Accelerate the formulation and improvement of supporting policies for the Traditional Chinese Medicine Law.

　　There’s a female engineer who, at the age of 34, left her “iron rice bowl” job at the Chinese Academy of Sciences to venture into the private sector. By the time she turned 40, she had founded a national pharmaceutical enterprise and has now become a prominent figure in the industry. The quote she admires most is from Sun Tzu’s “The Art of War”: “In all warfare, victory comes from unexpected tactics; proper strategy lies in combining the extraordinary with the conventional. The art of the extraordinary and the conventional never runs dry, just as rivers and streams never cease flowing.”

　　There’s a female entrepreneur who, despite heading a publicly listed company with a market capitalization of tens of billions, remains true to her original aspiration of “healing and helping people.” She’s deeply committed to charitable causes, and—rooted in an innate reverence for knowledge—she still delights in being called “Engineer Lei” today.

　　A female engineer, a female entrepreneur, a philanthropist... Lei Jufang, Chairwoman of Qizheng Tibetan Medicine, embodies all these roles and personas.

　　However, when you get closer to Lei Jufang, you’ll realize that the role of guardian of traditional ethnic medicine may well be the one that suits her best. Recently, a reporter from the Economic Reference News conducted an exclusive interview with Lei Jufang on issues such as perfecting and introducing supporting policies for the “Law on Traditional Chinese Medicine.” During the interview, although Lei Jufang spoke in a calm and measured tone, one could still sense her passionate dedication to the inheritance and development of traditional ethnic medicine and TCM.

　　Accelerate the establishment of a “separate regulatory oversight” management system for traditional Chinese medicine and Western medicine.

　　Article 3 of the Law on Traditional Chinese Medicine states: “The State shall vigorously develop the cause of traditional Chinese medicine, adopt a policy of giving equal importance to both TCM and Western medicine, establish a management system that is suited to the characteristics of TCM, and fully leverage the role of TCM in China’s medical and health undertakings.”

　　The accompanying detailed rules—the “Interim Measures for the Filing and Management of Traditional Chinese Medicine Clinics”—issued last November have shifted the management of TCM clinics from a licensing-based system to a filing-based system. To ensure a smoother transition between the new filing system and the previous management approach for TCM clinics, the relevant authorities have proposed a “categorized management with autonomous choice” approach. Under this new filing system, TCM clinics can only provide TCM services. Meanwhile, TCM clinics that were previously registered may independently choose their management model: they can either continue operating under the filing system and provide only TCM services, or—subject to meeting certain requirements—opt for approval-based management and rebrand themselves as “TCM (Comprehensive) Clinics.” Industry insiders view this new regulation as a harbinger of future specialized regulatory oversight for TCM services.

　　“Traditional Chinese medicine and Western medicine should as soon as possible adopt separate regulatory frameworks—these are two distinct paths, each following its own course without interfering with the other. Of course, on a voluntary basis, TCM and Western medicine can be partially integrated, but this integration must not be forced, nor should TCM ever be measured or even constrained by Western medical standards,” Lei Jufang emphasized.

　　She gave an example: The determination of the scope of “medicinal foods”—that is, foods that also serve as medicines—is a prime illustration of how Western pharmaceutical standards are being used to regulate traditional Chinese medicine. The "Shennong's Materia Medica," a foundational text followed by practitioners of traditional Chinese medicine, categorizes herbs into three grades: 120 superior-grade herbs, 120 intermediate-grade herbs, and 120 inferior-grade herbs. Among these, the statement—"The 120 superior-grade herbs are considered the 'ruler' herbs, primarily nourishing life in harmony with heaven and are non-toxic; even large or long-term doses will not harm the body"—refers to the fact that these 120 superior-grade herbs can be consumed as food and have health-promoting effects. The 120 intermediate-grade herbs are the "minister" herbs, playing a leading role in the treatment process; while the 120 inferior-grade herbs are the "assistant and messenger" herbs, serving to support and enhance the efficacy of the entire prescription. However, currently, many of these 120 superior-grade herbs have not yet been included on the list of medicinal foods, a situation that has sparked considerable debate within the industry, she pointed out.

　　Why can’t these time-tested, safe medicines—verified over many years by our ancestors—be included on the list of foods that also serve as medicines? Lei Jufang pointed out: “Currently, the verification of the medicinal properties and toxicity of many traditional Chinese medicines is conducted according to Western pharmaceutical standards, using a safety margin that’s 20 to 30 times the normal human dosage. It’s like asking a healthy person to eat twenty or thirty steamed buns in one sitting—of course, that would be harmful. Leaving aside whether such experimental requirements are truly scientific, it’s certain that they completely run counter to the inherent principles of traditional Chinese medicine. If this situation isn’t effectively reversed and genuine separation of Chinese and Western medicine management isn’t implemented, the advantages of traditional Chinese medicine—including those of ethnic minority medicines—will be greatly undermined, which will further hinder the inheritance and development of TCM.”

　　She emphasized that both in developed countries such as those in Europe, the United States, and Japan—where modern medicine is dominant and traditional medicine, represented by Chinese medicine, has begun to be gradually recognized and accepted—and in a small number of developing countries like India, which have retained relatively intact traditional medical systems, a regulatory management system that separates the oversight of traditional medicine from that of modern medicine has been adopted. This system has played a significant role in promoting the development of traditional medicine and safeguarding people’s health.

　　The detailed rules for the formal employment of personnel with specialized skills still need to be refined.

　　Article 15 of the "Law on Traditional Chinese Medicine" stipulates: “Individuals who have learned TCM through apprenticeship or who, after years of practical experience, have demonstrated exceptional expertise in medical skills may obtain qualification as a TCM physician upon recommendation by at least two TCM physicians and after passing the practical skills and efficacy assessment organized by the competent TCM authorities of the people's governments of provinces, autonomous regions, and municipalities directly under the central government.” The “Provisional Measures for the Examination and Registration Management of Physicians with Demonstrated Expertise in TCM Medical Skills,” which came into effect on December 20, 2017, further clarifies the specific implementation procedures.

　　“The introduction of these detailed rules has enabled a large number of folk traditional Chinese medicine practitioners to gain social acceptance, resolving the issue of assessment and registration for those who have studied TCM through apprenticeship for at least five years or who, after years of practical experience, have demonstrated exceptional expertise. This has a highly positive impact on the entire Chinese medicine and pharmaceutical industry,” said Lei Jufang.

　　“In fact, India’s regulatory framework for the registration of practitioners in traditional medicine is divided into two main categories: accreditation and registration for medical institutions, and accreditation and registration for non-medical institutions. This model has greatly boosted the growth of human resources in traditional medicine, thereby driving the overall development of traditional medicine in India. These are all successful examples that we should learn from and draw inspiration from,” she explained.

　　However, Lei Jufang emphasized, “Currently, some traditional Chinese medicine practitioners are still not fully covered—for example, students from other disciplines who have received higher education but did not major in clinical TCM. They are not treated differently when obtaining their physician qualifications, and this aspect still needs to be improved.”

　　“According to current regulations, pharmacy students at universities are not allowed to take the medical licensing exam immediately after graduation; they must first complete five years of apprenticeship under a qualified physician before becoming eligible. This requirement is unreasonable. After all, traditional Chinese medicine and Chinese herbal medicine are inherently inseparable. Students who already have a solid foundation in pharmacy—and thus some practical experience in prescribing—are well-positioned to make rapid progress if they undergo further apprenticeship. Therefore, we should allow them to sit for the qualification examination after just two years,” she added.

　　“When policies are being formulated, we can’t afford to overlook these individuals—we can’t treat students who have majored in pharmacy the same way we treat those who never went to college and have been apprenticing under masters since graduating from junior and senior high school,” Lei Jufang said.

　　The proportion of medications for acute conditions in women and children should be included in classic prescriptions.

　　Article 30 of the Law on Traditional Chinese Medicine states: “For compound Chinese medicinal preparations derived from time-honored classic prescriptions that meet the conditions stipulated by the state, when applying for drug approval numbers, only non-clinical safety study data may be submitted.”

　　As a complementary regulation, the "Regulations on Simplified Registration and Approval Management for Classic Traditional Chinese Medicine Formulas and Compound Preparations (Draft for Comments)" was recently released. The draft explicitly stipulates that "for classic formula preparations meeting the required standards, applicants may submit only pharmaceutical and non-clinical safety study data, exempting them from submitting pharmacological efficacy studies and clinical trial data." This new regulation will significantly shorten both the time and costs associated with the approval and launch of classic formula preparations. However, the draft clearly states that "the scope of application does not include acute conditions, critical illnesses, or infectious diseases, nor does it cover special patient populations such as pregnant women and infants," a provision that has sparked considerable debate within the industry.

　　“The contributions of traditional Chinese medicine and time-tested classic prescriptions go far beyond simply strengthening the body and promoting health; they also offer highly effective approaches for treating acute illnesses. For instance, in recent years, traditional Chinese medicine has played a vital role in the treatment of acute diseases such as SARS and influenza. To fully harness the advantages of traditional Chinese medicine in treating acute conditions, saving lives, and enhancing overall health—this is precisely what lies at the heart of medicine,” believes Lei Jufang.

　　“In addition,” Lei Jufang said, “in the areas of pediatric medicine, medication for pregnant women, and treatment of certain acute conditions, traditional Chinese medicine clearly has advantages over Western medicine. Excluding these more advantageous Chinese medicinal products from these fields would be tantamount to rendering oneself powerless—a truly regrettable situation!”

　　“For example, the ‘Five Tiger Soup,’ created by Li Ke, a renowned traditional Chinese medicine practitioner from Shanxi, is based on the classical theories of TCM. Although the formula consists of just five ingredients—ginger, jujube dates, white parts of green onions, black beans, and walnuts—and appears quite simple at first glance, it demonstrates remarkably effective results in treating children’s colds and fevers. In addition, the ancient prescription ‘Wen Jing Tang’ excels particularly in regulating menstrual cycles in gynecology, and there are many other classic prescriptions like those formulated by Zhang Zhongjing. All these time-tested, renowned formulas are highly effective and should definitely be included in the catalog of classic prescriptions,” she said by way of example.

　　“Currently, classic traditional Chinese medicine formulations processed by pharmaceutical companies in countries such as Japan and South Korea have already captured a significant share of the global TCM market. As the birthplace of these time-honored prescriptions, China should further strengthen its cultural confidence,” suggested Lei Jufang. “In the catalog of classic prescriptions, at least 20% should be dedicated to medications for pregnant women, children, and emergency conditions.”

　　Development Direction of Compound Yingcheng Chinese Herbal Granules

　　Article 3 of the Law on Traditional Chinese Medicine also states: “The development of TCM should follow the laws governing its development, adhere to the combination of inheritance and innovation, preserve and leverage the distinctive features and advantages of TCM, and make use of modern scientific and technological approaches to promote the advancement of TCM theory and practice.”

　　In fact, as society develops and people’s pace of life quickens, an increasing number of young people no longer have ample time to decoct traditional Chinese medicinal herbs in the conventional manner. Consequently, they are eager to improve the dosage forms of Chinese medicine while ensuring their therapeutic efficacy, making it more convenient to take. To meet this demand, numerous Chinese medicine manufacturers are continuously innovating and refining traditional dosage forms.

　　“Compound Chinese herbal granules, innovatively developed based on traditional Chinese medicine theories, represent the future direction of development. These granules are prepared by decocting prescriptions according to traditional methods and then extracting the resulting liquid into granular form. Patients simply need to brew them with hot water and take them orally—this not only offers convenience and speed but also ensures the efficacy of the medicine,” said Lei Jufang.

　　So, what’s the difference between compound Chinese herbal granules and Chinese herbal formula granules? Lei Jufang explained, “Chinese herbal formula granules are made by extracting and concentrating individual Chinese medicinal herbs into a standardized dosage form based on their active ingredients. They offer certain guarantees in terms of drug safety and dosage, but their production process lacks the application of traditional Chinese medicine’s principles of prescription formulation and syndrome differentiation. Compared to traditionally decocted herbal soups, their therapeutic efficacy is somewhat reduced and they cannot fully represent the true therapeutic potential of Chinese herbal medicine. In fact, each herb in a prescription carries its own energetic properties, and different herbs interact with one another. Therefore, compound Chinese herbal granules prepared using traditional decoction methods represent an effective combination of ancient prescriptions and modern high-tech processes, and can better ensure the efficacy of the medicine.”

　　“With the implementation of the filing system, we hope that the production and use of traditional Chinese medicine preparations within hospitals will be further liberalized. For example, the central government has already approved Gansu Province’s plan to establish a national comprehensive pilot zone for the development of the TCM industry. We suggest extending the scope of use for hospital-based preparations throughout Gansu Province—no longer limiting their use solely to hospitals themselves, but rather expanding it to cover the entire city and even the whole province. Many effective and safe prescriptions, based on the formulas passed down by veteran physicians, could then be prepared according to these traditional recipes and developed into compound granules of traditional Chinese medicine. This approach would not only further enhance the efficacy of TCM treatments but also help popularize TCM, reduce medical costs, and make TCM more accessible to the public,” said Lei Jufang.

　　Reporting Media: Economic Reference News

　　Source of the report: http://dz.jjckb.cn/www/pages/webpage2009/html/2018-04/16/content_42599.htm