Chinese herbal medicines, traditional Chinese medicine (TCM) preparations, and proprietary Chinese medicines are three essential components that support the development of TCM. However, the industry has long overlooked the importance of raw herbal materials, especially those used in decoctions. According to recent developments, decoction pieces have gained significant attention in the revision of the new edition of the Pharmacopoeia. There has been a notable increase in both the number of items and the specific quality control indicators. The issue of unifying the quality standards for medicinal herbs and their processed forms has received unprecedented attention during this revision. The reporter learned that there are approximately 4,886 research projects included in the new edition of the Pharmacopoeia. Out of these, around 1,000 are related to Chinese herbal medicines and their processed forms. These projects can be categorized into three levels: first, those with strong research foundations and the potential to meet international standards through advanced technologies; second, those that aim to improve current standards to reach domestic average levels; and third, those with weak research backgrounds that require more data and foundational work. According to experts, the upcoming "Guide to Clinical Medications of Chinese Herbal Materials and Decoction Pieces" will fill important gaps in clinical drug guidance. This guide is expected to enhance the practical application of herbal medicines in medical settings. Currently, about one-third of the herbal medicine varieties under revision have completed standard formulation and drafting, and are entering the review process by the Institute of Drug Control. Tu Pengfei, a member of the 9th National Pharmacopoeia Committee for TCM, mentioned that the 2010 edition added 150 new medicinal herbs and revised 318 others. The focus was on new varieties, revisions of existing ones, separate listings of multi-source herbs, updates to Latin names, and the application of modern technologies. Zhou Chaofan, an executive member of the Pharmacopoeia Commission, explained that new varieties are selected based on factors such as "upside-down" species—herbs already used in prescriptions but not yet included in the pharmacopoeia—and commonly used, well-researched varieties. Wild or endangered species are no longer considered for inclusion due to resource concerns. For unclear or chaotic ethnic medicines, in-depth historical research is required before setting standards. For the revision of old varieties, the focus is on improving weak standards, such as those with only basic source information. Errors or unreliable methods from previous standards are also being corrected. The new edition also addresses multi-source herbs by separating those with distinct traits and chemical compositions, making it easier to identify and regulate them. Quality control of medicinal materials remains a challenge. The new edition plans to adopt advanced technologies like DNA molecular markers for animal-based medicines, bioassays for qualitative and quantitative analysis, and fingerprinting techniques for comprehensive quality assessment. Regarding decoction pieces, the new edition highlights two major improvements: adding quality standards for over 400 new pieces and enhancing control indicators for existing ones. Previously, only a small number of decoction pieces had detailed quality standards, which were insufficient for proper regulation. The new edition focuses on mainstream processing methods while allowing local variations, ensuring consistency without imposing strict uniformity. In terms of content determination, the new Pharmacopoeia emphasizes highly specific identification methods and establishes a system that reflects the complexity of TCM. For example, the revised standard for Maqinzi now includes the conversion of strychnine into its oxide form as an indicator, ensuring better quality control after processing. The new edition also strengthens safety testing, including heavy metals, harmful elements, and pesticide residues. With improved standards, the industry may see a shift, eliminating weaker players and promoting growth among more regulated enterprises. This could lead to safer and more effective TCM products, both domestically and internationally. Experts believe that the updated guidelines, such as the upcoming "Clinical Use Guide for Chinese Herbal Materials and Decoction Pieces," will further enhance the proper use of these medicines in practice. As Zhou Chaofan noted, the success of the revision depends on how effectively these changes are implemented.

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