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Comprehensive classification by dosage form and efficacy.
Mainly: oral, topical, injectable, biologics.
Then it is classified according to efficacy, such as cardiovascular, gastrointestinal, etc.
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Since 2000, China has implemented a drug classification management system, which separates drugs from prescription drugs and over-the-counter drugs!
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Drug classification management is an internationally accepted management method. It is based on the principle of safety and effectiveness of drugs, according to their varieties, specifications, indications, dosages and routes of administration, etc., drugs are divided into prescription drugs and over-the-counter drugs and make corresponding management regulations.
Its significance is to ensure the safety of the people's medication, and its basic principle is to implement it step by step, suitable for the national conditions, and this management method fully reflects the concern of the people of the people.
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Legal analysis: The state implements a classified management system for drugs. According to the requirements of the Drug Administration Law, GMP and GSP for the classification management of drugs, the main provisions are:
1.Drugs and non-drugs should be stored separately (wholesale enterprises should be stored separately, and retail and tourism enterprises should set up non-drug areas). 2.
Prescription drugs and over-the-counter drugs are stored separately (wholesale enterprises should store them separately, and retail enterprises should set up prescription drugs and over-the-counter drugs). 3.Internal drugs and external drugs are stored separately (wholesale enterprises can store them in separate warehouses or groups, and retail enterprises can store them in separate cabinets).
Legal basis: Article 6 of the Law of the People's Republic of China on Drug Administration Cover or Stool Article 6 The state implements the drug marketing authorization holder system for drug administration. The marketing authorization holder shall be responsible for the safety, effectiveness and quality controllability of the drug in the whole process of drug development, production, operation and use in accordance with the law.
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Answers]: a, b, c, d
On the one hand, the implementation of classified drug management is to strengthen the sales control of prescription drugs and prevent consumers from causing drug abuse and endangering their health due to improper behavior; On the other hand, by standardizing the management of over-the-counter drugs, consumers should be guided to carry out self-medication scientifically and rationally, so as to ensure that the public can use drugs safely, effectively, conveniently and in a timely manner.
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Drug classification management refers to the division of drugs into different categories according to different chemical compositions, pharmacological effects and indications, and corresponding management. According to the regulations of the State Food and Drug Administration, drugs can be roughly divided into five categories, namely chemical drugs, biological products, neutral drugs, medical devices and food and drugs.
Chemicals refer to drugs prepared by chemical synthesis methods, such as various Western medicines that are commonly used in daily life. This kind of drug has the characteristics of significant effect and convenient medication, but it may produce different toxicity and need to be used with caution. Therefore, the approval, production and sales of chemical drugs need to be strictly controlled and managed.
Biological products refer to drugs prepared using biotechnology, such as vaccines, antibiotics, etc. This kind of drug has significant specificity and safety, and also has a relatively good effect on some chronic diseases. However, the production and testing of biological products require a high degree of technical support and strict standardized management.
Traditional Chinese medicine refers to the use of natural materials according to the theory or experience of Chinese medicine to treat diseases. Traditional Chinese medicine has a long history of use, which can meet the needs of some specific diseases, reconcile the balance of the human body, assist drugs, and play the role of invigorating qi and tonifying the kidney, dispelling wind and detoxifying, but it is necessary to pay attention to the interaction between traditional Chinese medicine and chemicals.
Medical devices refer to equipment, supplies, devices and other related products that are used on the surface or inside of the human body to play a role in diagnosis, compensation of physiological functions through physical, chemical or other means. This type of product is mainly diagnostic, ** and assistive products. Medical devices involve the field of life and health, and there are higher requirements for product quality management and approval.
Food and drug is a way to combine the list of food and drugs for management, and it is a management policy implemented by the national food and drug regulatory department in recent years, which is also a way to reduce duplicate approvals and shorten the approval cycle. These products need to properly control the boundaries between food and pharmaceuticals, while also meeting the quality, safety and efficacy requirements of their respective fields.
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Legal Analysis:1According to the principle of safety, effectiveness and convenience of use, drugs are managed according to their varieties, specifications, indications, dosages and routes of administration, respectively, according to prescription drugs and over-the-counter drugs2
Ensure that the public uses drugs safely, effectively, conveniently and in a timely manner, reasonably allocate medical and health resources, and reduce medical costs.
Legal basis: "Regulations on the Classification and Administration of Prescription Drugs and Non-prescription Drugs" Article 2 According to the different varieties, specifications, indications, dosages and routes of administration of drugs, drugs are managed as prescription drugs and non-prescription drugs. Prescription drugs must be prescribed by a licensed physician or licensed physician assistant before they can be dispensed, purchased, and used; Over-the-counter drugs do not require a prescription from a licensed physician or licensed physician assistant to be used at your discretion.
China is now a democracy in the crotch, and the people have no rights, and if they want to exercise their rights, they can only join the crotch, and then mix in a position with rights in it, and you will have the right to manage. Or like Sun Yat-sen......
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