Briefly describe the significance of a drug recall, read a brief description of the significance of

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Summary. Hello, I am very happy to answer for you, and the significance of reading a brief description of drug recall is that it is an internationally prevalent and very mature effective model for the management of defective drugs. The drug recall system is a good system, which is conducive to ensuring the safety of the people's medication, and is also of great significance to standardize the entire drug industry. In particular, the development scale, behavioral capacity, and sense of responsibility of drug manufacturers, as well as the survival and development environment of China's pharmaceutical enterprises, do not yet have the basis for the full implementation of drug recall.

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Hello, I am very happy to answer for you, the significance of reading a brief description of drug recall is that it is an effective model for the management of defective drugs that is very mature and prevalent in the world. The drug recall system is a good system, which is conducive to ensuring the safety of the people's medication, and is also of great significance to standardize the entire drug industry. In particular, the development scale, behavioral capacity, and sense of responsibility of drug manufacturers, as well as the survival and development environment of China's pharmaceutical enterprises, do not yet have the basis for the full implementation of drug recall. Tell me to bring Lee.

To a large extent, drug recalls are just a castle in the air, but only the trend and direction of the development of the pharmaceutical industry.

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Legal analysis: The drug manufacturer is the main body responsible for the drug recall. Overseas pharmaceutical manufacturers of imported drugs are also responsible for drug recalls as domestic pharmaceutical manufacturers.

Legal basis: "Measures for the Administration of Drug Recall" Article 19 The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government may, according to the actual situation, organize experts to evaluate the recall plan submitted by the drug manufacturer, and if it is considered that the measures taken by the drug manufacturer cannot effectively eliminate all the hidden dangers of the safety and control department, the drug manufacturer may be required to take more effective measures such as expanding the scope of the recall and shortening the recall time.

Legal analysis: The manufacturer is the main body responsible for the drug recall. Pharmaceutical manufacturers shall establish and complete a drug recall system, collect relevant information on drug safety, investigate and evaluate drugs that may have potential safety hazards, and recall drugs with potential safety hazards.

Overseas pharmaceutical manufacturers of imported drugs are responsible for the recall of imported drugs. If the recall is carried out in China, the importing unit shall be responsible for the implementation.

Legal basis: "Measures for the Administration of Drug Recall".

Article 1 In order to strengthen drug safety supervision and ensure the safety of drug use by the public, these measures are formulated in accordance with the Drug Administration Law of the People's Republic of China, the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, and the Special Provisions on Strengthening the Safety Supervision and Administration of Food and Other Products.

Article 2 The recall and supervision and management of drugs sold within the territory of the People's Republic of China shall be governed by these Measures.

Pharmaceutical manufacturers.

According to the query question bank questions, the main body of the drug recall is: a.drug regulatory authorities; b.Pharmaceutical manufacturers. c.drug users; d.Pharmaceutical business enterprises. The answer is B, so it's a pharmaceutical manufacturer.

According to the definition of drugs in Article 2 of the Drug Administration Law of the People's Republic of China: the term "drug caution" in this law refers to substances used to prevent, diagnose and diagnose human diseases, purposefully regulate human physiological functions, and stipulate indications or functional indications, usage and dosage, including traditional Chinese medicine, chemical drugs and biological products.

The main body responsible for drug recalls is the drug manufacturer. According to the law, the drug calls for hail and wild returns, which refers to the drug manufacturer in accordance with the prescribed procedures to withdraw the marketed drugs with potential safety hazards, of which the potential safety hazards refer to the unreasonable dangers that may be caused by the dangerous imitation of drugs and the safety of human health and life due to R&D, production and other reasons.

Article 82 of the Drug Administration Law.

If there are quality problems or other potential safety hazards in the drug, the marketing authorization holder shall immediately stop selling, inform the relevant drug business enterprises and medical institutions to stop selling and using, recall the drugs that have been sold, disclose the recall information in a timely manner, stop production immediately if necessary, and report the recall and disposal of the drug to the people's drug regulatory departments and health departments of provinces, autonomous regions and municipalities directly under the Central Government. Drug manufacturers, drug dealers and medical institutions shall cooperate.

If the marketing authorization holder of a drug should recall the drug in accordance with the law but fails to do so, the people's drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall order it to recall.

Legal analysis: The drug manufacturer is the main body responsible for the drug recall. Overseas pharmaceutical manufacturers of imported drugs, like domestic pharmaceutical manufacturers, are also the main body of drug recalls.

Legal basis: "Measures for the Administration of Drug Recall" Article 3 The term "drug recall" in these measures refers to the withdrawal of drugs that have been marketed and sold by drug manufacturers (including overseas pharmaceutical manufacturers of imported drugs, the same below) in accordance with the prescribed procedures.

The drug manufacturer and the company are the main body responsible for the drug recall; Overseas pharmaceutical manufacturers of imported drugs are also responsible for drug recalls, just like domestic pharmaceutical manufacturers.

Legal basis: The term "drug recall" in Article 3 of the "Measures for the Administration of Drug Recall" refers to the recall of drugs with potential safety hazards that have been marketed and sold by drug manufacturers (including overseas pharmaceutical manufacturers of imported drugs, the same below) in accordance with the prescribed procedures.

The health and life safety of the public are related to the health and life safety of the public, and once there is a serious adverse reaction to the drug after the market, it will lead to serious consequences. At present, in order to protect the interests of those suffering from defective drugs, many countries in the world have established a drug recall system, and good results have been achieved. In recent years, there have been a number of serious adverse drug reactions in China, most of which are recalled by multinational pharmaceutical companies, which has attracted the attention of China's leading pharmaceutical companies, pharmaceutical companies, the public and other parties.

China's drug regulatory department also attaches great importance to this, and has begun to make some preparations for the establishment of China's drug recall system. The United States is the first country to implement a drug recall system, its system is standardized, the procedures are rigorous, and the operability is strong, and the FDA has reduced the harm of defective drugs to the public and safeguarded the interests of consumers through the implementation of the drug recall system. The drug recall system and its implementation experience in the United States are worthy of reference by China's drug regulatory authorities.

Therefore, this paper focuses on the drug recall system in the United States, aiming to learn from the drug recall system in the United States and put forward corresponding management countermeasures and suggestions for the establishment of a sound drug recall system in China. In addition, this paper also analyzes the recall of defective drugs by multinational pharmaceutical companies in China. Through the analysis of the above events, the necessity, feasibility and implementation obstacles of China's drug recall system are currently established, and it provides reference for China's pharmaceutical enterprises to establish their own recall system.

Through the detailed introduction of the drug recall system in the United States and the analysis of the current situation of the establishment of the drug recall system in China, this paper mainly puts forward specific suggestions for the establishment of China's drug recall system from the two levels of pharmaceutical enterprises: the initial stage of establishing a drug recall system in China should be based on "compulsory recall, supplemented by voluntary recall", and a sound supervision mechanism should be established as soon as possible and specific recall management measures and punishment measures should be introduced. When China has established a drug recall system and has gone through the initial stage, a drug recall system of "voluntary recall as the mainstay, compulsory recall as a supplement" should be implemented.