Notice of Guangzhou Municipal People’s Government on Printing and Distributing Several Provisions of Guangzhou Municipality on Accelerating the Development of Biomedical Industry (Revised)

Notice of Guangzhou Municipal People’s Government on Printing and Distributing Several Provisions (Revised) on Accelerating the Development of Biomedical Industry in Guangzhou No.1 [2020] Notice of Guangzhou Municipal People’s Government on Printing and Distributing Several Provisions (Revised) on Accelerating the Development of Biomedical Industry in Guangzhou District People’s governments, municipal government departments and directly affiliated institutions: We hereby print and distribute "Several Provisions (Revised) on Accelerating the Development of Biomedical Industry in Guangzhou" to you, please earnestly organize their implementation. Problems encountered in the implementation process, please report to the Municipal Development and Reform Commission. Guangzhou Municipal People’s Government February 22, 2020 Several Provisions on Accelerating the Development of Biomedical Industry in Guangzhou (Revised) Chapter I General Provisions Article 1 In order to implement the national, provincial and municipal strategic emerging industry development plans and the Implementation Opinions on Accelerating the Development of Biomedical Industry in Guangzhou, improve the coordination level and comprehensive competitiveness of industrial policies in Guangzhou, concentrate resources to promote the high-end, large-scale and intensive development of biomedical industry, and build a national new drug innovation source, a global new drug clinical trial gathering place and a global biomedical industry. Article 2 These Provisions shall apply to enterprises, institutions, social organizations, trade organizations (or consortia) registered in accordance with the law within the administrative area of this Municipality, engaged in research and development, production, circulation, service and other production and business activities in biomedical related fields, with independent legal personality, and other support objects decided by the municipal government. Chapter II Enhancing the Ability of Innovation and R&D Article 3 For biological products, 1-6 kinds of traditional Chinese medicines and 1-2 kinds of chemicals independently developed and transformed in this Municipality,(Innovate the classification and definition rules of drugs, and adjust them in time according to the drug registration and classification standards issued by National Medical Products Administration) Give financial support in stages, and support the projects in the preclinical research stage to be included in the municipal science and technology plan; After review, the newly-launched new drug project of phase I, II and III clinical research will be awarded with a maximum of 3 million yuan, 5 million yuan and 10 million yuan respectively according to the approved expenses. If the drug/medical device clinical trial institution in Guangzhou is entrusted to carry out clinical trials, the reward amount will be increased by 50%, with a maximum of 4.5 million yuan, 7.5 million yuan and 15 million yuan (for phase II and III clinical trials, Guangzhou) For the enterprises in this Municipality that have obtained the first registration certificates of the second and third types of medical device products, the first registration certificate of each product will be awarded a maximum of 3 million yuan and 5 million yuan respectively according to the approved expenses after review. (Leading unit: Municipal Science and Technology Bureau, cooperating unit: Municipal Market Supervision Bureau, Health and Health Commission, Finance Bureau) Article 4 Support the construction of important public service platforms such as drug non-clinical safety evaluation institutions (GLP), drug/medical device clinical trial institutions (GCP), clinical trial service platforms, clinical research hospitals with special professional requirements, pilot projects and production platforms in biomedical industry, and the subsidy amount shall not exceed 30% of the total project investment, and the single project shall not exceed 30%. (Leading unit: Municipal Development and Reform Commission, cooperating unit: Municipal Science and Technology Bureau, Market Supervision Bureau, Health and Wellness Commission, Finance Bureau)Article 5 The biomedical enterprises and institutions in this city that have passed the national GLP certification will be given a one-time reward. If the certification items that have obtained the GLP certification documents for drugs for the first time reach more than 3 items, more than 6 items and more than 9 items, they will be given 1 million yuan, 2 million yuan and 4 million yuan respectively. A one-time award of 2 million yuan will be given to the biomedical enterprises and institutions in this city that have been certified by the International Committee for Evaluation and Accreditation of Laboratory Animals (AAALAC) for the first time. (Leading unit: Municipal Science and Technology Bureau, cooperating unit: Municipal Market Supervision Bureau, Health and Wellness Commission, Finance Bureau) Article 6 If R&D service institutions such as local GLP, CRO, and pilot platform of biomedical industry provide services for biomedical enterprises in this city that have no investment relationship with the R&D service institutions, they will be rewarded according to 5% of the annual contract amount and invoice basis, with a maximum of 30 million yuan; If a biomedical enterprise outside the city that has no investment relationship with this R&D service institution is introduced to settle in Guangzhou and provide services for it, it will be rewarded according to 5% of the annual contract amount and invoice basis, with a maximum of 30 million yuan. GCP institutions that have completed more than 10, 20 and 30 clinical trials of new drugs each year will be rewarded with 1 million yuan, 2 million yuan and 3 million yuan respectively. If the Phase I clinical research ward is built and put into use, a one-time reward of 2 million yuan will be given. (Lead unit: Municipal Science and Technology Bureau, and cooperating unit: Municipal Market Supervision Bureau, Health and Wellness Commission and Finance Bureau)Chapter III Perfecting the Clinical Research Service System Article 7 Support tertiary medical institutions to set up research wards. Clinical research wards are not included in the management of the number of beds in medical institutions, and are not included in the assessment of bed efficiency, turnover rate and utilization rate, and clinical research beds are subsidized. Support the construction of an innovative drug clinical trial service center led by the government in the early stage and gradually transformed into an independent third-party organization. (Lead unit: Municipal Health and Wellness Commission) Article 8 The professional structure, personnel, work performance, review ability and efficiency of the ethics committee of clinical research shall be included in the scope of grade evaluation and performance appraisal of medical institutions; Give a certain inclination to the medical staff who actively carry out and undertake clinical research in terms of post setting and post promotion; In the internal performance distribution of public hospitals, it is inclined to the frontline staff of clinical research; Incorporate clinical research into the main content of performance evaluation of professional title evaluation. (Lead unit: Municipal Health and Wellness Commission, Human Resources and Social Security Bureau) Article 9 Clinical trials initiated by researchers shall be regarded as scientific research projects and included in the performance evaluation of scientific research; The principal investigator who undertakes clinical trials (including innovative drugs and third-class medical devices) initiated by biomedical enterprises in this Municipality can recommend a researcher, and the recommended person can be regarded as undertaking a municipal science and technology project, and eligible clinical research (including drugs, medical devices, in vitro diagnostic reagents and clinical research initiated by researchers) can be registered as a technical contract; Establish an incentive mechanism for clinical trial institutions and research teams,The income from the transformation of scientific and technological achievements, the funds used for personnel in clinical trial projects, and the funds needed for the introduction of high-level talents and teams are not included in the total performance salary of the unit. (Lead unit: Municipal Science and Technology Bureau, Health and Wellness Commission, Human Resources and Social Security Bureau) Article 10 Full-time clinical researchers of medical institutions may, with the consent of their units, take part-time jobs in enterprises and other scientific research institutions, universities, social organizations, etc. and obtain legal remuneration, and may leave their posts to engage in innovative and entrepreneurial activities such as the transformation of clinical scientific and technological achievements. The income from part-time or off-duty entrepreneurship is not limited by the total performance salary of their units. (Lead unit: Municipal Human Resources and Social Security Bureau, Health and Health Commission) Chapter IV Promoting the Industrialization of Innovation Achievements Article 11 Support enterprises to carry out the consistency evaluation of generic drug quality and efficacy, and give 2 million yuan of financial support to the varieties of oral solid preparations in the basic drug list that have passed the consistency evaluation of generic drugs according to national regulations and other chemical preparations that have taken the lead in passing the consistency evaluation of generic drugs in the top three in China. (Leading unit: Municipal Bureau of Industry and Information Technology, cooperating unit: Municipal Finance Bureau, Market Supervision Bureau, Development and Reform Commission) Article 12 For technological transformation projects certified by the US Food and Drug Administration (FDA), European Drug Administration (EMEA), World Health Organization (WHO) and other institutions, the Guangzhou Municipal Fund for Promoting the High-quality Development of Industry and Information Technology will provide financial support of no more than 30% of the project investment and no more than 5 million yuan. (Lead unit: Municipal Bureau of Industry and Information Technology,Cooperating units: Municipal Market Supervision Bureau, Science and Technology Bureau, Finance Bureau) Article 13 Post-subsidy support will be given to new drugs (including innovative drugs, improved drugs and similar drugs) that have obtained new drug certificates or drug registration certificates, as well as classic prescriptions of traditional Chinese medicine, formula granules of traditional Chinese medicine, innovative medical devices and medical devices that have been registered or put on record, and the projects that are industrialized in this city will be 10% of the total project investment, with a maximum of 50 million yuan. (Leading unit: Municipal Development and Reform Commission, cooperating unit: Municipal Finance Bureau, Science and Technology Bureau, Health and Wellness Commission, and Market Supervision Bureau) Article 14 Projects in which Nobel Prize winners, lasker medical research awards laureates, academicians of China Academy of Sciences and other experts in the biomedical field bring projects, technologies and teams to Guangzhou for industrialization shall be supported according to 10% of the total project investment, and the maximum amount of a single project shall not exceed 100 million yuan. (Leading unit: Municipal Development and Reform Commission, cooperating unit: Municipal Science and Technology Bureau, Finance Bureau) Article 15 Support the pharmaceutical enterprises in this Municipality to introduce advanced technology from abroad to the industrialization in this Municipality or the industrialization led by enterprises in this Municipality, and give 10% of the technology transaction amount with a maximum of 10 million yuan. (Leading unit: Municipal Bureau of Commerce, cooperating unit: Municipal Finance Bureau, Guangzhou Customs, Huangpu Customs) Chapter V Strengthening Industrial Support and Guarantee Article 16 Support the addition of Chinese herbal pieces into the Guangdong Medical Insurance Drug List, and support the inclusion of exclusive Chinese medicinal varieties and ethnic medicines into the national medical insurance drug list. Explore personal account funds to buy commercial health insurance or use personal account funds to establish local characteristic health insurance.Some innovative drugs outside the scope of medical insurance catalogue will be included in the scope of protection. After the new medical service project is approved, the medical institution will independently set the trial price, and the special needs project will be subject to market adjustment price. Support the transfer of new medical service price items in Guangzhou into the catalogue of basic medical service items in Guangdong Province. Actively support innovative drugs to be purchased by Guangzhou Pharmaceutical Group, and serve the innovative development of pharmaceutical industry. (Lead unit: Municipal Medical Insurance Bureau) Article 17 Encourage and support biomedical enterprises to build production workshops and office buildings in this city, incorporate the intended land into the annual land use plan of the city and district, strengthen the protection of land use and marine forest, and accelerate the improvement of surrounding water, electricity, gas, roads, environmental protection, information and other supporting infrastructure. The system of leasing industrial land first and then transferring it, and transferring it in flexible years shall be implemented for biomedical industrial projects in this city. The lease term of lease right after lease shall not exceed 10 years, and the sum of the lease term and the subsequent lease term shall not exceed 50 years, and the lease term of flexible term shall not exceed 20 years. For particularly important projects, based on the market evaluation of land prices, the starting price of the transfer is comprehensively formulated with full consideration of the characteristics of the project. (Lead unit: the district governments, the Municipal Planning and Natural Resources Bureau, and the coordinating unit: the Municipal Development and Reform Commission) Article 18 The municipal science and technology department shall regularly notify the customs department of the biomedical related units that need to conduct scientific research, clinical research or import and export of production articles (reagents, instruments and equipment, biological samples, antibodies and reference drugs, etc.) all the year round. Customs departments actively support enterprises to carry out credit cultivation,Give corresponding customs preferential facilities to those who become customs certification enterprises. (Lead unit: Guangzhou Customs, Huangpu Customs, Municipal Science and Technology Bureau, and cooperating unit: Municipal Development and Reform Commission, Market Supervision Bureau) Article 19 With the consent of the municipal government, major public technology platforms and high-end industrialization projects, major biomedical platforms, centers, laboratories and industrial projects of Guangdong-Hong Kong-Macao Greater Bay Area International Science and Technology Innovation Center, and national biomedical reform pilot, base and platform projects shall be implemented in accordance with the "one thing" Article 20 Encourage and support leading enterprises to set up investment funds for biomedical industry, and guide other social capital to support the construction of new drugs, innovative medical device projects and biomedical industrial parks. The invested projects will be included in the green channels of relevant municipal and district departments in terms of review and approval, drug supervision and management, and given priority. (Lead unit: Municipal State-owned Assets Supervision and Administration Commission, Development and Reform Commission, and cooperating units: Municipal Finance Bureau, Bureau of Industry and Information Technology, Science and Technology Bureau, and Local Financial Supervision Bureau) Article 21 Establish a regional ethics committee for drug clinical trials, establish a unified ethics review platform, promote mutual recognition of ethics review, and improve the efficiency of ethics review. Strengthen the docking mechanism of the whole industrial chain of universities, research institutes, hospitals and enterprises, and arrange special funds of no more than 1 million yuan each year through the government’s purchase of services to support the regional ethics Committee of drug clinical trials and the Guangzhou Biomedical Industry Alliance.And carry out activities such as cooperation, training, exchanges, forums, exhibitions and other activities in the whole industry chain in Guangzhou’s national innovative biomedical venture capital service alliance, Guangdong Pharmaceutical Association’s drug clinical trial Committee, and bio-industry innovation think tank. (Lead unit: Municipal Health and Wellness Commission, Development and Reform Commission, and cooperating unit: Municipal Market Supervision Bureau) Article 22 These Provisions shall come into force as of the date of issuance and shall be valid for 5 years. Annex: Declaration Notes of Several Provisions of Guangzhou Municipality on Accelerating the Development of Biomedical Industry Annex: Declaration Notes of Several Provisions of Guangzhou Municipality on Accelerating the Development of Biomedical Industry According to the Provisions of Guangzhou Municipality on Accelerating the Development of Biomedical Industry (Revised) (hereinafter referred to as "Several Provisions"), in order to further standardize the management, it is hereby explained as follows: 1. The biomedical industry mentioned in the Several Provisions and this Guide refers to biomedicine, biomedical engineering, and biomedical engineering in the Implementation Opinions of Guangzhou Municipality on Accelerating the Development of Biomedical Industry. Two, Guangzhou city to promote the construction of Guangdong-Hong Kong-Macao Greater Bay Area leading group of biomedical and health industry special group office (located in the municipal development and Reform Commission) under the leadership of the municipal government, co-ordinate the organization and arrangement of all kinds of capital projects stipulated in the "Several Provisions". The competent business departments shall, according to the division of responsibilities, work out the annual capital budget in conjunction with the Municipal Finance Bureau, and organize the project declaration, examination and determination, management and supervision by item. 3. An entity applying for the support of Several Provisions (hereinafter referred to as the undertaking entity) shall meet the following conditions at the same time: it is registered in Guangzhou and pays taxes according to law, and has actual business premises.It has an independent legal person qualification and a standardized financial accounting system, and all business indicators are included in the relevant statistical scope of Guangzhou. Four, the monetary units mentioned in the "Several Provisions" are all calculated in RMB if they are not specified, and the amounts involving "not exceeding", "above" and "highest" all include this number. In principle, the relevant documents such as approval documents and certificates shall be subject to the approval within one year of the declaration time, and the relevant departments shall further clarify them when issuing the declaration guide. Five, the provisions of the policy by the lead department unified acceptance, involving all kinds of incentives, subsidies, subsidies and other funds use and management in accordance with the relevant provisions of the city. In principle, all departments will no longer formulate special policies for biomedicine (except existing policies). The same project, the same matter at the same time in line with the provisions of a number of policies or other municipal support policies, the municipal financial support funds in accordance with the principle of "high non-repetition"; At the same time, in line with the provisions of other support policies in this Municipality’s jurisdiction, you can apply to enjoy the relevant policies of the city and district at the same time, unless otherwise stipulated. Six, the competent department of business in conjunction with the municipal finance department to carry out regular and irregular inspections on the use of funds, to deal with the problems found in the inspection. During the inspection, it is found that the supported projects really cannot use the funds due to subjective and objective reasons, and the undertaking unit shall return the funds according to the original channels. Seven, the business department should establish a fund performance management system, according to the provisions of self-evaluation. The financial department should perform the duties of performance management. The results of performance evaluation should serve as an important basis for the competent business department to arrange funds in the next step, and deal with the problems found in performance evaluation.Eight, the public and relevant departments have the right to supervise the whole process of the use of financial funds, and all business departments and supervision, finance and auditing departments must seriously deal with relevant complaints. The undertaking unit shall accept the performance evaluation, supervision and inspection of the financial and auditing departments on the use and management of financial funds. Nine, the undertaking unit shall submit materials according to the requirements of the reporting guidelines issued by the competent business departments, and promise not to move out of the city within 10 years, not to change the tax obligation in this city, not to reduce the registered capital, not to change the statistical relationship, and to get support after approval; At the same time, we should make a written commitment to the authenticity of all the materials submitted. In the process of reporting and implementing the project, if there is fraud, defrauding financial funds and causing losses, or if the funds are not earmarked according to the regulations, the competent business department will cancel or recover the funds and inform the relevant departments of Guangzhou. All business departments should conduct due diligence review and check the application materials, and simultaneously push the above-mentioned information of dishonesty of the reporting unit to the Guangzhou public credit information management system, which will be included in the enterprise credit file to strengthen enterprise credit management. Ten, to resort to deceit, interception, misappropriation and other acts in violation of national laws and regulations or the relevant financial discipline, will be dealt with in accordance with the "Regulations on Penalties and Punishment of Financial Violations" (the State Council Decree [2005] No.427), and in accordance with the provisions, the allocated funds will be returned. Administrative institutions, enterprises and other personnel suspected of committing crimes shall be handed over to judicial organs for handling according to law.Publicity: voluntary publicity, printed and distributed by the Secretariat of the General Office of Guangzhou Municipal People’s Government on February 24, 2020.