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    Home > Active Ingredient News > Drugs Articles > In the practice of the new regulations, how to define the traditional Chinese medicine decoction pieces as "does not affect the safety and effectiveness"?

    In the practice of the new regulations, how to define the traditional Chinese medicine decoction pieces as "does not affect the safety and effectiveness"?

    • Last Update: 2021-07-01
    • Source: Internet
    • Author: User
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    On April 30, 2021, the last working day before the May Day holiday, the Shandong Provincial Drug Administration issued the "Guiding Opinions on the Determination of Safety and Effectiveness of Chinese Herbal Pieces Not Complying with Drug Standards",
    further explaining the new amendment The identification of "other drugs that do not meet the drug standards" stipulated in Item 7 of Article 98 of the Drug Administration Law mainly stipulates items that affect safety and effectiveness, items that do not affect safety and effectiveness, and limit values.
    Content

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    1.
    In law enforcement practice, how to grasp "safety and effectiveness is not yet affected"
      


    The second paragraph of Article 117 of the newly revised "Drug Administration Law" clearly stipulates that "If the Chinese herbal medicines produced and sold do not meet the drug standards and do not affect the safety and effectiveness, they shall be ordered to make corrections within a time limit and be given a warning

    .
    " This provision fully takes into account the diversity and complexity of Chinese herbal medicine pieces

    .
    However, in the current law enforcement practice, the country has not formulated specific regulations on how to control "safety and effectiveness"

    .
    Regarding how to apply this paragraph, in law enforcement practice, some drug regulatory agencies often only order corrections and warnings for decoction pieces of Chinese medicine that do not meet the standards but do not affect the safety and effectiveness, and they do not confiscate illegal drugs and illegal income.
    Such administrative penalties are actually misunderstandings and deviations in the understanding and enforcement of legal provisions

    .


    Chinese herbal medicine production enterprises have a high voice and urgently require the formulation of uniform standards

    .
    To this end, Anhui Province and Shandong Province Drug Administration have issued official versions on the basis of full investigation and demonstration.
    On December 24, 2019, the Anhui Province Drug Administration issued the "Chinese Medicine Decoction Pieces Not Complying with the Drug Standards.
    Notice on the Guiding Opinions Affecting the Determination of Safety and Effectiveness; April 30, 2021, the last working day before the May Day holiday, Shandong Provincial Drug Administration issued the "Chinese herbal medicine decoction does not meet the drug standards and does not affect safety "Guiding Opinions on Validity Confirmation", in addition, Shaanxi Province, Gansu Province, Guangdong Province, Sichuan Province and other provincial bureaus have successively issued drafts for soliciting opinions

    .


    2.
    Comparison of specific items and standards of "other drugs that do not meet drug standards"


    references:


    [1] Shandong Provincial Drug Administration website


    [2] Website of Anhui Provincial Drug Administration

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