A few days ago, it was learned from the website of the National Development and Reform Commission that the National Development and Reform Commission issued the "Notice on Organizing the Implementation of Special Projects for the Development of Biomedical Contracts and Production and Service Platforms" in order to implement the "13th Five-Year Plan".
The "Notice" pointed out the "Outline" "Opinions on Deepening the Reform of Examination and Approval System and Encouraging Innovation of Pharmaceutical Medical Devices", "13th Five-Year Plan for Strategic Emerging Industries", "13th Five-Year Plan for Biological Industry Development" and "Pharmaceutical Industry" Relevant deployment of the Development Planning Guide should be actively implemented
This notice was jointly drafted by the National Development and Reform Commission, the Ministry of Industry and Information Technology, the National Health and Health Commission, and the State Drug Administration. The goal is to thoroughly implement Xi Jinping's new era of socialism with Chinese characteristics and the spirit of the 19th Party Congress. During the period of strategic opportunity for accelerating the development of the bio-economy, we will focus on promoting supply-side structural reforms, actively promote the full implementation of the drug listing permit holder system, and focus on supporting a number of high-level, internationalized biomedical contract R&D and production service platform construction. We will focus on improving the capacity of biomedical R&D and production services, promoting the multiplier development of the bio-industry, and fostering new models of bio-economy.
The notice has three missions and two key support directions.
It also pointed out the requirements standards and conditions and organizational implementation plans for enterprises that declare biomedical contract production and service projects.
The following is the original notice
Notice on Organizing the Implementation of Special Projects for the Development of Biomedical Contract R&D and Production Service Platform
Development and Reform Office High Technology [2018] No. 633
The provinces, autonomous regions, municipalities directly under the Central Government and cities with separate plans, the Xinjiang Development and Construction Corps Development and Reform Commission, the Ministry of Industry and Information Technology, the Health and Family Planning Commission, and the Food and Drug Administration:
In order to implement the "13th Five-Year Plan", "Outline", "Opinions on Deepening the Reform of Examination and Approval System, and Encouraging Innovation of Pharmaceutical Medical Devices", "13th Five-Year Plan for Strategic Emerging Industries" and "13th Five-Year" Bio-industry Development Planning and Development of the Pharmaceutical Industry Development Planning Guide, the National Development and Reform Commission, the Ministry of Industry and Information Technology, the National Health and Health Commission, and the State Drug Administration intend to organize the implementation of biomedical contract development and production during the 13th Five-Year Plan period. Service platform construction special. The relevant matters are hereby notified as follows:
First, the overall ideas and goals
Deeply implement Xi Jinping's new era of socialism with Chinese characteristics and the spirit of the 19th National Congress of the Communist Party of China, grasp the strategic opportunity period of accelerated development of the bio-economy, focus on the structural reform of the supply side, and actively promote the full implementation of the drug listing permit holder system, with key support A group of high-level, international comprehensive bio-pharmaceutical contract research and development and production service platform construction, focus on improving bio-pharmaceutical R&D and production service capabilities, promote the multi-development of bio-industry, and foster a new model of bio-economy.
Through special implementation, we will effectively support the research and development and industrialization of innovative drugs, and strive to achieve the ability to provide services for the development of more than 100 new drugs each year; increase the scale of drug production, intensification and the efficiency of the development of the whole industry, and support a number of innovative and entrepreneurial SMEs. Development; drive the regional biomedical industry to further high-quality gathering, accelerate the cultivation and formation of a number of world-class biomedical industry clusters.
Second, the main task
(1) To be a strong advantage enterprise. Adapting to the growing demand for high-level R&D and production services in the biomedical field, promoting superior enterprises to continuously improve the level of efficient R&D and advanced manufacturing services, expand service areas, improve service systems, and create a group of comprehensive and internationally competitive professionals. The contract research and development and production service enterprises provide strong support for deepening the reform of the drug review and approval system.
(2) Enhance innovation ability. Leading contract R&D and production service enterprises will break through a number of common technologies, reduce the R&D and production costs, greatly improve the development efficiency of the bio-pharmaceutical industry, and accelerate the integration with the international advanced level, focusing on the key links in China's drug R&D and production chain.
(3) Promoting the development of agglomeration. Bring into play the radiation-driven effect of bio-pharmaceutical contract R&D and production service enterprises to stimulate innovation and entrepreneurship, promote the continuous integration of talents, capital and other factors, strengthen the cooperation linkage of all links in the industrial chain, enhance the level of industrial division of labor in the region, and build a good The industrial development ecology has accelerated the formation of a number of biomedical industry clusters with international influence.
Third, the key support direction
(1) Biomedical contract research and development services. We will focus on supporting competitive enterprises with strong industry influence, high standard quality assurance system, and sound public service mechanism. We will build contract research and development service platforms in pharmaceutical research, preclinical safety evaluation, and new drug clinical research. A comprehensive integrated contract research and development service platform for multi-link and international services.
(2) Biopharmaceutical contract production services. Focus on supporting the development and industrialization of innovative pharmaceutical production processes, the construction of contract production and service platforms for large-scale entrusted processing of listed drugs, and priority to support the mastery of drug production core technology, quality system and environmental health and safety (EHS) system in line with international standards and public service mechanisms. A sound scale and specialized contract production service platform.
Fourth, the reporting standards and conditions
(1) Enterprises that declare bio-pharmaceutical contract R&D service projects should be superior enterprises in relevant sub-sectors and have strong industry influence. In 2017, R&D service contracts amounted to more than 200 million yuan, with market-oriented public service mechanisms and complete The quality assurance system has a good foundation and accumulation in related frontier technologies.
(2) Enterprises that declare biopharmaceutical contract production and service projects should be superior enterprises in the field of new drug contract production and service. In 2017, the production service contract amount exceeds 300 million yuan, which can provide clinical sample preparation and commercial production of small molecule new drugs or macromolecular drugs. The service should have a high level of manufacturing technology and quality assurance, a market-oriented public service mechanism, and a good foundation and accumulation in relevant cutting-edge technologies.
V. Organization and implementation
(1) Please submit the project summary unit according to the “Administrative Measures for Investment Subsidy and Discount Interest Projects in the Central Budget†(Order No. 45 of the National Development and Reform Commission) and the Interim Administrative Measures for the Central Budget Investment (Subsidy) of the High-tech Industry Development Project and this Notify the relevant requirements, conscientiously do a good job in project organization, guide the project construction unit to prepare a project fund application report, include the online approval management platform for investment projects, and confirm the authenticity of the report and related annexes.
(2) Please submit the project's summary reporting unit in combination with the actual development of the local industry, select the project with good development and select it, and declare no more than 3 projects. The total investment of a single project shall not be less than 100 million yuan. Corporate. According to the local application projects, we will entrust a third party organization to organize the review.
(3) In order to give full play to the role of investment guidance in the central budget, the National Development and Reform Commission will provide central budgetary investment support for eligible projects based on the evaluation of third-party institutions. The national subsidy fund for individual projects is, in principle, 30% of the total investment of the project. Left and right, the amount does not exceed 100 million yuan.
(IV) The project construction unit shall formulate a construction plan in a realistic manner and explain the main contents of the fund application report and the authenticity of the relevant annexes. It is necessary to strictly control land acquisition, new building area and investment scale. The specific preparation requirements for the project fund application report are detailed in the annex.
(V) Please submit the project declaration documents and the project fund application report to the National Development and Reform Commission by June 30, 2018.
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