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    Home > Medical News > Medical World News > Disputes over direct administration of Chinese Herbal Pieces

    Disputes over direct administration of Chinese Herbal Pieces

    • Last Update: 2020-01-13
    • Source: Internet
    • Author: User
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    Due to the dispute over standards, the case has caused a huge shock in the industry, which has been debated continuously Until now, no authoritative department has made further explanation In 2017, Guangdong Province in the "reply on whether the Chinese Herbal Pieces processed in accordance with the processing specifications (standards) of other provinces can be produced, operated and used in our province": "at present, there is no law explicitly prohibiting the Chinese herbal pieces produced in accordance with the processing specifications of other provinces from operating and using in our province, so the Chinese Herbal Pieces processed in accordance with the processing specifications (standards) of other provinces are prohibited from operating and using in our province There are laws and regulations basis " As Guangdong's drug regulatory concept is more open and inclusive, it has always taken an open attitude towards the standard production of decoction pieces in other provinces However, at present, there are many standards for Chinese herbal pieces, many of which cannot be unified The industry is basically based on national standards, supplemented by provincial, municipal and local standards, and there are still some varieties without standards, so some enterprises can only use the existing standards for Chinese Herbal Pieces in other provinces, which brings legal risks In the reform of the new drug regulatory agency, the retail and use terminals are enforced by the local government, and the implementation standards of cases vary from place to place At the same time, there are two different understandings on the concept of law enforcement: The first is the open school, which believes that the law can be done without prohibition If there is a standard to revitalize traditional Chinese medicine, it should be regarded as legal, and there is nothing wrong with meeting market needs The other is conservatives, who think that at present, the standard management of different provinces is relatively disordered, and the quotation of the standards of other provinces should be the varieties that are not included in the national standards and local standards of the province, and the pieces are traditionally produced in the general principles of the Chinese Pharmacopoeia However, under the background of modernization and innovation of traditional Chinese medicine, the processing technology and appearance of pieces of traditional Chinese medicine in some provinces are quite different There are not only powder (grinding), broken wall, micro powder, but also tablets like x grass, which are pressed and shaped, collectively referred to as "direct tablets" In fact, on April 19, 2018, the State Food and Drug Administration issued the notice of the State Food and Drug Administration on the technical guidelines for the revision of the processing specifications of the provincial Chinese herbal pieces (No 16, 2018) The notice requires that the processing specifications of the provincial herbal pieces should be strictly in accordance with the relevant provisions of the drug administration law of the people's Republic of China and its implementation regulations, and the collection scope is limited to It is not allowed to collect the scientific research products that are still in the stage of scientific research without the recognized safety and effectiveness data, as well as the tablets, granules and other products that are routinely managed according to the preparation In the case of X-US, there are some disputes about the standards, such as smashing (grinding) powder and broken wall traditional Chinese medicine powder pieces The biggest disputes are also concentrated here At present, the scope of production of Chinese herbal pieces involved in the national drug production license is divided into 17 kinds of production or processing procedures according to the general principles for processing of Chinese Pharmacopoeia, such as: cutting, purification, frying, steaming, calcining, salt making, liquor making, etc the use method is more traditional, and the decoction is taken after boiling with water in the prescription of Chinese medicine; there is no such production scope as smashing (grinding) powder or breaking the wall, The processing standards of some Chinese herbal pieces outside the province have greatly exceeded the general principles Is it beyond the scope of production? Obviously, it has become the most controversial point in the court Recently, from Chongqing, Beijing, Hunan (for comments), Shandong, Gansu, 5 provinces and cities have released the information of canceling the local processing standards of Chinese herbal pieces and powder, which shows that the provinces have begun to rectify the chaos From the perspective of drug traceability, the author analyzes that there are at least three regulatory blind areas in the supervision of the production of traditional Chinese medicine powder or broken wall powder according to the standards of traditional Chinese medicine Pieces in some provinces First, the quality of the original medicinal materials can not be controlled, nor can it be traced back in the daily supervision That is to say, the raw materials or non medicinal parts are used to make powder The content test is generally qualified, but the efficacy is difficult to guarantee Second, the environmental standard for direct administration of decoction pieces is high, and the microbial limit requirements cannot be controlled The third is the dispute of the provincial drug inspection and reference standards in the qualitative analysis of fake and substandard drugs, as well as the use of reference materials and other complex issues.
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