Documents issued in many provinces, the management of traditional Chinese medicine formula particles will continue to be stricter

Traditional Chinese medicine formula granules are new formula medicines made from Chinese medicine decoction pieces as raw materials and processed through production processes such as extraction, separation, concentration, drying, granulation, and packaging
.
In recent years, with the rapid development of the Chinese medicine industry, the market scale of Chinese medicine formula granules has also begun to expand
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According to statistics, the market size of traditional Chinese medicine formula granules will reach 25.
5 billion yuan in 2020
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The agency predicts that the Chinese medicine formula granule industry will continue to grow rapidly in the next few years.
By 2023, the industry scale is expected to approach 50 billion yuan
.
It is worth noting that with the continuous expansion of the TCM formula granule market, in order to strengthen the management of TCM formula granules, standardize the production of TCM formula granules, and guide the healthy development of the industry, the State Food and Drug Administration issued the "Regarding the End of TCM Formula Granules" in February this year.
Announcement on Pilot Work, announcing that it will end the 20-year pilot work of traditional Chinese medicine formula granules
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The liberalization of the policy does not mean that the supervision is no longer strict, but more stringent
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For example, it is proposed in the announcement that a Chinese medicine formula granule manufacturer should have a complete production capacity of Chinese medicine processing, extraction, separation, concentration, drying, and granulation, and a production scale corresponding to the number of varieties produced and sold; Chinese medicine decoction pieces The production process of processing, water extraction, separation, concentration, drying, granulation and other traditional Chinese medicine formula particles shall comply with the relevant requirements of the Good Manufacturing Practice (GMP)
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In addition, after the announcement of the announcement, various localities have successively issued documents to accelerate the implementation of relevant rules
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In the near future, many provinces have issued documents to strengthen the management of traditional Chinese medicine formula particles
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For example, on September 14, the Beijing Municipal Drug Administration and Anhui Drug Administration issued notices to solicit opinions on the implementation rules (trial) of the management of traditional Chinese medicine formula granules, respectively, and solicit opinions from the public
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On September 7, Hebei Provincial Drug Administration also took the lead in drafting the "Rules for the Implementation of Hebei Province Traditional Chinese Medicine Formula Granule Management" (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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Looking at the overall management rules issued by various regions, the supervision of the Chinese medicine formula granule industry is becoming more and more stringent
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In fact, this also means that after the trial of traditional Chinese medicine formula granules, which has attracted much attention from the industry, the market of Chinese medicine formula granules is about to enter a stage of fierce competition.
In the future, relevant Chinese medicine companies will face huge competitive pressure
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Especially for the Chinese medicine formula granule companies on the track, the future market will further test the company's production and supply chain capabilities
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It is understood that traditional Chinese medicine formula granules generally need to go through the steps of Chinese medicine planting, decoction pieces production, granule production, and then to clinical adjustment.
In the case of fierce market competition, how companies can improve their supply chain capabilities while ensuring quality.
The key
.