Explanation of "The Drug Administration Law of the People's Republic of China"
On September 20, 1984, the Seventh Meeting of the Standing Committee of the Sixth National People's Congress passed the "Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Drug Administration Law"), which came into effect on July 1, 1985. This is another important law on medicine and hygiene in my country after the "Food Sanitation Law of the People's Republic of China", which provides a legal guarantee for the safety and effectiveness of medicines for the majority of the people, and marks that my country's medicine management has entered a new stage of legalization. , Has promoted the scientificization of my country's drug management and the modernization of medical and health work.
1. The purpose and significance of promulgating the "Drug Administration Law"
Medicine is a special kind of commodity. It has a dual nature, reasonable use, can benefit mankind, protect people's health, improper use, poor management, it will endanger people's lives, and even destroy people's physical and mental health, resulting in dependence. Medicines are also specific and priceless. Medicines must be used symptomatically. No medicine can cure all diseases. In an emergency, medicines for curing diseases and saving people will become very expensive. Medicines are also time-limited, and medicines can only be used when needed, otherwise no one cares about them. Drugs also have strict quality control. Only scientific methods can be used to determine that the drugs meet the prescribed quality standards for a certain period of time to ensure the safety and effectiveness of patients when they are used. Substandard drugs must not be produced, sold, or used. Because of these characteristics of drugs, any country must adopt special methods to manage drugs. The purpose of my country’s formulation of the "Drug Administration Law" is to determine the Party’s and the state’s policies and principles for drug supervision in the form of national laws, put the quality of drugs under the strict supervision of the country and the broad masses, and strengthen drugs. The supervision and management of medicines ensure the quality of medicines, improve the efficacy of medicines, ensure the safe and effective use of medicines for the people, and maintain the health of the people. The promulgation and implementation of the "Drug Administration Law" will vigorously promote the development of pharmaceutical production and medical and health services, and will have practical and far-reaching significance for protecting social productivity and ensuring the construction of my country's four modernizations.
①An epoch-making progress. my country has a history of thousands of years of managing drugs through laws and regulations. After the founding of New China, the state has also issued many administrative regulations and rules for the supervision and management of drugs. However, the "Drug Administration Law" is the first drug administration law promulgated through modern legislative procedures. It reflects the epoch-making progress of my country’s drug management legislation: first, drug management legal norms have become an important part of my country’s legal system; second, it clarifies the legal status of drug supervision and management; third, the "Drug Administration Law" "It is a comprehensive and comprehensive drug management law, which replaces the previous administrative regulations governing drugs, and has a higher legal status and effectiveness; fourth, it has laid a legal foundation for the construction of my country's drug regulatory system.
②It marks that my country's drug supervision and management has entered a new stage of legalization. After the founding of the People's Republic of China, most of my country's drug management regulations only stipulated what should be done, but did not stipulate legal responsibilities, so there was no way to deal with many serious violations. The promulgation and implementation of the "Drug Administration Law" has enabled the supervision and administration of drugs to have laws to follow, handle affairs in accordance with the law, and enter a new stage of legalization.
③It is conducive to giving play to the people's role in drug quality supervision. The promulgation and implementation of the "Drug Administration Law" has enabled the people to understand the management of drugs by law, aiming to ensure the safe and effective use of drugs for the people, safeguard the people's health, clarify the legal regulations and codes of conduct that ensure the quality of drugs, and enhance the awareness of the law. It must be followed, law enforcement must be strict, and violations must be investigated. Make drug quality supervision get the care and support of the whole society.
④Ensure and promote the healthy and rapid development of the pharmaceutical economy. The development of my country's economic reform has made the production, operation and international trade of medicines more active than ever. At the same time, more and more economic relations and economic activity norms must be fixed in legal form. Make pharmaceutical economic activities keep up with the new reform situation under the protection and restriction of the law, and make them develop healthily and rapidly.
2. The background of the "Drug Administration Law"
Since the founding of the People’s Republic of my country, China has attached great importance to the construction of pharmaceutical regulations. As early as February 1950, with the approval of the State Council, the Ministry of Health of the Central People's Government formulated and promulgated the "Interim Regulations on the Administration of Narcotic Drugs", and later formulated and promulgated the "Administrative Measures for Highly Toxic Drugs" and other regulations. The "Regulations on Drug Administration" was issued in 1963, and the "Regulations on Drug Administration" (for trial implementation) were issued by the State Council after revision in 1978, covering drug quality supervision, new drug approval, import and export inspection and inspection management There are clear regulations, established and improved the drug administration and drug inspection agencies of the central, provincial, prefectural and most counties, and strengthened the supervision and management of all aspects of drug production, operation, and use, so as to ensure the safe and effective use of drugs by the people. A lot of work has played an important role in promoting the production of medicines and developing medical and health undertakings. However, because the "Regulations on Pharmaceutical Administration (Trial)" does not provide for penalties for violators, the legal construction of pharmaceutical affairs is not sound, resulting in some drug quality accidents not being dealt with in time, and some illegal incidents cannot be handled. In addition, some mature experiences of the United Kingdom, Japan, the United States and other countries provide a reference for the formulation of my country's drug law. Therefore, starting from the health of the people across the country, summarizing the positive and negative experiences of the pharmaceutical administration since the founding of the People’s Republic of China, in accordance with the principle of seeking truth from facts, ensuring the scientificity and advancement of the law, continuity and stability, and insisting on the principle of learning from the masses The principle of reaching the masses is based on the extensive solicitation of opinions, and the State shall formulate and promulgate the "Drug Administration Law" to further strengthen the supervision and management of drugs.
Under the specific leadership of the Legal Affairs Committee of the National People’s Congress, the “Drug Administration Law” has solicited opinions from various provinces, autonomous regions, and municipalities directly under the Central Government. It has been held four times in major regional conferences across the country, the National Pharmaceutical Administration Working Conference, the National Pharmaceutical Administration Director and At the symposium attended by the State Medical Administration and other relevant departments, extensive discussions and amendments were carried out. They were submitted to the Sixth Session of the Standing Committee of the Sixth National People’s Congress for deliberation on July 4, 1984. Adopted at the seventh meeting. Chairman Li Xiannian issued an order on September 20, 1984. So far, the drug management legislation has been successfully completed.
3. The main content of the "Drug Administration Law" The "Drug Administration Law" has eleven chapters and 60 articles, and its main contents and main points are summarized in ten aspects:
1. Establish the guidelines and policies for the development of medicines in my country and the statutory departments for the supervision and administration of national medicines
①Clarify the purpose of my country's drug management legislation. Article 1 of the "Drug Administration Law" determines the purpose of drug administration legislation in accordance with the spirit of my country's constitution and is also the purpose of drug supervision and administration.
②Based on the actual situation of Chinese people's drug use, the major guidelines and policies for the development of drugs have been determined, that is, the country develops modern drugs and traditional drugs to give full play to their role in prevention, medical treatment and health care. This is in the interests of the people and is also an important feature of my country's drug management law.
③Establish the statutory department for national drug supervision and management. my country’s highest authority has passed legislation to authorize the health administration department of the State Council to be in charge of drug supervision and management. This has solved the problem of multiple government administrations in the national drug supervision and management work over the years, and is the fundamental guarantee for the implementation of the Drug Administration Law.
2. The "License" system is stipulated. Chapters 2, 3 and 4 of the Drug Administration Law mainly stipulate the licensing system for the production, operation and preparation of pharmaceuticals by medical units, namely "License for Pharmaceutical Production Enterprises" and "Drug Operation Enterprise License and Preparation License. The license system is a mandatory management system to strengthen product quality management and ensure product quality. It is a system that must be implemented by law.
3. Implement a drug approval system
Before a drug manufacturer produces a drug, it must report to the provincial health administrative department for approval and issue an approval number before it can be manufactured and sold. The production of new drugs must be approved by the Ministry of Health and issued with an approval number. However, except for the production of Chinese herbal medicine pieces. The production of drugs that have national standards or standards of provinces, autonomous regions, and municipalities directly under the Central Government must be reviewed and approved by the health administrative department of the province, autonomous region, or municipality directly under the Central Government after soliciting opinions from the competent drug production and marketing department at the same level, and issue an approval number, except for the production of Chinese herbal medicine. For drugs that have inaccurate curative effects, severe adverse reactions, or other reasons that endanger people's health, their approval number shall be revoked. Drugs whose approval number has been revoked shall not be continued to be produced or sold; those that have already been produced shall be destroyed or disposed of under the supervision of the local health administrative department. Drugs produced without the approval number shall be treated as counterfeit drugs.
4. Establish a drug supervisor
Article 46 of the "Drug Administration Law" stipulates that health administrative departments at or above the county level shall set up drug supervisors. Drug supervisors are appointed by pharmaceutical technicians, and the people's government at the same level will review and issue certificates, and give them legal responsibilities and obligations. Drug supervisors work under the leadership of the health administrative department at the same level.
5. Import and export drug inspection system
Article 27 of the "Drug Administration Law" stipulates that for the first imported drug, the importing unit must provide the drug's instructions, quality standards, inspection methods and other relevant materials and samples, as well as the certification documents approved by the exporting country (region) for production. The import contract can be signed only after the approval of the department. Article 28 stipulates that imported drugs must be inspected by a drug inspection agency authorized by the health administrative department of the State Council; only those that pass the inspection can be imported. The establishment of this system is an inevitable requirement of a sovereign state. The state must protect the health of the people, protect its own pharmaceutical production and business units, which means to protect its own interests.
6. Strengthen the management of Chinese herbal medicines
Chinese medicine is the quintessence of our country. The "Drug Administration Law" established the status of Chinese medicine, protected Chinese medicine, and encouraged the cultivation of Chinese medicine. It also emphasizes the acceptance conditions of Chinese herbal medicine processing enterprises, and stipulates regulations on the processing of Chinese herbal medicines. According to the characteristics of Chinese herbal medicines, unless otherwise specified by the state, the urban and rural market trade markets can sell Chinese herbal medicines to give full play to the prevention and Role in healthcare.
7. Implement special management on special drugs
The "Drug Administration Law" stipulates that the state controls narcotic drugs, psychotropic drugs, toxic drugs, and radioactive drugs. Implement special management methods. It also stipulates that narcotic drugs, including original plants, can only be produced by units designated by the health administrative department of the State Council in conjunction with relevant departments, and supplied by the health administrative departments of provinces, autonomous regions, and municipalities directly under the Central Government in conjunction with relevant departments in accordance with regulations. The import and export of narcotic drugs and psychotropic drugs within the scope prescribed by the health administrative department of the State Council must hold the Import Permit and Export Permit issued by the health administrative department of the State Council.
8. Legal liability is stipulated
Article 2 of the "Drug Administration Law" stipulates that these measures are applicable to all units and individuals involved in the production, operation, use, inspection, and scientific research of drugs.
The "Drug Administration Law" stipulates seven types of administrative responsibilities, also called seven types of administrative penalties: warning, confiscation of counterfeit and inferior drugs, confiscation of illegal income, fines, suspension of business for rectification, suspension of production, suspension of business, suspension of preparations, and revocation of licenses. Provides civil liability, namely compensation for damages. Criminal responsibility is stipulated, that is, the manufacture and sale of counterfeit and inferior medicines shall be investigated for criminal responsibility in accordance with and cf. Article 164 of the Criminal Law.
The "Drug Administration Law" stipulates three punishment departments, namely, the health administration department, the industry and commerce administration department, and the judicial department.
9. Power granted to relevant departments
The powers granted to administrative departments above the county level by the "Drug Administration Law" include three aspects: the power of drug supervision and management, the power of drug approval, and the power of administrative punishment. The administrative department for industry and commerce is granted: the power to supervise and manage the sale of Chinese medicinal materials in the farmer’s market and the power to administrative punishment for violations of the management of drug advertisements. The authorization of the judicial department is that individuals or persons directly responsible for the production or sale of counterfeit drugs for profit, which endangers people’s health, and cause serious consequences shall be investigated for criminal responsibility in accordance with the provisions of Article 164 of the Criminal Law (for those who produce or sell substandard drugs, Refer to Article 164 of the Criminal Law to investigate criminal responsibility).
10. Several concepts are clarified
The "Drug Administration Law" has clearly defined counterfeit drugs, inferior drugs, drugs, excipients, new drugs, drug manufacturers, and drug dealers. The connotation and extension of these noun concepts are legally determined.
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