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    Home > Active Ingredient News > Drugs Articles > The implementation of new drug law leads to butterfly effect, and some pharmaceutical enterprises apply for suspension of production

    The implementation of new drug law leads to butterfly effect, and some pharmaceutical enterprises apply for suspension of production

    • Last Update: 2019-12-05
    • Source: Internet
    • Author: User
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    [industry trends of pharmaceutical network] on December 4, 2019, Gansu Provincial Food and Drug Administration issued a notice on the suspension of production of Longxi Zhengda Pharmaceutical Co., Ltd the reason for the suspension was due to the shortage of funds, the suspension of production and sales This is the first pharmaceutical enterprise to apply for suspension of production after the implementation of the new drug administration law Since this year, pharmaceutical companies have been shutting down In fact, in addition to frequent changes in senior executives in the pharmaceutical industry, there have been endless news of drug companies shutting down For example, as early as July 25, Hubei Provincial Food and Drug Administration issued the notice on the announcement of the suspension of production of drug manufacturers (No 6 in 2019), including 34 drug enterprises such as APIs, Chinese herbal pieces and preparations On September 20, Jiangxi Provincial Food and Drug Administration issued two announcements on the suspension of production of pharmaceutical enterprises According to the announcement, both enterprises actively applied to stop production due to their own business adjustment Three days later, Jiangxi Provincial Drug Administration issued a notice again, saying that after the application of the enterprise, it agreed to cancel the drug business license of a drug enterprise in Jiangxi From the date of the spontaneous document, the company is not allowed to engage in drug business activities According to incomplete statistics, more than 50 pharmaceutical enterprises have stopped production in 2019, some of which have resumed production according to law Although there are always compelling reasons for enterprises to choose to stop production, stopping production does not mean that they can avoid supervision E.s.y.j.h [2009] No.9 document stipulates that: drug production enterprises shall suspend production for 6 months or more and report to the local relevant departments for filing within 20 days before the production stop, stating the reasons for the production stop, the date of production stop, the treatment measures for the remaining intermediate products, the maintenance methods adopted by the plant (facilities, equipment), etc If it is necessary to resume production, it shall be reported to the local Municipal Bureau for approval within 20 days before the resumption of production The local municipal bureau shall send personnel to carry out on-site inspection, and the resumption of production can be approved only when the conditions for resumption of production are met After resumption of production, the drug manufacturing enterprise shall submit the copies of the inspection reports of the first three batches of products to the local municipal food and Drug Administration for the record In addition, if Jiangxi Province requires to suspend production for more than 3 months, it shall report to the drug regulatory department in advance; if Shandong Province requires to suspend production for 6 months, it shall report to the drug regulatory department in advance It can be seen that the drug regulatory authorities have strict management measures for the production suspension of drug enterprises Therefore, for pharmaceutical enterprises, whether they are in the stage of renovation or are really unable to continue production, they should not be careless in meeting production conditions and quality standards In fact, with the implementation of the new drug administration law, the professional and professional inspection team taking office, the flight inspection at any time is putting forward a considerable test to the compliance production of pharmaceutical enterprises Perhaps, after the implementation of the new drug law, more enterprises will choose to stop production It is worth noting that, through careful observation of the enterprises that stop production, the author found that the majority of enterprises that stop production are Chinese herbal pieces This may be related to the increasingly strict supervision of Chinese herbal pieces by the state In recent years, with the improvement of pharmacopoeia standard and the increasing inspection of regulatory authorities, the life of Chinese herbal pieces has been difficult The new drug quality announcements issued by the multi local drug administrations are more or less related to Chinese herbal pieces And with the formal implementation of the new "Drug Administration Law" on December 1, industry insiders said that the days of Chinese herbal medicine enterprises may be more difficult Because Chapter 11 and Article 117 of the new drug administration law clearly stipulate that, in addition to confiscating the illegally produced and sold drugs and illegal income, those who produce and sell substandard drugs will also be fined not less than 10 times but not more than 20 times the value of the goods In addition, if the Chinese herbal pieces produced and sold do not meet the drug standards, even if the products do not affect their safety and effectiveness, they will still be fined between 100000 yuan and 500000 yuan Over the past ten years, the Chinese herbal medicine industry has seized the opportunity of the development of traditional Chinese medicine and achieved high-speed growth The market scale has grown from 24.2 billion yuan in 2007 to nearly 200 billion yuan in 2016, with an average annual growth rate of 26%, leading the pharmaceutical industry, which is the advantage of the Chinese herbal medicine field However, it should be noted that in recent years, Chinese herbal pieces are also becoming frequent customers in the list of national and provincial unqualified drugs: according to the annual analysis report on unqualified data of drug quality in 2017, 80% of the unqualified drugs in the national sampling test in 2017 are Chinese herbal medicine Statistics show that the number of unqualified Chinese herbal medicines is very prominent, accounting for 64% of the total number of unqualified drugs, and the proportion of Chinese herbal pieces is also greatly increased According to the current national regulatory situation, TCM reform policy and industry regulation will continue to push forward in a large scale, or further promote the standardized development of the industry, SMEs will be more likely to be merged and reorganized, and the increasing industry concentration will be the development trend of the industry in the future In this period of time, the enterprises that choose to stop production will not be a few.
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