The regulation of traditional Chinese medicine formula granules continues to be stricter, and manufacturers will face major challenges

On November 1, 2021, the trial of traditional Chinese medicine formula granules was officially ended and fully liberalized
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In this regard, the industry said that in the context of the liberalization of traditional Chinese medicine formula particles, the establishment of a more complete standard system will be an important basis for standardizing the development of traditional Chinese medicine formula particles
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It is understood that the country has recently issued a notice to regulate the clinical use of Chinese medicine formula granules in medical institutions
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Recently, the National Health Commission and the State Administration of Traditional Chinese Medicine jointly issued the "Notice on Regulating the Clinical Use of TCM Granules in Medical Institutions" (hereinafter referred to as the "Notice")
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It is understood that in order to promote the rational and standardized use of TCM formula granules in medical institutions, the "Notice" clarifies that when formulating rules for the management of TCM formula granules, localities must further refine the clinical rational and standard use of TCM formula granules to ensure the main status of TCM decoction pieces
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At the same time, the "Notice" clarified that health and health departments at all levels must regulate the use of traditional Chinese medicine formula granules in medical institutions, and medical institutions that can provide Chinese medicine services after approval or filing can use Chinese medicine formula granules
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In addition, the notice also requires doctors to inform patients before prescribing prescriptions for traditional Chinese medicine granules to protect patients' right to know and to choose
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The industry generally believes that this is another important regulatory document for TCM formula granules following the joint release of the "Announcement on Ending the Pilot Work of TCM Formula Granules" by the State Food and Drug Administration and other four departments in February this year
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It is worth noting that, in order to speed up the formulation of standards for TCM formula granules that meet the new national technical requirements, various localities have already begun to publish documents to further regulate the production and clinical use of TCM formula granules, and promote their industrial upgrading
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For example, in November, the Xinjiang Uygur Autonomous Region Drug Administration, Health Commission, and Medical Security Bureau also jointly issued the "Implementation Rules for the Management of Traditional Chinese Medicine Granules in Xinjiang Uygur Autonomous Region (Trial)" (hereinafter referred to as the "Rules")
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Among them, the "Detailed Regulations" clarified the main status of adherence to Chinese medicine decoction pieces, will support enterprises to maintain integrity and innovation, and encourage the development of traditional Chinese medicine formula granules and industrial technology upgrades
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Also clarified the standard management of traditional Chinese medicine formula granules
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According to the requirements of the "Detailed Regulations", the granules of Chinese medicine formula produced, sold and used in the autonomous region should meet the national drug standards
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If there is no national drug standard, it shall comply with the standard set by the Autonomous Region Drug Administration
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Earlier in February, the Yunnan Provincial Drug Administration also established a special working group to actively carry out investigations and discussions, and combined with the actual situation of Yunnan Province, formulated the "Yunnan Province Traditional Chinese Medicine Formula Granule Quality Standard Establishment Work Procedures and Application Information Requirements" (Trial)
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Judging from the current implementation regulations issued by various provinces, in order to better promote the development of the domestic Chinese medicine formula granule industry, all regions have put forward higher requirements and more standards for its production, storage, and transportation links
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For manufacturers, it is necessary to fulfill the main responsibilities and related obligations of the whole life cycle of drugs, strengthen management and control in the production and management process, and ensure the quality and safety of traditional Chinese medicine formula granules, so as to help companies usher in more development opportunities in the future
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