Ethnic medicines are being marginalized, severely hindering innovation in Tibetan medicine.

　　The photo shows Ms. Lei Jufang, a member of the National Committee of the Chinese People's Political Consultative Conference and Chairperson of Tibet Qizheng Tibetan Medicine Co., Ltd., at the Two Sessions.

　　“The number of ethnic medicine varieties included in the National Medical Insurance Catalogue has been declining. During the screening process for the ethnic medicine catalogue, relying solely on experts from Western and Traditional Chinese medicine for evaluation and screening creates blind spots. We should fully involve ethnic medicine experts in the evaluation system to prevent insufficient understanding of ethnic medicines by evaluation experts, which could otherwise lead to the marginalization of ethnic medicines in the review process,” said Lei Jufang, a member of the National Committee of the Chinese People's Political Consultative Conference and Chairwoman of Qizheng Tibetan Medicine Co., Ltd., to Hexun.com on March 2.

　　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 ethnic medicines when adding new 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 dosage forms. 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. Dosage forms that are more conducive to clinical use—such as new formulations like tablets and capsules—should be considered for inclusion in the updated catalog. Third, when selecting new 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 experts from both traditional Chinese and Western medicine fields.

　　“The standards set in 1995 are now being used after 20 years. Some specialized terms were originally translated from ancient texts, and there are certain issues regarding the names and dosages of medicinal ingredients. For example, the disease names used back then differ from today’s 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 relevant 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 being directly applied to Tibetan medicines—those already holding approval numbers now face even greater hurdles in verification than those applying for new drugs, ultimately forcing many to abandon their efforts, 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, step up 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 efforts should be implemented in a phased manner to accelerate the innovation process. Moreover, during routine changes in dosage forms of Tibetan medicines, some validation experiments involving excipients could be exempted.

　　News source: Hexun.com

　　News link: http://news.hexun.com/2015-03-02/173660636.html