Lei Jufang: Recommends prioritizing the development of a catalog of classic, time-tested prescriptions for ethnic medicines and approving their commercial development.

　　At the 2017 National Two Sessions, Lei Jufang, a member of the National Committee of the Chinese People's Political Consultative Conference and Chairwoman of Qizheng Tibetan Medicine, submitted a proposal focusing on prioritizing the development of a catalog of classic prescriptions for ethnic medicines. In her proposal, she pointed out that under the leadership of relevant authorities, considerable groundwork has already been laid over several years in the compilation of classic prescriptions of traditional Chinese medicine; 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 traditional Chinese medicine and the drug regulatory agencies to, in accordance with the spirit of the "Law on Traditional Chinese Medicine," prioritize the compilation and cataloging of those "ancient ethnic prescriptions that are still widely used today, demonstrably effective, and possess distinctive characteristics and advantages," complete their compilation and cataloging as soon as possible, and approve their development and utilization.

　　The following is the original text of the proposal submitted by Lei Jufang, a member of the National Committee of the Chinese People's Political Consultative Conference and Chairwoman of Qizheng Tibetan Medicine:

　　Proposal 1: A proposal recommending the prioritized development and approval of a catalog of time-honored classic prescriptions of 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 medical systems practiced by all ethnic groups in China, including both Han and minority ethnic medicines. 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 principles 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, in its "Four Medical Tantras," already listed 443 commonly used classic prescriptions; 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 bearing drug registration numbers. 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 employed 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 classic 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 classic 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, clearly establishing that the “catalog” is 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 formulas has already laid a solid foundation over several years. However, the compilation and cataloging of classic formulas 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 "Law on Traditional Chinese Medicine," prioritize the compilation and cataloging of those ancient ethnic formulas 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, ethnic autonomous regions or influential national medicine industry associations will be entrusted to organize experts in ethnic medicine to develop selection criteria for classic prescriptions of 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 systematic approach of compiling and cataloging a batch of mature products, promptly reviewing and approving them, and then promptly releasing them.

　　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 dosage forms. Similarly, topical administration is a hallmark feature 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 classical prescriptions.

　　Proposal 2: A proposal to fully leverage the role of distinctive and appropriate ethnic medicine techniques in patient rehabilitation.

　　In the current reform of the healthcare system, it has always been a challenging issue to ensure that doctors can earn dignified incomes from their clinical practice while simultaneously implementing the separation of medicine and pharmaceuticals in public hospitals. Moreover, with the promotion of the three-tier healthcare system, a major challenge is how to rapidly enhance the clinical skills and technical expertise of primary-care physicians so that they can effectively handle the large volume of patients suffering from common and frequently occurring diseases.

　　The promotion and application of appropriate technologies in traditional medicine should play a crucial role in addressing the challenges mentioned above. In recent years, the State Administration of Traditional Chinese Medicine and the China Association of Chinese Medicine have carried out extensive efforts to promote and implement TCM’s appropriate technologies for common and frequently occurring diseases at the grassroots level, achieving remarkable results that have demonstrated the feasibility of this approach. We believe that while promoting TCM’s appropriate technologies nationwide, we should also pay close attention to the nationwide dissemination of appropriate technologies from ethnic minority medicine, particularly in the areas of rehabilitation for chronic diseases.

　　First, promoting and applying simple, easy-to-implement, and culturally distinctive ethnic medical techniques nationwide will help preserve and carry forward the traditional medicinal culture. Ethnic medicine represents the crystallization of health wisdom from ethnic regions. Over the course of thousands of years of development, ethnic medicine has not only accumulated numerous prescriptions and unique medicinal substances but has also developed a wealth of “simple, effective, and affordable” therapeutic techniques that are distinctly characteristic of ethnic medicine—for example, the topical application method and medicinal bath therapy in Tibetan medicine, as well as the herbal acupuncture therapy used by the Miao people. These therapeutic techniques have stood the test of thousands of years of clinical practice and constitute an important part of the treasure trove of Chinese medicine. By promoting these appropriate techniques, we are taking a crucial step toward both preserving and developing ethnic medicine and fostering ethnic unity.

　　Second, the appropriate technologies of traditional medicine can help make up for the shortcomings of modern rehabilitation techniques, thereby highlighting the country’s strategic initiative of giving equal emphasis to both Chinese and Western medicine. Compared with modern rehabilitation techniques, traditional rehabilitation methods place greater emphasis on aligning with the natural order, balancing yin and yang, nurturing both body and spirit, harmonizing movement and stillness, unblocking and regulating meridians, bolstering vital energy while expelling pathogenic factors, and providing comprehensive care. Traditional rehabilitation approaches are rich and diverse. Take, for example, the Tibetan medical therapies of applying ointments to the “white channels” and medicinal baths—these traditional external treatments operate on principles that differ from those underlying modern medical rehabilitation theories. They do not require mastery of complex medical theories for implementation; their procedures are simple and straightforward, placing minimal additional burden on clinical diagnosis and treatment. Moreover, these therapies do not necessitate specialized therapists or rehabilitation specialists—family members or caregivers can easily carry them out, thus saving substantial human and material resources in healthcare settings. When used in combination with modern rehabilitation methods, they can significantly enhance clinical treatment outcomes, a fact that has already been confirmed by clinical research.

　　Third, the appropriate technologies of traditional medicine are particularly well-suited to addressing the current shortage of rehabilitation services at the primary healthcare level. Although modern rehabilitation technology—a relatively new discipline—has seen extremely rapid development in China in recent years, compared with more established disciplines such as internal medicine and surgery, rehabilitation techniques still have much room for learning and improvement at the primary care level. There is still a long way to go before these techniques can be widely adopted and applied across the country. However, with the promotion of the three-tier medical care system, an increasing number of patients requiring rehabilitation now must receive rehabilitation treatment at the community-level primary healthcare facilities. To bridge the gap between this growing demand for rehabilitation and the current reality, the appropriate technologies of traditional medicine can play a crucial role. Before modern rehabilitation techniques were introduced to China, Chinese physicians had already been using these traditional rehabilitation therapies to treat patients and achieve remarkable health outcomes. These therapeutic approaches are simple to perform, easy to master, and do not require sophisticated equipment or facilities; they can be learned without extensive training. They also involve low infrastructure investment and are inexpensive to deliver, making them highly suitable for use in primary and rehabilitation healthcare settings.

　　The state encourages the development of traditional medicine in ethnic minority regions. Today, ethnic medicines have transcended these regions and are now reaching not only the entire country but also the world at large. While effectively alleviating patients’ suffering, they have also gained recognition from both traditional Chinese medicine and Western medicine practitioners on the mainland. Facts have proven that ethnic medicine can be effectively utilized even in non-ethnic minority regions. In light of this, it is recommended that the state promote the application of simple, easy-to-implement, and highly effective ethnic medical techniques in clinical diagnosis and treatment on the mainland—especially in the rehabilitation of chronic diseases—so that the health wisdom of ethnic medicine can benefit an even greater number of patients.

　　Proposal 3: 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 strategies 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 in a manner that takes into account their specific characteristics. We should encourage appropriate innovations in dosage forms for ethnic medicines and avoid adopting a one-size-fits-all approach when it comes to modifying existing formulations. We suggest that, while fully respecting intellectual property rights, we should encourage appropriate formulation modifications for 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 Chinese market. For example, due to geographical and historical factors, many standardized Tibetan medicines are predominantly available as powders. Among the 200 varieties listed in the Tibetan Medicine Standards issued by the Ministry of Health, more than 90 are powdered preparations. 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 conditions of Tibetan areas, which are characterized by low levels of economic development and a predominantly nomadic lifestyle, making them “simple, convenient, and cost-effective.” Yet today, powdered preparations are increasingly difficult to promote and apply in mainland China. In fact, modern formulation techniques—such as encapsulation and tablet compression—can easily address this dosage-form issue without compromising therapeutic efficacy. Moreover, many Tibetan medicines are currently available in the form of decoctions or powdered decoctions; transforming these into granules would not only preserve the original therapeutic essence and efficacy but also make 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 through dosage-form modifications to meet the requirements of the mainland Chinese 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, resulting in numerous approved dosage-form modifications and spurring a boom in the Chinese medicine market. For instance, products such as Tasly’s Compound Danshen Dropping Pills and Kangyuan’s Guizhi Fuling Capsules are prime examples of successful dosage-form innovations. 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 time to take advantage of modern pharmaceutical technologies for dosage-form improvements or to reap the benefits of the then-current drug-review policies and technological upgrades—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 reformulations. 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 effects of topical analgesics are closely linked to the activation of C-nerve fibers in the local skin, rather than the previously held view that they exert their effects through transdermal absorption followed by anti-inflammatory and analgesic actions. Similarly, most current pharmacological evaluation methods are designed to assess the systemic analgesic effects of drugs administered orally, rather than evaluating localized pain relief. To some extent, this makes the path toward reformulating topical medications even more challenging than that for oral medications—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 therapeutic value. These characteristics make them ideally suited for leveraging modern technologies to further develop and expand upon them, creating a variety of safe and effective topical dosage forms that can enrich today’s clinical treatment options. Yet under the current regulatory framework, realizing this vision remains exceedingly difficult.

　　In summary, we believe that reformulating Tibetan medicinal products represents an optimal approach for both inheriting and innovating, as well as 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 external medications—thereby promoting the market application of Tibetan medicine and fostering the healthy development of regional ethnic economies.

　　Reporting media: Sohu Finance

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