What Is Approval Basis?

The production of a new drug or a drug that already has a national standard must be approved by the drug regulatory department of the State Council, and the unique number of the drug must be specified in the approval document. This number is called the drug approval document number.

Approval Number

produce

Drug approval document format:

How to check the authenticity of the approval number of medicines and health foods?

I. Inquiry of drugs to the State Food and Drug Administration

2. There are currently two types of approval numbers for health foods:

1. "Health food and healthy word" query on the website of the Ministry of Health, the specific method is as follows: open the official website of the Ministry of Health, click on the "data query" column on the right side of the website, "health related product query", click on the pop-up page "Health Food Approval Announcement Catalog", and then select the query based on the approval period of the product.

2. "Chinese Food and Healthy Words" can be searched on the website of the State Food and Drug Administration. The specific method is as follows: Open the official website of the State Food and Drug Administration and click "Health Food" in the "Basic Data Query" column on the right side of the website. In the pop-up page, click "Health Food", and then enter the relevant information of the product to query (preferably enter the product name).

"Notice on Unified Reissue and Standardization of Drug Approval Document Format" (Guo Yao Jian Note [2002] No. 33) Published on January 28, 2002

Provinces, autonomous regions, and municipalities directly under the Central Drug Administration, the Ministry of Health of the People's Liberation Army:

The drug approval number is a sign of the legality of drug production. The "Drug Administration Law" stipulates that the production of drugs "is subject to the State Council

Approved by the drug regulatory department, and issued a drug approval number. "Due to historical reasons, at present,

The format of the quasi-document number varies, which is not conducive to unified management and supervision. To strengthen the number of drug approval documents

According to the "Notice on Doing a Good Job in the Uniform Exchange of Drug Approval Numbers" issued by the State Drug Administration

[2001] No. 582), has now standardized the new drug approval document format, and will soon

Drugs that have been legally produced will be reissued with a drug approval document number. The relevant matters are notified as follows:

I. Drug approval document format: National Medicine Standard + 1 letter + 8 digits, trial production drug approval document format: National

Medicine test word + 1 letter + 8 digits.

The letter "H" is used for chemical drugs, and the letter "Z" is used for traditional Chinese medicine.

Use the letter "B" for products, the letter "S" for biological products, and the letter "T" for in vitro chemical diagnostic reagents.

Use the letter "F", and use the letter "J" for imported packaged drugs. The first and second digits are the source code of the original approval document number.

The "10" represents the drug approved by the former Ministry of Health, and "19" and "20" represent the State Drug Administration before January 1, 2002

For drugs approved by the Administration, other provinces using the first two digits of each province's administrative division code (see Annex I) are the original provincial health

Drugs approved by the administrative department. The third and fourth digits are the last two digits of the year of the year of the year when the approval document number is renewed, but they are derived from the health

The approval numbers of the Ministry of Health and the State Drug Administration still use the last two digits of the original year number. 5th to 8th digit

Is the sequence number.

Please refer to Annex II for the renewal instructions of approval number.

2. An approval document number is issued for each specification of each drug. Except for the Drug Commission approved by the State Drug Administration

In addition to contract manufacturing and off-site processing, different manufacturers of the same drug issue different drug approval numbers.

3. New drugs, generic drugs approved for production after January 1, 2002 and rectification or re-evaluation through local standards

Drugs that have been upgraded to national standards will all adopt the new drug approval document format.

4. The Registration Certificate No. of the chemical drug approved for issuance after January 1, 2002

The formula is also partially changed, in which the letter "X" is changed to "H", and other parts are unchanged. The old form registration certificate number that was originally issued is

Replaced the "Import Drug Registration Certificate" with a new format.

V. After the drug approval document number and chemical drug import drug registration certificate number are reissued, the original form approval document number and note are printed.

The packaging label of the registration certificate number shall be banned from circulation after June 30, 2003.

Attachment: 1. The administrative division code of the People's Republic of China adopted by the drug approval number

2. Unified reissue and standardization of drug approval document format description

State Drug Administration

January 28, 2002

Annex I:

Administrative division code of the People's Republic of China for drug approval number

Code	State / Province / State)	Code	State / Province / State)
110000	Beijing	420000	Hubei Province
120000	Tianjin	430000	Hunan Province
130000	Hebei Province	440000	Guangdong Province
140000	Shanxi Province	450000	Guangxi Zhuang Autonomous Region
150000	Inner Mongolia Autonomous Region	460000	Hainan
210000	Liaoning Province	500000	Chongqing
220000	Jilin Province	510000	Sichuan Province
230000	Heilongjiang Province	520000	Guizhou Province
310000	Shanghai	530000	Yunnan Province
320000	Jiangsu Province	540000	Tibet Autonomous Region
330000	Zhejiang Province	610000	Shaanxi Province
340000	Anhui Province	620000	Gansu province
350000	Fujian Province	630000	Qinghai Province
360000	Jiangxi Province	640000	Ningxia Hui Autonomous Region
370000	Shandong Province	650000	Xinjiang Uygur Autonomous Region
410000	Henan Province

Annex II:

Unified reissue and standardization of drug approval document format instructions

I. Where the original drug approval number issued by the Ministry of Health is renewed to the corresponding category of the Chinese medicine standard (test), the first two digits are "10", and the third and fourth digits are the last two digits The last 4 digits of the sequence number are rearranged. For example: "Weiyao Zhunzi (1997) X-01 (1)" was reissued as "Chinese Medicine Zhunzi H10970001".

2. For drug approval numbers issued by the State Drug Administration before December 31, 2001, those that differ from the new approval number format will be uniformly reissued in the new format. For the original years "1998" and "1999", the first and second digits after the reissue are "19"; for the original years, "2000" and "2001", the first and second digits after the reissue are "20". The third and fourth digits are still the last two digits of the year of the original approval document number. See the following table for details:

Original number	New symbol	Sequence number
Chinese medicine standard (test) word X00000000 series	Chinese medicine standard (test) word H00000000	constant
Chinese medicine standard (test) (1998) X-0000 series	Chinese medicine standard (test) word H19980000	Rearrange
Chinese medicine standard (test) (1999) X-0000 series	Chinese medicine standard (test) word H19991000	Orchestration from 1000
Sinopharm XF00000000 series	National Medicine Standard H00000000	Orchestration since 3000
National Medicine Standard (1998) XF-0000 Series	National Medicine Standard H19980000	Orchestration since 3000
National Medicine Standard (1999) XF-0000 series	National Medicine Standard H19990000	Orchestration from 4000
Chinese medicine standard (test) (1998) Z-0000 series	Chinese medicine standard (test) word Z19980000	constant
Chinese medicine standard (test) (1999) Z-0000 series	Chinese medicine standard (test) word Z19991000	Orchestration from 1000
National Medicine Standard ZF00000000 Series	National Medicine Standard Z00000000	Orchestration since 3000
National Medicine Standard (1998) ZF-0000 series	National Medicine Standard Z19980000	Orchestration since 3000
National Medicine Standard (1999) ZF-0000 series	National Medicine Standard Z19990000	Orchestration from 4000
Chinese medicine standard (test) (1998) manufacturers S-0000 series	Chinese medicine standard (test) word S19980000	Rearrange
Chinese medicine standard (test) (1999) manufacturers S-0000 series	Chinese medicine standard (test) word S19991000	Orchestration from 1000
National Medicine Standard SF00000000 Series	National Medicine Standard S00000000	Orchestration since 3000
National Medicine Standard (1998) SF-0000 series	National Medicine Standard S19980000	Orchestration since 3000
National Medicine Standard (1999) SF-0000 series	National Medicine Standard S19990000	Orchestration from 4000
National Medicine Standard (year number) D-0000 series	National Medicine Standard T00000000	Rearrange
National Medicine Standard (year number) J (S) -0000 series	National Medicine Standard J00000000	Rearrange
Medicinal new excipient approval number	National Medicine Standard F00000000	Rearrange

3. The drug approval number issued by the original provincial drug supervision and administration department shall be renewed according to the province abbreviation in the original approval number, and the corresponding province code shall be used in the new format drug approval number, and the number of the new approval number shall be The third and fourth digits are the last two digits of the reissue year, and the sequence number is rearranged.

For example, the original chemical "Jingwei Pharmaceutical Standard (1996) No. 000001" was reissued as "National Pharmaceutical Standard H11020001", and the meanings of the letters and numbers are: "H" for chemical drugs, and "11" for Beijing municipal administration The first two digits of the division code, "02" is the last two digits of the year of reissue, and "0001" is the new sequence number.

Drugs that have been rectified or re-evaluated to national drug standards through local standards are now local drug approval numbers or have been re-issued to the national drug standard XF00000000 and other types, but different from the new approval number format, the above requirements should also be met , Add province code for unified reissue. After the TCM drug approval number is reissued, the ZZ ×××× prefix will no longer be used.

Published on January 28, 2002