Committee Member Lei Jufang: Appropriately Relax Approval Requirements for Ethnic Medicines

　　The promulgation of the “Law on Traditional Chinese Medicine” and the 2017 National Medical Insurance Catalog has increased the proportion of newly included ethnic medicines from Tibetan, Miao, Mongolian, Uyghur, and other minority groups. However, at the ongoing Two Sessions nationwide, 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%,” she said. “With the implementation of the Traditional Chinese Medicine Law, we should as soon as possible establish a system for product registration and appropriately adjust the review and approval procedures.” The “Traditional Chinese Medicine Law,” promulgated last year, explicitly states: “The term ‘traditional Chinese medicine’ as used in this law refers to the collective designation of all ethnic groups’ medicines in China, including those of the Han ethnic group and minority ethnic groups.”

　　This law places greater emphasis on the development of time-honored classic prescriptions from ancient texts, providing a significant boost to ethnic medicine. However, compared with the years of groundwork already invested in organizing and compiling classical Chinese medicine formulas, the systematic cataloging and compilation of classic prescriptions from Tibetan, Mongolian, Uyghur, and other ethnic groups have yet to be initiated. Lei Jufang explained that, in the earliest evaluations of the national medical insurance formulary, the process was largely led by experts in traditional Chinese medicine, who primarily assessed the current state of development of both Chinese and Western medicines from a macro perspective, lacking sufficient understanding of ethnic medicine. This situation persisted until the 2009 edition of the medical insurance formulary, during which the number of ethnic medicines included in the formulary either remained unchanged or even declined.

　　“At the time, everyone thought that ethnic medicines were still not mature enough and lacked sufficient data,” said Lei Jufang. “Over the years, whenever new drug development in the Tibetan medicine industry was mentioned, everyone tended to give up. Now, with the requirement for Phase III clinical trials, some companies have simply turned away.” It is reported that ethnic medicines—represented by Tibetan, Mongolian, Uyghur, and other traditional systems—possess well-established medical theoretical systems and extensive classical texts. Among them, Tibetan medicine boasts 443 commonly used classic prescriptions documented in the “Four Medical Tantras” 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 around 150 per ethnic group—total approximately 1,050 in all. Yet, only a few dozen of these have been developed into nationally approved drug products with registration numbers. In response, Lei Jufang suggests that, under the unified guidance of the State Administration of Traditional Chinese Medicine, the autonomous regions or influential national associations of ethnic medicine should be entrusted with organizing expert panels of ethnic medicine specialists to formulate 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 and promoting their development and utilization.

　　Liang Jun, Executive Vice President and Secretary-General of the China Association for Ethnic Medicine, reminded: “There are differences between the conditions addressed in the original classic prescriptions and current medical conditions. For example, a drug that was recently added to the national medical insurance catalog was originally 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.”

　　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 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 instance, 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 modifying 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. “Ethnic medicines could try undergoing review specifically for single-disease indications,” Lei Jufang pointed out. “Since currently ethnic medicines are reviewed according to the standards for traditional Chinese medicine, the review policies need to be appropriately adjusted for Tibetan medicine 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 reviewing changes to existing dosage forms.”

　　Brief Information on Delegates and Committee Members:

　　Lei Jufang, female, born in January 1953, from Lintao, Gansu Province. She currently serves as the Chairperson and General Manager of Tibet Qizheng Tibetan Medicine Co., Ltd. She has previously served as a deputy to the Tenth National People's Congress, a member of the Eleventh National Committee of the Chinese People's Political Consultative Conference, a standing committee member of the All-China Federation of Industry and Commerce, and a vice president of the China Association for Promoting Public Welfare.

　　Reporting media: China Economic Net

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