Qi Zheng Tibetan Medicine’s Lei Jufang: Propose Establishing a Category for Ethnic Medicines in Drug Registration Management

　　For a long time, ethnic medicine has made significant contributions to the health and reproduction of the people thanks to its distinctive theoretical characteristics, abundant and unique medicinal resources, and clinically proven efficacy and safety that have been verified over millennia. It also plays an important role in the prevention and treatment of major diseases and chronic illnesses in the ongoing reform of the medical and healthcare system. The report of the 18th National Congress of the Communist Party of China explicitly called for "strongly supporting the development of traditional Chinese medicine and ethnic medicine," placing ethnic medicine on an equal footing with traditional Chinese medicine and thus attaching great importance to the status of ethnic medicine. As a result, ethnic medicine is now facing unprecedented development opportunities.

　　However, at present, ethnic medicines still face significant policy barriers in their development, a problem that is particularly evident in the drug registration and management process. According to the current “Measures for Drug Registration Management,” ethnic medicines are reviewed under the category of traditional Chinese medicine, giving rise to numerous difficulties—and even the phenomenon of “forcing feet into shoes” has become all too common. All of this severely hinders the research and development of new ethnic medicines as well as the overall advancement of ethnic pharmaceuticals, as evidenced by:

　　First, the difficulty of developing new ethnic medicine drugs has significantly increased. To meet the requirements for registration and review of new Chinese medicines, the claimed indications and therapeutic effects of new ethnic medicine drugs must reflect the relevant requirements of both ethnic medicine, traditional Chinese medicine, and modern medicine. This not only increases the workload involved in the development of new ethnic medicine drugs but also gives rise to numerous technical challenges, such as terminological conflicts between traditional Chinese medicine and ethnic medicine for the same disease, contradictions in medical interpretations, and confusion in clinical syndrome differentiation. As a result, both researchers and clinical investigators find themselves at a loss as to how to proceed. For example, according to Tibetan medicine, "mastopathy" is considered a heat-related condition, whereas traditional Chinese medicine views it as a yin-related condition that cannot be treated by clearing heat. If a clinical research unit specializing in traditional Chinese medicine is invited to conduct clinical trials, how should the Chinese medicine researchers respond? On the other hand, if a Chinese medicine unit is not involved, Tibetan medicine hospitals clearly cannot meet the requirement for conducting multi-center clinical trials (currently, only two Tibetan medicine hospitals have clinical trial qualifications, while multi-center studies require at least three participating centers). How, then, should the sponsor make its decision? Consequently, ethnic medicine—once poised to become one of the key sources for China’s new drug development—now faces particularly daunting challenges in the field of innovative drug research and development.

　　Second, the regulatory requirements for drug registration do not align with the actual situation of ethnic medicine development, thereby hindering ethnic medicines from innovatively reformulating outdated dosage forms. Under current review standards, any change in dosage form must be accompanied by bioequivalence studies or demonstrably improved safety profiles. However, it is extremely difficult to meet these review requirements when the reformulation aims primarily at enhancing patient compliance—for instance, transforming large, dark, and hard pills into tablets that better suit the medication-taking habits of inland populations. Moreover, the state encourages secondary development of well-established, efficacious drugs originally developed by the originator manufacturers. Yet, due to differences in pharmaceutical theoretical systems and formulation characteristics, many ethnic medicines treat a wide range of conditions—some even covering seven or eight different indications or more. According to the current Drug Registration Management Regulations, when applying for new drug registration, all the original indications and primary therapeutic uses of the original product must undergo Phase II and Phase III clinical trials. Leaving aside the enormous financial resources and lengthy research timelines required for clinical trials, from a technical standpoint, such comprehensive testing is virtually impossible. For example, some disease names used in the past no longer exist today; furthermore, certain conditions may not be suitable for the new dosage forms, while others might actually benefit greatly from them. The list of such complexities could go on indefinitely. Nevertheless, under the current “one-size-fits-all” approach, it has become virtually impossible for ethnic medicines undergoing dosage-form reformulations to obtain approval.

　　Third, registration applications for ethnic medicine formulations already covered by national standards continue to be rejected. Although numerous classic ethnic medicines are included in the ministry-issued standards, due to historical reasons and the underdeveloped state of the ethnic medicine industry, many such formulations have standards but no actual manufacturing enterprises. These formulations boast a long history of clinical use and enjoy a certain degree of assurance regarding efficacy and safety; they are relatively easy to develop and produce. Once brought into production, they could significantly alleviate the shortage of ethnic medicine varieties. However, despite being a win-win situation—benefiting both the nation and the people and achieving twice the result with half the effort—this promising endeavor remains difficult to realize owing to issues with the review and approval policies.

　　Obviously, the current registration regulations have virtually blocked the path for the development of new ethnic medicines, which is unfair to ethnic medicine and detrimental to its development.

　　Of course, we have observed some encouraging changes in the current setup and practical work of technical departments—for instance, the Center for Drug Evaluation has reorganized its former Chinese Medicine Division into the Department of Chinese and Ethnic Medicines Pharmacy and the Department of Clinical Studies for Chinese and Ethnic Medicines. In the review process of new Tibetan medicines, experts in Tibetan medicine have also been invited to evaluate the scientific basis underlying the formulation of prescriptions. These developments reflect the growing recognition within drug review efforts of the unique characteristics of ethnic medicines. However, we’ve also noticed that the crucial software—the guiding principles for reviewing ethnic medicines—has not undergone any significant changes; instead, it continues to follow the “Measures for Drug Registration,” issued back in 2007, which categorizes ethnic medicines under the umbrella of traditional Chinese medicine. Given the substantial differences between ethnic medicines and traditional Chinese medicine in terms of both pharmaceutical theory and clinical practice, as well as the marked distinctions between the developmental stages of the ethnic medicine industry and the traditional Chinese medicine industry, we urge that ethnic medicines be treated as a separate category in the review of new drugs.

　　First, develop separate guiding principles for the review and approval of new drugs derived from traditional ethnic medicines. Fully take into account the unique characteristics and developmental stages of these ethnic medicines, and differentiate the principles governing the creation of new ethnic-medicine products, generic versions, formulation changes, and supplementary applications from those applicable to traditional Chinese medicines, chemical drugs, and biologics.

　　Second, in the review and approval process for new ethnic medicines, under the technical guidance of drug review personnel from the National Medical Products Administration, ethnic medicine experts should be responsible for the theoretical and clinical aspects. At the same time, experts in traditional Chinese medicine and specialists from ethnic regions should be invited to jointly evaluate the quality standards and pharmacological effects of ethnic medicines.

　　Third, appropriately increase the number of clinical research bases for ethnic medicines to meet the demand for clinical studies of new ethnic medicine products.

　　Fourth, ethnic medicine products currently under review that still adhere to the evaluation and approval principles for traditional Chinese medicine should be treated differently from TCM. For example, ethnic medicines should be allowed to conduct generic versions of products urgently needed in clinical practice; the requirements for dosage form changes for ethnic medicine products should be relaxed; and for ethnic medicines with multiple indications, clinical studies may focus on the primary indication only.

　　Source: NetEase Finance

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