Opinions on strengthening the administration of traditional Chinese medicine preparations in medical institutions

Opinions on strengthening the administration of traditional Chinese medicine preparations in medical institutions

Traditional Chinese medicine preparations for medical institutions are fixed traditional Chinese medicine prescriptions prepared and approved by medical institutions according to the clinical needs of their own units. For a long time, Chinese medicine in medical institutions to meet clinical needs, play an important role in promoting the development of Chinese medicine but there is uneven development, and the traditional Chinese medicine and the clinical needs, advantages and features not enough problems such as. According to the "Drug Administration Law" and relevant regulations, to implement the "CPC Central Committee and State Council opinions on deepening the reform of medical care system" ({2009}6 and the "State Council on supporting and promoting the development of Chinese medicine cause a number of opinions" (the {2009}22), follow the law of development in medicine, fully embodies the traditional Chinese medicine preparation the characteristics of traditional Chinese medicine preparation, strengthen the management of medical institutions, to promote the development of the traditional Chinese medicine medical institutions, the commission the following opinions:

I. profound understanding of the importance of developing traditional Chinese medicine preparations in medical institutions

Medical institutions of traditional Chinese medicine developed by prescription of traditional Chinese medicine with good clinical effect for a, with the exact clinical efficacy, convenient use, low cost and other advantages, reflects the Chinese geographical characteristics, hospital characteristics, professional characteristics and the doctor's clinical experience, is an important part of Chinese clinical medicine. The use of medical institutions of traditional Chinese medicine can make up for lack of commercially available Chinese medicine products, to meet the needs of the service of the masses of Chinese medicine; to serve clinical needs, help to improve the clinical curative effect of traditional Chinese medicine; to the construction and development of characteristic specialty and drives the hospital to maintain favorable play characteristics and advantages of Chinese medicine can effectively inherited the name of clinical experience; the old Chinese medicine experts, is conducive to promoting the inheritance and innovation of traditional Chinese medicine; to lay a good foundation for the development of new drugs, is conducive to the promotion of Chinese medicine research and development. The opinions of the State Council on supporting and promoting the development of Chinese medicine cause ({2009}22) pointed out that it is necessary to encourage and support medical institutions to develop and apply traditional Chinese medicine preparations". To support and promote the development of traditional Chinese medicine preparations in medical institutions is of great significance for deepening the reform of the medical and health care system, improving the people's health and promoting a harmonious society.

Two, to develop the basic principles of traditional Chinese medicine preparations in medical institutions

First, the distinctive features. The development of traditional Chinese medicine in medical institutions should be closely related to the characteristics of the traditional Chinese medicine in the medical institutions, focusing on the characteristics of the region and the spectrum of diseases, and reflecting the traditional features and rationality of the process and dosage forms.

The two is effectiveness. To develop medical institutions, traditional Chinese medicine should pay attention to safety, give prominence to curative effect, guarantee the quality and facilitate the use. It should be adapted to the level of local economic and social development.

Three, focus. The development of traditional Chinese medicine preparations in medical institutions should be overall planning, focusing on key areas and varieties, avoiding blind pursuit of varieties and quantities, and changing the situation of small but complete, many and scattered.

Four is heavy heritage. The development of traditional Chinese medicine preparations in medical institutions should be based on the clinical practice of famous old Chinese medicine practitioners and combined with the clinical experience and academic heritage of famous old doctors.

Five, follow the rules. The development of medical Chinese medicine preparations should not only reflect the dialectical treatment, emphasize the traditional characteristics of Chinese medicine, but also follow the basic rules of drug research and development, and pay attention to the accumulation of clinical use data and the evaluation of the effect.

Six is to seek development. The development of medical institutions of traditional Chinese medicine to bring social benefits in the first place, in order to meet the needs of patients, standardized management, and constantly improve the level of hospital preparations, the name, the construction and development of Chinese medicine service.

Three. Strengthen the registration management of traditional Chinese medicine preparations in medical institutions

(a) of all provinces, autonomous regions and municipalities directly under the central government and drug supervision and management departments should be based on the "Drug Administration Law", "Drug Administration Law" Regulations for the implementation of other laws and regulations, strengthen supervision and management of medical institutions of traditional Chinese medicine preparation, protection of medical institutions of traditional Chinese medicine is safe, effective and controllable quality. In accordance with the "measures for the administration of registration of medical preparations in medical institutions" (Trial) requirements, combined with local conditions to develop the implementation details, highlighting the tradition and embodies the characteristics of traditional Chinese medicine theory, develop TCM clinical advantages, laying a foundation for the development of new drugs of traditional Chinese medicine.

(two) "measures for the administration of registration of medical preparations in medical institutions" (Trial) in the regulations, according to the theory of traditional Chinese medicine prescription, prepared by the traditional process (i.e. the preparation process does not make the material basis for treatment of diseases of the original prescription changes), and the prescription in the medical institutions with more than 5 years (including 5 years) Chinese medicine preparation using historical data, can offer 1317. neutral structure by using the traditional preparation process refers to the preparation process and the traditional process is basically the same, including Chinese herbal medicine by crushing or only with water extraction made of solid, semi-solid and liquid dosage forms of traditional and modern forms, including wine, tincture made by traditional method.

The medical institutions have more than 5 years (including 5 years) refers to the use of history to provide medical institutions for more than 5 consecutive years of text documents (such as prescription, scientific research records, clinical records, and provide relief) 100 cases above relatively complete.

(three) safety evaluation should be paid attention to in clinical research of traditional Chinese medicine preparations in medical institutions. A medical institution that does not have an ethics committee shall apply for the clinical research of traditional Chinese medicine preparations, and may entrust the ethical organs and ethics committees of other medical institutions that have been submitted to the Drug Administration for supervision according to the regulations