Recently, nine departments including Beijing Medical Security Bureau, Beijing Municipal Health Commission (hereinafter referred to as "Beijing Municipal Health Commission"), and Beijing Drug Administration jointly issued the "Several Measures to Support the High quality Development of Innovative Medicine in Beijing (2025)" (hereinafter referred to as "Several Measures 2025"), launching 32 new measures to further strengthen policy support for the entire chain of research, production, review, and use of innovative drugs and medical devices, optimize the allocation of factor resources, cultivate a high-quality innovation ecosystem, and promote the high-quality development of innovative drugs and medical devices. In 2024, the Beijing Municipal Medical Security Bureau and nine other departments jointly issued the "Several Measures to Support the High Quality Development of Innovative Medicine in Beijing (2024)". On the basis of systematically reviewing the implementation effectiveness of the previous version of policies, the "Several Measures 2025" closely focuses on the development needs of the entire chain of innovative pharmaceutical industry, and optimizes and upgrades in clinical trials, review and approval, production and circulation. The relevant person in charge of the Medical Equipment Department of the Beijing Municipal Health Commission recently said in an interview with Science and Technology Daily that the release of "Several Measures 2025" is not only a forward-looking layout for the development of the biopharmaceutical industry in Beijing, but also a vivid practice of actively cultivating new quality productivity and effectively meeting the needs of the people for disease prevention and treatment. The "Several Measures 2025" proposes to enhance the efficiency of review and approval, deepen the pilot review and approval of clinical trials of innovative drugs, shorten the approval time from 60 working days to 30, continuously expand the variety of innovative drug pilot projects, and expand the pilot scope to medical devices. Song Yuqin, Vice President of Peking University Cancer Hospital, analyzed that deepening the pilot program for clinical trial review and approval of innovative drugs will help further improve the efficiency of clinical trial review and approval of innovative drugs, shorten the drug development and marketing cycle, and stimulate the R&D drive of domestic pharmaceutical companies. How to shorten the approval deadline from 60 working days to 30? The reporter learned that the Beijing Municipal Drug Administration has established a pre-approval mechanism for clinical trial review and project initiation, changing the original serial approval and preparation work to parallel promotion, shortening the time limit for clinical trial application review and approval, and achieving rapid initiation after approval. In terms of improving the efficiency of review and approval, the "Several Measures 2025" also proposes to deepen the pilot program of drug supplementary application review and approval, compress the review time limit from 200 working days to 60, and strive to expand the pilot scope to generic drug applications. Drug supplement application refers to the application that pharmaceutical companies need to submit when making changes to the original approved items such as drug production process and quality standards in order to improve efficiency after the drug is approved for market. The significantly shortened time limit for drug supplement application review can not only accelerate the iteration and upgrading of drug production technology, improve market competitiveness, but also help enterprises to quickly introduce better quality products to the market and meet people's health needs, "said Song Yuqin. At present, some pharmaceutical companies have already enjoyed policy dividends. Not long ago, China Resources Shuanghe Pharmaceutical Co., Ltd. submitted a supplementary application to change the registration standards for its pediatric compound amino acid injection. In just 19 working days, the Beijing Municipal Drug Administration efficiently completed pre service tasks such as filing and sampling inspection, while the National Drug Administration completed the entire review and approval process. This far exceeds our expectations. After shortening the review deadline, it effectively reduces the institutional costs of enterprises, accelerates the transformation of drug research and development results, and comprehensively improves overall operational efficiency, "said the relevant person in charge of the company. The reporter learned that as of now, the Beijing Municipal Drug Administration has received 14 pilot varieties, completed 5 pre service projects, and officially approved 2 varieties. The first batch of landing varieties includes key varieties that urgently need to be changed after listing, such as centralized procurement and pediatric medication. The review and approval time has been shortened by more than 70%, effectively promoting the improvement of the quality and efficiency of drug supplementary application review and approval in Beijing. The "Several Measures 2025" to promote the application of artificial intelligence encourages enterprises to establish artificial intelligence research and development centers in Beijing, strengthen data demand docking, carry out research on AI enabled new target discovery, new mechanism exploration, compound screening, case follow-up, etc. It also proposes to promote the application of artificial intelligence technology, improve regulatory evaluation measures, and promote the integrated innovation and standardized development of "AI+medical health". These measures closely grasp the development trend of artificial intelligence, taking the construction of high-quality datasets and the promotion of high-level artificial intelligence applications as the starting point, and synchronously exert efforts from both data governance and model application, to build an empowering system for artificial intelligence to support the development of innovative medicine. ”The person in charge of the Information Department of the Beijing Municipal Health Commission said. The "Several Measures 2025" specifies the construction of a large-scale model evaluation system for the medical and health industry, targeting AI+pathology, AI+medical imaging, AI+auxiliary diagnosis, AI+surgical planning, AI+pharmaceuticals and other directions, supporting the development and application of models in no less than 10 scenarios. It is reported that after the application of relevant large models, they will play an important role in three dimensions. One is to efficiently assist in improving the efficiency of medical and health services, meeting the growing demand of the public for fair access to high-level medical and health services; Secondly, comprehensively empower health management and carry out health interventions; The third is to empower drug development, playing an auxiliary role in multiple aspects such as target discovery, candidate drug screening, preclinical research, clinical trials, and marketization. Based on the abundant medical and technological resources in Beijing, the development pattern of 'artificial intelligence+medical health' has formed a 'combination of software and hardware'. ”The person in charge of the Information Department of the Beijing Municipal Health Commission said. In terms of hard infrastructure, relying on existing medical networks, health clouds, and shared assistant platforms, the Beijing Municipal Health Commission has achieved intensive deployment of computing power, data, development toolchains, and model applications in the cloud; In terms of software construction, the Beijing Municipal Health Commission follows the idea of "using clinical needs as a driving force to promote the convergence and development of the artificial intelligence medical and health industry", and sorts out each link in the incubation process of artificial intelligence products, exploring the construction of an artificial intelligence product research and development application model. In recent years, with the rise and development of translational medicine and precision medicine, many important scientific research achievements need to be rapidly industrialized in the construction of high-quality biological sample libraries. A biological sample library is an important guarantee for achieving this goal.? A biological sample bank, also known as a "biobank," is a biological application system that centralizes the storage of various human biological materials for clinical treatment of diseases and life science research. The high-quality biological sample library is a core driving factor for the development of major national scientific and technological infrastructure and the pharmaceutical industry. It is a 'national key tool' that supports innovation in precision medicine, translational medicine, and biopharmaceutical technology. It has irreplaceable strategic value in promoting breakthroughs in the depth and breadth of medical research, safeguarding people's health, and promoting the development of the pharmaceutical industry. ”Zhang Xiaoyan, Secretary General of the National Technical Committee for Standardization of Biological Samples, said. The "Several Measures 2025" proposes to initiate the construction of a fully automated and intelligent biological sample library for key specialized diseases such as tumors, cardiovascular and cerebrovascular diseases, and neurodegenerative diseases, and promote the application of high-quality sample data resources such as stroke. According to relevant experts' analysis, this move will help deepen the mining and application of high-quality sample data, providing key support for breakthroughs in precision diagnosis and treatment and efficient drug development. At present, 35 tertiary hospitals in Beijing have established biological sample banks, but due to low standardization and digitization, there is still room for improvement in the sharing and utilization of samples and related data. ”The relevant person in charge of the Science and Education Department of the Beijing Municipal Health Commission revealed that in order to solve the problem of scattered biological sample resources and insufficient sharing and application, they are preparing a construction plan, considering piloting the construction of a specialized disease fully automated intelligent biological sample library, and using artificial intelligence technology to carry out intelligent follow-up, promoting the formation of high-level and easy-to-use biological sample and data resources, and assisting medical research and innovative drug and device development. (New Society)