Lei Jufang: I suggest prioritizing the development of a catalog of classic, time-tested prescriptions for ethnic medicines and encouraging appropriate improvements in dosage forms for Tibetan medicine.

　　Proposal 1: Proposal on Recommending the Priority Development and Approval of a Catalog of Time-Honored Formulas for Ethnic Medicines

　　In 2016, the "Law on Traditional Chinese Medicine and Ethnic Medicine" was promulgated amid widespread public attention, explicitly stating: "The term 'Traditional Chinese Medicine and Ethnic Medicine' as used in this Law refers to the collective designation of the medical systems of all ethnic groups in China, including those of the Han and minority nationalities. It is a medical system that reflects the Chinese nation's understanding of life, health, and disease, characterized by a long-standing historical tradition as well as unique theoretical and technical approaches." This represents significant support and impetus for the development of ethnic medicine. The law also emphasizes the importance of developing classic prescriptions from ancient texts—a first-ever elevation of this issue to the level of legal recognition. As is well known, ethnic medicines represented by Tibetan, Mongolian, Uyghur, and other ethnic groups possess sophisticated medical theoretical systems and extensive classical literature. In the eighth century, Tibetan medicine already had 443 commonly used classic prescriptions documented in the "Four Medical Tantras"; Mongolian medicine still relies on more than 300 such classic prescriptions today, while Uyghur medicine continues to use over 200 classic prescriptions. Currently, the number of classic prescriptions from Tibetan, Mongolian, Uyghur, Dai, Zhuang, and Kazakh medicine that have been officially recognized through examinations amounts to approximately 1,050, averaging about 150 per ethnic group. Regrettably, only a few dozen of these prescriptions have been developed into nationally approved pharmaceutical products. Despite having undergone thousands of years of clinical practice and proven efficacy, these classic prescriptions remain widely used in hospitals of Tibetan, Mongolian, Uyghur, and other ethnic groups; some varieties are even used both domestically and internationally, fully demonstrating their therapeutic advantages and enduring vitality—making them highly worthy of further exploration and utilization.

　　The "Law on Traditional Chinese Medicine" also explicitly outlines the development pathway for classic prescriptions, proposing that they can be developed into “compound Chinese medicinal preparations derived from time-honored classical prescriptions.” The implementing rules further stipulate that “specific management measures shall be formulated jointly by the drug regulatory authority under the State Council and the competent authority for traditional Chinese medicine.” The “time-honored classical prescriptions” referred to in the preceding paragraph are those recorded in ancient Chinese medical texts that remain widely used today, have proven efficacy, and possess distinct characteristics and advantages. The specific catalog of such prescriptions shall be jointly formulated by the competent authority for traditional Chinese medicine under the State Council and the drug regulatory authority, thereby clarifying that the “catalog” constitutes a fundamental step in the development of classic prescriptions and can enrich the content of the 2007 Drug Registration Regulations by adding a classification for classic prescriptions.

　　Under the leadership of the relevant authorities, the compilation of classic traditional Chinese medicine prescriptions has already established a foundation of several years’ work; however, the compilation and cataloging of classic prescriptions from ethnic groups such as Tibetan, Mongolian, and Uyghur have yet to be initiated. Therefore, we urge the competent authorities for TCM and the drug regulatory agencies to, in accordance with the spirit of the “Traditional Chinese Medicine Law,” prioritize the compilation and cataloging of those ancient ethnic classic prescriptions that “are still widely used today, have proven efficacy, and possess distinct characteristics and advantages,” complete their formulation, and approve their development and utilization. To this end, we recommend:

　　First, under the unified guidance of the State Administration of Traditional Chinese Medicine, we will entrust autonomous regions of ethnic minorities or influential academic societies in the ethnic medicine sector to organize experts in ethnic medicine to develop principles for selecting classic prescriptions from various ethnic groups and compile a corresponding catalog. This catalog will be jointly reviewed and approved by the State Administration of Traditional Chinese Medicine and the National Medical Products Administration, with priority given to approving their development and utilization.

　　Second, to enable the ethnic medicine industry to quickly reap the policy benefits brought by the “Traditional Chinese Medicine Law,” we can adopt a mechanism of systematically organizing and cataloging mature products, promptly reviewing and approving them, and then promptly releasing them—thus establishing a systematic framework.

　　Third, when the National Medical Products Administration and the State Administration of Traditional Chinese Medicine are formulating technical guidelines for the registration of time-honored ethnic medicinal formulas, they should fully take into account the distinctive features of commonly used dosage forms in ethnic medicines and allow for the preservation of these unique formulations, thereby avoiding a one-size-fits-all approach. For example, Tibetan medicines are often administered in solid dosage forms such as pills and powders, with small dosages; therefore, following traditional preparation methods, they are well-suited for being made into pills, tablets, capsules, and other similar dosage forms. Similarly, topical administration is a hallmark of Tibetan medicine; hence, we should encourage the continued use of classic topical dosage forms for Tibetan medicines, so as to facilitate their inheritance and safeguard their unique characteristics.

　　Fourth, encourage ethnic medicine enterprises to conduct new drug research and development or develop new dosage forms based on approved classic prescriptions.

　　Proposal No. 2: Proposal on Encouraging Appropriate Formulation Improvements for Tibetan Medicine

　　Currently, with the state’s guidance and encouragement of innovative new drug development, domestic pharmaceutical companies have seen significant shifts in their R&D priorities for new drugs. The proportion of truly novel drugs has risen dramatically, while the number of products involving merely reformulation or generic imitation has become exceedingly small. Compared to previous years, when Chinese traditional medicine was largely characterized by low-level reformulations and generics, we’ve made tremendous progress. It’s fair to say that the changes in new drug review policies have played a crucial role in steering China’s traditional Chinese medicine industry toward innovation and transformation.

　　However, since the current review and approval process for Tibetan medicine and other ethnic medicines still follows the standards set for traditional Chinese medicine, we believe that, for the Tibetan medicine industry—and indeed for other ethnic medicine industries with relatively low levels of industrialization—these review policies need to be adjusted appropriately and differentiated. We should encourage appropriate innovations in dosage forms for ethnic medicines, and we must avoid adopting a one-size-fits-all approach when it comes to modifying existing dosage forms. We recommend that, while fully respecting intellectual property rights, we should encourage appropriate modifications to certain suitable varieties within Tibetan medicine. The specific reasons are as follows:

　　First, many Tibetan medicinal products have a long history, proven efficacy, and excellent safety profiles. However, their dosage forms currently limit their wider adoption and promotion. Reformulating these products is an essential step toward modernization and entry into the mainland market. For example, due to geographical conditions and historical factors, many standardized Tibetan medicines are predominantly available in powder form. Among the 200 varieties listed in the Tibetan Medicine Standards issued by the Ministry of Health, more than 90 are powders. These powdered formulations represent the crystallization of Tibetan medical wisdom and have been used for over a century—or even millennia—in Tibetan regions. They are also perfectly suited to the economic development level of Tibetan areas, which are characterized by primarily nomadic lifestyles and relatively low income levels; thus, they embody the principles of simplicity, convenience, and affordability. Yet today, it’s increasingly difficult to promote these powdered formulations in the mainland. In fact, modern formulation techniques—such as encapsulation and tablet compression—can easily address this dosage-form issue without compromising efficacy. Moreover, many Tibetan medicines are currently available in the forms of decoctions or powdered decoctions. Transforming these into granules not only preserves the original therapeutic essence and efficacy but also makes them much more convenient to take. However, under current regulatory review standards, reformulating existing products is discouraged. Merely improving compliance between different dosage forms is insufficient; often, such reforms must demonstrate superior efficacy to be approved. As a result, inadvertently, the path for Tibetan medicines to adapt their dosage forms to meet the requirements of the mainland market has been effectively blocked.

　　Second, the modernization of Tibetan medicine has lagged far behind that of traditional Chinese medicine. Consequently, it is inappropriate to apply the same standards when evaluating dosage-form modifications in Tibetan medicine and traditional Chinese medicine. The modernization of traditional Chinese medicine can be traced back to the 1980s; particularly from the late 1990s until before 2005, Chinese pharmaceutical companies seized the opportunity to leverage modern pharmaceutical technologies to address shortcomings in traditional Chinese medicine, thereby making significant improvements and upgrades. As a result, numerous modified dosage forms were approved, spurring a boom in the Chinese medicine market. For instance, Tasly’s Compound Danshen Dropping Pills and Kangyuan’s Guizhi Fuling Capsules are both highly successful examples of dosage-form modifications. In contrast, the modernization of Tibetan medicine has spanned less than a decade. Moreover, due to technical limitations and insufficient awareness among Tibetan medicine manufacturers, Tibetan medicines simply did not have enough time to take advantage of modern pharmaceutical technologies for product reformulation or to reap the benefits of the then-current drug review policies and technological advancements—such as the allowance for dosage-form modifications—before these policies were completely closed off to them. This clearly constitutes an unfair situation. According to incomplete statistics, among the 200 varieties included in the Tibetan medicine departmental standards, only about 10 are available in modern dosage forms such as capsules, tablets, and granules.

　　Third, for a long time, our regulatory framework for topical medications—especially topical local medications—has been relatively stringent. When it comes to changes in dosage forms of topical medications or converting oral formulations into topical ones, we have required detailed explanations regarding the scientific basis, rationality, efficacy, and safety of such formulation changes. However, these considerations are not entirely appropriate when applied to topical local medications. This is because the transdermal absorption theory does not fully apply to topical analgesics (in other words, conventional methods for detecting transdermal drug absorption into the bloodstream are not entirely suitable for traditional topical analgesics). Research has shown that the pain-relieving effect of topical analgesics is closely linked to the activation of C-nerve fibers in the local skin, rather than the previously held view that they exert their effects by first being absorbed through the skin and then producing anti-inflammatory and analgesic actions. Similarly, most of today’s pharmacological evaluation methods are designed to assess the analgesic effects of systemic administration, rather than to evaluate localized pain relief. To some extent, this makes the path toward reforming topical medications even more challenging than that for oral drugs—a stark contrast to the current U.S. approach, which adopts a relaxed filing system for topical medications containing active ingredients already listed in the official catalog. Likewise, Japan’s OTC market boasts an impressive array of topical analgesics (so much so that many Chinese consumers travel to Japan specifically to purchase these products), a phenomenon closely tied to Japan’s policies on topical applications. As a distinctive feature of Tibetan medicine, topical treatments—including patch therapy, bath therapy, topical application, and poultice therapy—have a long history and boast an abundant repertoire of prescriptions, extensive clinical experience, and significant clinical value. These characteristics make them ideally suited for leveraging modern technologies to further develop and expand them into various safe and effective topical dosage forms, thereby enriching current clinical treatment options. Yet, under the existing regulatory framework, realizing this vision remains exceedingly difficult.

　　In short, we believe that reformulating Tibetan medicinal products represents an optimal approach for both inheriting and innovating, while accelerating the secondary development of superior, time-tested Tibetan medicines. These classic Tibetan remedies, having been used for millennia, are the most likely to meet the stringent requirements of proven efficacy and high safety. However, we must further draw on modern scientific methods to conduct more in-depth research into their mechanisms of action, underlying material bases, and quality stability. At the same time, during the reformulation process, we should pay close attention to the selection of appropriate formulations, avoiding excessive or indiscriminate changes. Moreover, Tibetan medicine enterprises should take the lead in this effort to prevent repeating past mistakes. Therefore, we recommend that, taking into account the unique characteristics of Tibetan medicine, the issue of reformulating Tibetan medicines be treated with appropriate differentiation. We should encourage improvements in the dosage forms of classic Tibetan medicinal products—especially the development of topical formulations—and thereby promote the market application of Tibetan medicine and foster the healthy development of regional ethnic economies.

　　Reporting media: Pharmaceutical Economic News

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