On November 7, the Ministry of Industry and Information Technology, the National Development and Reform Commission, the Ministry of Science and Technology, the Ministry of Commerce, the National Health and Family Planning Commission and the State Food and Drug Administration jointly issued the "Pharmaceutical Industry Development Planning Guide" (hereinafter referred to as the "Planning Guide").
The "Planning Guide" mainly sets goals for the development of the pharmaceutical industry during the "13th Five-Year Plan" period from eight aspects:
Industry scale:
The main business income maintained a medium-high growth rate, with an average annual growth rate of more than 10%, and its proportion in the industrial economy increased significantly.
Technological innovation:
The R&D investment of enterprises continues to increase, and by 2020, the R&D investment intensity of enterprises above designated size in the whole industry will reach more than 2%. The quality of innovation has significantly improved, new drug registration has accounted for a larger proportion of drug registration, a number of high-quality innovation achievements have been industrialized, and breakthroughs have been made in the international registration of new drugs.
Product quality:
Quality standards for drugs and medical devices have been improved, quality management practices in all aspects have been effectively implemented, and product quality and safety guarantees have been strengthened. Basically completed the quality and efficacy consistency evaluation of generic oral solid preparations of essential drugs. More than 100 pharmaceutical enterprises have passed the international advanced GMP certification.
Green development:
Compared with 2015, in 2020, energy consumption per unit of industrial added value of enterprises above designated size will be reduced by 18%, carbon dioxide emissions per unit of industrial added value will be reduced by 22%, water consumption per unit of industrial added value will be reduced by 23%, emissions of volatile organic compounds (VOCs) will be reduced by more than 10%, and the green production level of chemical raw materials will be significantly improved.
Intelligent Manufacturing:
By 2020, the automation and informatization level of pharmaceutical production process will be significantly improved, the key process processes of large enterprises will be basically automated, the utilization rate of manufacturing execution system (MES) will reach more than 30%, and a number of intelligent manufacturing demonstration workshops will be built.
Supply assurance:
The national capacity to ensure the supply of basic drugs and commonly used low-cost drugs has been strengthened, the shortage of clinical drugs has been significantly improved, and generic drugs whose patents have expired that are urgently needed for clinical use have been basically put on the market. The national pharmaceutical reserve system has been further improved, and the capacity for emergency research and development and emergency production in response to public health emergencies has been significantly enhanced.
Organizational structure:
The restructuring and integration of the industry is accelerating, and the degree of concentration is constantly improving. By 2020, the proportion of main business income of the top 100 enterprises will increase by 10 percentage points, and the leading role of large enterprises in the development of the industry will be further strengthened.
Internationalization:
Pharmaceutical exports increased steadily, and the proportion of export delivery value in sales revenue reached 10%. The export structure improved significantly, and the proportion of exports of preparations and medical equipment increased. The scale of overseas investment has increased, international technical cooperation has deepened, and the capacity for international development has been greatly improved.
In terms of main tasks, the "Planning Guide" also puts forward specific plans from the aspects of enhancing industrial innovation capacity, improving quality and safety level, enhancing supply security capacity, promoting green transformation and upgrading, promoting the deep integration of the two and optimizing the industrial organizational structure.
Innovation ability improvement project:
1. Construction of pharmaceutical manufacturing innovation center. Build an innovation center for pharmaceutical and medical device manufacturing industry, integrate government and social investment, research institutes and enterprise R&D forces, clinical research resources of medical institutions, enterprise industrialization capabilities and other resources, carry out cooperation on common key technical issues of industrial development, achieve 10-15 key technological breakthroughs, improve the innovation capacity of the whole industrial chain, and promote innovation-driven development.
2. Construction of innovation and entrepreneurship service platform for small and micro enterprises. We will support the establishment of service platforms for innovation and entrepreneurship, such as business incubators, open laboratories, and centers for transforming scientific and technological achievements, and support the innovation activities of small and micro enterprises.
3. Venture capital plan for pharmaceutical industry. Guide social capital to establish more than 50 pharmaceutical industry venture capital funds, with a total scale of more than 10 billion yuan, to provide investment and financing support for pharmaceutical technology innovation projects.
4. Pharmaceutical research and development data and public resource platform construction. Support the construction and integration of disease clinical information database, biological sample database, compound database, traditional Chinese medicine chemical component database, drug impurity standard product database, drug package material additive database, to realize the open sharing of data and resources, and provide services for pharmaceutical research and development in the industry.
Product quality upgrade project:
1. Chemical generic drug quality upgrade plan. We will fully implement the task of evaluating the consistency of quality and efficacy of oral solid preparations of essential drugs, support the technological transformation and quality upgrading of large varieties of generic drugs, and support the development and application of new pharmaceutical excipients.
2. Plan for sustainable utilization of Chinese medicinal materials resources. China has carried out a national survey of traditional Chinese medicine resources, established a dynamic monitoring and technical service network for traditional Chinese medicine resources, established a protection system for traditional Chinese medicine germplasm resources, protected medicinal germplasm resources and biodiversity, and guided enterprises to build standardized planting and breeding bases for traditional Chinese medicine.
3. TCM quality improvement plan. We implemented the project to revitalize and develop traditional Chinese medicine, and supported the improvement of the quality of key products such as traditional Chinese medicine decoction pieces, essential Chinese medicine, and traditional Chinese medicine injections. Formulate and improve the production quality control standards and product standards of large varieties of traditional Chinese medicine, and establish the whole process traceability system of traditional Chinese medicine.
4. Vaccine quality improvement Program. Focusing on the key varieties of immunization program vaccines, the development of multi-conjugate and multi-valent vaccines, the technology upgrade and production process optimization of existing vaccines, improve the quality of key nodes in the production process control, improve the circulation cold chain traceability system, and ensure the quality and safety of vaccines.
5. Medical device quality improvement plan. Promote the upgrading of basic, universal and high-risk medical device quality standards, support medical device enterprises to improve the level of process technology, carry out product clinical quality verification, and improve stability and reliability.
Drug supply assurance Project:
1. Construction of drug production and supply information system. Promote the interconnection and sharing of information systems such as drug production statistics, bidding and procurement, clinical drug use, and medical insurance payment among departments to provide support for ensuring drug supply. Establish a drug shortage early warning system, monitor the production and supply of key varieties, predict the shortage of drug supply, and release early warning information in a timely manner.
2. Construction of centralized production base for small varieties of drugs. Select production enterprises with strong comprehensive strength, high quality management level and concentrated approval documents of small varieties of drugs, lay out 3-5 concentrated production bases of small varieties of drugs in the country, and improve the supply guarantee ability of a number of small varieties.
3. Construction of emergency drug R&D and industrialization base. In response to emerging infectious diseases and other emergency needs that threaten national public health security, we will build bases for rapid research and development and production of drugs and vaccines that combine military and civilian activities, relying on qualified enterprises and scientific research institutions, to meet the needs of disease prevention and control.
4. Construction of medical reserve information system. The central and local medical reserve information systems shall be interconnected, reserve information monitoring and data query, reserve plan issuance, and real-time scheduling of reserve varieties shall be completed online, and emergency response capabilities shall be improved.
Pharmaceutical green development Project:
1. Development and application of green production technology. With a focus on chemical raw materials, clean production processes such as substitution of toxic and harmful raw materials, biosynthesis and biocatalysis, and solvo-free separation will be developed and applied to improve the level of unorganized emission control of volatile organic compounds and the treatment of three wastes such as fermentation bacteria residues; Promote the application of ecological production technology of Chinese medicinal materials, strengthen the management of production inputs, and improve the comprehensive utilization level of non-medicinal parts of Chinese medicinal materials and industrial production waste of Chinese medicinal materials.
2. Green factory demonstration project construction. We will support the construction of a number of green demonstration factories with low energy consumption and emissions in accordance with advanced international standards, and encourage enterprises to carry out cleaner production and technological upgrading for energy conservation and emission reduction.
3. Construction of green park for chemical raw materials. Select suitable areas with strong environmental bearing capacity and environmental protection governance, build 3-5 chemical API recycling economy parks, and promote the development of API production clusters.
Pharmaceutical intelligent Manufacturing Engineering:
1. Development and application of medical management information system. Support the development of a number of management information systems that meet the characteristics of the pharmaceutical industry and are applied to R&D, production and quality management, focusing on automated batch control technology, Manufacturing execution system (MES), process analysis technology (PAT), process knowledge management system (PKS), etc. And around the key process unit operation with analysis, learning, decision-making, execution of the intelligent management system.
2. Construction of intelligent drug production workshop. Support the construction of more than 20 demonstration workshops for the intelligent production of raw materials and preparations, and comprehensively apply various information technologies, equipment and management systems to realize the automation and intelligence of the production process; Support the construction of more than 5 drug production workshops applying continuous manufacturing technology, and explore the transformation of drug production mode from intermittent production to continuous production.
3. Construction of automatic production workshop for medical devices. Support the construction of more than 10 automated production demonstration workshops based on the characteristics of discrete manufacturing of medical devices, change the situation of manual assembly and manual testing of most medical devices, improve the level of mechanical assembly, achieve automated material distribution, quality testing and customized production, and systematically improve the stability and reliability of medical devices.
International competitiveness improvement project:
1. Pharmaceutical internationalization strategy. Support the construction of a number of high-standard preparation production bases, through the European and American GMP certification. We will encourage international registration of new drugs, chemical generics, traditional Chinese medicines and biosimilars, so that 3-5 new drugs and more than 200 chemical generics can be launched in the markets of developed countries. We will encourage enterprises to improve their ability to operate in the international market, establish sales channels for the international market, and cultivate made-in-China brands.
2. Construction of overseas production bases. Support enterprises to acquire or invest in the construction of overseas production bases for chemical raw materials, preparations, and Chinese medicinal materials, promote international cooperation on production capacity, make full use of overseas environmental resources, and better serve the local market.
3. International technical exchange and cooperation. Support international personnel and technology exchanges, introduce and export advanced products and technologies, encourage foreign enterprises to set up research and development, production bases in China, and carry out international multi-center clinical trials of new drugs.
In view of the development of key areas, the Planning Guide defines the development direction of biological drugs, chemical drugs and traditional Chinese medicine respectively.
First, biological drugs
1. Antibody drugs. Focus on the development of antibody drugs for tumors, immune system diseases, cardiovascular diseases and infectious diseases, such as PCSK9 inhibitors for the treatment of hypercholesterolemia, tumor immunotherapy drugs PD-1/ PD-L1, RANKL for the treatment of osteoporosis and other new drugs with outstanding clinical value. Accelerate the development of new antibodies such as antibody coupling drugs, bifunctional antibodies, and antibody fusion proteins. Promote the industrialization of large varieties of biosimilar drugs with high clinical demand, focusing on TNF-α, CD20, VEGF, Her2, EGFR And other target products to improve patient access to medication.
2. Recombinant protein drugs. Sugar specific