All localities are accelerating the implementation of the standard of traditional Chinese medicine formula particles!

Since February 10, the State Food and Drug Administration, the State Administration of Traditional Chinese Medicine and other four departments jointly issued the "Announcement on Ending the Pilot Work of TCM Formula Granules", deciding to end the pilot work of TCM formula granules, and clarifying the supervision matters after the pilot work is completed Since then, in order to accelerate the implementation of the Chinese medicine formula granule policy, various provincial drug regulatory departments have begun to issue implementation rules one after another to actively implement the requirements of the "Announcement"
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For example, on September 7, the Hebei Provincial Drug Administration took the lead in drafting the "Rules for the Management of Hebei Province Traditional Chinese Medicine Formula Granules" (draft for comments)
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Among them, specific requirements are put forward for many aspects such as production management, use management, drug standards, and filing
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On the same day, the Drug Administration of Ningxia Hui Autonomous Region also issued a notice on the public solicitation of the "Rules for the Management of Traditional Chinese Medicine Granules in Ningxia Hui Autonomous Region (Trial) (Draft for Solicitation of Comments)"
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The draft for comments includes seven chapters and 27 articles, and multiple measures are taken to strengthen the filing and supervision of Chinese medicine formula granules
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On August 12, the Shandong Provincial Food and Drug Administration issued the "Shandong Province Traditional Chinese Medicine Formula Granule Production Quality Management Guidelines (Trial)", which put forward quality management requirements for the institutions and personnel of the manufacturing enterprises, plants and facilities, and equipment
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On July 27, the Hainan Provincial Food and Drug Administration and the Provincial Administration of Traditional Chinese Medicine jointly issued the "Implementation Rules for the Management of Traditional Chinese Medicine Granules in Hainan Province (Trial)" (hereinafter referred to as the "Implementation Rules of Hainan Province")
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In addition to the above-mentioned provinces, the Food and Drug Administration of Gansu, Zhejiang, Guizhou and other provinces (autonomous regions and municipalities) have also issued their respective standards for traditional Chinese medicine formulation granules
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The industry believes that this will lay a solid foundation for improving the overall quality control of traditional Chinese medicine
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In fact, the standard of traditional Chinese medicine formulation particles has always been the focus of the industry, and in recent years, the process of building relevant national standards has been accelerating
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Among them, it is worth mentioning that on April 29, the State Food and Drug Administration approved and promulgated the first batch of national drug standards (160) of Chinese medicine formula granules
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In addition, there are 39 Chinese medicine formula granules national drug standards are under review, and another 246 types of Chinese medicine formula granules have enterprises that are conducting standard research.

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In the context of the country's continuous progress in the construction of relevant standards for traditional Chinese medicine formula particles, and the provincial drug regulatory departments have stepped up to formulate and release relevant standards for traditional Chinese medicine formula particles, the industry believes that the market competition for traditional Chinese medicine formula particles will become more and more fierce in the future
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However, the industry also pointed out that for the industry to develop in a healthy and orderly manner, strict standard setting and supervision during and after the event are always indispensable
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It can be seen from the "Announcement" and the implementation rules issued by various localities that the end of the trial of Chinese medicine formula granules does not mean relaxation of management
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Rather, while "releasing" traditional Chinese medicine formula granules, it further refines the capacity requirements for manufacturers, and emphasizes that manufacturers of Chinese medicine formula granules should perform the main responsibility and related obligations of the whole life cycle of medicines, and strengthen risk management
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In this context, manufacturers need to fulfill the main responsibility and related obligations of the whole life cycle of drugs in the future, strengthen management and control in the production and management process, and ensure the quality and safety of traditional Chinese medicine formula particles in order to better assist the industry.
Healthy development
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