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    Home > Active Ingredient News > Drugs Articles > The Drug Administration issued a document, by the end of December to basically achieve the national selection of selected varieties traceable

    The Drug Administration issued a document, by the end of December to basically achieve the national selection of selected varieties traceable

    • Last Update: 2020-11-19
    • Source: Internet
    • Author: User
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    On August 28, the State Drug Administration officially issued the "Announcement on doing a good job in the construction of the information-based traceability system for key varieties" (hereinafter referred to as the "Draft for Comments"), proposing that by December 31 this year, the basic realization of the national centralized procurement of drugs selected varieties, narcotic drugs, psychotic drugs, blood products and other key varieties can be traced.
    The Draft for Comments shows that at present, all eight construction standards required for the construction of the drug information traceability system have been issued and implemented, including the Guidance for the Construction of the Drug Information Trace System, the Requirements for drug traceability code coding, the Basic Technical Requirements for drug traceability systems, the Basic Data Set for Drug Manufacturers' Traceability, the Basic Data Set for Drug Use Of Traces, the Basic Data Set for Drug TraceAbility, and the Basic Technical Requirements for Drug Traceability.
    in terms of specific task arrangements, the Draft for Comments makes it clear that drug market licensing holders should implement the main responsibility of quality management of the whole process, establish an information-based traceability system, and collect the whole process traceability information.
    Drug listing license holders bear the primary responsibility for the construction of the traceability system, can build their own traceability system, can also entrust the construction of third-party technical institutions, in accordance with the unified drug traceability coding requirements, the drug sales and packaging units at all levels assigned a traceability mark.
    the same packaging specifications are allowed to be traced only in the same traceability system.
    At the time of production, the storage information should be stored in the traceability system, and when selling the drug, the relevant trace information should be provided to the downstream related enterprises or related institutions through the traceability system, so that the downstream enterprises can verify the feedback.
    timely and accurate access to information on the entire process of the drugs produced by the licensed holders of the drug market.
    , medicine is a special commodity, the quality and safety of drugs and people's health is closely related.
    The industry pointed out that the realization of drug traceability is the legal responsibility and main responsibility of enterprises, only in this way can we achieve "sources can be identified, to be traceable, responsibility can be investigated", while in the event of quality problems can be timely recall of related products, find reasons for consumers to inject strong drugs for drug safety.
    years, the state has also issued a series of documents to encourage support for drug traceability system construction, to further ensure drug safety.
    , as on 1 December 2019, the newly amended Drug Administration Act was put into effect, which explicitly stated that a system of drug traceability would be established and improved.
    Among them, the principles of building drug traceability system are: regulatory authorities set the system, build standards, realize multi-code co-existing, can be compatible with the original electronic supervision code, can also be compatible with the international commonly used GS1 and other codes;
    for the selection of varieties, its coverage is wide, and the procurement scale is huge, the third batch of harvesting scale of tens of billions of yuan.
    in the process of selecting varieties in these collections, how to ensure the quality and safety of drugs is a major problem.
    In fact, in order to ensure the quality and safety of drugs, while stopping the phenomenon of malicious procurement of drug dealers, so far this year, there have been Jiangxi, Shanxi, Gansu, Shandong, Sichuan, Jiangsu, Liaoning, Hunan, Hainan, Anhui, Ningxia, Jiangxi, Hubei and other places have issued a text, began the 2020 drug inspection operations.
    Many regions also mention the concept of traceability, such as Gansu in the inspection focus is clear, drug management enterprises focus on checking whether the drug purchase channels are legal, the purchase and sale of drug certificates, tickets, accounts, goods, money can correspond to each other, drug purchase and sale deposit and implementation of GSP requirements, especially whether the drug purchase and sale records are complete, true, business behavior can be traced.
    , the State Drug Administration officially issued a request by the end of this year to basically achieve the national centralized procurement of selected varieties traceability.
    is only three months away from the target, and it's time for companies to be ready.
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