Since the reform and opening-up, China's traditional Chinese medicine (TCM) industry has continued to develop and has initially established a sizable industrial system. It has become a strategic sector with strong growth potential and broad market prospects for China's national economy and social development. However, overall, China's TCM quality standards system remains incomplete, with outdated testing methods and control technologies. Production processes and formulation techniques are relatively low-level. The R&D platform for TCM is inadequate, resulting in weak innovation capacity. Most TCM enterprises have low management standards, limited market competitiveness, and lack international competitiveness. To strengthen technological progress and innovation and advance the modernization of TCM, this outline has been formulated.
I. Guiding Principles, Basic Principles, and Strategic Objectives
(I) Guiding principles for the modernization of traditional Chinese medicine.
The guiding principle for the modernization of traditional Chinese medicine (TCM) is to be guided by Comrade Jiang Zemin's important thought on "Three Represents," inherit and promote TCM theory, apply scientific theories and advanced technologies, and advance TCM modernization. We will focus on the domestic market while actively expanding into international markets. Driven by technology, led by enterprises, oriented by market demands, and supported by policy, we will fully leverage China's advantages in TCM resources, markets, and talent to build a national TCM innovation system. Through innovation and breakthroughs in key technologies, we will gradually restructure TCM product lines and upgrade industrial capabilities, establishing a competitive modern TCM industry.
(II) Basic Principles for Modernizing Traditional Chinese Medicine Development.
1. Integrate inheritance with innovation. Uphold the unique strengths of Traditional Chinese Medicine (TCM), leverage scientific theories and advanced technologies, and draw on modern pharmaceutical and international botanical drug development experiences. Actively explore the TCM knowledge base to drive continuous innovation, develop proprietary innovative TCM products, and comprehensively enhance research, development capabilities, and production standards.
2. Sustainable resource utilization and industrial development. While making full use of resources, protect them along with the environment, biodiversity, and ecological balance. Special attention must be paid to the restoration and regeneration of endangered and scarce Chinese medicinal materials to prevent loss, degradation, and extinction, ensuring the sustainable use of Chinese medicinal resources and the sustainable development of the Chinese medicine industry.
3. Jointly advance government guidance and enterprise-led initiatives. The government sets national strategic goals and creates a favorable development environment to guide the modernization of traditional Chinese medicine. Enterprises innovate continuously based on market needs and development, aligning with national strategic objectives.
4. Integrate overall planning with regional development. Fully consider the overall plan while leveraging each region's unique conditions and advantages to boost economic growth. Align with the Western Development Strategy by advancing modernization of traditional Chinese medicine (TCM) to improve ecological environments in western regions, develop eco-friendly economies, and strengthen their comprehensive economic capacity.
5. Promote synergistic development with modernization of traditional Chinese medicine (TCM). While advancing the modernization of TCM medicines, place strong emphasis on modernizing TCM practices to ensure mutual reinforcement and coordinated progress. Strengthen foundational research on TCM theory and establish an efficacy evaluation system that reflects the unique strengths and characteristics of TCM.
(3) Strategic goals for the modernization of traditional Chinese medicine.
Adhere to the policy of "inheriting and innovating, achieving leapfrog development." Rely on technological progress and innovation to build a national modern traditional Chinese medicine (TCM) innovation system. Establish and refine standards and specifications for modern TCM, develop a portfolio of innovative TCM products with proven efficacy, break through key technologies in TCM research, development, and industrialization, and cultivate a competitive modern TCM industry. Maintain China's leading position in TCM science and technology, enable the transition from traditional to modern TCM industries, and contribute to national economic and social development as well as human health.
1. Build a modern Chinese medicine innovation system for the nation. Under the government's macro-guidance, integrate resources from universities, research institutes, and pharmaceutical companies through comprehensive planning, resource restructuring, and mechanism innovation to establish a modern Chinese medicine innovation system featuring a complete R&D framework, advanced technical equipment, a well-balanced talent structure, strong innovation capabilities, and scientific, standardized management. By 2010, develop platforms for foundational research, applied development, and supporting infrastructure in Chinese medicine, with priority support for 2–3 key laboratories, 10 Chinese medicine R&D centers, 20 national engineering and technology research centers, and 10 Chinese medicine industrial bases.
2. Formulate and refine modern standards and specifications for Chinese medicine. Leverage advanced scientific and technological methods to strengthen research on quality control technologies, establishing and improving standards and specifications for the cultivation (or breeding), R&D, production, and sales of Chinese medicine products to ensure their safety, efficacy, and controllable quality. By 2010, establish and refine modern quality standards for 500 commonly used Chinese medicinal herbs and 500 commonly processed Chinese herbal medicines (including corresponding formula granules); complete the optimization evaluation of process conditions and enhancement of quality control measures for traditional proprietary medicines in the National Essential Medicines List; and complete research on 200 chemical reference substances for Chinese medicine.
3. Develop a portfolio of TCM products with proven efficacy. While ensuring therapeutic effectiveness, modernize traditional TCM dosage forms and enhance quality control standards. Accelerate the development of new TCM products that are effective, safe, and have controllable quality. By 2010, launch 100 new TCM products and complete secondary development for 100 existing traditional Chinese patent medicines; finalize the review and enhancement of current national TCM standard varieties; increase export share of high-value-added, high-tech TCM products, and aim to get 2–3 TCM varieties into mainstream international pharmaceutical markets.
4. Establish a modern Chinese medicine industry with competitive market advantages. Prioritize support for a group of large enterprises or multinational groups that possess independent intellectual property rights and international competitiveness, fostering an environment conducive to overall economic growth, regional development, and a competitively advantaged modern Chinese medicine sector. By 2010, aim to cultivate approximately 5 enterprise groups with annual sales exceeding 50 billion yuan and 10 groups with annual sales exceeding 30 billion yuan. Significantly increase the international market share of Chinese medicine products.
II. Key Tasks
(I) Innovation Platform Construction.
1. Mobilize resources from all sectors to establish and enhance a modern platform for Chinese medicine research and development. Conduct studies on Chinese medicine screening, efficacy evaluation, safety assessment, clinical evaluation, adverse reaction monitoring, and the production technologies, processes, and quality control of Chinese medicinal materials, processed Chinese herbs (including formula granules), and proprietary Chinese medicines.
2. Strengthen the National Key Laboratory of Traditional Chinese Medicine (TCM) and the National Engineering and Technology Research Center for TCM. Leverage existing strengths, highlight unique features, and implement a comprehensive layout to establish an integrated TCM industrial base that seamlessly connects cultivation, R&D, and production in a coordinated manner, driving the comprehensive modernization of TCM.
3. Strengthen the construction of infrastructure for Chinese medicine research and development, improve experimental conditions, enhance the level of instrumentation and animal standards, and build an information sharing platform.
(2) Standardization.
1. Strengthen standardized cultivation of Chinese medicinal materials and research on processing standards for Chinese herbal decoction pieces. Establish quality standards and limits for harmful substances for both, comprehensively improving their quality. Enhance research on chemical reference substances for commonly used Chinese medicines and establish a national repository of standard reference materials for traditional Chinese medicine.
2. Strengthen scientific, quantitative research on quality control technologies tailored to the unique characteristics of traditional Chinese medicine (TCM), and enhance quality control standards for TCM patent medicines, processed herbal pieces (including formula granules), and new TCM drugs. Focus on TCM injections and progressively expand the application of fingerprint analysis and other methods in TCM quality control.
3. Promote and implement Good Agricultural and Collection Practices for Chinese Herbal Medicines, Good Manufacturing Practice for Pharmaceutical Products, Good Laboratory Practice for Nonclinical Studies, Good Clinical Practice for Clinical Trials, and Good Supply Practice for Pharmaceutical Products. Standardize the research, development, production, and distribution of traditional Chinese medicine, and continuously enhance industry standardization.
(3) Basic Theory Research.
1. Strengthen interdisciplinary collaboration to deeply investigate the pharmacologically active constituents, mechanisms of action, and formulation principles of traditional Chinese medicine (TCM), and actively advance research in TCM genomics, proteomics, and related fields.
2. Prioritize research and innovation in the foundational theories of Traditional Chinese Medicine (TCM), particularly those closely linked to its modernization, such as syndrome differentiation, formula composition, and herb properties. Explore their scientific underpinnings to fuel TCM's modern development.
(4) Innovation in Traditional Chinese Medicine Products.
1. Select time-tested traditional Chinese medicine formulas with proven efficacy, safety, and distinctive characteristics to develop modern pharmaceutical products.
2. Improve traditional Chinese medicine (TCM) formulations while ensuring therapeutic efficacy, enhance quality control standards, and develop new TCM products with proven effectiveness, controllable quality, and safe usage to comprehensively elevate the overall quality of TCM products.
3. Conduct targeted new drug research and development in compliance with international market demands and the regulatory requirements of specific countries to achieve drug registration in developed nations, facilitating the entry of Chinese medicines into mainstream pharmaceutical markets in those regions.
(V) Cultivating Advantageous Industries.
1. Strengthen research on key technologies for Chinese medicine extraction, separation, and purification, and promote the adoption of advanced, applicable technologies. Enhance enterprise competitiveness, accelerate the industrialization of modern Chinese medicine products, and foster the development of large-scale Chinese medicine brands, markets, and enterprises.
2. Strengthen intellectual property protection for traditional Chinese medicine (TCM), develop patented products, register exclusive trademarks, and implement a brand strategy. Gradually shift from exporting raw herbs and minimally processed goods to increasing the proportion of TCM patent medicines, drive industrial upgrading, and expand into international markets for TCM.
3. Advance corporate mergers and reorganizations under market mechanisms to cultivate a group of core TCM enterprises characterized by innovative products, advanced technology, superior equipment, disciplined management, and entrepreneurial spirit, along with several multinational TCM companies. This will establish enterprises as the primary drivers of modernization in traditional Chinese medicine.
(VI) Protection and sustainable use of traditional Chinese medicine resources.
1. Conduct a census of Chinese medicinal resources and establish an early warning mechanism for endangered wild resources; protect genetic and germplasm resources of Chinese medicines, strengthen selective breeding and research on medicinal seed sources to prevent variety degradation and resolve issues of source confusion.
2. Establish a traditional Chinese medicine (TCM) database and germplasm resource repository to collect data on TCM varieties, origins, therapeutic effects, and preserve TCM germplasm resources.
3. Strengthen research on cultivating and domesticating wild medicinal herbs, advance cultivation techniques to achieve standardized planting and industrial production of medicinal materials; enhance plant protection research and promote green medicine development.
4. Strengthen the breeding of new traditional Chinese medicine (TCM) varieties, conduct research on substitutes for rare and endangered TCM resources, and ensure the sustainable development of TCM.
III. Key Measures
(I) Strengthen the overall planning of modernization in traditional Chinese medicine and establish an efficient, coordinated management mechanism.
1. Strengthen leadership in advancing the modernization of traditional Chinese medicine (TCM) by establishing an interdepartmental joint meeting system. Enhance communication and coordination to foster collaboration, creating an efficient and well-coordinated management mechanism that supports TCM modernization.
2. Relevant departments and localities should develop corresponding development plans and key tasks based on national strategic goals and priorities for the modernization of traditional Chinese medicine, aligning with their respective functions and leveraging regional strengths, characteristics, and actual conditions.
(2) Establish a multi-channel investment system for the modernization of traditional Chinese medicine.
1. The State has established a special program for the modernization of Chinese medicine, increasing investment in technology, industry development, and talent cultivation.
2. Local governments at all levels should increase investment in traditional Chinese medicine (TCM) research, development, and industry by aligning with regional economic development plans and leveraging local advantages, unique characteristics, and actual conditions.
3. TCM enterprises should further increase their R&D investment, with R&D spending reaching over 5% of sales by 2010.
4. Leverage market-based mechanisms such as venture capital to expand funding channels for the research, development, and commercialization of new Chinese medicines, attracting private sector investment in modernizing the industry.
(3) Increase policy support for the traditional Chinese medicine industry.
1. The nation is developing the traditional Chinese medicine (TCM) industry as a major strategic sector, supporting strategic adjustments to its product structure. It encourages the industrialization of flagship TCM products with proven efficacy and strong originality, while promoting the adoption of new technologies, processes, and equipment by enterprises to enhance the technological content and market competitiveness of TCM products.
2. The government supports Chinese medicine enterprises in actively expanding into international markets and competing globally. It encourages these enterprises to increase exports through various forms based on international market demand, with a focus on boosting the global market share of high-value-added Chinese medicine products and facilitating their entry into mainstream international pharmaceutical markets. Exports of Chinese medicine products shall comply with relevant policies on technology-driven trade development.
3. Promote industrialization of traditional Chinese medicine (TCM). The state encourages large-scale, standardized, and intensive production of TCM herbs and processed decoction pieces to transform distribution channels. It also encourages pharmaceutical and trading enterprises to participate in the construction of TCM herb bases, develop contract farming, and ensure consistent quality. Local governments should provide agricultural policy support for the development of TCM cultivation and breeding. Conservation, sustainable use, and comprehensive development of TCM resources should be integrated into national initiatives such as poverty alleviation and western region development.
4. Formulate pricing and tax policies to advance the modernization of traditional Chinese medicine (TCM). Pricing authorities shall establish policies that encourage enterprises to produce high-quality TCM products with independent intellectual property rights. Enterprises importing equipment for introducing advanced technologies, upgrading production processes, or conducting research on common and critical TCM production technologies shall receive tax incentives in accordance with relevant regulations.
5. Improve the registration and review system for traditional Chinese medicine (TCM). Implement expedited approval procedures for TCM innovative products that are key priorities of national support, and prioritize their inclusion in the National Essential Medicines List and the medical insurance drug coverage list.
(4) Strengthen management and protection of Chinese herbal resources and intellectual property rights.
1. In light of new developments in the modernization of traditional Chinese medicine, establish the "Regulations on the Protection and Management of Traditional Chinese Medicine Resources."
2. Based on the actual needs of protecting traditional Chinese medicine (TCM) resources, adjust the list of protected species, regulate the use of wild TCM resources, and fully reflect the basic policy of encouraging artificial cultivation and breeding of TCM materials.
3. Formulate an intellectual property strategy for the traditional Chinese medicine (TCM) industry to proactively address international patent competition. Strengthen enforcement efforts. Protect TCM intellectual property and promote innovation in TCM.
4. Accelerate patent examination to shorten review cycles, leverage the patent system to expedite technology commercialization, and generate economic benefits.
(5) Accelerate the development of talent for modernizing traditional Chinese medicine.
1. Cultivate a cohort of academic and technical leaders, senior production managers, business executives, international trade experts, legal professionals, practical technology specialists, and composite talents to meet the needs of modernization in traditional Chinese medicine.
2. Actively leverage the resources of traditional Chinese medicine (TCM) institutions and other relevant universities to train professionals, while also emphasizing talent development through production and research practices.
3. Leverage joint ventures to cultivate urgently needed domestic professionals in modernized traditional Chinese medicine (TCM), encourage relevant personnel to study abroad for advanced technologies and management expertise, and develop globally competitive talent.
4. Accelerate reforms to the science and technology system, establishing mechanisms and an environment that foster talent development and mobility.
(VI) Further expand international cooperation and exchange in the field of traditional Chinese medicine.
1. Strengthen international cooperation and exchange in traditional Chinese medicine (TCM). Enhance collaboration with countries and regions worldwide on TCM policies and regulations, as well as on standardization and management of traditional medicines, to create favorable external conditions for the modernization of TCM.
2. Strengthen cultural promotion of traditional Chinese medicine (TCM), showcasing its development achievements and scientific research outcomes. Continue to encourage and support TCM universities and medical institutions in conducting formal TCM education and medical services abroad, advancing the global reach of TCM to serve human health.
(7) Fully leverage the role of traditional Chinese medicine industry associations.
TCM industry associations shall fulfill their roles in service, self-discipline, representation, and coordination. They should promote market standardization, facilitate information exchange and technical-economic cooperation, drive enterprise innovation and product quality improvement, protect intellectual property rights and related interests, and actively advance the modernization of traditional Chinese medicine.