Lei Jufang, a member of the National Committee of the Chinese People's Political Consultative Conference and Chairwoman of Qizheng Tibetan Medicine: Relax the准入 requirements for ethnic medicines and appropriately adjust the review and approval system.

　　The promulgation of the "Law on Traditional Chinese Medicine" and the 2017 National Reimbursement Drug List have increased the proportion of newly included ethnic medicines from Tibetan, Miao, Mongolian, Uyghur, and other minority groups. However, at the ongoing Two Sessions of the National People's Congress, Lei Jufang, a member of the National Committee of the Chinese People's Political Consultative Conference and Chairwoman of Qizheng Tibetan Medicine, pointed out that the cataloging and compilation work for classic ethnic prescriptions has yet to begin, and a clear “catalog” remains absent.

　　“The vast majority of natural medicines are traditional Chinese medicines, while ethnic medicines account for less than 1%. With the implementation of the Traditional Chinese Medicine Law, we should as soon as possible establish a system for product approval and appropriately adjust the review and approval procedures,” she said.

　　Access Dilemma

　　The “Traditional Chinese Medicine Law,” enacted last year, explicitly states: “The term ‘traditional Chinese medicine’ as used in this Law refers to the collective designation of the medical systems of all ethnic groups in China, including both Han and minority ethnic medicines.”

　　This law places greater emphasis on the development of time-honored classical prescriptions, providing a significant boost to ethnic medicine. However, compared to the years of groundwork already laid in the compilation of classic Chinese medicine formulas, the systematic organization and cataloging of classic prescriptions from ethnic groups such as Tibetan, Mongolian, and Uyghur have yet to be initiated.

　　Lei Jufang told a reporter from the 21st Century Business Herald that, in the earliest evaluations of the medical insurance catalog, Chinese medicine experts were essentially in charge. These evaluations primarily assessed the current state of development of both traditional Chinese medicine and Western medicine from a macro perspective, with insufficient understanding of ethnic medicines. This situation persisted until the 2009 edition of the medical insurance catalog, during which the number of ethnic medicines included in the catalog either remained unchanged or even declined.

　　“At the time, everyone thought that ethnic medicines weren’t yet mature enough and there wasn’t much available data,” Lei Jufang said. “Over the years, whenever new drug development in the Tibetan medicine industry was mentioned, everyone just gave up. Now, with the requirement for Phase III clinical trials, some companies have become hesitant and even turned away.”

　　It is reported that ethnic medicines represented by Tibetan, Mongolian, and Uyghur medicine possess well-developed medical theoretical systems and classical texts. Among them, Tibetan medicine includes 443 commonly used classic prescriptions in the "Four Medical Tantras" dating from the 8th century AD; Mongolian medicine still relies on more than 300 classic prescriptions today, while Uyghur medicine has over 200 such prescriptions in use.

　　However, the number of traditional ethnic medicines that have been registered and bear official batch numbers is very limited. Currently, the classic prescriptions from Tibetan, Mongolian, Uyghur, Dai, Korean, Zhuang, and Kazakh medicine—averaging about 150 prescriptions per ethnic group—total roughly 1,050. Yet, only a few dozen of these have been developed into nationally approved pharmaceutical products with drug registration numbers.

　　“In this situation, the inheritance of most ethnic medicines can only rely on hospital preparations—but hospital preparations cannot leave the hospital premises, severely limiting patients’ access,” Wang Ju, former Deputy Director of the Cultural Promotion Department of the State Ethnic Affairs Commission, told a reporter from the 21st Century Business Herald. “It is necessary to further refine the registration system for classic prescriptions of ethnic medicines.”

　　In this regard, Lei Jufang suggests that, under the unified guidance of the State Administration of Traditional Chinese Medicine, the autonomous region or influential ethnic medicine industry associations should be entrusted with organizing ethnic medicine experts to develop principles for selecting classic prescriptions and compiling a corresponding catalog. This catalog would then 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.

　　Liang Jun, Executive Vice President and Secretary-General of the Chinese Society for Ethnic Medicine, reminded: “There are differences between the conditions originally addressed in classic, time-honored prescriptions and current medical conditions. For example, a drug that was recently added to the national medical insurance catalog was once used to treat leprosy; however, since leprosy has now virtually disappeared, there is no longer any need to conduct clinical trials for this particular indication.”

　　Appropriately adjust the review and approval system.

　　In the recently released new edition of the National Reimbursement Drug List, the number of ethnic medicines included has increased significantly. In the new list, Western medicines and traditional Chinese medicines account for 51% and 49% respectively, essentially remaining at parity. Relevant authorities specifically organized a panel of experts in ethnic minority medicine to review and evaluate these ethnic medicines, adding a total of 41 new ethnic medicines—a 90% increase.

　　However, Lei Jufang pointed out: “Currently, there are still many shortcomings in the review and approval process for ethnic medicines. For example, the existing review system does not encourage changes in dosage forms, thereby blocking the path for Tibetan medicines to adapt their formulations to meet the requirements of the mainland market.”

　　The therapeutic indications of many traditional ethnic medicines, when translated into Chinese, tend to be broadly stated. Current regulatory requirements stipulate that “all indications must be validated” when changing dosage forms or manufacturing processes. However, according to modern medical diagnostic criteria, the indications for traditional ethnic medicines can even exceed seven or eight. Consequently, applications for changes in dosage form often find it difficult to gain approval.

　　Many ethnic medicines cannot be commercialized or modernized due to their dosage forms. The modernization of Tibetan medicine lags far behind that of traditional Chinese medicine. The modernization of traditional Chinese medicine can be traced back to the 1980s; between the late 1990s and before 2005, traditional Chinese medicine was improved and upgraded by leveraging modern pharmaceutical technologies to address its traditional shortcomings, and a large number of newly formulated products received approval.

　　However, the history of modernizing Tibetan medicine is still less than 10 years old, and no substantial transformation of Tibetan medicinal products to modern pharmaceutical technologies has yet been achieved. Moreover, due to geographical conditions and historical factors, most Tibetan medicinal products are in powder form; among the 200 varieties included in the national standards, more than 90 are powders. Yet, powdered formulations are difficult to promote and apply in mainland China.

　　“Ethnic medicines could be subject to review based on individual disease categories,” Lei Jufang pointed out. “Since ethnic medicines are currently reviewed according to the standards for traditional Chinese medicines, the review policies need to be appropriately adjusted for Tibetan medicines and other ethnic medicines with lower levels of industrialization. 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 dosage forms.”

　　Reporting media: 21st Century Business Herald

　　Report link: http://epaper.21jingji.com/html/2017-03/08/content_57572.htm