Chapter I General Provisions
Article 1 In order to deeply implement the State Council's "Several Opinions on Promoting High-quality Development of National High-tech Industrial Development Zones" (Guofa [2020] No. 7), and comprehensively implement the requirements of Qingdao Municipality to speed up the revitalization and development of the real economy of the three-year action related to the deployment of the requirements of the city of Qingdao to foster the development of the biomedicine and medical device industry clusters featured by the health care To create a "China Kangwan" with international influence and domestic competitiveness, the implementation rules are formulated according to the "Qingdao High-Tech Zone on revitalization of the real economy to promote the development of medical and pharmaceutical industry cluster" (Qingdao High-Tech Management [2022] No. 14). The "Qingdao Biomedical Industry Policies" or Qingdao City Policies referred to in the Rules refer to Qingdao's "Several Policies and Measures on Supporting the High-Quality Development of the Biomedical Industry" (Qingzhengbanfa [2020] No. 6).
Article 2 These rules apply to the enterprises whose place of business registration, tax collection and management relationship, and statistical relationship (only for the enterprises that are included in the statistics) are within the scope of the main park in the northern part of Jiaozhou Bay of the Hi-tech Zone (hereinafter referred to as the "Hi-tech Zone"), and which are legally operating in a lawful and compliant manner, with sound financial systems, independent legal personality, and independent accounting, and are engaged in research, development, production, and sales related to the medical and pharmaceutical industries. Pharmaceutical industry-related research and development, production, sales and service enterprises and organizations.
Article 3 The newly introduced enterprises (projects) in this rule refer to those enterprises and institutions that have signed investment agreements with Qingdao High-tech Industrial Development Zone Management Committee (hereinafter referred to as "Hi-tech Industrial Development Zone Management Committee") within the scope of the "Qingdao High-tech Industrial Development Zone Policy on Revitalizing the Real Economy and Promoting the Development of Medical and Pharmaceutical Industries" (Qingdao High-tech Management 〔2022〕 No. 14) after the release and implementation of the policy. Enterprises (projects) that have signed investment agreements with Qingdao Hi-tech Industrial Development Zone Management Committee (hereinafter referred to as "Hi-tech Zone Management Committee") within the validity period of the policy.
Article 4 These rules follow the principles of compliance with laws and regulations, fairness and impartiality, simplicity of operation and focus on effectiveness.
Chapter II Declaration Matters
Article 5 Encouragement of Medical Device R&D
5-1 For the medical devices that carry out clinical trials in China and transformed in our region, on the basis of enjoying the "Qingdao Biomedical Industry Policy", Hi-tech Zone will give 1:1.5 matching grants. Accordingly, to obtain the clinical record certificate, into the clinical trial of Class II, Class III 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 certificate of registration of Class II and Class III medical devices products (excluding Class II diagnostic reagents and equipment parts), the urban areas at the two levels according to the actual investment in 50% of the R & D costs were given a maximum of not more than 5 million yuan, 25 million yuan, a single enterprise in the urban areas at the two levels of the maximum funding of up to 25 million yuan per year.
(a) reporting conditions
1. The reporting body in line with the relevant provisions of Article 2 of these rules;
2. The reporting body has been awarded the corresponding annual "Qingdao Biomedical Industry Policy" to support the medical device R & D subsidies.
(2) Reporting materials
1. Qingdao Hi-tech Industrial Development Special Funds Application Form;
2. Declaration of the unit's responsibility commitment;
3. Declaration of the unit's credit certificate (up to the date of the project within two years of the date of declaration).
(3) Declaration time
Declaration within one year from the date of fulfillment of the declaration conditions during the policy period.
5-2 The registration fees for Class II and Class III medical device products are subsidized in accordance with 100% of the first registration fee, with the maximum annual subsidy for a single enterprise not exceeding 500,000 yuan. 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.
(I) reporting conditions
1. The reporting subject meets the relevant provisions of Article 2 of these Rules;
2. The reporting subject obtains the Class II and Class III Medical Device Registration Certificate within the validity period of the policy.
(2) Declaration materials
1. Application form for special funds for industrial development of Qingdao Hi-Tech Zone;
2. Commitment of responsibility of the declaring unit;
3. Business license of the declaring body;
4. Certificate of Registration of Medical Devices, and proof of innovative medical devices;
5. Invoice of registration fee;
6. 6. Credit certificate of the declaring organization (within two years as of the date of project declaration);
7. Other related materials.
(3) Declaration time
The following year to declare the previous year's award.
Article VI Encouragement of new drug research and development
To carry out 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 a 1:1 matching grants. 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 classical 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, respectively, according to the 40% of the actual investment in R & D expenses 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 costs, and the maximum funding of 30 million yuan per year for a single enterprise will be given at the two levels of urban areas. To obtain a certificate of registration of 1-3 types of new veterinary drugs, urban areas at both levels according to 40% of the actual investment in R & D costs up to 10 million yuan, a single enterprise urban areas at both levels up to 20 million yuan per year.
(a) reporting conditions
1. the reporting body in line with the relevant provisions of Article 2 of these rules;
2. drugs in the domestic clinical trials, and ultimately industrialized in our region;
3. the reporting body has been awarded the corresponding annual "Qingdao Biomedical Industry Policy" to encourage innovation of new medicines award subsidies.
(2) Declaration materials
1. Application form for special funds for industrial development of Qingdao Hi-Tech Zone;
2. Commitment letter of responsibility of the declaring entity;
3. Credit certificate of the declaring entity (within two years as of the date of the project declaration).
(3) Filing Time
Filing within one year from the date of fulfillment of the filing conditions during the policy period.
Article VII Encourage the development of traditional Chinese medicine and special medical food
To obtain the approval of drug registration for the compound preparation of the classic Chinese medicine prescription, in the enjoyment of the "Qingdao Biomedicine Industry Policy" based on the high-tech zones to give 1:1 matching 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 supporting funding. 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 up to 6 million yuan of funding per year.
(a) reporting conditions
1. The reporting body in line with the relevant provisions of Article 2 of these rules;
2. The reporting body has been awarded the corresponding annual "Qingdao Biomedical Industry Policy" to support the development of traditional Chinese medicine and special medical food awards and subsidies.
(2) Declaration materials
1. Application form for special funds for industrial development of Qingdao Hi-tech Zone;
2. Commitment of responsibility of the declaring entity;
3. Credit certificate of the declaring entity (within two years as of the date of the project declaration).
(3) Filing Time
Filing within one year from the date of fulfillment of the filing conditions during the policy period.
Article VIII Support for the Industrialization of Medical Devices
8-1 To obtain the certificate of registration of Class II and Class III medical devices and the implementation of industrialization projects 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, 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 of 20% of the amount of funding, a single enterprise urban areas at both levels up to 20 million yuan.
(a) the reporting conditions
1. the main body of the declaration in line with the relevant provisions of Article 2 of the Rules;
2. to obtain the registration certificate of Class II and Class III medical devices and the implementation of the industrialization in our region;
3. the main body of the declaration has been awarded the corresponding year of the "Qingdao Biomedicine Industry Policy" to support the industrialization of medical device R & D results of the award subsidies.
(2) Reporting materials
1. Qingdao Hi-tech Industrial Development Special Funds Application Form;
2. Reporting unit's responsibility commitment;
3. Reporting unit's credit certificate (within two years from the date of the project declaration).
(3) Reporting Time
Reporting within one year from the date of fulfillment of the reporting conditions during the policy period.
(D) Other Matters
1. Investment in fixed assets refers to the investment related to the production of medical devices that have obtained the certificate of registration within the validity period of the policy, including investment in production plants, production equipment, production auxiliary equipment, research and development and testing equipment. The investment subsidy for the production plant does not exceed 30% of the total subsidy amount.
8-2 For projects that have obtained the registration certificates of Class II and Class III medical devices and are implemented in our region for industrialization, the actual investment in fixed assets (excluding land cost) is more than 10 million yuan and less than 50 million yuan, and the Hi-tech Zone will give subsidies according to 8% of the actual investment. The actual investment of more than 100 million yuan to implement the "one to discuss".
(I) reporting conditions
1. the reporting body in line with the relevant provisions of Article 2 of the Rules;
2. the reporting body in the policy validity period to obtain the registration certificate of Class II and Class III medical devices and the implementation of the industrialization in our region;
3. actual investment in fixed assets of more than 10 million yuan, less than 50 million yuan in the policy validity period and the High and New Technology Zone Management Committee signed an investment agreement. High-tech zone management committee signed an investment agreement, at the time of reporting has been completed and accepted (land acquisition type projects) and put into production, to the first application in the statistics network reporting platform into the database approved data shall prevail.
(2) Reporting materials
1. Qingdao Hi-tech Industrial Development Special Funds Application Form;
2. Declaration of the unit's responsibility commitment;
3. Declare the subject of the business license;
4. Enterprises and the Hi-tech Industrial Development Zone Management Committee signed an investment agreement;
5. "Medical device registration certificate" "medical equipment production license" "medical device production product registration form Medical Device Manufacturing Product Registration Form;
6. Documents proving the completion of the matters committed by the enterprise in the agreement and the completion of the indicators linked to the subsidy;
7. Project completion and acceptance report (land-taking projects), and photographs of the site where the project is put into operation;
8. Documents proving the approval of the amount of investment in fixed assets;
9. Credit certificates of the declaring units (within two years as of the date of project declaration);
Within two years of the date of project declaration;
9. Within two years from the date of project declaration;
10. Other relevant materials.
(3) Reporting time
The following year to declare the previous year's award.
(D) Other matters
1. Investment in fixed assets refers to the policy validity period to obtain a registration certificate of medical device production-related investment, including production plant, production equipment, production of auxiliary equipment, research and development and testing equipment and other investments. The investment subsidy for the production plant does not exceed 30% of the total subsidy amount.
2. In principle, the fixed asset investment subsidies are allocated in annual installments, the first to the fifth year of the subsidy rate of no more than 15%, 20%, 20%, 20%, 20%, 25% of the total subsidy, respectively.
3. To obtain registration certificates of Class II and Class III medical devices and the implementation of industrialization projects in our region, the actual investment in fixed assets (excluding land costs) of more than 100 million yuan to implement the "one-issue".
Article IX support for the industrialization of drugs
9-1 To obtain drug registration approvals (including APIs, innovative excipients) and the implementation of industrialization projects 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, fixed assets (excluding land costs, the same below) actual investment of more than 100 million yuan, 500 million yuan or less, the urban areas at both levels according to the actual investment of 20% of the amount of funding, a single enterprise urban areas at both levels up to 40 million yuan.
(a) reporting conditions
1. The main body of the declaration in line with the relevant provisions of Article 2 of the Rules;
2. Access to drug registration approvals (including APIs, innovative excipients) and the implementation of the industrialization of the region;
3. The main body of the declaration has been awarded the corresponding year of the "Qingdao Biomedicine Industry Policy" to support the industrialization of pharmaceutical R & D results of the award subsidies.
(2) Reporting materials
1. Qingdao Hi-tech Industrial Development Special Funds Application Form;
2. Declaration of the unit's responsibility commitment;
3. Declaration of the unit's credit certificate (up to the date of the project within two years of the date of declaration).
(3) Declaration Time
Declaration within one year from the date of fulfillment of the declaration conditions during the policy period.
(D) Other Matters
1. Investment in fixed assets refers to the investment related to the production of medical devices that have obtained the certificate of registration within the validity period of the policy, including investment in production plants, production equipment, production auxiliary equipment, research and development and testing equipment. The investment subsidy for the production plant does not exceed 30% of the total subsidy amount.
9-2 For projects that have obtained drug registration approvals (including APIs and innovative excipients) and are implemented in our region for industrialization, with actual investment in fixed assets of more than 20 million yuan and less than 100 million yuan, the Hi-tech Zone will provide subsidies at 8% of the actual investment.
(I) reporting conditions
1. the subject of the declaration meets the relevant provisions of Article 2 of the Rules;
2. the subject of the declaration in the policy validity period to obtain drug registration approvals and the implementation of the industrialization of the zone;
3. actual investment in fixed assets of more than 20 million yuan, less than 100 million yuan in the policy validity of the signing of an investment agreement with the High and New Technology Zone Commission, the completion and acceptance of the declaration has been completed in the time of declaration. At the time of declaration has been completed and acceptance (land acquisition type projects) and put into production, to the first application in the statistical network reporting platform into the database approved data shall prevail.
(2) Reporting materials
1. Qingdao Hi-tech Industrial Development Special Funds Application Form;
2. Declaration of the unit's responsibility commitment;
3. Declare the main business license;
4. Enterprises and the Hi-tech Industrial Development Zone Management Committee signed an investment agreement;
5. "Drug registration approvals", "Certificate of Registration of New Veterinary Drugs";
6.
6. Documents proving the completion of the matters committed by the enterprises in the agreement and the completion of the targets linked to the subsidies;
7. Project completion and acceptance report (land acquisition projects), photos of the production site;
8. Documents proving the approval of the amount of investment in fixed assets;
9. Documents proving the platform for the registration of information on raw materials, medicinal auxiliaries and medicinal packages;
9. Documents proving that the registration information of API, medicinal excipients and medicinal packages has been made public;
10.
10. Credit certificate of the reporting unit (within two years as of the project reporting date);
11. Other relevant materials.
(3) Reporting time
The following year to declare the previous year's award.
(D) Other matters
1. Investment in fixed assets refers to the investment related to the production of drugs that have obtained registration approvals within the validity period of the policy, including investment in production plants, production equipment, production support equipment, research and development and testing equipment. The investment subsidy for the production plant shall not exceed 30% of the total subsidy amount.
2. In principle, the fixed asset investment subsidies are allocated in annual installments, with the subsidy ratio from the first to the fifth year not exceeding 15%, 20%, 20%, 20%, and 25% of the total amount of subsidies, respectively.
3. To obtain drug registration approvals (including APIs, innovative excipients) and the implementation of industrialization projects in our region, fixed assets (excluding land costs) actual investment of 500 million yuan or more of the implementation of the "one-issue".
The tenth article to promote enterprises to develop the market
10-1 for the winning national drug centralized volume purchasing and procurement amount of more than 100 million yuan of varieties, 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 and rural areas are given a maximum of 6 million yuan reward for each variety.
(a) the reporting conditions
1. The reporting body in line with the relevant provisions of Article 2 of these rules;
2. The reporting body has been awarded the corresponding year "Qingdao Biomedical Industry Policy" to support enterprises to participate in the national drug centralized volume purchasing awards and subsidies.
(2) Declaration materials
1. Application form for special funds for industrial development of Qingdao Hi-Tech Zone;
2. Commitment of responsibility of the declaring entity;
3. Credit certificate of the declaring entity (within two years as of the date of project declaration).
(3) Declaration time
Declared within one year from the date of meeting the declaration conditions during the policy period.
10-2 For large-scale high-end medical device equipment, on the basis of enjoying the "Qingdao Biomedical Industry Policy", the high-tech zone to give 1:1 supporting funding. Accordingly, the urban areas at both levels in accordance with the standard of not more than 60% of the first sales price of the product in the year of commissioning to give incentives to the urban areas at both levels up to 20 million yuan.
(a) reporting conditions
1. The reporting body in line with the relevant provisions of Article 2 of these rules;
2. The reporting body has been awarded the corresponding annual "Qingdao Biomedical Industry Policy" to support the production of large-scale high-end medical device equipment awards.
(2) Reporting materials
1. Qingdao Hi-tech Industrial Development Special Funds Application Form;
2. Declaration of the unit's responsibility commitment;
3. Declaration of the unit's credit certificate (up to the date of the project within two years of the date of declaration).
(3) Declaration time
Declared within one year from the date of meeting the declaration conditions during the policy period.
10-3 Encourage high-tech zone medical and pharmaceutical enterprises product varieties into the national essential drugs catalog, the national basic medical insurance drug catalog and the national, provincial and municipal centralized purchasing catalog. For the new entry 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.
(A) reporting conditions
1. The main body of the declaration in line with the relevant provisions of Article 2 of the Rules;
2. The policy validity period of the medical and pharmaceutical enterprises in the Hi-tech Zone products as an exclusive variety of the first time included in the "National Basic Medical Insurance, Workers' Compensation Insurance and Maternity Insurance Drug Catalog".
(2) Declaration materials
1. Application form for special funds for industrial development of Qingdao Hi-tech Zone;
2. Commitment letter of responsibility of the declaring unit;
3. Business license of the declaring body;
4. Relevant certificates of the products of medical and pharmaceutical enterprises in Hi-tech Zone as exclusive varieties;
5. Agreement on negotiated drugs of exclusive drugs with the State Bureau of Medical Security;
6. Exclusive drug negotiation drug agreement with the State Medical Security Bureau;
6. Credit certificate of the declaring unit (within two years from the date of project declaration);
7. Other relevant materials.
(C) reporting time
The following year to declare the previous year's award.
10-4 The new U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Japan's Pharmaceutical and Medical Devices Agency (PMDA), the World Health Organization (WHO) and other institutions to obtain the approval of the qualification of overseas marketing of pharmaceutical products (including APIs) and medical devices, in the enjoyment of the "Qingdao Biomedicine Industry Policy" based on the Hi-tech Zone to give a 1:1 matching funding. Accordingly, each product in the urban areas at both levels to give a maximum of 2 million yuan of funding, a single enterprise in the urban areas at both levels up to a maximum of 10 million yuan.
(a) reporting conditions
1. The reporting body in line with the relevant provisions of Article 2 of these rules;
2. The reporting body has been awarded the corresponding annual "Qingdao Biomedical Industry Policy" to support the adoption of international certification award.
(2) Declaration materials
1. Qingdao Hi-tech Industrial Development Special Funds Application Form;
2. Declaration of the unit's responsibility commitment;
3. Declaration of the unit's credit certificate (up to the date of the project within two years of the date of declaration).
(3) Declaration Time
Declared within one year from the date of fulfillment of the declaration conditions during the policy period.
Article XI Comprehensive Contribution Reward
The newly introduced enterprises, according to the scale of production and marketing, economic contribution, technological progress, industry driven, etc., by agreement can be given to a certain number of years, the amount of the comprehensive contribution of the incentive, the general project incentives for a period of time, in principle, not more than five years, the major project incentives for a period of time, in principle, not more than 10 years.
(A) reporting conditions
1. The main body of the declaration in line with the relevant provisions of Article 2 and 3 of these rules;
2. Major projects are the world's top 500 enterprises, China's top 100 pharmaceutical industry enterprises (ranked by the main business income) or domestic and foreign listed companies in the high-tech zone to invest in the construction of the medical and pharmaceutical projects, or total investment of more than 3 billion yuan in the medical and pharmaceutical projects.
(2) Reporting materials
1. Qingdao Hi-tech Zone Industrial Development Special Funds Application Form;
2. Declaration unit responsibility commitment;
3. Declaring subject business license;
4. Investment agreement signed by the enterprise and the management committee of Hi-tech Zone;
5. The enterprise's commitment to complete the matters in the agreement and the target completion materials linked to subsidies;
6. Proof of completion of targets;
6. Proof of tax payment of the enterprise in the previous year;
7. Proof of business income of the enterprise in the previous year, or enterprise income tax, value-added tax return, or financial audit report issued by an accounting firm;
8. Proof of credit of the declaring organization (within two years as of the date of declaration of the project);
9. Other related materials.
(3) Filing Time
The following year to declare the previous year's award.
Article XII Supporting Enterprises to Become Bigger and Stronger
12-1 For enterprises in the field of medical and pharmaceutical related industries registered as independent legal persons in the Hi-tech Zone and incorporated in the Unified System, the annual business revenue for the first time reaches RMB 50 million yuan, RMB 100 million yuan and RMB 300 million yuan, and a one-time award of RMB 500,000 yuan, RMB 1 million yuan and RMB 1.3 million yuan, respectively, in accordance with the principle of making up for the difference in promotion, and the manufacturing enterprises will be given a full award. Enterprises in the for-profit service industry will be rewarded in accordance with 50% in principle.
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 their R & D and production business, for the first time the annual operating income exceeded 30 million yuan of the organization, a one-time award of 1 million yuan.
(I) Reporting Conditions
1. The reporting body complies with the relevant provisions of Article 2 of the Rules;
2. The annual business revenue exceeds 30 million yuan (only for organizations such as CRO/CMO/CDMO), 50 million yuan, 100 million yuan, and 300 million yuan for the first time within the validity period of the policy;
3. In accordance with the classification of the industries of the national economy, the manufacturing industry enterprises and for-profit service enterprises are based on the industry categorization of the statistical department.
(2) Reporting materials
1. Qingdao Hi-tech Industrial Development Special Funds Application Form;
2. Letter of Commitment on the Responsibility of Reporting Units;
3. Business License of Reporting Subjects;
4. Proof of the business income of the enterprises for the previous year, or the tax returns of the enterprises for enterprise income tax and value-added tax, or financial audit reports issued by accounting firms;
5. Audit report;
5. CRO/CMO/CDMO and other organizations need to provide relevant service business documents, such as service contracts, invoices, etc.
6. Credit certificates of the declaring organization (within two years of the date of the project declaration);
7. Other relevant materials.
(C) declaration time
The following year to declare the previous year's award.
12-2 For pharmaceutical or medical device listed license holder entrusted high-tech zone enterprises to produce its holdings of pharmaceutical and 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 new sales revenue over the previous year, 6% of the award, the urban areas at both levels up to a maximum of 10 million yuan.
(A) reporting conditions
1. The reporting body in line with the relevant provisions of Article 2 of these rules;
2. The reporting body has been awarded the corresponding year "Qingdao Biomedical Industry Policy" to support the commissioning of the product production of the award.
(2) Reporting materials
1. Qingdao Hi-tech Industrial Development Special Funds Application Form;
2. Declaration of the unit's responsibility commitment;
3. Declaration of the unit's credit certificate (up to the date of the project within two years of the date of declaration).
(3) Declaration Time
Declared within one year from the date of fulfillment of the declaration conditions during the policy period.
Article 13: Vigorously Introducing Industry Leading Enterprises
Vigorously introducing the world's top 500 medical and pharmaceutical enterprises, China's top 100 enterprises in the pharmaceutical industry (ranked according to the main business revenue), 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), according to the fixed assets (excluding land costs, the same below) the actual investment of 20% to give financial support for a single project output value scale (or sales revenue) of 500 million yuan (including) to 1 billion yuan of the funding up to 10 million yuan, a single project output value scale (or sales revenue) of 100 million yuan (including) to the maximum funding, the maximum amount of 10 million yuan, the maximum amount of 10 million yuan. 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, on the basis of Qingdao City funding, 1:1 supporting funding.
(I) Reporting conditions
1. Within the validity period of the policy, Qingdao Hi-tech Zone registered and set up an independent legal personality of the headquarters or regional headquarters;
2. Declared by the main body recognized by the relevant departments as the headquarters or regional headquarters;
3. Within the validity period of the policy, declared by the main body of the continuous operation of more than one year (including), the declaration of the year of the previous year's annual statistical accounting The scale of output value (or sales revenue) is not less than 500 million yuan (inclusive);
4. Signing an investment agreement with the Hi-tech Zone Management Committee within the validity period of the policy, and the project has been completed and accepted at the time of filing (land-taking projects) and put into operation, subject to the data approved by the first application in the statistical network direct reporting platform database.
(2) declaration materials
1. Qingdao Hi-tech Industrial Development Special Funds Application Form;
2. Declaration of the unit's responsibility commitment;
3. Declare the subject of the business license;
4. Last year's Fortune released the list of the world's top 500 companies, last year's China Pharmaceutical Industry Information Center released the Chinese pharmaceutical industry 100 companies (ranked by the main business revenue), the top 100 enterprises (ranked by the main business revenue). The list of enterprises (ranked by main business revenue), or the relevant materials of enterprises listed on the domestic and international stock exchanges;
5. The investment agreement signed between the enterprise and the management committee of the hi-tech zone;
6. Proof of the completion of the matters promised by the enterprise and the completion of the indicators linked to subsidies in the agreement;
7. The project completion acceptance report (for the land type projects), and the photos of the site of the commissioning;
8. Approved documents proving the amount of investment in fixed assets;
9. Documents proving the business income of the enterprise in the previous year, or enterprise income tax, value-added tax returns, or financial audit reports issued by accounting firms;
10. List of headquartered enterprises recognized by the relevant municipal government departments;
11. Credit certificates of the declaring units (within two years from the date of the project);
12. Within two years from the date of declaration);
12. Other relevant materials.
(3) Declaration time
The following year to declare the previous year's award.
(D) Other matters
1. Investment in fixed assets refers to the investment related to the production of medical and pharmaceutical enterprises that have obtained the certificate of registration within the validity period of the policy, including investment in production plants, production equipment, production support equipment, research and development and testing equipment. The investment subsidy for the production plant shall not exceed 30% of the total subsidy amount.
2. In principle, the fixed asset investment subsidies are allocated in annual installments, with the subsidy percentage for the first to fifth years not exceeding 15%, 20%, 20%, 20% and 25% of the total subsidy amount, respectively.
Article 14 Promotion of Service Platform Construction
14-1 For the construction of pharmaceutical contract research and development organizations (CROs), pharmaceutical contract outsourcing production organizations (CMOs), pharmaceutical contract custom R&D and production organizations (CDMOs) and other industrial application infrastructure platforms, as well as medical big data clinical research application center, testing and inspection center, translational medicine center and other industrial public service platforms, in addition to enjoying the "Qingdao Biomedicine Industry Policy," the Hi-tech Zone will give 1:1 Matching Funding. Accordingly, the urban areas at both levels in accordance with the fixed assets (excluding land costs) 40% of the actual investment to give funding, urban areas at both levels up to a maximum of 40 million yuan.
(A) reporting conditions
1. The reporting body in line with the relevant provisions of Article 2 of these rules;
2. The reporting body has been awarded the corresponding annual "Qingdao Biomedical Industry Policy" to support the construction of industrial application of basic platforms and public service platforms to subsidize the construction of awards.
(2) Declaration materials
1. Application form for special funds for industrial development of Qingdao Hi-tech Zone;
2. Commitment letter of responsibility of the declaring entity;
3. Credit certificate of the declaring entity (within two years as of the date of project declaration).
(3) Declaration Time
Declaration within one year from the date of fulfillment of the declaration conditions during the policy period.
(IV) Other Matters
1. Investment in fixed assets includes investment in production plants, production equipment, production auxiliary equipment, R&D and testing equipment. The investment subsidy for the production plant shall not exceed 30% of the total subsidy amount.
2. The shortage of urgently needed, strategic significance of the major industrial science and technology innovation platform, can be "a case by case", in accordance with the law and regulations to give up to 100 million yuan of construction and operation support.
14-2 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 given 5% funding, up to a maximum of 5 million yuan; the region's enterprises to use the recognized public service platform in the region (and the organization does not have an investment relationship) and other R & D service institutions to carry out technical services, to the commissioning party according to the annual 5% of the actual transaction amount, and the maximum annual funding for a single enterprise shall not exceed 5 million yuan.
(I) Reporting conditions
1. The reporting body complies with the relevant provisions of Article 2 of the Rules;
2. The platform is built and operated before the release of this policy or is built and put into use within the validity period of the policy;
3. There is no affiliation or investment relationship, such as shareholding, controlling, etc., between the entrusted party (industrial public service platform) and the entrusted party (medical and pharmaceutical enterprises or institutions). The relationship.
(2) Reporting materials
1. Qingdao Hi-tech Industrial Development Special Funds Application Form;
2. Declaration of the unit's responsibility commitment;
3. Declaring the subject of the business license;
4. Service statistics (according to the service or commissioned objects, service content, contract amount, the amount of realized services, the contract time statistics);
4.
5. Service contracts, invoices, bank payment documents, etc.
6. List of service invoices (invoice name, invoicing unit, invoice content, invoice code, invoice number, invoice amount, invoice time, etc., in the order of invoicing time);
7. Proof of the enterprise's last year's business income from the Nationwide System, or the Enterprise Income Tax or Value-Added Tax return form Or the financial audit report issued by the accounting firm;
8. Credit certificate of the declaring organization (within two years as of the project declaration date);
9. Other related materials.
(C) declaration time
The following year to declare the previous year's award.
Article 15 Encouragement to carry out the relevant qualification certification
To obtain the relevant qualification of the enterprise, in the enjoyment of "Qingdao Biomedical Industry Policy" based on the high-tech zone to give 1:1 matching funding. Accordingly, to obtain the national drug non-clinical research quality management standard (GLP) certification of enterprises (organizations), the urban areas at both levels to give a maximum of 6 million yuan of funding; to obtain the national drug clinical trial quality management standard (GCP) certification of enterprises (organizations), the urban areas at both levels to give a maximum of 10 million yuan of funding; has obtained the GCP qualification of the enterprises (organizations), each new 1 GCP certification professional disciplines, the urban areas at both levels to give 1 million yuan of funding, each unit of the urban areas at both levels of the cumulative funding of up to 10 million yuan.
(a) reporting conditions
1. The reporting subject meets the relevant provisions of Article 2 of these rules;
2. The reporting subject has been awarded the corresponding annual "Qingdao Biomedical Industry Policy" to encourage the development of the relevant qualification certification awards and subsidies.
(2) Declaration materials
1. Qingdao Hi-tech Industrial Development Special Funds Application Form;
2. Declaration of the unit's responsibility commitment;
3. Declaration of the unit's credit certificate (up to the date of the project within two years of the date of declaration).
(3) Declaration Time
Declared within one year from the date of fulfillment of the declaration conditions during the policy period.
Article 16 Support for Insurance Escort
Actively encourage the relevant insurance institutions to provide medical device and biomedical human clinical trial liability insurance, biomedical product liability insurance, and other customized comprehensive insurance products, and eligible medical and pharmaceutical institutions and enterprises, according to their actual premiums paid by 20% of the subsidy, the maximum amount of individual policies up to 500,000 yuan, a single enterprise annual The maximum subsidy will not exceed 2 million yuan for a single policy and 2 million yuan for a single enterprise per year.
(I) Reporting conditions
1. The main body of the declaration is registered in Qingdao Hi-tech Zone, with independent legal personality of the medical device and biomedical human clinical trial sponsors and medical and pharmaceutical enterprises or institutions;
2. Purchase within the policy validity period of the medical device and biomedical human clinical trial liability insurance, biomedicine (including medical device) product liability insurance Insurance products such as medical device and biomedical human clinical trial liability insurance, biomedical (including medical device) product liability insurance;
3. Medical device and biomedical clinical trial liability insurance policyholders within the validity period of the policy to obtain clinical trial approvals or clinical trial notification or filing certificates, and will soon be carrying out clinical trials. Biomedical (including medical devices) product liability insurance policyholder in the policy validity period to obtain a product registration certificate;
4. The same policy shall not be repeated to apply for subsidies. In case of surrender, the financial subsidy funds will be returned.
(2) Reporting materials
1. Qingdao Hi-tech Zone Financial Special Funds Application Form;
2. Reporting unit responsibility commitment;
3. Reporting subject business license;
4. Declared varieties to obtain the acceptance number of the application for registration, obtaining the approval of the clinical trial, enter the clinical trial, or to obtain the approval of the drug number, the Ethics Committee approvals Clinical trial program summary and other relevant documents; "Drug Registration Approval", "Medical Device Registration Certificate" and other relevant documents;
5. Purchase of insurance invoices and policies;
6. Enterprises or organizations related to scientific and technological qualifications or patent certificates, etc.;
7. Reporting unit credit certificate (up to the date of the project within two years of the date of filing);
8. Other Relevant materials.
(C) Reporting time
The following year to declare the previous year's award.
Article XVII Increasing Talent Rewards and Cultivation
17-1 Encouragement Award for Executive Team. For the new introduction of enterprises in line with the direction of the medical and pharmaceutical industry and the annual main business income of a certain scale, for three consecutive years to its senior management personnel incentives. Among them, enterprises whose annual main business income reaches 50 million yuan (inclusive) or more will be rewarded according to the standard of 20,000 yuan per person per year; enterprises whose annual main business income reaches 100 million yuan (inclusive) or more will be rewarded according to the standard of 30,000 yuan per person per year; enterprises whose annual main business income reaches 500 million yuan (inclusive) or more will be rewarded according to the standard of 50,000 yuan per person per year. The incentive funds will be allocated to the enterprise's account. (The senior management talents 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, chairman of supervisors, chief economist, chief accountant, or equivalent level positions, the total number of which is not more than 10 persons per enterprise and not more than 30% of the total number of the enterprises.)
(I) Reporting conditions
1. The reporting body complies with the relevant provisions of Article 2 and 3 of the Rules;
2. The business revenue of the reporting body in the previous year of the reporting year reaches 50 million yuan (inclusive) or more, 100 million yuan (inclusive) or more, 500 million yuan (inclusive) or more;
3. The senior management personnel shall be the on-the-job employees of the reporting body and shall Hi-Tech Zone to pay individual income tax, the same senior executives can make declarations for three consecutive years, but for the senior executives serving in more than one eligible enterprise, the senior executives can only make declarations in the name of one of the enterprises.
(2) Declaration materials
1. Application form for special funds for industrial development of Qingdao Hi-tech Zone;
2. Commitment letter of the declaring unit;
3. Business license of the declaring body;
4. Investment agreement signed between the enterprise and the management committee of Hi-tech Zone;
5. Proof of the enterprise's income of the previous year; or Enterprise income tax, value-added tax returns or financial audit reports issued by accounting firms;
6. Valid identification documents, labor (employment) contracts, on-the-job work certificates or letters of assignment from the parent company of the parent company of the superior holding, certificates of social security payment, certificates of tax payment for personal income tax, etc. of senior managers;
7. Proof of the number of people who have paid social security in the enterprise;
8. .Credit certificate of the declaring organization (within two years as of the date of project declaration);
9. Other relevant materials.
(3) Declaration time
The following year to declare the previous year's award.
17-2 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 annual incentive for each institution does not exceed 1 million yuan, for three consecutive years.
(A) reporting conditions
1. The reporting subject meets the relevant provisions of Article 2 of the Rules;
2. The reporting subject of the training of professionals and the enterprises in the region signed a labor contract for one year and pay social security in the Hi-tech Zone for one year.
(2) Reporting materials
1. Application form for special funds for talent development in Qingdao Hi-tech Zone;
2. Commitment letter of responsibility of the reporting unit;
3. Business license of the reporting body;
4. Qualification documents of the recognized education and training institutions;
5. Training agreement signed between the training institutions and training personnel;
6. Training agreement signed between the training institutions and training personnel;
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6. Labor contracts and social security payment certificates signed between the training personnel and the enterprises in the district;
7. Other materials to be provided.
(C) Reporting time
Declared within one year after meeting the reporting conditions during the policy period.
Article 18 Rental Subsidies
Newly introduced enterprises in the medical and pharmaceutical fields applying for renting R&D, office buildings or production plants within the scope of the High-Tech Zone may be granted rental subsidies upon agreement. The subsidy standards are:
For R&D and office buildings with a leasing area of 1,000 square meters or less, the annual subsidy per square meter shall not exceed RMB 450 yuan; for those with a leasing area of more than 1,000 square meters, the annual subsidy per square meter shall not exceed RMB 270 yuan.
Production plant rental area of 2,000 square meters (including) below, the subsidy per square meter per year does not exceed 150 yuan; more than 2,000 square meters, the subsidy per square meter per year does not exceed 90 yuan.
The rental subsidy, in principle, is a "pay first, make up later" subsidy for five consecutive years. The subsidy rate from the first to the fifth year is 100%, 80%, 60%, 40% and 20%. In the case 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 is not more than 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 rental subsidy policy once.
(I) Reporting conditions
1. The main body of the declaration is in line with the relevant provisions of Article 2 and 3 of the Rules;
2. The leased R & D, office space or production plant needs to be within the scope of the high-tech zone.
(2) Reporting materials
1. Application form for special funds for industrial development of Qingdao Hi-tech Zone;
2. Commitment letter of responsibility of the reporting unit;
3. Business license of the reporting body;
4. Investment agreement signed by the enterprise and the management committee of Hi-tech Zone;
5. Proof material of carrier area commissioned by the lessor to a third party (with relevant qualification);
6. Proof of carrier area issued by a third party (with relevant qualifications) commissioned by the lessor;
6. Lease agreement and rent invoice of the carrier in which the enterprise is stationed;
7. Proof of completion of the matters committed by the enterprise in the agreement and completion of the indicators linked to the subsidy;
8. Proof of the enterprise's tax payment of the previous year;
9. Proof of the declaring unit's creditworthiness (within two years of the date of declaration of the project);
10. p>10. Other related materials.
(C) Declaration time
The following year to declare the previous year's award.
Article 19 Subsidies for House Purchase
Newly introduced enterprises in the field of medical and pharmaceutical companies to purchase R&D and office buildings within the scope of the High-Tech Zone and for their own use can be given subsidies for house purchase upon agreement. Subsidy standards are:
Purchase of R&D and office buildings built on industrial land can be given a maximum subsidy of up to 2 million yuan according to 5% of the purchase price; purchase of R&D and office buildings built on commercial land can be given a maximum subsidy of up to 5 million yuan according to 10% of the purchase price. The subsidies will be allocated in five years, with the subsidy rate from the first to the fifth year being 15%, 20%, 20%, 20%, and 25%, and will be honored according to the relevant assessment of the enterprises.
(I) reporting conditions
1. The reporting body is in line with the relevant provisions of Article 2 and 3 of the Rules;
2. The reporting body to purchase the R & D, office space needs to be within the scope of the High-tech Zone, in which the R & D, office space built on industrial land, in principle, the number of storeys of the building is not less than 8.
(2) Reporting materials
1. Qingdao High-tech Zone Industrial Development Special Funds Application Form;
2. Declaration of the unit's responsibility commitment;
3. Declare the subject of the business license;
4. Enterprises and the High-tech Zone Management Committee to sign an investment agreement;
5. Enterprises purchasing contracts, purchase invoices, property rights registration certificates Materials;
6. Documents proving the completion of matters committed by the enterprise in the agreement and the completion of indicators linked to the subsidy;
7. Proof of the enterprise's tax payment for the previous year;
8. Credit certificate of the declaring organization (within two years as of the date of declaration of the project);
9. Other relevant materials.
(C) declaration time
The following year to declare the previous year's award.
Article 20 Encouragement to organize and participate in major exhibitions
Exhibition incentives. Medical and pharmaceutical enterprises and industrial parks in the region to participate in the China International Medical Device Expo, China International Welfare Expo and China International Rehabilitation Expo, China Medical Equipment Conference and other international and domestic large-scale comprehensive or professional exhibitions to give exhibition support, the enterprises and industrial parks need to be at least 15 working days prior to the start of the exhibition to apply for, and after review and approval, can be awarded 50% of the actual booth fee, special installation fee. 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.
(I) Reporting conditions
1. The subject of the report meets the relevant provisions of Article 2 of the Rules;
2. The subject of the report participates in the China International Medical Device Expo, China International Welfare Expo & China International Rehabilitation Expo and China Medical Equipment Conference during the policy period;
3. The subject of the report is at least 15 working days prior to the commencement of the exhibition for For the record, and supplemented with relevant materials after the end of the actual exhibition.
(2) Reporting Materials
Recorded materials at least 15 working days before the start of the exhibition:
1. Business license of the declaring entity;
2. Recorded form for the participation of Qingdao Hi-Tech Medical and Pharmaceutical Enterprises in the exhibition;
Additional materials after the end of the exhibition:
3. Application for the Special Funds for the Development of Qingdao Hi-Tech Zone Industries;
4. Declaration unit responsibility commitment;
5. Participation in the China International Medical Device Expo, China International Well-being Expo & China International Rehabilitation Expo, China Medical Equipment Conference booth rental and special installation contract, cost breakdown, invoice copy and on-site exhibition photo information;
6. Declaration unit credit certificate (within two years as of the project declaration date);
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7. Other related materials.
(3) Declaration Time
Declaration within one year after meeting the declaration conditions during the policy period.
Chapter III Declaration Procedures
Article 21 Declaration by Enterprises. Declare the main body of the application to the project introduction department, as required to submit paper declaration materials, materials in triplicate and stamped with the official seal of the declaring unit.
Article 22 The preliminary examination of the project. The introduction of the project department for the preliminary examination of the application materials, materials integrity, authenticity and standardization does not meet the requirements, inform the reporting unit to amend the complementary or to make a statement, if necessary, can be organized to review the project, the formation of the preliminary examination of the views.
Article 23 Project Review. The introduction of the project department to complete the project review will be submitted to the Department of Economic Development or the party department, the financial sector, the relevant departments to review the annual funding budget combined with the issuance of the funding plan.
Article 24 Disbursement of funds. The financial sector according to the economic and development departments, party departments or financial sector funding plan in accordance with the procedures for the disbursement of funds.
Article 25 In accordance with the municipal incentive funds to give matching support, enterprises must first apply for municipal incentives, municipal incentives to be allocated, enterprises need not report the supporting materials, in accordance with these rules corresponding to the district-level matching policy provisions to be awarded.
Chapter IV Supervision and Inspection
Article 26 The unit applying for the funds of this policy, such as fraudulent funds or not follow the regulations on the use of the funds, once found, the relevant departments have the right to recover the incentive funds that have been issued to the enterprise will be announced and notified, and will not be admitted to the unit policy application within three years. Unit policy application will not be accepted within three years. If a crime is suspected, it will be transferred to the judicial organs according to the law. If there is a need to return to the financial situation of the enterprise, may not apply for subsidies based on this policy.
Article 27 The relevant functional departments shall strengthen supervision and management, timely tracking and evaluation of business operations and project implementation, and promote the institutionalization and standardization of policy implementation.
Article 28 Upon receipt of the funds, the unit receiving the policy funding support should carry out account processing in accordance with the provisions of the relevant national financial and accounting system, use the funds in strict accordance with the provisions, and consciously accept the supervision and inspection of the relevant functional departments.
Chapter V Supplementary Provisions
Article 29 The Nasdaq of these rules refers to the high-tech zone entered into the statistical network reporting platform for industrial legal entities above designated size, qualified construction legal entities, legal entities above designated size in the wholesale and retail industry, legal entities above designated size in the lodging and catering industry, real estate development and operation of legal entities, services above designated size. Legal entities in the real estate development and operation industry, legal entities in the service industry above scale, and projects with total planned investment of 5 million yuan and above.
Article 30 In the implementation of these rules, and the state, provinces and municipalities of the relevant policies and regulations of the conflict, or encountered in the state, provinces and municipalities of the policies and regulations of the adjustment to the state, provinces and municipalities of the relevant provisions shall prevail.
Article 31 The implementation time and validity of these rules are the same as "Qingdao High-tech Zone on revitalizing the real economy to promote the development of medical and pharmaceutical industry agglomeration of a number of policies" (Qingdao High-tech Management [2022] No. 14).
Article 32 These rules shall be interpreted by the Department of Investment Promotion of Qingdao High-Tech Zone, and the policy consulting telephone number is: 68686957,66966688. If the supporting support is given in accordance with the "Qingdao Biomedical Industry Policy", the municipal requirements shall prevail.
Attachments:
1. Qingdao Hi-tech Industrial Development Special Funds Application Form
2. Qingdao Hi-tech Financial Special Funds Application Form
3. Qingdao Hi-tech Talent Development Special Funds Application Form
4. Declaring Unit Responsibility Commitment Letter (Agreement Cashing Version)
5. Declaration unit responsibility commitment (universal policy version)
6. Qingdao Hi-Tech Zone Medical and Pharmaceutical Enterprises Exhibition Filing Form
