How to obtain the approval number of patented drug production and sales?

Drug approval is troublesome, and you will not be given a green light just because you are a patented drug. If you must go, you must go. The production of new drugs or drugs that meet the national standards must be approved by the drug supervision and administration department of the State Council, and the patent number of the drug must be indicated in the approval document. This number is called the drug approval number. A pharmaceutical production enterprise can produce the drug only after obtaining the drug approval number. Drug approval number format: Chinese traditional medicine quasi-character+1 letter +8 digits, trial production drug approval number format: Chinese traditional medicine trial production character+1 letter +8 digits.

The letter "H" stands for chemicals, the letter "Z" stands for traditional Chinese medicine, the letter "B" stands for health care drugs rectified by the State Administration of Pharmaceutical Products, the letter "S" stands for biological products, the letter "T" stands for in vitro chemical diagnostic reagents, the letter "F" stands for pharmaceutical excipients and the letter "J" stands for imported sub-packaged drugs. The first and second digits are the source codes of the original approval number, where "10" stands for drugs approved by the former Ministry of Health, and "19" and "20" stand for drugs approved by the State Pharmaceutical Products Administration before 1 2002 and other drugs approved by the former provincial health administrative department. The third and fourth digits are the last two digits of the year of renewal of the approval number, but the approval numbers of the Ministry of Health and National Medical Products Administration still use the last two digits of the original approval number. The 5th to 8th digits are serial numbers.

Due to historical reasons, the provincial drug authorities have the authority to approve drugs, and some drugs use local approval numbers, such as "Jingwei Yaozhu" and "Huwei Yaozhu". These drugs are approved according to the local drug standards of provinces and municipalities directly under the central government, which is not conducive to the unified management of drugs by the state. In order to ensure the safety of clinical medication, after 1999, the state upgraded the past local drug standards to national drug standards, cleaned up and rectified the drugs in the format of "X (provincial) health care drug standards", issued the approval number of "National Drug Standards" for drugs that met the national standards, and eliminated drugs that did not meet the national standards. At the same time, the new drug approval authority was assigned to the US Food and Drug Administration.

The drug approval numbers of quasi-characters of traditional Chinese medicine are divided into the following categories: "quasi-characters H, S, Z and B of traditional Chinese medicine" and "quasi-characters H of traditional Chinese medicine" are chemicals; "National Medicine Zhun Er S" is a biological medicine; "National Medicine Zhunzi Z" is a Chinese patent medicine; The third-class proprietary Chinese medicines commonly used in pharmacies belong to "National Medicine Zhunzi" regardless of the extraction process or whether there are any toxic or side effects; Zhunzizi B is a kind of medicine with therapeutic and health care functions. Both traditional Chinese medicine and western medicine can apply for the batch number of "National Medicine Zhunzi B" as long as they are clinically proved to have no toxic and side effects. Because western medicine generally has obvious toxic and side effects, the current "National Medicine Zhunzi B" is mostly Chinese medicine.