Central finance to pay, multi-sector joint efforts to promote research and development and production outsourcing

Pharmaceutical Network On June 13th, the pharmaceutical industry again welcomed the heavy support documents, to further remove obstacles to the listing holder system, by the central government and local governments directly to promote pharmaceutical research and development outsourcing and production outsourcing servicesdays ago, the National Development and Reform Commission, the Ministry of Industry and Information Technology, the Health and Reform Commission, the State Drug Administration jointly issued the "on the organization and implementation of biopharmaceutical contract research and development and production service platform construction special notice" (hereinafter referred to as "Notice"), the four ministries to organize the implementation of bio-pharmaceutical contract research and development and production service platform construction specialthe project will focus on supporting biopharmaceutical contract research and development services, supporting the leading enterprises in the construction of contract research and development services in the areas of pharmaceutical research, preclinical safety evaluation, clinical research of new drugs and other sub-sectorsthe special will also focus on supporting biopharmaceutical contract production services, support innovative drug production process development and industrialization, listed drugs large-scale commissioned processing and other contract production service platform constructionpopular point, the special to support the development of theresearch and development outsourcing and production outsourcing (contract) services, support the development of new drugs, to build a number of comprehensive strength, international competitiveness of professional contract research and development and production services enterprises, as well as accelerate the formation of a number of world-class bio
industrial clustersthe rapid reform of the pharmaceutical industry, drug review reform, consistency evaluation, national science and technology special and key research and development plans, innovative products, clinically urgently needed products and break the import monopoly of products to the market, clinical trials open ..One by one, the new reform policy has come out and landedThis time, the focus is on the listing licensing holder system that untie the research and development and production linksbefore, the country has been in the field of drugs to launch the drug licensing holder system, and has been piloted, landing, achieved some resultsThis special project is to further remove obstacles to the full implementation of the drug market licensing holder system, paving the way to promote the drug supply side of structural reformAlthough the construction of the special projectset in the notice only points to the field of drug research and development and production, however, following the introduction of the drug market licensing holder system, similar to theregistry system has also begun to pilot, and not long ago by the State Council issued a document to further expand the scope of the pilotin accordance with the industry practices of drug first and medical devicefollow, in the future, similar support for research and development outsourcing and production outsourcing construction in the field of medical devices, the implementation of special projects, really possibleaccording to the Notice, the central government will directly give the special construction of strong financial supportBy the declared, after evaluation of eligible projects, a single project state subsidy funds in principle for the total investment of the project about 30%, the amount of up to 100 million yuan However, pharmaceutical companies must also meet certain basic standards and conditions for declaring projects Research and development outsourcing enterprises in 2017 research and development services contract amount must exceed 200 million yuan, production outsourcing enterprises in 2017 production services contract amount must exceed 300 million yuan the implementation of this special construction, research and development and production outsourcing field of the existing advantages of enterprises, is a great benefit to reduce costs, expand the scale, further enhance competitiveness, become the industry leader and the implementation of this special project will also accelerate the implementation of the listing holder system in the industry, accelerate the change of the industry's existing research and development and production pattern, create innovative products to speed up the listing, expel and eliminate a number of low-end competitive enterprises, but also enhance the professional and large-scale production capacity of Chinese pharmaceutical companies, as well as enhance China's competitiveness in global new drug research and development accessories: Development and Reform Office (2018) No 633
provinces, autonomous regions, municipalities directly under the Central Government and planned single-listed cities, Xinjiang Production and Construction Corps Development and Reform Commission, industry and information authorities, health and family planning committee, food and drug regulatory bureau: to implement the "13th Five-Year Plan" Outline", "on deepening the review and approval system reform to encourage pharmaceutical medical devices Innovative Opinions" "13th Five-Year Plan" strategic emerging industries development plan, "13th Five-Year" bio-industry development plan, "pharmaceutical industry development planning guide" related deployment, the National Development and Reform Commission, the Ministry of Industry and Information Technology, the National Health and Health Commission, the State Drug Administration to organize the implementation of biopharmaceutical contract research and development and production service platform construction during the "13th Five-Year Plan" period The relevant matters are hereby notified as follows: in-depth implementation of Xi Jinping's new era of socialist ideas with Chinese characteristics and the spirit of the 19th National Congress of the Party, grasp the strategic opportunity period for accelerated development of the bioeconomy, focus on promoting the structural reform of the supply side, actively promote the full implementation of the drug market licensing holder system, focus on supporting a number of high-level, international comprehensive biomedical contract research and development and production service platform construction, focus on upgrading biomedical research and development and production service capabilities, promoting the doubling of the development of the bio-industry, and fostering a new model of bio-economic through special implementation, effectively support the research and development and industrialization of innovative drugs, and strive to achieve the annual capacity of more than 100 new drug development services, improve the scale of drug production, intensive level and the development efficiency of the whole industry, support the development of a number of innovative and entrepreneurial small and medium-sized enterprises, promote the regional biopharmaceutical industry to further high-quality gathering, accelerate the cultivation and formation of a number of world-class biopharmaceutical industry clusters (i) to strengthen the advantages of enterprises To meet the growing demand for high-level research and development and production services in the field of biomedicine, promote the superior enterprises to continuously improve the level of efficient research and development and advanced manufacturing services, expand the service field, improve the service system, build a number of comprehensive strength, international competitiveness of professional contract research and development and production services enterprises, in order to deepen the implementation of the drug review and approval system reform to provide strong support (ii) to enhance innovation capability To guide contract research and development and production service enterprises around China's drug research and development, production chain needs to improve the key link, break through a number of common technologies, reduce research and development and production costs, greatly improve the efficiency of the development of the biopharmaceutical industry, speed up the integration with the international advanced level (iii) to promote the development of agglomeration To give full play to the radiation-driven effect of biopharmaceutical contract research and development and production service enterprises, stimulate the vitality of innovation , promote the continuous convergence of talents, capital and other elements, strengthen the cooperation and linkage of all links in the industrial chain, enhance the level of industrial division of labor and coordination in the region, build a good industrial development ecology, and accelerate the formation of a number of biopharmaceutical industry clusters with international influence (1) Biopharmaceutical contract research and development services Focus on supporting enterprises with strong industry influence, high standard quality assurance system, and sound public service mechanism, and build contract research and development service platform in the sub-sector areas such as pharmaceutical research, preclinical safety evaluation, clinical research of new drugs, and give priority to supporting integrated contract research and development service platforms that can provide multi-link and international services (2) Biopharmaceutical contract production services Focus on supporting the development of innovative drug production process and industrialization, listed drugs large-scale commissioned processing and other contract production service platform construction, priority support to master the core technology of drug production, quality system and environmental health and safety (EHS) system and international standards, a sound public service mechanism of large-scale, specialized contract production service platform (1) The enterprise that declares the research and development service project of biopharmaceutical contract shall be the dominant enterprise in the relevant sub-sector, has strong industry influence, the amount of the 2017 research and development service contract exceeds 200 million yuan, has a market-oriented public service mechanism and a complete quality assurance system, has a good foundation and accumulation in the relevant cutting-edge technology (2) The enterprise that declares the production service project of biopharmaceutical contract shall be the dominant enterprise in the field of production service of the new drug contract, the production service contract amount in 2017 exceeds 300 million yuan, can provide the clinical sample preparation and commercial production service of small molecule new drugs or macromolecule drugs, should have a high level of production and manufacturing technology and quality assurance level, have a market-oriented public service mechanism, and have a good foundation and accumulation in the relevant cutting-edge technology (1) Invite the project summary reporting units to do a good job in the organization of the project work, guide the project construction unit to prepare the project fund application report, incorporate the project fund application report, and confirm the authenticity of the report and related annexes in accordance with the Measures for the Administration of Investment Subsidies and Discount Projects within the Central Budget (National Development and Reform Commission Decree No 45), the Interim Measures for the Administration of Investment (Subsidies) in the Central Budget of High-Tech Industrial Development Projects and the relevant requirements of this notice (2) Request each project summary reporting unit to combine the actual development of local industries, select the projects with good basis for development to be declared on merit, declare no more than 3 projects, the total investment of a single project is not less than 100 million yuan, the project declaration subject should in principle be an enterprise legal person Based on the local declaration of the project, we will entrust a third-party organization to organize the review (3) In order to give full play to the guiding role of investment in the central budget, the National Development and Reform Commission shall give investment support to eligible projects according to the evaluation of third-party institutions, and the state subsidy funds for individual projects shall in principle be about 30% of the total investment of the project, amounting not exceeding 100 million yuan (4) The project construction unit shall formulate the construction plan in a realistic manner and explain the main contents of the fund application report and the authenticity of the relevant annexes We should strictly control land acquisition, new building area and investment scale Details of the requirements for the preparation of the project funding application report are in the annex (5) invite the project summary reporting units to submit the project declaration documents and the electronic version of the project fund application report to the National Development and Reform Commission by June 30, 2018 The General Office of the National Development and Reform Commission
the General Office of the Ministry of Industry and Information Technology
the General Office of the National Health and Health Commission (Constitution) the Office of the State Drug Administration (Acting Chapter of the General Office of the General Administration of Food and Drug Administration) May 31, 2018