2024 Jinshan District Biomedical R&D Innovation and Platform Project Application Notice

In accordance with the "Several Policies of Jinshan District on Deepening Industrial Transformation and Upgrading and Promoting the High-quality Development of the Real Economy" and the "Implementation Rules for the Policies of Scientific and Technological Innovation and Digital Transformation in Jinshan District", the relevant matters related to the declaration of biomedical R&D, innovation and platform projects in Jinshan District in 2024 are hereby notified as follows:

1. Scope of declaration

In 2024, the Jinshan District Science and Technology Commission will implement biomedical R&D, innovation and platform projects, and in principle, solicit projects that have obtained various approvals, listed or completed acceptance in the past three years (after January 1, 2021). Specifically, it can be divided into the following individual items:

1. R&D and listing of major innovative products

2. Consistency evaluation of generic drugs

3. The company obtains the drug registration approval

4. Enterprises carry out clinical trials

5. The enterprise obtains the medical device registration certificate

6. Technical public service platform

Second, the declaration time

Online Declaration:

June 28, 2024 - July 23, 2024

Document review and submission of paper materials:

July 24, 2024 - July 31, 2024

3. Application process

1. Project application and preliminary review: register and log in to Jinshan District "One Network Office" - "I want to do". After filling in the form, please submit it for online review before July 23, 2024.

2. Submit paper materials: After passing the preliminary examination, please submit the stamped application materials in duplicate (application form and related attachments) to the window of the District Science and Technology Commission (window 05-06, No. 05-06, District D, 2nd Floor, Administrative Service Center, No. 555 Longshan Road, Shanyang Town, Jinshan District) for formal review.

3. Project review and publicity: The District Science and Technology Commission will organize expert review after centralized acceptance, and select the best for evaluation, and publicize it to the public after being reviewed and approved by the relevant departments of the district. Projects that have no objection after publicity will be given financial support.

Fourth, the requirements for material submission

All written materials should be printed on both sides of A4 paper, and must be signed and sealed. Use ordinary paper materials as the cover, and do not use binding methods with protruding edges such as rubber rings and folders.

annex

2024 Jinshan District Biomedical R&D, Innovation and Platform Project Application Guidelines

In accordance with the "Several Policies of Jinshan District on Deepening Industrial Transformation and Upgrading and Promoting the High-quality Development of the Real Economy" and the "Implementation Rules for Jinshan District's Science and Technology Innovation and Digital Transformation Policies", in order to do a good job in the application of biomedical R&D, innovation and platform projects in Jinshan District in 2024, this application guide is hereby formulated.

1. R&D and listing of major innovative products

(1) Application requirements

1. The applicant shall be registered within the scope of Jinshan District, have independent legal personality, and be engaged in biomedical research and development, production and service, and the sales settlement shall be in Jinshan District;

2. The reporting unit should have a sound financial management system, and there has been no serious dishonesty and illegal behavior in the past three years;

3. In principle, the applicant shall obtain the new drug certificate and drug registration approval document after January 1, 2021, and the R&D and marketing drugs belong to the innovative drugs of major national and municipal science and technology projects;

4. Obtain drug marketing authorization and realize production and sales in Jinshan District.

(2) Required materials

1. Application Form for Special Funds for the Development of Biomedical Industry in Jinshan District - Major Innovative Products;

2. New drug certificate and drug registration approval documents related materials (copies);

3. The applicant has obtained the national and municipal science and technology major special certification materials (copy);

4. The 2022 and 2023 financial audit reports of the reporting unit (copy);

5. Other supporting materials that need to be provided.

The above materials must be true and valid, and the copies must be stamped with the official seal of the reporting unit.

(3) Supporting standards

For innovative drugs that have won major national and municipal science and technology projects, 100% of the amount of funding from national or municipal departments will be matched, with a maximum support of 10 million yuan.

2. Consistency evaluation of generic drugs

(1) Application requirements

1. The applicant shall be registered within the scope of Jinshan District, have independent legal personality, and be engaged in biomedical research and development, production and service, and the sales settlement shall be in Jinshan District;

2. The reporting unit should have a sound financial management system, and there has been no serious dishonesty and illegal behavior in the past three years;

3. In principle, after January 1, 2021, the applicant shall complete the consistency evaluation of the quality and efficacy of generic drugs, obtain the approval of the State Drug Administration, and settle the sales in Jinshan District.

(2) Required materials

1. Application Form for Special Funds for the Development of Biomedical Industry in Jinshan District - Consistency Evaluation of Generic Drugs;

2. Approval documents and related application materials obtained through consistency evaluation (copies);

3. Declare the product sales contract and sales voucher (copy);

4. The 2022 and 2023 financial audit reports of the reporting unit (copy);

5. Other supporting materials that need to be provided.

The above materials must be true and valid, and the copies must be stamped with the official seal of the reporting unit.

(3) Supporting standards

For generic drugs that have passed the consistency evaluation of drug quality and efficacy, the maximum support of 1 million yuan/variety will be given on the basis of merit. Different specifications of the same drug are regarded as the same variety.

3. The enterprise obtains the drug registration approval

(1) Application requirements

1. The applicant shall be registered within the scope of Jinshan District, have independent legal personality, and be engaged in biomedical research and development, production and service, and the sales settlement shall be in Jinshan District;

2. The reporting unit should have a sound financial management system, and there has been no serious dishonesty and illegal behavior in the past three years;

3. In principle, the applicant shall obtain the drug registration approval document and produce and sell it for the first time in Jinshan District after January 1, 2021.

(2) Required materials

1. Application Form for Special Fund for the Development of Biomedical Industry in Jinshan District - Drug Registration Approval;

2. Relevant materials of drug registration approval documents (copies);

3. Drug sales contract and sales voucher (copy);

4. The 2022 and 2023 financial audit reports of the reporting unit (copy);

5. Proof of R&D expenses of declared products (if the project is initiated, the original special audit report shall be submitted);

6. Other supporting materials that need to be provided.

The above materials must be true and valid, and the copies must be stamped with the official seal of the reporting unit.

(3) Supporting standards

For traditional Chinese medicine, chemical drugs and biological products (including preventive biological products and therapeutic biological products) that have obtained drug registration approval (including newly obtained transfer approval) for the first time in Jinshan District and are produced and sold, 10% of the actual research and development cost of the product will be subsidized, and the best will be given a maximum of 2 million yuan of support. Different specifications of the same drug are regarded as the same variety.

Fourth, enterprises carry out clinical trials

(1) Application requirements

1. The applicant shall be registered within the scope of Jinshan District, have independent legal personality, and be engaged in biomedical research and development, production and service, and the sales settlement shall be in Jinshan District;

2. The reporting unit should have a sound financial management system, and there has been no serious dishonesty and illegal behavior in the past three years;

3. In principle, the applicant shall obtain clinical approval documents and enter the clinical trial stage after January 1, 2021, and the drug will be transformed in Jinshan District.

(2) Required materials

1. Application Form for Special Funds for the Development of Biomedical Industry in Jinshan District - Clinical Trials;

2. Drug clinical trial approval document (copy);

3. Supporting materials related to clinical trial research, such as drug clinical trial application form, approval document of the ethics committee, clinical research contract signed between the applicant and the clinical research institution (copy);

4. The 2022 and 2023 financial audit reports of the reporting unit (copy);

5. Proof of R&D expenses of declared products;

6. Other supporting materials that need to be provided.

The above materials must be true and valid, and the copies must be stamped with the official seal of the reporting unit.

(3) Supporting standards

1. For Class 1 traditional Chinese medicine, chemical drugs and biological products that have obtained clinical approval and carried out clinical trials (the confirmatory clinical trial stage such as cell therapy and gene therapy is equivalent to phase III), according to 10% of the project's R&D investment, the phase I clinical trial will be supported by up to 1 million yuan, and the phase II and phase III clinical trials will be supported by up to 2 million yuan respectively;

2. For Class 2-3 traditional Chinese medicine, chemical drugs, preventive biological products, and therapeutic biological products that have obtained clinical approval and carried out phase II and III clinical trials, according to 10% of the project R&D investment, the maximum support of 500,000 yuan will be given for phase II clinical trials, and the maximum support of 1 million yuan will be given for phase III clinical trials;

3. Improved new drugs (including Class 2 biological products, chemical drugs, and traditional Chinese medicines) and generic drugs (including Class 3 and Class 4 biological products and chemical drugs) that have completed human bioequivalence tests (referred to as BE tests) or clinical effectiveness tests will be supported by up to 500,000 yuan according to 10% of the project's R&D investment.

5. The enterprise obtains the medical device registration certificate

(1) Application requirements

1. The applicant shall be registered within the scope of Jinshan District, have independent legal personality, and be engaged in the research and development, production and service of medical devices, and the sales settlement shall be in Jinshan District;

2. The reporting unit should have a sound financial management system, and there has been no serious dishonesty and illegal behavior in the past three years;

3. In principle, the applicant shall obtain the registration certificate of Class II and Class III medical devices after January 1, 2021 and sell and settle in Jinshan District.

(2) Required materials

1. Application Form for Special Funds for the Development of Biomedical Industry in Jinshan District - Medical Devices;

2. Medical device registration certificate or innovative medical device approval certificate (copy);

3. Declare the product sales contract and sales voucher (copy);

4. The 2022 and 2023 financial audit reports of the reporting unit (copy);

5. Proof of R&D expenses of declared products (if the project is initiated, the original special audit report shall be submitted);

6. Other supporting materials that need to be provided.

The above materials must be true and valid, and the copies must be stamped with the official seal of the reporting unit.

(3) Supporting standards

For those who have newly obtained the registration certificate of Class III medical devices, 10% of the actual R&D cost of the product will be given a maximum of 2 million yuan of support; For those who newly obtain the registration certificate of Class II medical devices, 10% of the actual R&D cost of the product will be supported by up to 500,000 yuan.

6. Technical public service platform

(1) Application requirements

1. The applicant is registered within the scope of Jinshan District, has independent legal personality, and is engaged in the research and development, production and service of biomedicine or medical devices, as well as other institutions, social organizations and other institutions, and the sales settlement is in Jinshan District;

2. The reporting unit should have a sound financial management system, and there has been no serious dishonesty and illegal behavior in the past three years;

3. In principle, after January 1, 2021, the applicant shall invest in the construction of professional and technical public service platforms such as R&D pilot test, clinical research, inspection and testing, and innovative technology, which have passed the verification of fixed assets and have been officially operated.

(2) Required materials

1. Application Form for Special Funds for the Development of Biomedical Industry in Jinshan District - Public Service Platform;

2. Platform project filing/approval, land/real estate and other supporting materials (photocopy);

3. List of platform service facilities or equipment and instruments;

4. Platform management measures, rules and regulations;

5. Third-party audit report on fixed asset investment (original verification, submit copy);

6. Part of the service contract, invoice (copy).

7. Other supporting materials that need to be provided.

The above materials must be true and valid, and the copies must be stamped with the official seal of the reporting unit.

(3) Supporting standards

1. Support the construction of important service platform projects such as biomedical third-party testing services, laboratory animal services, contract research and development, drug screening, pharmacology and toxicology research, and after identification, 10% of the fixed asset investment of the project will be supported by up to 5 million yuan;

2. Support the collaborative innovation of top scientist teams of enterprises and universities, hospitals, and R&D institutions, and give up to 5 million yuan of support to major platforms such as synthetic biology platforms, clinical sample resource banks, and data centers jointly funded and constructed, according to 10% of the project's fixed asset investment.

Source: Shanghai Jinshan

Shanghai Industrial Policy Service Center

Policy Services Department: Director Fang

Telephone-WeChat: 15618903837

*The policy content published in this article is compiled and interpreted by the Shanghai Industrial Policy Service Center, if there is any error, please contact us.

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