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    Home > Medical News > Latest Medical News > Chinese medicine tablets into the traceability system! The first batch of 20 pharmaceutical wholesale enterprises were selected.

    Chinese medicine tablets into the traceability system! The first batch of 20 pharmaceutical wholesale enterprises were selected.

    • Last Update: 2020-09-04
    • Source: Internet
    • Author: User
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    Pharmaceutical Network August 13 - August 11, Hebei Provincial Drug Administration official website issued "on the promotion of drug circulation traceability system drug and beverage tablets traceability work notice" (hereinafter referred to as "Notice"), a batch of Chinese medicine tablets into the drug circulation traceability system, and selected 20 pharmaceutical wholesale enterprises to carry out chinese medicine tablets standard data control and traceability data upload work.
    Drink tablets retrospective "Hebei program" Hebei this time included in the drug circulation traceability system of Chinese medicine tablets mainly include the implementation of the "Chinese Pharmacopoeia", "Ministry of Health Drug Standards" of Chinese medicine first volume, "Hebei Province Chinese medicine tablets preparation norms" 2003 edition, "Hebei Province Chinese medicine standards" 2018 version of Chinese medicine tablets varieties, as well as other Chinese medicine tablets involving wholesale enterprises operating varieties.
    noteworthy, Hebei Province this time selected 20 pharmaceutical wholesale enterprises (see table below) for Chinese medicine tablets standard data control and traceability data upload work.
    requires enterprises to form a variety coding correspondence in accordance with product information such as the name, implementation standard, production enterprise and origin of Chinese medicine tablets, and against the standardized control table (first batch) of basic data of Chinese medicine drink tablets.
    the "administrative area information" of the supplier and customer's region and center of the chinese medicine tablets in this unit, and form the corresponding relationship of the regional code. Form
    The first batch of Chinese medicine tablets added to the list of retrospective enterprises in Hebei Province in accordance with the "Notice" requirements, the above 20 wholesale enterprises need to be in all varieties after the completion of the control, raw cost enterprises Chinese medicine tablets into and out of XML data files, in accordance with the original pharmaceutical preparation purchase and sale of XML data upload method, daily upload to the system.
    on August 12, 2020 to complete the Chinese medicine beverage varieties control and traceability data upload work.
    Some industry sources pointed out that Hebei this time to wholesale enterprises as a chinese medicine tablets traceable grasp is not surprising, last year the province has issued a request to the province's wholesale pharmaceutical enterprises and retail chain enterprises must be all joined by September 15 drug traceability system in Hebei Province.
    " document at the time pointed out that the drug traceability system first of all the implementation of the approval number and registration number management (imported drugs) of drugs into the scope of monitoring, the Chinese medicine tablets into the scope of monitoring has been in the follow-up plan.
    and into the net after the drug business enterprises daily report drug purchase and sale information is also in last year's document has been clear, this time only the Chinese medicine tablets are also included.
    industry chain supervision is still to strengthen the control of Chinese medicine tablets can be said to be one of the key points of supervision in recent years.
    at the national drug registration management and post-market supervision work meeting at the beginning of the year, also proposed to focus on the difficult areas of drug safety, highlighting problems, in-depth implementation of Chinese medicine tablets, practicing pharmacists "certificate" and other special rectification.
    fact, in recent years, with the strengthening of supervision work, industry quality awareness, the quality of domestic Chinese herbal medicine and Chinese medicine tablets improved year by year.
    data show that last year, the national sampling of 54,188 batches of Chinese herbal medicine and drink tablets quality inspection, the average pass rate has reached 91%, the overall quality of the situation shows a steady trend towards good.
    2013-2019, the national Chinese herbal medicine and drink tablets sampling pass rate (source: China Food and Drug Inspection Research Institute) Chinese medicine drink tablets and preparations production and operation units, as well as the Chinese herbal medicine market to implement the main responsibility, especially as the source of the production enterprises.
    Article 39 of the Drug Administration Law stipulates that Chinese medicine tablets shall fulfill the relevant obligations of the licensed holders of Chinese medicines, carry out the whole process of management over the production and sale of Chinese medicine tablets, establish a traceability system for Chinese medicine tablets, and ensure the safety, effective and traceability of Chinese medicine tablets.
    , the sampling of Chinese medicine tablets is mainly in the sales and use of the link sampling.
    In accordance with the relevant provisions, if the sampling of Chinese medicine tablets does not meet the standard provisions or detect illegal ingredients, the drug supervision department indicating the place where the production enterprise is located shall, in accordance with the provisions of the delivery inspection report and the "notice of the proposed announcement", be marked by the production enterprise in the service receipt to confirm in writing whether the unqualified products involved have been produced, in order to take appropriate regulatory measures.
    "Pharmaceutical Economics" reporter retrieved the 2020 national drug regulatory information published on the website of the State Drug Administration, involving non-conforming Chinese medicine tablets have 14 issues, a total of 123 batches of unqualified Chinese medicine tablets, of which 23 batches of marked production enterprises denied production, accounting for 18.7%.
    can be seen, unqualified Chinese medicine tablets marked production enterprises deny that the production situation still exists.
    analysts believe that the improvement of Chinese medicine tablets traceability, traceability system can greatly reduce the occurrence of similar situations, such as the Chinese medicine tablets into the scope of monitoring hebei drug traceability system, on the first batch of drug wholesale enterprises and video transmission conditions mature enterprises to pilot video transmission off-site monitoring, enterprise warehouse video surveillance into the drug circulation off-site monitoring system, drug regulatory authorities can see the drug business warehouse video surveillance.
    addition, the Application of Internet of Things, Barcode, Radio Frequency Identification (RFID), Big Data and other technologies is also expected to strengthen the quality assurance of Chinese medicine tablets from the circulation chain.
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