Shandong issues new plans, and the qualified traditional Chinese medicine preparations are included in the medical insurance

[pharmaceutical Station industry trends] a few days ago, Shandong industry and Information Technology Commission announced that in order to further promote the healthy and rapid development of traditional Chinese medicine industry and scientifically guide the R & D and production of traditional Chinese medicine formula granules in Shandong Province, 6 departments have organized the preparation of the implementation plan for the pilot work of traditional Chinese medicine formula granules in Shandong Province (hereinafter referred to as the implementation plan) According to the implementation plan, the main content of the pilot study is the production process, quality standard, management control, safety, effectiveness and quality controllability of traditional Chinese medicine formula granules In principle, the research cycle is 2-3 years, forming replicable and generalizable experience in technical innovation The required funds shall be raised by the participating enterprises (units) According to the requirements of the pilot, all enterprises of traditional Chinese medicine in Shandong Province that have obtained the drug production license and have the production scope of granules can participate in the pilot study In addition, in principle, it is also agreed that other provinces have carried out pilot production of traditional Chinese medicine production enterprises to adhere to higher standards and set up traditional Chinese medicine production enterprises or branches in Shandong to participate in the pilot   According to the implementation plan, the pilot enterprises shall have complete production capacity for processing, extracting, concentrating, drying and granulating of Chinese herbal pieces; encourage enterprises to introduce new technologies and technologies such as international advanced extraction and concentration; complete research on production process procedures and quality standards of more than 200 kinds of Chinese herbal formula granules at least, and have strong research and development capacity and enough of Chinese herbal science and technology The company has the ability to invest in scientific research and production funds, provide guarantee for project research, and have the ability of product release, recall and other quality management Research pilot enterprises should select clinical research and trial units of traditional Chinese medicine formula granules in hospitals above the second level (including the second level) in Shandong Province, guide clinical rational drug use, collect and summarize relevant information of clinical research Medical institutions shall follow the principle of trial voluntariness, select the traditional Chinese medicine formula particles produced by the research pilot enterprises on record, and the research pilot enterprises shall directly or entrust the distribution Medical institutions and research pilot enterprises should sign the quality assurance agreement, strengthen the training of medical personnel on the rational use of traditional Chinese medicine formula particles, formulate enterprise risk prevention and control measures, and ensure the clinical use safety of traditional Chinese medicine formula particles It is understood that every year, Shandong Provincial Department of industry and information technology will test and evaluate the research value, quality level and application prospect of product R & D and production and clinical application of research pilot enterprises It is allowed to continue to retain the pilot qualification for those who meet the product quality technical regulations, meet the requirements of safety, effectiveness and consistency, and have good clinical research effect If there are quality and safety problems in the products after inspection and evaluation, rectification and re registration shall be carried out within a time limit, or clinical trial shall be stopped until the qualification of the research pilot enterprise is cancelled I have learned that in addition to Shandong, other regions have also included Chinese herbal pieces and preparations in the scope of medical insurance For example, from January 2018, Hebei Province's regulations on traditional Chinese medicine officially implemented stipulates that qualified medical institutions of traditional Chinese medicine will be included in the scope of designated medical institutions of basic medical insurance, and qualified medical projects of traditional Chinese medicine, decoction pieces of traditional Chinese medicine, proprietary Chinese medicine and traditional Chinese Medicine preparations of medical institutions will be included in the scope of payment of basic medical insurance fund For another example, Xuzhou City will include eligible traditional Chinese medicine services in the scope of medical insurance reimbursement The eligible TCM diagnosis and treatment projects (including TCM appropriate technology), Chinese herbal pieces, Chinese patent medicine and TCM preparations of medical institutions shall be included in the payment scope of medical insurance, the proportion of medical insurance reimbursement shall be increased, and the starting line of TCM hospitals and diseases mainly treated by TCM shall be reduced According to the industry, the inclusion of TCM medical institutions in designated medical institutions of basic medical insurance is a long-term implementation of security measures to promote the development of TCM, which is conducive to improving the "sense of access" of people's health.