The law of traditional Chinese medicine is about to come out. Can classic famous prescriptions be applied without clinical application?

Source: Yigu 2016-08-30 on December 9, 2015, the executive meeting of the State Council of China adopted the law on traditional Chinese medicine (Draft) and submitted it to the Standing Committee of the National People's Congress for deliberation On December 21, 2015, the 18th meeting of the Standing Committee of the 12th National People's Congress deliberated on the draft law of traditional Chinese medicine for the first time On August 29, 2016, the 22nd Meeting of the Standing Committee of the 12th National People's Congress was opened in the Great Hall of the people Zhang Dejiang, chairman of the Standing Committee of the National People's Congress, presided over the meeting, and Ma Kai, vice premier of the State Council, attended the meeting At the meeting, the Legal Committee of the National People's Congress reported on the revision of the Chinese medicine law (Draft) The revised draft will be reviewed by the Standing Committee meeting After the 18th session of the Standing Committee of the National People's Congress conducted the preliminary examination of the draft law of traditional Chinese medicine, the legal committee widely solicited opinions through holding symposiums, conducting field research, publishing the draft in full, and put forward suggestions for revision to the Standing Committee on six major issues through research Can classic prescription apply without clinical application? It is suggested to add provisions: "when applying for drug approval number, only non clinical safety research data can be provided for the production of qualified traditional Chinese medicine compound preparations from ancient classic prescriptions The specific administrative measures shall be formulated by the drug regulatory department under the State Council in conjunction with the competent department of Chinese medicine " "The ancient classical and famous prescriptions mentioned in the preceding paragraph refer to the prescriptions recorded in ancient Chinese medicine classics which are still widely used, have definite curative effects and have obvious characteristics and advantages The specific catalogue shall be formulated by the competent department of traditional Chinese medicine under the State Council in conjunction with the drug regulatory department " According to the first paragraph of Article 8 of the original draft, the personnel engaged in medical activities of traditional Chinese medicine shall obtain the qualification of traditional Chinese medicine doctors and register for practice in accordance with the provisions of the law on practicing doctors However, those who have learned traditional Chinese medicine in the way of teachers or who have been practicing medicine for many years can obtain the qualification of traditional Chinese medicine doctors after passing the examination organized by the provincial competent department of traditional Chinese medicine Some experts and the public also proposed that traditional Chinese medicine has its unique theory and technical methods, and the content of the qualification examination of traditional Chinese medicine doctors should reflect the characteristics of traditional Chinese medicine Some localities, departments and the public have proposed that those who learn traditional Chinese medicine by way of teachers or have practical expertise for many years to participate in the qualification examination of traditional Chinese medicine doctors should be recommended by traditional Chinese medicine doctors After the study, the following modifications are suggested: first, the provisions are added: "the content of the qualification examination of traditional Chinese medicine doctors should reflect the characteristics of traditional Chinese medicine." The second is to make it clear that those who have learned traditional Chinese medicine in the form of teachers or have been practicing it for many years should be "recommended by at least two doctors of traditional Chinese medicine" to participate in the assessment organized by the provincial competent department of traditional Chinese medicine The first is that "the people's government at or above the county level shall incorporate the cause of traditional Chinese medicine into the national economic and social development plan, and promote the development of traditional Chinese medicine as a whole." Second, "organizations and individuals who have made outstanding contributions to the cause of traditional Chinese medicine shall be commended and rewarded in accordance with the relevant provisions of the state." Third, the state "establishes the database and directory of traditional Chinese medicine knowledge protection, and improves the protection system" Fourth, the people's government at or above the county level shall "include the development funds of traditional Chinese medicine in the financial budget of the same level" In order to improve the quality of traditional Chinese medicine and promote the healthy development of the cause of traditional Chinese medicine, it is suggested to further strengthen the supervision and management of the cultivation and circulation of traditional Chinese medicine, the processing of traditional Chinese medicine Pieces in medical institutions and the preparation of traditional Chinese medicine preparations It is suggested to make the following modifications: first, to increase the regulations on the cultivation and cultivation of traditional Chinese medicine, and to "strictly manage the use of agricultural inputs" by the state; and "strengthen the ecological environment protection of genuine traditional Chinese medicine production base", and at the same time make clear“ Genuine Chinese herbal medicines refer to those that are selected through long-term clinical application of traditional Chinese medicine and are produced in specific regions Compared with the same kind of herbal medicines produced in other regions, they have better quality and curative effect, stable quality and high popularity " The second is to make it clear that "pharmaceutical manufacturers shall establish a record system for the purchase inspection of Chinese herbal medicines" and "Chinese herbal medicine operators shall establish a record system for the purchase inspection and purchase and sale of Chinese herbal medicines" Third, it is clear that "doctors of traditional Chinese medicine who practice in village medical institutions, rural doctors who have knowledge and recognition ability of traditional Chinese medicine, can self grow and self collect local traditional Chinese medicine according to the relevant provisions of the state and use it in their practice activities." Fourth, it is clear that medical institutions should "abide by the relevant regulations on the processing of Chinese Herbal Pieces" and "ensure the safety of drugs"; and "if the preparation of Chinese herbal preparations is entrusted, the entrusting party and the entrusted party shall bear corresponding responsibilities for the quality of the prepared Chinese herbal preparations" To strengthen the support for the theoretical research of traditional Chinese medicine, one article is added to the general provisions, which stipulates: "the State supports the scientific research and technological development of traditional Chinese medicine, encourages the scientific and technological innovation of traditional Chinese medicine, promotes the application of scientific and technological achievements of traditional Chinese medicine, and improves the scientific and technological level of traditional Chinese medicine." At the same time, a special chapter "scientific research of traditional Chinese medicine" is set up, which stipulates four aspects: first, the State encourages scientific research institutions, colleges and universities, medical institutions and pharmaceutical manufacturers to carry out scientific research of traditional Chinese medicine Second, the state has taken measures to support the collation, research and utilization of ancient Chinese medicine literature, the academic thoughts and diagnosis and treatment experience of famous Chinese medicine experts, and folk Chinese medicine technology and methods Third, the state establishes and improves the scientific and technological innovation system, evaluation system and management system in line with the characteristics of traditional Chinese medicine Fourth, the state should take measures to strengthen the scientific research on the basic theories of traditional Chinese medicine, the methods of syndrome differentiation and treatment, the prevention and treatment of major diseases and other projects that have a significant role in promoting the scientific and technological progress of traditional Chinese medicine Article 35 of the draft on strengthening the construction of the standard system of traditional Chinese medicine stipulates that the State shall strengthen the construction of the standard system of traditional Chinese medicine and formulate standards for technical requirements that need to be unified The national and industrial standards of traditional Chinese medicine shall be formulated and published by the relevant departments of the State Council in accordance with their functions and duties for free reference by the public Some members of the Standing Committee and the public put forward that the standard system is an important basis for the management of traditional Chinese medicine At present, some standards of traditional Chinese medicine are relatively backward and cannot meet the needs of the development of traditional Chinese medicine It is suggested that the standards of traditional Chinese medicine should be updated and revised in a timely manner, and that the formulation of standards should reflect the characteristics of traditional Chinese medicine Some members of the public put forward that the standards of traditional Chinese medicine should be published on the websites of relevant departments for the convenience of public access It is suggested that the above provisions should be revised as: "the state strengthens the construction of the standard system of traditional Chinese medicine, formulates standards according to the characteristics of traditional Chinese medicine for the technical requirements that need to be unified and revises them in a timely manner." "The national and industrial standards of traditional Chinese medicine shall be formulated or revised by the relevant departments of the State Council in accordance with their duties and published on their websites for free reference by the public."