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    Home > Active Ingredient News > Drugs Articles > Establish and improve drug traceability system to ensure drug safety

    Establish and improve drug traceability system to ensure drug safety

    • Last Update: 2019-03-08
    • Source: Internet
    • Author: User
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    [China Pharmaceutical network industry news] in recent years, vaccine and drug safety incidents have been exposed frequently, which has aroused strong concern of relevant departments on drug and vaccine safety issues It is reported that safety problems may occur in every link from production, circulation, use to recycling of drugs If drug information is lack of traceability, it is difficult to find out the root cause of any link In addition, if the traceability platform built by the pharmaceutical companies is lack of supervision, the product traceability source code is likely to be embezzled and sold wantonly However, it is difficult to guarantee whether the drugs purchased by the consumers come from the original pharmaceutical companies Therefore, the establishment of a drug traceability platform is conducive to drug companies and pharmacies to strengthen self-discipline and reduce the time and cost of drug purchase At the same time, it plays a positive role in promoting the honest management of drug market and ensuring the quality and safety of drugs It is understood that, in fact, China has made an exploration of drug traceability earlier Supervision code management system was founded in 2005 In the process of implementation, due to the high cost of electronic supervision code equipment, heavy workload, the risk of enterprise business data leakage and other reasons, it is quite controversial in the industry, especially by the opposition of physical pharmacies Some drugstore staff think that cost is the key factor that makes it difficult to continue the implementation of drug electronic supervision code In recent years, the physical drugstore has been impacted by many aspects, the profit is meager, and there are other bar codes or traceability codes on the drug packaging that can be used to identify and trace the authenticity of drugs The existence of electronic supervision codes is a bit like repeated construction In the context of the dispute over the electronic regulatory code, on March 1, 2017, China's drug electronic regulatory platform officially stopped updating However, on August 24, 2018, the website of the State Food and Drug Administration released the opinions of the office of the State Food and Drug Administration on the guidance on the construction of drug information traceability system (Draft for comments), which is open to the public In the opinion draft, it is clear that the ownership of drug traceability data is "who generated and who owned" Without the authorization of the owner, the operator of drug information traceability system shall not disclose the traceability information to the third party without authorization At the same time, third-party enterprises are encouraged to use drug traceability data in a reasonable and compliant way to serve the society Encourage industry associations, holders and drug distributors to explore the market trading mechanism of drug traceability data and establish a long-term market-oriented mechanism for drug traceability According to the industry, the draft may mean that the electronic drug supervision code system that has been stopped may be restarted A few days ago, some people pointed out that it is an important measure to ensure the safety of drugs to establish and improve the traceability system of drug information and realize "one code to the end" and whole process monitoring "At present, information technology is developing rapidly If we can manage the whole process of each box of drugs from production to patients' medication with technical means, it is equivalent to that each box of drugs has its own electronic file Consumers or regulatory departments can clear all the information of drugs just by scanning the code And once there is any problem, it can immediately reduce the harm " That's what the industry says In addition, the industry proposes that a unified national traceability code and a unified information traceability system can be established The drug traceability code should be easy to read, so that the ordinary people can read and supervise at any time when scanning the code, so that there is no hiding place for problematic drugs, and improve the quality and safety of drugs In addition, to establish a drug traceability system, it is necessary to supervise the whole process of tracking, instead of following the "heavy construction, light supervision" of food traceability At present, the establishment of domestic drug traceability system is still in a toddler stage, and there is still a long way to go in the future.
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