The supervision of Chinese medicine is continuously upgraded!

In recent years, both national and local levels have begun to issue a series of favorable policies to promote the high-quality development of Chinese medicine and the industry
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In this context, the Chinese medicine industry has entered a period of rapid development, and the market space is also expanding
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However, it should be noted that at the same time, the state's supervision of the Chinese medicine industry has also begun to become more stringent
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It is understood that this is because most of the current quality standards of traditional Chinese medicine products mostly use a single component for content determination and quality control, without forming an overall control of the effect component, and in the actual production process, there are inherent quality differences in the same product produced by different manufacturers.
Uneven, due to unstable clinical efficacy and safety
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Among them, it is worth mentioning that due to the special development history, scientific system and industry requirements of Chinese medicine, for a long time, most Chinese medicine instructions still have "unclear" expressions
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In this context, in order to regulate the development and use of traditional Chinese medicines, the state has also begun to issue a series of documents to revise and improve the product manuals of traditional Chinese medicines
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Recently, the National Medical Products Administration website published the "Technical Guidelines for the Revision of Safety Information Items in the Labels of Marketed Chinese Medicines (Draft for Solicitation of Comments)" (hereinafter referred to as "Draft for Comments")
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The main content of the draft opinion includes four parts: overview, basic principles, revision details, and revision of the safety information items of imported Chinese medicines and natural medicines
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Among them, the revised detailed rules mainly involve five safety information items, including warnings, adverse reactions, contraindications, precautions, and medications for special populations, and provide guidance for different focuses
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Among them, for the existing safety research results, the corresponding safety information item in the manual should not be marked "not yet clear"
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The industry believes that the issuance of this document is aimed at strengthening the supervision and management of the labeling of Chinese medicines on the market and accelerating the revision of the safety information items of the labeling of Chinese medicines on the market
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At the same time, it also means that relevant departments are further regulating the development of the Chinese medicine industry
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In fact, many policies in recent years have vigorously promoted the modernization and standardized development of the Chinese medicine industry..
For example, the in-depth implementation of the "Traditional Chinese Medicine Law" and the improvement of the quality standards of the new version of the "Pharmacopoeia" present a new pattern for the development of the Chinese medicine industry; earlier to strengthen registration management and standardize the specification of Chinese patent medicines, the Food and Drug Administration also The organization drafted the "Technical Guidelines for Specification Expression of Chinese Patent Medicines (Draft for Soliciting Comments)"
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The "Draft of Opinions" made detailed requirements around the general principles of the specification of Chinese patent medicines and examples of the specifications of different dosage forms of Chinese patent medicines
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It can be seen from the whole that the supervision of traditional Chinese medicine is becoming stricter from production to instructions
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In this context, the industry believes that in the future, in addition to focusing more on the research and development of innovative Chinese medicines with relatively high academic content, and striving to introduce more innovative products with characteristics, companies should pay more attention to standardized development in all aspects of production and sales.
Always pay attention to the policies introduced by relevant departments and actively improve them
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