Qi Zheng Tibetan Medicine Committee Member Lei Jufang: The state should increase its support for innovation in Tibetan medicine.

　　“Qizheng Tibetan Medicine is a pharmaceutical company based in Tibet. Located in a minority ethnic region, it faces an even stronger need to integrate cultural heritage preservation with economic development. As such, we feel the significance of the ‘Four Comprehensive’ national strategic blueprint all the more keenly,” said Lei Jufang, a member of the National Committee of the Chinese People's Political Consultative Conference and Chairwoman of Qizheng Tibetan Medicine, in a recent interview with reporters. “Only by steadfastly pursuing the direction and strategy outlined in the ‘Four Comprehensive’ approach can we overcome all developmental bottlenecks and obstacles, ensuring a bright future for the inheritance and thriving of the unique cultural strengths of each ethnic group.” According to our reporter, at this year’s session, Lei Jufang brought three proposals covering topics such as innovation in ethnic medicine, protection of traditional Chinese (ethnic) medicinal resources, and medical insurance coverage for serious illnesses.

　　“The number of ethnic medicines included in the National Medical Insurance Catalogue is showing negative growth. During the screening process, relying solely on Western and traditional Chinese medicine experts for evaluation and selection creates blind spots. We should fully involve ethnic medicine experts in the evaluation system to prevent insufficient understanding of ethnic medicines by the review experts, which could otherwise lead to the marginalization of ethnic medicines in the review process,” said Lei Jufang.

　　In response to the above-mentioned issues, Lei Jufang suggests the following measures: First, we should step up the implementation of national policies supporting ethnic medicines. In the national and relevant department’s medical insurance catalogs, greater emphasis should be placed on including ethnic medicines among newly added pharmaceutical products. The number of ethnic medicine varieties should be expanded in proportion to the historical growth rate of support for traditional Chinese medicines, while also broadening the existing variety formulations. Second, for newly added ethnic medicine varieties, special attention should be given to those that have already been included in certain provincial medical insurance catalogs and have demonstrated good clinical performance. Varieties with formulations that are more conducive to clinical use—such as new dosage forms like tablets and capsules—should be considered for inclusion in the latest edition of the catalog. Third, when selecting newly added ethnic medicine varieties, priority should be given to those with a solid clinical research foundation. Finally, a pool of expert reviewers specializing in ethnic medicines should be established. The sections on ethnic medicines in both the national and local medical insurance catalogs should be jointly reviewed by experts in ethnic medicine or specialists in ethnic medicines, along with relevant experts from both traditional Chinese and Western medicine fields.

　　“The standards set in 1995 have now been in use for 20 years. Some specialized terms were originally translated from ancient texts, and there are certain issues regarding the names of medicinal materials and dosages. For example, the disease names used back then differ from today’s current understanding. Moreover, to make it more convenient for patients to take the medication, companies have made changes to the dosage forms. However, the verification process is complex and challenging, and the administrative approval procedures are cumbersome.”

　　In the “Proposal on Strongly Supporting Innovation in Ethnic Pharmaceutical Dosage Forms in Drug Registration,” Lei Jufang pointed out that the requirements of drug registration regulations do not align with the actual situation of Tibetan medicine development, resulting in few innovative Tibetan medicinal products and a limited variety of dosage forms. Even worse, some regulatory review procedures are directly applied to Tibetan medicines; for those already holding approval numbers, the verification process has become even more challenging than applying for new drugs, ultimately forcing many to give up, thereby severely hindering innovation in dosage forms.

　　Lei Jufang hopes that the state will, based on the unique characteristics of Tibetan medicine, establish technical review thresholds that are suited to the current realities of Tibetan medicine development, increase support for industrial innovation in Tibetan medicine, and encourage the reformulation of classic Tibetan medicinal products and major varieties that have shortcomings in their existing dosage forms. In clinical trials for new Tibetan medicines, certain indications should be selected and approved according to the actual conditions of the product; such measures should be implemented step by step to accelerate the innovation process. Moreover, during routine changes in dosage forms of Tibetan medicines, some validation experiments involving excipients could be exempted or reduced.

　　News Source: Shanghai Securities Journal

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