随着信息技术快速发展，人工智能、智能制造将推动药品行业向高质量、高效率、可持续发展，部分中 药企业已在生产改造升级、降本增效方面积累经验，奠定品牌建设基础。 刘春说，《规定》明确鼓励企业将质量管理体系延伸到中药材生产全过程，运用现代科技加快自动化、 数字化、智能化建设，有序建立关键环节的可视化视频监控，探索应用在线检验和监测，逐步采用信息 化实时记录替代传统纸质记录，促进中药数智化转型；同时，持续强化原料质量审核，加强过程控制， 严格质量管理，引导和督促企业在保证质量基础上，推动生产改造升级，提升中药质量，打造更好的中 药品牌。 （文章来源：经济日报） 本报北京9月18日讯（记者佘惠敏）国家药监局近日公布《中药生产监督管理专门规定》（以下简称 《规定》），将于2026年3月1日起施行。国家药监局药品监管司监管一处处长刘春介绍，《规定》的实 施将为严格把关源头质量、加强中药生产全过程控制、提升中药质量、因地制宜发展中药新质生产力发 挥积极作用。 "《规定》是在《药品生产监督管理办法》和《药品生产质量管理规范》及其相关附录基础上，根据中 药生产特点制定的专门要求，是进一步加强和规范中药生产及其监督管理的补充。"刘 ...

Core Viewpoint - The National Medical Products Administration has announced new regulations for the supervision of traditional Chinese medicine (TCM) production, effective from March 1, 2026, emphasizing comprehensive quality control throughout the entire production process [1]. Group 1: Regulatory Framework - The new regulations focus on controlling the quality of TCM from the source of raw materials to production, release, post-market monitoring, and risk management [1]. - The regulations aim to address key issues affecting TCM production and quality, proposing targeted solutions for the standardized development of TCM materials [1]. Group 2: Quality Management - There is an emphasis on the quality assessment of TCM materials, strengthening supplier audits, and promoting the implementation of Good Agricultural Practices (GAP) for TCM materials [1]. - TCM enterprises are encouraged to extend their quality management systems throughout the entire production process of TCM materials, thereby reducing intermediaries in the supply chain [1]. Group 3: Production Process Control - The regulations call for enhanced quality control during the production process, optimization of process validation requirements, and clear guidelines for uniform processing and extraction deviation control [1]. - There is a focus on the research validation and supervision management of entrusted and contracted production of TCM, as well as strict oversight of TCM injection production to ensure quality [1].

Core Insights - The 10th Smart Pharmaceutical Academic Industry Conference was held in Tianjin, showcasing advancements in traditional Chinese medicine and smart manufacturing [1][3] - Tianshili Pharmaceutical Group played a significant role in the conference, presenting its strategic layout and technological breakthroughs in smart manufacturing [3][10] - The conference emphasized the importance of digital transformation in the pharmaceutical industry, with Tianshili leading initiatives to establish industry standards [3][10] Group 1: Conference Highlights - The conference gathered over 300 industry elites and top experts, including Academician Zhang Boli, to discuss the future of smart pharmaceuticals [1] - Tianshili's Chairman Zhou Hui and other executives presented reports on the company's advancements in digital quality systems and smart manufacturing technologies [3][5] - The event featured the launch of the "Pharmaceutical Industry Digital Action Tianjin Initiative," highlighting Tianshili's leadership in industry transformation [3][10] Group 2: Technological Innovations - Tianshili's digital quality system integrates blockchain traceability, AI process optimization, and smart equipment control, enhancing product quality consistency to international standards [5][12] - The company developed a fifth-generation high-speed jet granulator, addressing production challenges and significantly improving efficiency [7][8] - Tianshili's smart production line automates the entire process from raw material input to finished product packaging, showcasing its commitment to technological advancement [8][12] Group 3: Research and Development - Tianshili has established a comprehensive R&D model that integrates modern Chinese medicine, biopharmaceuticals, and precision medicine, leading to the launch of new products [12] - The company has completed three new drug registration applications and seven clinical research applications in the past year, with a pipeline of 98 products, including 33 innovative drugs [10][12] - Tianshili's commitment to digital transformation and R&D innovation positions it as a leader in modernizing the traditional Chinese medicine industry [12][13] Group 4: Future Outlook - The release of the Tianjin Initiative marks a new phase of collaborative innovation in the pharmaceutical industry's digital transformation [13] - Tianshili aims to empower the health of China through its "Digital Chinese Medicine + Innovative Chinese Medicine" strategy, emphasizing the necessity of digital transformation for the industry [13] - The company is poised to continue leading the modernization of traditional Chinese medicine through technological advancements and patient-centered approaches [13]