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    Home > Active Ingredient News > Drugs Articles > Guiding opinions of the general office of the State Council on promoting the healthy development of the pharmaceutical industry

    Guiding opinions of the general office of the State Council on promoting the healthy development of the pharmaceutical industry

    • Last Update: 2016-03-14
    • Source: Internet
    • Author: User
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    Source: People's governments of all provinces, autonomous regions and municipalities directly under the central government, ministries and commissions under the State Council, and organizations directly under the State Council (GBF [2016] No 11, March 14, 2016) The pharmaceutical industry is an important foundation to support the development of medical and health services, a sunrise industry with strong growth, relevance and driving force, and plays a positive role in benefiting people's livelihood and stabilizing growth It is of great significance to develop the pharmaceutical industry in order to deepen the reform of the medical and health system, promote the construction of a healthy China, and cultivate a new driving force for economic development Since the reform and opening up, China's pharmaceutical industry has made great progress, with rapid growth of industrial scale and significantly enhanced supply capacity However, it still faces problems such as weak independent innovation capacity, unreasonable industrial structure and irregular market order At present, the rapid development of global pharmaceutical science and technology, the profound adjustment and reform of the pharmaceutical industry, and the continuous growth of people's health demand all put forward urgent requirements for the transformation and upgrading of the pharmaceutical industry In order to promote the core competitiveness of China's pharmaceutical industry and promote the sustainable and healthy development of the pharmaceutical industry, the following opinions are proposed with the consent of the State Council 1 General requirements (1) guiding ideology Fully implement the spirit of the 18th National Congress of the Communist Party of China and the third, fourth and fifth plenary sessions of the 18th Central Committee of the Communist Party of China, firmly establish and practically implement the development concept of innovation, coordination, green, opening and sharing in accordance with the decision-making and deployment of the party Central Committee and the State Council, take the initiative to meet the new round of industrial reform, and deepen the opening and cooperation by optimizing the application environment, strengthening the support of elements, adjusting the industrial structure, strict industrial supervision and deepening the opening and cooperation To stimulate the innovation vitality of the pharmaceutical industry, reduce the cost of the whole process from research and development to marketing of pharmaceutical products, accelerate the system and mechanism reform in the field of approval, production, circulation and use of pharmaceutical products, promote the intelligent, service-oriented and ecological development of the pharmaceutical industry, realize the medium and high-speed development of the industry and the transformation to the medium and high-end, and constantly meet the multi-level and diversified health needs of the people (2) basic principles Adhere to market leading and government guidance Strengthen the dominant position of enterprises in the market, so that the market plays a decisive role in the allocation of resources and better play the role of the government Cooperate with the implementation of relevant medical reform policies, improve the industrial policy and regulatory system, standardize the market order, pay attention to the mutual promotion of industrial upgrading and promotion and application, and create a fair competition environment Adhere to innovation driven and open cooperation We will improve the innovation environment, promote the in-depth integration of government, industry, University, research and application, strengthen the building of pharmaceutical technology innovation capacity, and promote innovation in technology, products, and business models We will accelerate the integration of pharmaceutical product management, quality, standards and registration systems with the rest of the world, make full use of international resources, and strengthen global industrial layout and international cooperation Adhere to industrial agglomeration and green development Promote the agglomeration of chemical APIs to the park with strong environmental carrying capacity and good production supporting conditions To guide the integration of planting (breeding) and processing of traditional Chinese medicine and national medicine enterprises We will promote the circular production of enterprises, the circular combination of industries and the circular transformation of parks, and promote the green transformation and upgrading of the pharmaceutical industry and the development of green security We will continue to improve quality and ensure supply Strengthen the main responsibility of enterprise quality, improve the quality standards and testing system, and ensure the safety and effectiveness of products We will strengthen capacity-building in the production and supply of essential drugs, improve the information network for the circulation of pharmaceuticals, establish fast channels for the review, approval and market access of drugs in short supply and innovative drugs, and improve the capacity of supply assurance (3) main objectives By 2020, the innovation capacity of the pharmaceutical industry will be significantly improved, and the supply guarantee capacity will be significantly enhanced, 90% The above major patent expired drugs have been imitated and listed, and the shortage of drugs in clinical use has been effectively alleviated; the industry is developing green, safe and efficient, and the quality management level has been significantly improved; the industrial organization structure has been further optimized, the system and mechanism have been gradually improved, and the market environment has been significantly improved; the scale of the pharmaceutical industry has been further expanded, and the annual growth rate of the main business income is higher than 10% The growth rate of industrial added value continues to be among the forefront of all industrial industries 2 Main tasks (4) strengthen technological innovation and improve core competitiveness Promote the innovation ability We will intensify the reform of the scientific and technological system and improve the pharmaceutical collaborative innovation system for government, industry, University and research We will strengthen the construction of innovation capacity in the fields of original research drugs, first generic drugs, traditional Chinese medicine, new preparations, high-end medical devices, optimize the allocation of scientific and technological resources, and build a scientific and efficient scientific and technological innovation base with reasonable layout Using database, computer screening, Internet and other information technologies, we will build public service platforms for research and development, industrialization, safety evaluation and clinical evaluation of pharmaceutical products We should actively develop the space for mass innovation, vigorously promote mass innovation and entrepreneurship, cultivate a group of innovative small and medium-sized enterprises with characteristic technology and high-end talents, promote the transformation of R & D outsourcing enterprises to the whole process innovation, and improve the research and development capacity of new pharmaceutical products We will promote the industrialization of major drugs We will continue to promote the creation of new drugs, accelerate the development of chemical drug preparation technologies such as chiral synthesis, enzyme catalysis and crystal control, promote the development and engineering of biotechnology such as large-scale cell culture and purification, antibody coupling, serum-free and protein-free medium culture, and improve the technical level of long-term, slow controlled release, targeting and other new preparations Guided by the clinical drug demand, in the fields of tumor, cardiovascular and cerebrovascular diseases, diabetes, neurodegenerative diseases, mental diseases, high incidence immune diseases, major infectious diseases, rare diseases, etc., we focus on the development of targeted, highly selective and new mechanism of action therapeutic drugs, and focus on the imitation of foreign patent expired drugs with great market potential and clinical urgent need We will accelerate the development and industrialization of new biological drugs, such as antibodies, proteins and peptides We will improve the vaccine supply system, and actively create hand, foot and mouth disease vaccines, new polio vaccines, cervical cancer vaccines and other urgently needed varieties and new adjuvants To meet the needs of children's drug use, new varieties, dosage forms and specifications that meet the physiological characteristics of children should be developed We will carry out fixed-point production of essential drugs that are clinically necessary, in small quantities, and in short supply in the market, strengthen production capacity building and regular reserves, and meet the basic drug demand of the masses Accelerate the transformation and upgrading of medical devices It focuses on the development of key components such as digital detector, superconducting magnet, high heat capacity X-ray tube, precise positioning and navigation of operation, data acquisition, processing and analysis, three-dimensional (3D) printing of biology, etc We have developed PET-CT and PET-MRI, superconducting magnetic resonance imaging system (MRI), multi row spiral CT, color ultrasound diagnosis, image guided radiotherapy, proton / heavy ion tumor treatment, medical robot, health monitoring, telemedicine and other high-performance diagnostic and therapeutic equipment We will promote the industrialization of in vitro diagnostic equipment and supporting reagents, such as full-automatic biochemical analyzer, chemiluminescent immunoanalyzer, high-throughput gene sequencer, five class hematology analyzer We will develop high-end implant and intervention products, such as heart valve, pacemaker, fully degraded vascular stent, artificial joint and spine, cochlear implant, and medium and high-end rehabilitation aids Actively explore the research and development of medical devices based on the theory of traditional Chinese medicine We will promote the modernization of traditional Chinese medicine We will carry out research on the technical standards of traditional Chinese medicine, ethnic medicine and their clinical application, strengthen the formulation of technical standards for cultivation (cultivation) of traditional Chinese medicine, establish a standard system for authentic traditional Chinese medicine, and strengthen the protection of geographical indication products in the field of traditional Chinese medicine We will carry out the breeding of fine varieties of traditional Chinese medicine and the promotion of modern planting (breeding) and production technology, and build a standardized planting (breeding) and large-scale processing integration base in suitable areas We will accelerate the establishment of a dynamic monitoring system for traditional Chinese medicine resources and carry out an assessment of the impact on the ecological environment of the utilization of wild traditional Chinese medicine resources Strengthen the construction of production, circulation and use traceability system of traditional Chinese medicine and traditional Chinese medicine, and improve the quality and safety level of traditional Chinese medicine products We will develop modern extraction and purification technology of traditional Chinese medicine, research and develop preparation technology such as mucosal drug delivery that conforms to the characteristics of traditional Chinese medicine, and promote the application of quality control, automation and online monitoring technology in the production of traditional Chinese medicine In the field of superior treatment of traditional Chinese medicine, promote the secondary development and application of classic famous prescriptions, and develop a batch of traditional Chinese medicine products with definite curative effect, high safety, clear effective ingredients and clear mechanism of action Strengthen the theoretical research of ethnic medicine, promote the development of ethnic medicine systems such as Tibetan medicine, Uygur Medicine, Mongolian medicine and Dai medicine, improve the level of preparations in ethnic medicine medical institutions, and create new varieties with resource characteristics and therapeutic advantages 5 Accelerate quality upgrading and promote green and safe development Strict production quality management Fully implement and strictly implement the new GMP, improve the quality management system of the whole life cycle and the whole industrial chain, implement the quality management of the whole staff, the whole process and all-round, and improve the drug safety traceability system Strictly enforce the production environment standards such as temperature control and cleanliness, strengthen the management of documents such as management standards and working standards, and establish quality management systems such as quality risk prevention and control, supplier audit, continuous stability inspection and quality authorized person Strengthen the consciousness of the first responsible person of quality and safety in pharmaceutical enterprises, and implement the main responsibility of quality Strengthen quality and safety training, strictly manage environment, occupational health and safety (EHS), and improve the quality of employees We will standardize production and operation activities, focus on solving problems such as emphasizing certification over implementation and hardware over software, strengthen supervision over the quality of essential drugs, and urge pharmaceutical manufacturers to comprehensively improve their quality management Improve quality control technology Establish scientific and effective quality standards and control methods, promote the application of advanced quality control technology, improve product design, optimize process routes, improve the whole process quality control system from raw materials to finished products, and effectively improve drug quality We will accelerate the development and application of control technologies such as chemical impurity, solubility, solvent residue and drug crystal form, and improve the purity and stability of products We will strengthen the research on biological properties such as biological activity, equivalence and utilization, enhance the ability to control the variability of biological processes such as fermentation and cell culture, and strive to improve the safety and effectiveness of biological products such as vaccines Increase the research on the material basis of traditional medicine products such as traditional Chinese medicine and ethnic medicine, improve the quality stability of cosolvent, and reduce the incidence of adverse reactions Improve the quality standard system We will improve the national drug standard system with Pharmacopoeia of the people's Republic of China as the core, implement the action plan for improving the standards of drugs and medical devices, promote the upgrading of quality standards for basic drugs, high-risk drugs, pharmaceutical excipients, packaging materials and basic, universal and high-risk medical devices, and improve the technical specifications and quality control for the production of traditional Chinese medicine and ethnic medicine Standards, improve the scientificity, rationality and operability of standards, and strengthen the authority and seriousness of standards Further improve the drug quality evaluation system, establish drug impurity database, quality evaluation methods and testing platform Improve the consistency evaluation methods and technical specifications of generic drugs, carry out third-party testing and evaluation, and improve the quality of generic drugs Focus on the consistency evaluation of the quality and efficacy of essential drugs, and comprehensively improve the quality of essential drugs Carry out the risk assessment of harmful residues of traditional Chinese medicine, strengthen the safety assessment of traditional Chinese medicine injection, and maintain the quality and safety of traditional Chinese medicine products Accelerate the improvement of public technical service platforms such as measurement, standards, inspection and testing, certification and accreditation, and encourage the construction of third-party quality service platforms
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