To thoroughly implement the decisions and plans of the Provincial Party Committee and Provincial Government regarding high-quality development, continuously optimize review and approval services, and accelerate the high-quality development of the province’s pharmaceutical industry, the following measures are hereby established.
I. Supporting the Innovation and Development of Pharmaceutical Products
(1) Accelerate the Construction of Research Service Platforms. Accelerate the construction of innovation platforms in fields such as biomedicine, traditional Chinese medicine, and high-end medical devices. Establish a biomedicine R&D system oriented toward market demand, guide innovation platforms toward open collaboration, and prioritize projects addressing critical technological challenges and bottlenecks that enterprises urgently need to resolve. Promote new models of contract research and manufacturing, and introduce a group of internationally competitive Contract Research Organizations (CROs) or Contract Development and Manufacturing Organizations (CDMOs).Encourage cities with strong industrial foundations to build specialized pharmaceutical incubators and promote the construction of R&D platforms for key generic technologies. Support universities, research institutes, and technical support institutions—such as the Provincial Food and Drug Testing Institute and the Provincial Medical Device and Pharmaceutical Packaging Testing Institute—in establishing national-level key laboratories. Encourage innovation platforms, universities, research institutes, and other entities to engage in open collaboration with enterprises, establish pre-project communication mechanisms for research initiatives, and assist enterprises in resolving technical challenges. (Led by the Provincial Department of Science and Technology and the Provincial Drug Administration)
(2) Accelerate the enhancement of clinical trial service capabilities. Support the high-standard construction and high-level development of clinical trial institutions, and continuously promote improvements in the overall quality and efficiency of clinical trials. Allow medical institutions to exclude the number of beds used exclusively for clinical trials of innovative drugs and medical devices from their total bed count. Improve the alliance for mutual recognition of clinical trial ethics reviews to achieve mutual recognition of ethics approvals among medical institutions. (Led by the Provincial Drug Administration and the Provincial Health Commission)
(3) Strengthen support for innovation. From 2023 to 2025, for innovative drugs (Class 1 chemical drugs, Class 1 biological products, and Class 1 traditional Chinese medicines) developed within the province that complete Phase I, II, or III clinical trials, financial support of up to 40% of R&D expenditures—with maximum amounts of 10 million yuan, 20 million yuan, and 30 million yuan, respectively—will be provided upon review; the cumulative annual support per enterprise shall not exceed 100 million yuan.For products entering the National Special Review Procedure for Innovative Medical Devices, financial support of up to 2 million yuan will be provided upon review. (Led by the Provincial Department of Science and Technology)
(4) Support the Inheritance and Innovation of Traditional Chinese Medicine. Encourage TCM enterprises to engage in in-depth exchanges and cooperation with TCM hospitals to advance the stepwise transformation of classic TCM formulas into hospital-prepared formulations and, further, into new TCM drugs. Prioritize support for the R&D of TCM used to prevent and treat major diseases such as cancer and rare diseases, as well as pediatric medications, and strengthen the cultivation of major TCM proprietary medicine products. (Led by the Provincial Drug Administration)
II. Enhancing Testing and Inspection Service Capabilities
(5) Accelerate the construction of the major regulatory service platform. Guided by the principle of “rooted in Shandong, radiating to surrounding regions,” we will innovate operational management and compensation incentive mechanisms to develop the Provincial Food, Drug, and Medical Device Innovation and Regulatory Service Platform (hereinafter referred to as the “Major Platform”) into a large-scale, fully accredited, and highly capable testing and industrial development service institution.To meet enterprise testing needs, prioritize the construction of a Drug Safety Evaluation Center, a 10-meter electromagnetic compatibility laboratory, and a large-animal preclinical evaluation laboratory. Expand testing capabilities in fields such as medical imaging, active surgical devices, passive implants, artificial intelligence, ergonomics, and rehabilitation devices. Build a stable, high-quality professional testing and inspection team. Innovate management models, grant the Large Platform operational autonomy, and develop it into a domestically leading, world-class testing and inspection laboratory.(Led by the Provincial Drug Administration and the Provincial Department of Finance)
(6) Establish an Authorized Testing Laboratory for Radioactive Pharmaceuticals. In response to industrial development needs and guided by a forward-looking approach, plan and construct a testing laboratory for radioactive pharmaceuticals. Upon completion, the laboratory will be managed by the Provincial Food and Drug Testing Institute, integrated into a unified quality management system, and will serve the research, development, and production of radioactive pharmaceuticals in the local and surrounding regions. (Led by the Provincial Drug Administration)
(7) Establish a complementary testing and inspection matrix. Promote the development of a new “one core, multiple wings” testing service framework centered on the Provincial Food and Drug Testing Institute and the Provincial Medical Device and Pharmaceutical Packaging Testing Institute, supplemented by third-party testing institutions and enterprise self-inspection.Building upon municipal-level testing institutions, support the construction of pharmaceutical and medical device laboratories, accelerate the expansion of testing capabilities, undertake relevant testing tasks, and provide convenient and efficient services to enterprises nearby. Support the establishment of medical device testing laboratories in areas with concentrated medical device industries. (Led by the Provincial Drug Administration)
III. Improving the Review and Inspection Service System
(8) Establish high-level medical device innovation service stations. Fully leverage the role of the Shandong Innovation Service Station of the Medical Device Technical Review Center under the National Medical Products Administration to provide targeted services and promote the structural upgrading and technological innovation of the medical device industry.For medical device products in our province that are innovative, key, or complex—such as in vitro diagnostic reagents, diagnostic instruments and equipment, implantable and interventional devices, and high-end diagnostic and therapeutic equipment—we will provide timely, proactive assistance and enhanced guidance at critical stages including R&D, application submission, and clinical trials to facilitate the commercialization of scientific and technological achievements. We will accelerate the development of medical device review and inspection capabilities, further strengthen technical expertise, and elevate the level of medical device innovation services. (Led by the Provincial Drug Administration)
(9) Expand review and approval resources. Following the “jointly established by province and city, managed by the province but operated by the city” model, explore the establishment of review and inspection sub-centers in cities with strong pharmaceutical industry foundations to provide “one-stop” services for the rapid development of the biopharmaceutical industry. (Led by the Provincial Drug Administration and the Provincial Party Committee’s Office of Institutional Reform)
IV. Enhancing the Efficiency of Review and Approval Services
(10) Implement proactive services. Establish a tracking service system for key industrial parks, key projects, and major innovative products. For products included in the innovation or priority special approval procedures, intervene early to provide “one-on-one” services covering the entire process, including R&D, testing and inspection, clinical trials, registration, and production and market launch. Establish a “case-by-case” working mechanism for key projects to help resolve major challenges and difficulties encountered during project construction. Guide key pharmaceutical industrial parks to establish specialized teams to provide enterprises with routine consultation services on registration and application.(Led by the Provincial Drug Administration)
(11) Optimize review and inspection processes. Establish a Technical Review Committee to regularly deliberate on supplementary information requests, the status of data rectifications, and review opinions, thereby standardizing review criteria and improving review quality. Establish a “precise and expedited review” mechanism for medical devices, conducting collective or centralized reviews based on product complexity. Implement a “three-in-one” approach for drug manufacturing licensing, GMP compliance, and registration inspections, ensuring a single inspection covers multiple requirements.For medical devices with the same operating principles and intended uses, as well as essentially identical structural composition, production conditions, and manufacturing processes, registration inspections may be conducted through document review, with verification of the authenticity of products used for testing and clinical trials. (Led by the Provincial Drug Administration)
(12) Improve the efficiency of testing services. Implement a dual-track management system for drug testing, giving priority to registration testing in accordance with the law for drugs included in the accelerated market authorization procedure. Except for medical devices with relatively complex structural compositions or operating principles, the average testing time for non-powered medical devices and diagnostic reagents will be reduced to 60 working days, and for powered products to 90 working days. (Led by the Provincial Drug Administration)
V. Optimizing Product Promotion and Application
(13) Implement online listing for innovative products upon initial market entry. Optimize online listing policies, establish a green channel for pharmaceutical companies to list innovative drugs and medical consumables upon initial market entry, simplify listing procedures to the greatest extent possible, and shorten listing times. Allow medical institutions to procure and use these products autonomously, thereby accelerating the market launch and sales of pharmaceutical companies’ innovative products. (Led by the Provincial Medical Insurance Bureau and the Provincial Public Resources Trading Center)
VI. Strengthening Standards and Brand Development
(14) Strengthen the Leading Role of Standards. Guide and support qualified entities to engage in the introduction of technical standards and international cooperation, and actively participate in the formulation of relevant international, national, and industry standards in the biomedical field. By 2025, promote the formulation and revision of more than 10 national and industry standards for medical devices. Formulate and improve the Shandong Provincial Standards for Traditional Chinese Medicine Granules, and release and implement the Shandong Provincial Standards for Traditional Chinese Medicinal Materials and the Shandong Provincial Specifications for the Processing of Traditional Chinese Medicinal Slices. (Led by the Provincial Market Regulation Bureau and the Provincial Drug Administration)
(15) Promote the “Quality Shandong Medicine” Initiative. Guide industry associations to thoroughly implement the “Quality Shandong Medicine” construction project, cultivate a group of branded products and well-known enterprises in the pharmaceutical sector, and guide enterprises toward brand-oriented and high-end development. Deepen the implementation of Good Manufacturing Practice (GMP), strengthen the exchange of risk information, and guide enterprises to continuously improve their quality management systems. (Led by the Provincial Drug Administration)
(16) Establish a high-end platform for pharmaceutical innovation and development. Encourage the hosting of various academic conferences and the creation of innovation exchange platforms. Support relevant cities in organizing high-level conferences on the development of the pharmaceutical, medical device, and cosmetics industries, establishing platforms for information exchange and win-win cooperation. Promote resource sharing and complementary advantages to further extend the province’s pharmaceutical industry chain. (Led by the Provincial Drug Administration)
VII. Strengthening the Foundation for Industrial Development
(17) Improve and refine the drug safety accountability system. Organize warning education and regulatory training for the heads of production and operation enterprises and personnel in key positions to reinforce corporate primary responsibility. Strictly implement the joint responsibility of Party and government authorities for drug safety, strengthen drug safety evaluations, and ensure the fulfillment of local and departmental regulatory responsibilities. (Led by the Provincial Drug Administration)
(18) Launch a campaign to enhance quality and safety. Adhere to the principle of integrating supervision with service, increase the intensity of regulatory guidance, strengthen the investigation and handling of issues, and safeguard the bottom line of drug quality and safety. Leverage the role of industry associations to establish and improve industry standards and enhance the standardization of enterprise production and operations. Organize assessments of testing capabilities at manufacturing enterprises and provide guidance to improve drug testing capabilities. Urge enterprises to strengthen pharmacovigilance capacity building and guide them in enhancing their emergency response capabilities for drug safety. (Led by the Provincial Drug Administration)
(19) Strengthen regulatory science research. Encourage pharmaceutical manufacturers, particularly those newly established, renovated, or expanded, to advance smart manufacturing; accelerate the development of an intelligent early-warning regulatory platform for pharmaceutical production risks; and research and formulate inspection guidelines for smart manufacturing. Support the establishment of specialized research guidelines for the regulation of pharmaceuticals and medical devices within provincial key R&D projects. Strengthen the regulation of high-end novel medical devices such as proton therapy systems; explore new regulatory models; and provide a “Qilu model” for the national regulation of high-end novel medical devices.(Led by the Provincial Department of Science and Technology and the Provincial Drug Administration)
(20) Enhance regulatory capabilities. Strengthen the development of a provincial-level professional and specialized team of pharmaceutical inspectors, and promote the establishment of municipal and county-level teams of pharmaceutical inspectors that meet operational needs and correspond to regulatory responsibilities. Municipal and county-level market regulation departments shall strengthen the allocation of pharmaceutical regulatory enforcement personnel within their comprehensive law enforcement teams to ensure they possess the necessary professional regulatory staff, funding, and law enforcement equipment commensurate with their regulatory responsibilities. Regularly organize and implement skills competitions in areas such as inspections, testing and analysis, and law enforcement case handling to enhance the capabilities of regulatory personnel.Advance scientific research and disciplinary development in Shandong’s drug regulation sector, and encourage participation in provincial Natural Science Foundation projects. (Responsibility lies with the Provincial Drug Administration, the Provincial Party Committee’s Office of Institutional Reform, the Provincial Department of Science and Technology, and the Provincial Department of Human Resources and Social Security, in accordance with their respective duties)
