Drug safety is related to the health and life safety of the broad masses of the people, to the healthy economic development and social stability and progress, and to the image of the Party and the government. Our country has always attached great importance to drug safety work. In order to let the masses better understand the relevant drug laws and regulations and drug safety knowledge, the author, as a law enforcement officer of basic drug safety supervision, briefly introduces the basic knowledge of drug management, hoping to give people a reassuring, reasonable and safe direction of drug use.

Definition scope

Article 102 of the Drug Administration Law stipulates: "Drugs refer to substances used to prevent, treat and diagnose human diseases, purposefully regulate human physiological functions and prescribe indications or functional indications, usage and dosage. Including Chinese medicines, Chinese herbal pieces, Chinese patent medicines, chemical raw materials and their preparations, antibiotics, biochemical drugs, radiopharmaceuticals, serum, vaccines, blood products and diagnostic drugs.

The definition of drugs in our country includes several points. First, the purpose and method of use are the basic points to distinguish drugs from food and other substances. No substance is essentially a drug. It can only be called a drug if it is used according to certain methods and quantities to achieve the purpose of treating, preventing or diagnosing a certain disease. Secondly, the law clearly stipulates that Chinese medicines include traditional medicines (traditional Chinese medicines, Chinese herbal pieces, Chinese patent medicines) and modern medicines. Thirdly, the scope of drugs in China is limited to medicines for human use.

Classified management

1. Traditional medicine and modern medicine. Drugs are classified into traditional and modern drugs according to the centralized classification methods involved in the laws and regulations of drug administration. Traditional medicines are historical medicines inherited by countries, regions and nationalities, including botanical medicines, mineral medicines and animal medicines. Their discovery, production and application are based on the experience and theory of traditional medicine. Traditional medicines in China mainly include traditional Chinese medicines and national medicines. Modern medicine generally refers to chemicals developed since the 19th century. Its characteristic is to screen and determine the efficacy of drugs by modern medical theories and methods, and to prevent and treat diseases according to modern medical theories.

2. Prescription and non-prescription drugs. The state implements a classification management system for prescription drugs and non-prescription drugs. According to the safety of drugs, drugs are divided into prescription drugs and non-prescription drugs. Prescription drugs (Rx) refer to medicines that can be purchased and used on the prescription of licensed physicians and licensed assistant physicians. OTC refers to drugs that are published by the national drug regulatory authorities and can be purchased by themselves without the prescription of licensed physicians and licensed assistant physicians. OTC drugs can be classified as Class A OTC drugs and Class B OTC drugs according to their safety.

3. New drugs, generic drugs and preparations for medical institutions. According to the types of applications, they are classified into new drugs, generic drugs and pharmaceutical preparations of medical institutions. New drugs refer to drugs that have not been marketed in China. Generic medicine refers to the imitation of drug varieties that have been approved by the state for listing and have national drug standards. Medical institution preparations refer to fixed prescription preparations prepared and used by medical institutions according to their clinical needs.

4. Special drugs. Drugs under special management refer to drugs that are more strictly controlled than other drugs under the legal system formulated by the state. Article 35 of the Drug Administration Law stipulates that "the State shall exercise special control over narcotic drugs, psychotropic drugs, toxic drugs for medical use and radioactive drugs." In addition, the state also exercises special control over the circulation of preventive biological products, precursor chemicals and stimulants.

5. Identification of drugs by drug approval number. The format of the National Drug Approval Number is as follows: Chinese Pharmaceutical Accuracy (Test)+1 Chinese Pinyin Letter+8 Arabic Numbers. Among them, the word "quasi" represents the drug approved by the state for formal production, and the word "trial" represents the drug approved by the state for trial production. There are seven letters representing different categories of drugs: H for chemical drugs, Z for traditional Chinese medicine, S for biological products, B for health care drugs, T for in vitro chemical diagnostic reagents, F for pharmaceutical excipients, J for imported sub-packaged drugs.

The top two of the eight Arabic figures represent the source of the original approval numbers, 10 of which represent the drugs approved by the former Ministry of Health, 19 and 20 represent the drugs approved by SFDA before 1 January 2002, and the other figures represent the administrative codes of provinces, autonomous regions and municipalities directly under the Central Government. Such as: Beijing 11, Tianjin 12, Hebei 13, Shanxi 14, Inner Mongolia 15, Liaoning 21, Jilin 22, Heilongjiang 23, Shanghai 31, Jiangsu 32, Zhejiang 33, Anhui 34, Fujian 35, Jiangxi 36, Shandong 37, Henan 41, Hubei 42, Hunan 43, Guangdong 44, Guangxi 45, Hainan 46, Chongqing 50, Sichuan 51, Guizhou 52, Yunnan 53, Tibet 54, Shaanxi 61, Gansu 62, Qinghai 63, Ningxia 64, Xinjiang 6 5. The third and fourth digits represent the last two digits of the year A.D. when the approval number was renewed. The last four digits of the number are serial numbers. For example: 1. The approval number of a drug is H34023744, which indicates that the drug is a chemical. The original approval number was issued by the Anhui Provincial Drug Supervision and Administration Department. In 2002, the approval number was changed uniformly, and the order number of the product was 3744. 2. The approval number of a drug is Z10970011, which indicates that the drug is Chinese medicine. The original approval number was issued by the Ministry of Health in 1997, and the order number is 0011.