Title: Jinan Municipal People's Government issued a notice on accelerating the high-quality development of biomedicine and health industry of a number of policies and measures
In order to deeply implement the strategy of industrial strength of the city, to accelerate the promotion of biomedicine and health industry of high-end high-quality and high efficiency, professional specialization and expertise, cluster agglomeration and intensive development, to create an internationally competitive biomedicine cluster, to enhance the city's advanced manufacturing industry and the digital economy development capacity level. Economic development level, combined with the actual city, the development of a number of policies and measures are as follows.

I. Increase support for research and development innovation

(a) Support product development and innovation. Encourage new drugs, new medical equipment research and development, the commitment to land in the city production of innovative products to give certain awards. Among them, to enter the I, II, III phase 1 clinical trial research of new drugs (the same variety of different indications or different dosage forms of the combined calculation), each project graded to give R & D units 2 million yuan, 3 million yuan, 5 million yuan one-time incentives for the same year, each unit cumulative total of up to 20 million yuan in incentives; to enter the I, II, III clinical trial research of 2 types of For new drugs entering phase I, II and III clinical trials, each project will be given a one-time award of 1 million yuan, 2 million yuan and 3 million yuan respectively, with a cumulative maximum of 10 million yuan for each unit in the same year; for the completion of clinical trial studies on Class III medical devices and non-in vitro diagnostic reagents Class II medical devices, each project will be given a one-time award of 2 million yuan and 500,000 yuan for each unit in the same year, with a cumulative maximum of 20 million yuan for each unit. For new veterinary drugs entering clinical trial research, each project will be given a one-time reward of 1 million yuan to the R&D unit, and each unit will be given a total reward of up to 3 million yuan in the same year. (Responsible units: Municipal Bureau of Industry and Information Technology, Municipal Bureau of Science and Technology, Municipal Market Supervision Bureau, Municipal Bureau of Agriculture and Rural Affairs)

(2) Support for the inheritance and innovation of traditional Chinese medicine. Support enterprises, medical institutions, colleges and universities, scientific research institutions, etc. to carry out research on the secondary development of large varieties of pCms drugs to increase the indications, the secondary development of large varieties of pCms drugs to increase the function of the main (or indications) into the phase Ⅲ clinical trial research and commitment to land in the city production, to give a one-time reward of 2 million yuan, the same year, the maximum cumulative total of incentives for each unit can be rewarded 6 million yuan. Support for the promotion of the classic famous direction of medical institutions preparations, medical institutions preparations to new Chinese medicines step by step transformation, each obtain a medical institution preparations for the record varieties can be rewarded 30,000 yuan, the same year, each unit up to a maximum of 150,000 yuan; for the national or provincial filing of the production of traditional Chinese medicine formula particles manufacturers, each new varieties of formula particles approved to give a one-time reward of 30,000 yuan, the same year, each unit Each unit will be rewarded a total of up to 2 million yuan; to promote the resumption of production of dormant varieties of traditional Chinese medicine, a one-time reward of 100,000 yuan per variety will be given to each unit that obtains a resumption notification and a change in the process of proprietary Chinese medicines for the record or obtains an approval. (Responsible units: Municipal Bureau of Industry and Information Technology, Municipal Health Commission, Municipal Market Supervision Bureau)

(3) Support enterprises to strengthen the construction of innovation capacity. Registered in the city's annual summary revenue (within the city) reached 5 billion yuan, 15 billion yuan or more, and the annual summary of R & D investment (plus deduction caliber) reached 500 million yuan, 1.5 billion yuan or more of the biomedical headquarters enterprises, respectively, according to the previous year's summary of R & D investment (plus deduction caliber) of 10%, 15% of the incentives. (Responsible units: Municipal Bureau of Industry and Information Technology, Municipal Taxation Bureau, Municipal Bureau of Statistics)

(d) Support enterprises (organizations) to carry out qualification certification. The new through the new version of the national drug non-clinical research quality management standard (GLP), drugs (including medical devices) clinical trial quality management standard (GCP), China National Accreditation Service for Conformity Assessment (CNAS) qualification certification of biomedical enterprises or organizations to give a certain amount of incentives. Among them, for the first time to obtain GLP certification project reached 3 major items, 5 major items of the unit, were given 1 million yuan, 2 million yuan incentives; for the new GCP qualification and certification of the unit to give 500,000 yuan one-time incentive, and on this basis, each new record of professional and business can be another 50,000 yuan incentives; the first time to obtain the CNAS certification of the unit was given a reward of 200,000 yuan. For pharmaceuticals and Class III medical devices to obtain FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), PMDA (Japan Pharmaceutical and Medical Devices Agency) certification of the enterprise, each certified product will be given a one-time reward of 1 million yuan, and each enterprise will be rewarded up to 5 million yuan. (Responsible units: Municipal Bureau of Industry and Information Technology, Municipal Health Commission, Municipal Market Supervision Bureau)

Two, support for innovation to accelerate industrialization

(E) support for the transformation of innovative achievements. The new approval or registration certificate and in the city production, settlement of innovative products, according to the following standards to give a one-time incentive: 1 class of new drugs each variety of reward 30 million yuan, the same year each enterprise can get the maximum reward of 100 million yuan; 1 class of new veterinary drugs each variety of reward 10 million yuan, the same year each enterprise can get the maximum reward of 30 million yuan; the third class of innovative medical devices or Class A, Class B Each variety of medical equipment will be rewarded 3 million yuan, and each variety of other Class III medical equipment will be rewarded 1 million yuan, and each enterprise will be rewarded up to 6 million yuan in the same year; each batch of special medical formula will be rewarded 1 million yuan, and each enterprise will be rewarded up to 3 million yuan in the same year. Accelerate the product research and development and industrialization of epidemic prevention materials, the research and development and production of vaccines, nucleic acid detection class, rescue medicines, medical equipment class and other epidemic prevention and control products for the first time to obtain the three types of medical devices, innovative drug registration approvals of the enterprise, each product were given 2 million yuan, 3 million yuan one-time incentives. (Responsible units: Municipal Industry and Information Technology Bureau, Municipal Market Supervision Bureau, Municipal Agriculture and Rural Affairs Bureau, Municipal Health Commission)

(F) support for the consistency evaluation of generic drugs. Variety through the generic drug quality and efficacy consistency evaluation (excluding exemption BE test) of enterprises, according to the standard of 2 million yuan per variety to give a one-time incentive, which belongs to the same variety of the first three domestic through the consistency evaluation of a one-time incentive of 3 million yuan; variety of the year the new included in the catalog of veterinary drugs than the test and obtain the approval of the document number (excluding the exemption BE test), according to the standard of 1 million yuan per variety to give a one-time incentive. Variety 1 million yuan standard to give a one-time incentive. The number of varieties awarded to each enterprise in the same year shall not exceed 5. (Responsible units: Municipal Market Supervision Bureau, Municipal Agriculture and Rural Affairs Bureau in accordance with the division of responsibilities to implement)

(VII) to support the development of listed license holders (registrants) commissioned production. Support for the acquisition of drugs or medical devices listed license holder (registrant) entrusted to the city enterprises to produce listed licensed products, since the start of production of the product within 3 years, according to the actual commissioned production of each variety of contract implementation (subject to the invoice) of 5% of the commissioned production enterprise incentives. Single species of each enterprise for three years, the maximum cumulative reward of 3 million yuan, the same enterprise can be rewarded up to 5 million yuan per year, the maximum cumulative reward for three years 10 million yuan. (Responsible units: Municipal Bureau of Industry and Information Technology, Municipal Market Supervision Bureau)

(H) support the development of product promotion and application. Encourage medical institutions to give priority to the use of innovative products, the use of innovative products for medical institutions, according to the use of 5% of the value of the volume of incentives, a single medical institution can be rewarded up to 5 million yuan per year. Support the medical beauty anti-aging production enterprises to increase the promotion and application of products, independent innovation of new products successfully marketed and sold, according to the standard of 100,000 yuan per product to give a one-time incentive, the same year, each enterprise can get a total of up to 500,000 yuan of incentives. (Responsible units: Municipal Industry and Information Technology Bureau, Municipal Health Insurance Bureau, Municipal Market Supervision Bureau, Municipal Health Commission)

Three, to promote the development of industrial clustering scale

(ix) support the construction of key projects. For new investment in fixed assets (excluding land investment) actual investment of 50 million yuan (including) or more of biomedicine and major industrial projects in health, after completion and acceptance, according to the actual investment amount of 10% of the one-time incentive, a single project can be rewarded up to 10 million yuan. (Responsible units: Municipal Bureau of Industry and Information Technology, Municipal Development and Reform Commission, Municipal Investment Promotion Bureau, Municipal Health and Wellness Commission)

For projects newly approved as state-level smart health care enterprises and smart health care demonstration bases, a one-time subsidy will be given according to 10% of the project's total investment (excluding the land cost) after the completion and acceptance of the project, with a maximum subsidy of 10 million yuan for a single project. A one-time reward of 500,000 yuan will be given to enterprises (units) newly approved as national-level intelligent healthy aging demonstration. (Responsible units: Municipal Bureau of Industry and Information Technology, Municipal Bureau of Civil Affairs, Municipal Health Commission)

(j) Support for large-scale cultivation of Chinese medicinal herbs. Relying on the city's rich Chinese herbal resources, actively develop and expand large-scale planting of Chinese herbal medicines, and increase the protection of the registration of geographical indications of authentic Chinese herbal medicines. The new planting area of 500 acres (including) or more Taoist medicinal herbs planting base of the construction of the main unit, according to 500 yuan / mu to give a one-time incentive, the maximum award of 1 million yuan. To obtain the national and provincial Taoist medicinal herbs seed breeding and ecological planting base units to give 500,000 yuan, 300,000 yuan of one-time incentives. (Responsible units: Municipal Bureau of Industry and Information Technology, Municipal Bureau of Agriculture and Rural Development, Municipal Health Commission, Municipal Market Supervision Bureau)

(xi) Accelerate the development of industrial agglomeration. Vigorously carry out the construction of the industrial chain supply chain ecosystem, support the main enterprises of the biomedical chain to build pharmaceutical key raw materials, packaging materials, equipment and equipment, such as supporting parks, the formation of the chain of enterprises to share the value of each other to promote mutual advancement of stable supporting consortium. Strengthen the business investment, international investment, precision investment policy support, targeting the world's top 500, domestic and foreign listed biomedical enterprises and China's top 100 companies in the pharmaceutical industry, to increase investment. Actively promote the cultivation of industrial clusters, and strive to create provincial and national biomedical (big health) industry clusters. (Responsible units: Municipal Bureau of Industry and Information Technology, Municipal Development and Reform Commission, Municipal Investment Promotion Bureau, Municipal Health Commission)

Four, improve the construction of the service system

(XII) to enhance the audit and validation of service capacity. Enhance the ability of drug and medical device registration services, the implementation of the whole process of tracking services for major innovative products, from policy advice, communication and coordination, and other aspects of the provision of support. Enhance the capacity of inspection and testing organizations to strengthen the technical support for the development of the biomedical industry. Support the development of third-party product registration, GMP compliance consulting, quality system certification organizations to better serve the biomedical industry. (Responsible units: Municipal Market Supervision Bureau, Municipal Agriculture and Rural Affairs Bureau, Municipal Industry and Information Technology Bureau)

(xiii) Enhancement of traditional Chinese medicine service capacity. For the introduction of national medical masters, national famous Chinese medicine practitioners (practicing medicine in Jinan and with apprentices for more than 2 months a year) of medical rehabilitation institutions, were given 500,000 yuan, 300,000 yuan one-time incentives; for the new national and provincial Chinese medicine scientific research project funding, respectively, according to the higher level of funding of 30%, 20% of the one-time incentives; for the recognized "brand of Chinese medicine hall (Chinese medicine hall)", 100,000 yuan of incentives. ", a one-time award of 100,000 yuan; for the new evaluation of national, provincial and municipal Chinese medicine advantages and characteristics of the education and training base of medical institutions, were given 300,000 yuan, 200,000 yuan, 100,000 yuan one-time award. (Responsible units: Municipal Industry and Information Technology Bureau, Municipal Health Commission)

(xiv) Enhancement of R & D outsourcing service capacity. Accelerate the cultivation and introduction of contract R&D organizations (CROs), contract outsourcing production organizations (CMOs), contract customized R&D and production organizations (CDMOs), experimental animal service platforms, and clinical transformation service platforms for advanced medical technologies. Increase the government's efforts to purchase services and support third-party participation in industrial development services. (Responsible units: Municipal Bureau of Industry and Information Technology, Municipal Bureau of Science and Technology, Municipal Health Commission)

V. Guarantee Measures

(XV) Strengthening Organizational Leadership. Give full play to the role of the city's leading group for promoting the development of biomedicine and major health industries, coordinate the city's work on the development of biomedicine and major health industries, and coordinate the resolution of major issues and problems encountered in the advancement of work. The office of the leading group should establish and improve the supervision and assessment, regular meetings and other mechanisms to promote the implementation of the work in detail and achieve results on the ground. Responsible units in accordance with the division of responsibilities to do a good job of annual policy funding budget, policy implementation and other work. (Responsible units: the city to promote the development of biomedicine and health industry leading group member units)

(p) Strengthen talent support. The company insists on recruiting and cultivating talents, and further strengthens the cultivation and reserve of innovative talents. The city's talent service support policies (30), Jinan talent development environment policies (30) and other related policies have been utilized to attract more biomedical and big health industry talents to develop in Jinan. The city has the advantage of abundant scientific and educational resources, and supports enterprises and institutions in Jinan to adopt the modes of school-enterprise cooperation, industry-teaching fusion, and order cultivation to cultivate high-level skilled personnel and composite skilled personnel. Encourage enterprises to establish academicians, postdoctoral workstations, the introduction of domestic and foreign top talent with technology, team to the city to implement biomedicine and health industrialization projects, to give key support. (Responsible units: Municipal Party Committee Organization Department, Municipal Human Resources and Social Security Bureau)

(xvii) Coordinate financial support. Promote the high-quality development of biomedicine and big health industry funds into the city, district-level financial funds co-ordination arrangements. Make full use of the city's new and old kinetic energy conversion fund to actively support product research and development in the field of biomedicine and big health, the construction of key projects, as well as medical services, smart health care, intelligent community health care center and other projects, to equity investment, market-oriented equity participation and other ways to invest in and facilitate the landing of key innovative projects. Provide key support to other major matters determined by the municipal party committee and municipal government to promote the development of biomedicine and big health industry. (Responsible units: Municipal Bureau of Finance, Municipal Bureau of Industry and Information Technology)

These policies and measures are applicable to biomedical and big health enterprises or organizations with independent legal personality and independent accounting within the scope of registration, tax collection and management and statistical relations in the city. Biomedicine and big health enterprises or organizations are those engaged in research and development, production and service-related work in the fields of pharmaceuticals (including veterinary drugs), medical devices, genes and cells, special medical foods, biomedical engineering, biotechnology, medical aesthetics and anti-ageing, and health services in the field of biomedicine and big health industry. The subsidy funds in this policy measure will be shared by the city and the district and county where the enterprise (organization) is located in the ratio of 1:1, and similar policies will be implemented in accordance with the principle of "no duplication in terms of height". Responsible units listed in the first for the implementation of the lead organization units, according to the unified deployment of the declaration of the implementation of the rules, the implementation of the policy involves safety production, green development, credit management and other issues, in accordance with the relevant provisions of the implementation. According to the annual funding budget arrangement and the project declaration, the implementation of competitive evaluation of the project.

These policies and measures shall come into force on November 10, 2022, and shall be valid until November 9, 2025. Circular of the People's Government of Jinan Municipality on the Issuance of Several Policies for Promoting the Development of Biomedicine and Great Health Industry in Jinan City (Jinan Zheng Zi)