Core Competency
Improve the registration system for ethnic medicines and appropriately delegate review and approval authority.
Release time:
2017-03-02 11:11
On March 2, Qizheng Tibetan Medicine held a symposium titled “The 2017 National Two Sessions Proposal on Prioritizing the Release of a Catalog of Time-Honored Formulas for Ethnic Medicines.” At the symposium, reporters learned that, with the implementation of the state’s plan to promote the development of traditional Chinese medicine, the ethnic medicine industry has enjoyed robust growth in recent years. In the 2016 edition of the National Reimbursement Drug List, more than 40 additional varieties of Tibetan, Mongolian, Uyghur, and other ethnic medicines were added. Although this increase falls far short of the growth seen in Western and traditional Chinese medicines, it represents the largest-ever increase in ethnic medicines included in the National Reimbursement Drug List over the years.
Lei Jufang, a member of the National Committee of the Chinese People's Political Consultative Conference and Chairwoman of Qizheng Tibetan Medicine, stated that many proposals and motions submitted at previous Two Sessions have been implemented. For example, the 2006 and 2009 editions of the medical insurance catalog not only failed to increase the number of ethnic medicines included but actually reduced it. In 2014, she submitted a proposal titled “On the Need for Clearer Classification of Ethnic Medicines in the Medical Insurance System.” Currently, the expert panel responsible for selecting items for the medical insurance catalog has added numerous experts specializing in ethnic medicines. Additionally, the proposal she submitted several years ago advocating for exempting ethnic medicines from clinical trials has also been implemented, as the exemption from clinical trials was incorporated into the "Traditional Chinese Medicine Law."
“Unfortunately, there are still many shortcomings in the review and approval process for ethnic medicines,” Lei Jufang admitted frankly. For example, due to historical reasons, the scope of indications for many ethnic medicines becomes broad when translated into Chinese. Current review principles require that “all indications must be verified” when changing dosage forms or manufacturing processes. However, according to modern medical diagnostic criteria, ethnic medicines may have as many as seven or eight or even more indications, making it extremely difficult for such medicines to obtain approval when applying for changes in dosage form. She suggested that ethnic medicines could try adopting a single-disease-specific review approach.
Moreover, the ongoing research on the catalog of classic traditional Chinese medicine formulas has yet to initiate work on a catalog of classic ethnic medicine formulas. Lei Jufang believes that this approach will inevitably lead to another setback in the development of ethnic medicines when it comes to classic formulas. She calls on the competent authorities for TCM and the drug regulatory agencies to, when drafting the catalog of ancient classic formulas, ensure fair treatment of time-honored ethnic medicine formulas that meet the prescribed criteria, in accordance with the spirit of the “Law on Traditional Chinese Medicine,” and to accelerate the research and promulgation of a catalog of classic ethnic medicine formulas.
Liang Jun, Executive Vice President and Secretary-General of the Chinese Society for Ethnic Medicine, also stated that classic prescriptions are the crystallization of ancient people’s knowledge and wisdom. Having been used by populations for hundreds or even thousands of years from ancient times to the present, they have already undergone rigorous verification of their effectiveness in human bodies. Those that proved ineffective have long since been weeded out and no longer require clinical trials. In contrast, Western medicines, before being chemically synthesized, had never been tested on humans; thus, it is essential to verify their efficacy and safety in human subjects.
Liang Jun believes that there are significant differences between the conditions addressed by the original classic prescriptions and today’s prevalent diseases. For example, a drug recently added to the medical insurance catalog was originally used to treat leprosy, but since leprosy has now virtually disappeared, there is no longer any need to conduct clinical trials for such drugs during verification. If all these drugs were required to undergo verification, it would be even more challenging than reapplying for approval of a completely new drug. In reality, all that’s needed is a single toxicology study to complete the process.
Wang Ju, former Deputy Director of the Cultural Promotion Department of the State Ethnic Affairs Commission, stated that ethnic medicines have grown alongside each ethnic group. Due to their long-term and extensive use within their respective ethnic communities, these medicines have already developed into highly sophisticated systems within those communities. At this stage, the most critical issue is to formulate a comprehensive national-level plan for the development of ethnic medicines and, at an appropriate time, to consider mobilizing resources from local governments to collectively promote the development of ethnic medicine.
She pointed out that currently, the administration responsible for ethnic medicines is the Administration of Traditional Chinese Medicine. However, given the relatively limited capacity-building efforts within this administrative body, most professionals are focused on strengthening the capabilities of traditional Chinese medicine. Meanwhile, ethnic medicines encompass a remarkably diverse range of categories, and the Tibetan, Mongolian, and Uyghur medicinal systems have all developed specifically in their respective regions. Local governments possess deep and nuanced understanding of the unique cultural characteristics of their regions; therefore, it would be appropriate to delegate the authority for reviewing and approving ethnic medicines at the right time.
Reporting media: Pharmaceutical Economic News
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