The Ministry of Industry and Information Technology, the National Health and Family Planning Commission, and the State Food and Drug Administration have jointly issued the "Guidelines for the Development of the Pharmaceutical Industry", which is a clear direction for accelerating the transformation of the pharmaceutical industry from large to strong during the 13th Five-Year Plan period. Traditional Chinese medicine has been listed as one of the key areas for development. It is clear that the research on compound, effective parts and active ingredients of key Chinese medicines for the dominant diseases of traditional Chinese medicine will be carried out, and modern Chinese medicines with stable quality and controllable clinical advantages will be developed.
The "Guide" clarifies that by 2020, the scale economy will achieve steady growth, the innovation capability will be significantly enhanced, the product quality will be improved comprehensively, the supply security system will be more perfect, the pace of internationalization will be significantly accelerated, and the overall quality of the pharmaceutical industry will be greatly improved. The Guide proposes eight major tasks: enhancing industrial innovation capability, improving quality and safety, improving supply security, promoting green transformation and upgrading, promoting deep integration of the two industries, optimizing industrial organization structure, improving international development level, and expanding new fields. Develop new formats.
The "Guide" proposes to improve the quality standard system of traditional Chinese medicine, improve the quality control level of the whole industrial chain of Chinese medicine, and improve the uniformity and controllability of product quality. Protect and inherit the traditional brand of traditional Chinese medicine.
In the implementation of the product quality upgrade project, the implementation of the sustainable utilization plan of Chinese herbal medicine resources: the national Chinese medicine resources survey, the establishment of a dynamic monitoring and technical service network of Chinese medicine resources, the establishment of a traditional Chinese medicine germplasm resources protection system, the protection of medicinal germplasm resources and Biodiversity guides enterprises to build standardized cultivation and breeding bases for Chinese herbal medicines. It will also implement the Chinese medicine quality improvement plan: implement the Chinese medicine revitalization development project, support the quality improvement of key products such as traditional Chinese medicine decoction pieces, traditional Chinese medicine essential medicines, and traditional Chinese medicine injections; formulate and enhance the production quality control standards and product standards of large-scale Chinese medicine varieties, and construct the whole process of Chinese herbal medicines. Traceability system.
Promote the application of ecological production technology of Chinese herbal medicines, strengthen the management of production inputs, and improve the comprehensive utilization level of non-medicinal parts of Chinese herbal medicines and production wastes of Chinese medicine industry. Leading the formulation of international standards for Chinese medicine, creating conditions for Chinese medicine to go global, and encouraging enterprises to build a shortage of Chinese herbal medicine production bases overseas.
The Guide clearly states that it will vigorously develop key areas such as biopharmaceuticals, new chemical drugs, high-quality Chinese medicines, high-performance medical devices, new auxiliary materials and pharmaceutical equipment. Among them, the specific development direction of the Chinese medicine field is pointed out.
For Chinese patent medicines, we will explore classic prescriptions for cardio-cerebral vascular diseases, autoimmune diseases, gynecological diseases, digestive diseases, etc., and develop new prescriptions, effective parts and effective ingredients of traditional Chinese medicines to accelerate the promotion of curative effects. Research and development and industrialization of innovative Chinese medicines with high clinical value. For the listed varieties, use modern science and technology to dig deep into clinical value, identify the dominant treatment areas, and develop new indications. Carry out re-evaluation of efficacy, safety, preparation process and quality control after drug marketing, and achieve breakthrough in international registration of new drugs.
For Chinese herbal medicines and traditional Chinese medicine decoction pieces, we will focus on the development of artificial breeding techniques for endangered and scarce medicinal materials, and promote the wild planting and breeding of musk, agarwood, and Cordyceps sinensis; improve the standardized production and processing technology of bulk medicinal materials, and improve the quality of traditional Chinese medicine from the source.
For ethnic medicines, the construction of ethnic medicine germplasm resources will be promoted, systematically researching and evaluating the safety and effectiveness of ethnic medicines, improving key technologies such as production, processing and preparation of ethnic medicines, improving product quality and cultivating distinctive varieties.
For industrialization technology, we will focus on the development of large-scale and high-efficiency separation and preparation technologies for traditional Chinese medicine ingredients, and conform to the characteristics of traditional Chinese medicine, such as slow-release, transdermal and mucosal administration, physical modification and taste masking, to improve the quality control of production processes. Improve inspection and testing techniques and standards.