In order to deeply implement the State Council's "Several Opinions on Promoting the High-quality Development of National High-tech Industrial Development Zones" (Guofa [2020] No. 7), comprehensively implement the requirements of Qingdao Municipality to accelerate the three-year action related to the revitalization and development of the real economy, accelerate the cultivation of biopharmaceuticals and medical devices industry clusters featuring recreation and health care, and to create an internationally influential and domestically competitive "China Kang Valley", combined with the Qingdao City, "on supporting the high-quality development of biomedical industry a number of policies and measures" (Qingdao Government Office [2020] No. 6) (hereinafter referred to as "Qingdao Biomedical Industry Policy") and the actual work of high-tech zones, the development of this policy.
First, the scope of application
This policy applies to the industrial and commercial registration, tax collection and management relations and statistical relations in the high-tech zone in the northern part of the main park Jiaozhou Bay (hereinafter referred to as the High-tech Zone), the legal compliance business, have a sound financial system, with independent legal personality, the implementation of independent accounting, engaged in the medical and pharmaceutical industry, related to research and development, production, sales and service of the enterprise and institutions.
Second, the policy measures
(a) Encourage innovative product development
Article 1 Encouragement of medical device research and development
For clinical trials in the country and the transformation of medical devices in our region, in the enjoyment of the "Qingdao Biomedical Industry Policy" on the basis of the High-tech Zone to give 1:1.5 supporting funding. Accordingly, to obtain the clinical record certificate, into the clinical trial of the second class, three types of medical devices, urban areas at both levels according to the actual investment of 50% of the R & D costs were given a maximum of 2.5 million yuan, 7.5 million yuan of funding for a single enterprise urban areas at both levels of the maximum funding of up to 15 million yuan per year. To obtain the second and third class medical device registration certificate products (excluding the second class diagnostic reagents and equipment parts), the city two levels according to the actual investment in R & D costs of 50% were given a maximum of not more than 5 million yuan, 25 million yuan of funding, a single enterprise urban two-level maximum annual funding of not more than 25 million yuan.
The registration fee for Class II and Class III medical device products will be subsidized according to 100% of the first registration fee, and the maximum annual subsidy for a single enterprise will not exceed 500,000 RMB. For enterprises that have obtained registration certificates for innovative medical devices, on the basis of the above funding subsidies, a single Class II product will be rewarded with an additional 500,000 yuan, and a single Class III product will be rewarded with an additional 1.5 million yuan.
Article 2 Encouragement of new drug research and development
For clinical trials in the country and the transformation of new drugs in our region, in the enjoyment of the "Qingdao Biomedical Industry Policy" on the basis of the High-tech Zone to give 1:1 supporting funding. Accordingly, the chemical drug innovation drug (former Class 1 chemical drugs), biologics innovation drug (former Class 1 biologics), Chinese medicine innovation drug and natural medicine (former Class 1 traditional Chinese medicine), complete preclinical research and obtain the clinical acceptance number or default clinical, the urban areas of the two levels of up to 2 million yuan per item of financial assistance; other new drugs urban areas of up to 1 million yuan per item of financial assistance. For innovative chemical drugs, innovative biologics, innovative Chinese medicines and natural medicines, the completion of Phase I, Phase II and Phase III clinical trial studies, the maximum funding of up to 6 million yuan, 12 million yuan and 40 million yuan will be given at the municipal level according to 40% of the actual investment in research and development costs, and the maximum funding for a single enterprise will be up to 100 million yuan per year at the municipal level. Improved new drugs of chemical drugs (former Class 2 chemical drugs), improved new drugs of biological products, listed biological products (former Class 2-8 biological products), improved new drugs of traditional Chinese medicines, ancient classic Chinese medicine compound preparations, the same name and the same formula of natural medicine (former Class 2-8 traditional Chinese medicines and natural medicines), to complete the phase Ⅰ, Ⅱ, Ⅲ clinical trial research, the urban and rural areas at the two levels according to the actual investment in the R & D costs of 40% were given a maximum of not more than 4 million yuan, 8 million yuan, 40 million yuan, 40 million yuan, a single enterprise at the two levels of funding up to more than 100 million yuan a year. To give a maximum of 4 million yuan, 8 million yuan, 16 million yuan, a single enterprise at the municipal level of up to 40 million yuan per year. For the generic drugs (the original 3-4 types of chemical drugs) that have obtained the approval of drug registration, the maximum funding of 10 million yuan will be given at the two levels of urban areas according to 40% of the actual investment in R & D expenses, and the maximum annual funding of 30 million yuan will be given at the two levels of urban areas for a single enterprise. To obtain a certificate of registration of 1-3 types of new veterinary drugs, urban areas at both levels according to the actual input of 40% of the R & D costs to give a maximum of 10 million yuan, a single enterprise urban areas at both levels of the maximum funding of up to 20 million yuan per year.
Article 3 Encourage the development of traditional Chinese medicine and specialty food
To obtain the approval of the classic Chinese medicine formula compound preparation for drug registration, in the enjoyment of "Qingdao Biomedicine Industry Policy" on the basis of the High-tech Zone to give 1:1 supporting funding. Accordingly, the urban and rural areas will be given a maximum of 2 million yuan of funding for each item. To obtain the certificate of registration of special medical use formula, in order to enjoy the "Qingdao Biomedical Industry Policy" on the basis of the high-tech zone to give 1:1 matching funds. Accordingly, the urban areas at both levels to give a maximum of 2 million yuan of funding for each item, a single enterprise urban areas at both levels of funding up to 6 million yuan per year.
(B) to encourage the industrialization of innovation results
Article IV support for the industrialization of medical devices
To obtain the certificate of registration of Class II and Class III medical devices and the implementation of industrial projects in our region, in the enjoyment of "Qingdao Biomedical Industry Policy" on the basis of the High-tech Zone to give 1:1 matching funds. Accordingly, fixed assets (excluding land costs, the same below) actual investment of more than 50 million yuan, less than 100 million yuan, the urban areas at both levels according to the actual investment amount of 20% of the funding, a single enterprise urban areas at both levels up to 20 million yuan.
The actual investment in fixed assets of more than 10 million yuan, less than 50 million yuan, the high-tech zone according to the actual investment amount of 8% of the grant. The actual investment of more than 100 million yuan to implement the "one to discuss".
Article V support for the industrialization of drugs
To obtain drug registration approvals (including APIs, innovative excipients) and the implementation of the industrialization of the project in our region, in order to enjoy the "Qingdao Biomedical Industry Policy" on the basis of the High-tech Zone to give 1:1 supporting funding. Accordingly, the fixed assets (excluding land costs, the same below) actual investment of more than 100 million yuan, 500 million yuan or less, the urban areas of the two levels of the actual investment amount of 20% of the grant, a single enterprise urban areas of the two levels of the maximum not more than 40 million yuan.
The actual investment in fixed assets of more than 20 million yuan, less than 100 million yuan, the high-tech zone according to the actual investment amount of 8% of the grant. Actual investment of more than 500 million yuan of the implementation of the "one to discuss".
Article 6 Promote enterprises to explore the market
The winning national drug centralized volume purchasing and procurement amount of more than 100 million varieties, in the enjoyment of "Qingdao Biomedical Industry Policy" on the basis of the Hi-tech Zone to give 1:1 supporting funding. Accordingly, the urban areas at both levels to give each variety of up to 6 million yuan reward; large high-end medical equipment, in the enjoyment of "Qingdao Biomedical Industry Policy" on the basis of the high-tech zone to give 1:1 supporting funding. Accordingly, the urban areas at both levels in accordance with not more than the product put into production year the first sales price of 60% of the standard to give incentives, urban areas at both levels up to 20 million yuan.
Encourage high-tech zone medical and pharmaceutical enterprises product varieties into the national essential drugs directory, the national basic medical insurance drug directory and the national, provincial and municipal centralized purchasing directory. For new entries into the "national basic medical insurance, workers' compensation insurance and maternity insurance drug catalog" of the exclusive varieties, the high-tech zone to give a one-time bonus of 200,000 yuan for each variety.
The new U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), the World Health Organization (WHO) and other institutions to obtain the qualification of the overseas listing of pharmaceuticals (including APIs) and medical devices, in the enjoyment of "Qingdao Biomedicine Industry Policy" based on the Hi-tech Zone to give 1:1 matching funding. Accordingly, the urban areas at both levels to give a maximum of 2 million yuan of funding for each product, a single enterprise urban areas at both levels up to a maximum of 10 million yuan.
(C) to promote the development of medical and pharmaceutical industry agglomeration
Article VII Comprehensive Contribution Reward
The new introduction of enterprises, according to the scale of production and marketing of enterprises, economic contribution, technological progress, industry driven by a certain number of years after the agreement can be given by the agreement, the amount of the comprehensive contribution of the incentive, general project incentives for the award period in principle does not exceed 5 years, the award period of the major project incentives for the award period in principle does not exceed 10 years. No more than 10 years in principle.
Article VIII support enterprises to grow stronger
In the high-tech zone registered independent legal person and the medical and pharmaceutical industry related to the field of enterprises, the first time the annual operating income reached 50 million yuan, 100 million yuan, 300 million yuan, in accordance with the principle of making up for the difference in the promotion of 500,000 yuan, 1 million yuan, 1.3 million yuan of one-time incentives were given to the manufacturing industry to give the full amount of incentives, for-profit service enterprises, in principle, in accordance with 50% of the total amount of incentives. In principle, the service industry enterprises will be rewarded in accordance with the proportion of 50%.
Encourage high-tech zone contract research and development organizations (CRO), contract outsourcing production organizations (CMO), contract custom R & D and production organizations (CDMO) and other institutions to expand the R & D and production business, for the first time in the annual operating income exceeded 30 million yuan of the organization, a one-time 1 million yuan reward.
For drug or medical device listed license holders entrusted high-tech zone enterprises to produce their holdings of pharmaceutical products, and sales tax settlement in the high-tech zone, the high-tech zone enterprises to undertake the task of commissioned production, in the enjoyment of the "Qingdao Biomedical Industry Policy" on the basis of the high-tech zone to give 1:1 supporting funding. Accordingly, the urban areas at both levels according to the variety of the previous year's new sales revenue of 6% of the award, the urban areas at both levels up to a maximum of 10 million yuan.
Article IX vigorously introduce industry leading enterprises
Vigorously introduce the world's top 500 medical and pharmaceutical enterprises, China's top 100 enterprises in the pharmaceutical industry (according to the ranking of the main business income) or domestic and foreign listed medical and pharmaceutical enterprises. In the high-tech zone to set up headquarters or regional headquarters, continuous operation for more than 1 year (including), and in the high-tech zone statistical accounting annual output value scale (or sales revenue) of not less than 500 million yuan (including), in accordance with the fixed assets (excluding land costs, the same below) 20% of the actual investment in the funding, the single project output value scale (or sales revenue) 500 million yuan (including) to 1 billion yuan of the funding of the maximum of not more than 10 million yuan, the single project output value scale (or sales revenue) 500 million yuan (including) to 1 billion yuan of the funding. The maximum subsidy for a single project with an output scale (or sales revenue) of 1 billion yuan (inclusive) to 1.5 billion yuan shall not exceed 20 million yuan, and the maximum subsidy for a single project with an output scale (or sales revenue) of more than 1.5 billion yuan (inclusive) shall not exceed 30 million yuan. For particularly significant projects, in Qingdao City, on the basis of funding, to give 1:1 supporting funding.
(D) Improve the environment for the development of medical and pharmaceutical industry
Article 10 Promote the construction of service platforms
For the construction of pharmaceutical contract research and development organizations (CRO), pharmaceutical contract outsourcing production organizations (CMO), pharmaceutical contract custom R & D production organizations (CDMO) and other industrial application of basic platforms, as well as clinical research and application of medical data center, testing and detection center, translational medicine center and other industrial public services Translational Medicine Center and other industrial public service platforms, in the enjoyment of "Qingdao Biomedical Industry Policy" on the basis of the high-tech zone to give 1:1 supporting funding. Accordingly, the urban and rural areas in accordance with the actual investment in fixed assets (excluding land costs) 40% of the grant, the maximum urban and rural areas not more than 40 million yuan. The shortage of urgently needed, strategic importance of the major industrial science and technology innovation platform, can be "a one-off" to give up to 100 million yuan of construction and operation support.
Registered in the high-tech zone of the medical and pharmaceutical industry public service platform, in accordance with its medical and pharmaceutical industry in Qingdao City, related enterprises (and the organization does not have an investment relationship) of the annual contract of the actual amount of services to be funded, the maximum of not more than 5 million yuan; enterprises in the region to use the recognized public service platform in the region (and the organization does not have an investment relationship) and other research and development service institutions to carry out technical services, the commissioning party by the actual amount of the annual transaction, the commissioning party by the amount of the annual transaction, the commissioning party by the amount of the actual amount of the actual transaction. The commissioning party will be subsidized at 5% of the actual annual transaction amount, with the maximum annual subsidy for a single enterprise not exceeding 5 million yuan.
Article 11 Encouragement to carry out the relevant qualification certification
For enterprises to obtain the relevant qualification, in the enjoyment of the "Qingdao Biomedical Industry Policy" on the basis of the High-tech Zone to give 1:1 supporting funding. Accordingly, to obtain the national drug non-clinical research quality management standard (GLP) certification of enterprises (institutions), the urban areas at both levels to give up to 6 million yuan of funding; to obtain the national drug clinical trial quality management standard (GCP) certification of enterprises (institutions), the urban areas at both levels to give up to 10 million yuan of funding; has obtained the GCP qualification of the enterprises (institutions), each new GCP certification of 1 professional Disciplines, the urban areas at both levels to give 1 million yuan in funding, each unit of the urban areas at both levels of the cumulative funding of up to 10 million yuan.
Article 12 Support for insurance escort
Actively encourage the relevant insurance institutions to provide medical devices and biomedical human clinical trial liability insurance, biomedical product liability insurance and other customized comprehensive insurance products, qualified medical and pharmaceutical institutions and enterprises, according to their actual premiums paid by 20% to be funded, a single policy up to a maximum of 500,000 yuan, a single enterprise annual funding up to 2 million yuan. The maximum funding does not exceed 2 million yuan.
Article 13 Increase Talent Reward and Cultivation
Encouragement Award for Executive Team. For newly introduced enterprises that are in line with the direction of the medical and pharmaceutical industry and whose annual main business revenue reaches a certain scale, the senior management personnel will be rewarded for three consecutive years. Among them, the annual main business income of 50 million yuan (including) or more enterprises, according to the standard of 20,000 yuan per person per year; annual main business income of 100 million yuan (including) or more enterprises, according to the standard of 30,000 yuan per person per year to give awards; annual main business income of 500 million yuan (including) or more enterprises, according to the standard of 50,000 yuan per person per year to give awards. The incentive funds will be allocated to the enterprise's account. (The senior management personnel referred to in this policy are required to pay social insurance in the Hi-tech Zone, the scope of which includes the chairman, vice chairman, executive director, general manager, deputy general manager, chief supervisor, chief economist, chief accountant, or equivalent level positions, the total number of which is no more than 10 per enterprise and no more than 30% of the total number of enterprises.)
Encourage talent training. Encourage domestic and foreign specialized training institutions to register in our region to carry out medical and pharmaceutical professionals training. Training institutions in the region, the annual training of professionals and enterprises in the region to sign a labor contract for one year and pay social security in our region for one year, according to the standard of 1,000 yuan per person to be rewarded, the maximum amount of up to 1 million yuan per year per institution, for three consecutive years.
Article 14 Rental Subsidies
Newly introduced enterprises in the field of medical and pharmaceutical companies applying for the rental of high-tech zone within the scope of the R & D, office space or production plant, by agreement can be given rental subsidies. Subsidy standards are:
R & D, office space rental area of 1,000 square meters (including) below, the annual subsidy of up to 450 yuan per square meter; more than 1,000 square meters of the part of the annual subsidy of up to 270 yuan per square meter.
Production plant rental area of 2,000 square meters (including) below, the annual subsidy per square meter does not exceed 150 yuan; more than 2,000 square meters of the part of the annual subsidy per square meter does not exceed 90 yuan.
In principle, the rental subsidy is implemented as "pay first and make up later", and can be subsidized for five consecutive years. From the first year to the fifth year, the subsidy rate is 100%, 80%, 60%, 40% and 20%. Under the circumstance that the total amount of rental subsidy remains unchanged, the subsidy ratio can be adjusted according to the actual situation of the enterprise, and the maximum length of continuous subsidy shall not exceed eight years. The rental subsidy will be honored according to the relevant assessment of the enterprise. In principle, the same enterprise can only enjoy the rent subsidy policy once.
Article 15 Subsidies for House Purchase
Newly introduced enterprises in the field of medical and pharmaceutical products can be granted subsidies for the purchase of R&D and office buildings within the Hi-tech Zone for their own use as agreed upon. The subsidy standards are:
For the purchase of R&D and office buildings built on industrial land, a maximum subsidy of 2 million RMB will be given according to 5% of the purchase price; for the purchase of R&D and office buildings built on commercial land, a maximum subsidy of 5 million RMB will be given according to 10% of the purchase price. Subsidies are allocated in five years, the first year to the fifth year of the subsidy rate of 15%, 20%, 20%, 20%, 20%, 25%, and according to the relevant assessment of the enterprise to be honored.
Article 16 Encouragement of organizing and participating in major exhibitions
Encouragement of holding major international and domestic conferences (including exhibitions, summits, forums, academic exchanges, etc.), exhibitions and other activities of the medical and pharmaceutical industry in high-tech zones, and the major international and domestic activities held, and after evaluation, give the activity organizer (or organizer) a maximum of 2 million yuan of funding support for the activity, and the particularly significant activities may be The "one thing at a time".
Exhibition incentives. Medical and pharmaceutical enterprises and industrial parks in the region to participate in the China International Medical Device Expo, China International Well-being Expo and China International Rehabilitation Expo, China Medical Equipment Conference and other international and domestic large-scale integrated or professional exhibitions to give exhibition support, enterprises and industrial parks need to be at least 15 working days before the start of the exhibition to apply for the approval of the audit, can be based on the actual booth fee, 50% of the cost of the special exhibition fee to give the incentive. The maximum amount of incentive per enterprise per exhibition is 100,000 RMB, and the maximum cumulative amount per year is not more than 500,000 RMB.
III. By-laws
Article 17 Newly introduced enterprises (projects) in this policy refer to those enterprises (projects) that have signed investment project agreements with the management committee as required during the validity period of the implementation of this policy. In principle, the total amount of cumulative subsidies obtained by an enterprise based on Articles 7, 14 and 15 of this policy shall not exceed the cumulative major economic contribution of the district realized by the enterprise during the policy period. Tax-related expenditures for obtaining the incentives shall be borne by the enterprise, organization or individual. From the date of enjoying the policy, the enterprise needs to promise not to move out of the Hi-tech Zone, not to change its tax obligations in the Hi-tech Zone, and not to reduce its registered capital within 15 years. If the above commitments are violated, Hi-Tech Zone has the right to recover all the district-level support funds obtained under this policy.
This policy in accordance with the municipal incentive funds to give supporting support, must first apply for municipal incentives, municipal incentives to be approved, the enterprise does not need to reapply, the district in accordance with the municipal incentives to support the matching ratio of funds to be rewarded directly.
This policy in the twelfth premium funding incentives from the management committee of the financial special expenses, the thirteenth talent training incentives from the management committee of the special expenses of talent development, the rest of the required funds from the management committee of the special expenses of industrial development.
Article 18 The declaring enterprise shall report the relevant materials accordingly, and be responsible for the authenticity and accuracy of the declared data and information, and bear the corresponding legal responsibility. For falsehoods and fraudulent means of obtaining incentive funds, once found, will withdraw its corresponding qualifications, and recover the allocated funds according to law.
Article 19 of the high operating income, economic contribution, high technology content, good market prospects, industry-driven projects, agreed by the Management Committee, can be "one case at a time" to focus on support.
Article 20 This policy is interpreted by the Qingdao Hi-tech Zone Management Committee, effective for three years from the date of issuance; within the validity period of this policy, such as municipal policy adjustments, this policy is adjusted accordingly.
Hi-tech Zone has been issued in the validity of the same type of industrial policy, in accordance with the "high, not repeated" principle of implementation. In the process of implementation, and national laws and regulations and relevant provincial and municipal provisions of the conflict, the national laws and regulations and relevant provincial and municipal provisions shall prevail.
