be produced and sold.
The format of the drug approval number is "Chinese medicine standard (test) letter 8 digits". Among them, "medicine" represents medicine, which is the most basic nature (different from health food and medical equipment), "quasi" represents the drug approved by the state, and "trial" represents the drug approved by the state for trial production. As shown in the table
Name
Meaning of Representative
Medicine
Representative drugs
Quasi
Drugs approved for production on behalf of the State
Try
Drugs approved for trial production on behalf of the State
Letters include H, Z, S, B, T, F and J, which respectively represent different categories of drugs: H represents chemical drugs, Z represents proprietary Chinese medicines, S represents biological products, B represents health care drugs, T represents in vitro chemical diagnostic reagents, F represents pharmaceutical excipients, and J represents imported sub-packaged drugs. Refer to the table below.
Alphabet Categories
Meaning of Representative
H
Representative Chemicals
Z
On behalf of Chinese patent medicine
S
On behalf of biological products
B
On behalf of health care drugs
T
Representative in vitro chemical diagnostic reagents
F
On behalf of pharmaceutical excipients
J
On behalf of the import of sub-packaged drugs
Traditional Chinese patent medicines commonly used in pharmacies belong to "Chinese medicine standard Z" regardless of the extraction process and toxic and side effects. "Chinese medicine standard B" is a drug with therapeutic and health care effects. Whether it is traditional Chinese medicine or western medicine, if it is clinically proved that there are no toxic and side effects, it can apply for the batch number of "Chinese medicine standard B". As western medicine generally has obvious toxic and side effects, while most traditional Chinese medicines have not passed safety verification, therefore, the current "Chinese medicine standard word B" is mostly traditional Chinese medicine.
The first and second digits of the 8 digits represent the source of the original approval number, of which 10 represents the drugs approved by the former Ministry of Health; 19 and 20 represent the drugs approved by the national drug regulatory authority; 11 Beijing, 12 Tianjin, 13 Hebei Province, 14 Shanxi Province, 15 Inner Mongolia Autonomous Region, 21 Liaoning Province, 22 Jilin Province, 23 Heilongjiang Province, 31 Shanghai City, 32 Jiangsu Province, 33 Zhejiang Province, 34 Anhui Province, 35 Fujian Province, 36 Jiangxi Province, 37 Shandong Province, 41 Henan Province, 42 Hubei Province, 43 Hunan Province, 44 Guangdong Province, 45 Guangxi Zhuang Autonomous Region, 46 Hainan Province, 50 Chongqing City, 51 Sichuan Province, 52 Guizhou Province, 53 Yunnan Province, 54 Tibet Autonomous Region, 61 Shaanxi Province, 62 Gansu Province, 63 Qinghai Province, 64 Ningxia Hui Autonomous Region, 65 Xinjiang Uygur Autonomous Region.
The third and fourth representatives reissue the last two digits of the year of the approval number, but the approval number from the Ministry of Health and the State Drug Administration still uses the last two digits of the original number. The 5th, 6th, 7th and 8th digits are the sequence number of the approval number.
As shown in the table
Numbers
Meaning of Representative
10
Drugs approved on behalf of the former Ministry of Health
19、20
Drugs approved on behalf of national drug regulatory authorities
11
Beijing
12
Tianjin
13
Hebei Province
14
Shanxi Province
15
Inner Mongolia Autonomous Region
21
Liaoning Province
22
Jilin Province
23
Heilongjiang Province
31
Shanghai
32
Jiangsu Province
33
Zhejiang Province
34
Anhui Province
35
Fujian Province
36
Jiangxi Province
37
Shandong Province
41
Henan Province
42
Hubei Province
43
Hunan Province
44
Guangdong Province
45
Guangxi Zhuang Autonomous Region
46
hainan province
50
Chongqing Municipality
51
Sichuan Province
52
Guizhou Province
53
Yunnan Province
54
Tibet Autonomous Region
61
Shaanxi Province
62
Gansu Province
63
Qinghai Province
64
Ningxia Hui Autonomous Region
65
Xinjiang Uygur Autonomous Region
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