Core Viewpoint - Since the beginning of the 14th Five-Year Plan, Shaanxi's drug regulatory system has effectively implemented reforms in drug safety risk prevention and control, aiming for comprehensive regulation of drugs, vaccines, medical devices, and cosmetics by the end of 2025 [1][2] Group 1: Regulatory Reforms - The Shaanxi drug regulatory system has established an integrated operational mechanism to enhance regulatory capabilities, ensuring clear functions and smooth operations of regulatory agencies [1] - The implementation of party and government responsibilities in drug regulation has been effectively carried out, with a well-established food and drug safety committee mechanism at provincial, municipal, and county levels [1] Group 2: Support for Industry Development - Continuous reforms in the review and approval system have supported the high-quality development of the "two products and one device" (drugs, cosmetics, medical devices) industry [1] - The approval of the first Class I innovative drug, Mesylate Prefofovir Tablets, marks a breakthrough for Shaanxi in Class I innovative drugs [1] - Five Class III innovative medical devices have been approved for market entry, and two new cosmetic raw materials have been filed with the National Medical Products Administration [1] - A total of 196 drug varieties have passed or been deemed to have passed the consistency evaluation of generic drugs [1] Group 3: Smart Regulation Initiatives - Shaanxi has established a comprehensive drug regulatory business system and a vaccine (drug) traceability regulatory system, achieving a "one network" operation for drug and device regulation across provincial, municipal, and county levels [2] - Key drugs such as vaccines, special drugs, blood products, and selected products from centralized procurement have achieved full-chain traceability [2] - The integration and sharing of various regulatory information have enabled closed-loop management for risk identification, warning, and response [2]

Core Insights - The provincial drug regulatory authority is advancing smart regulation through information technology, aiming to enhance regulatory efficiency and quality during the 14th Five-Year Plan period [2][3] Group 1: Smart Regulation Framework - The authority emphasizes a unified approach to smart regulation across the province, adopting a centralized construction model to ensure system interconnectivity and data sharing, thereby avoiding information silos [2] - A comprehensive smart regulation platform is being developed with a "123+X" architecture, which includes one drug regulatory data center, two portals, three support systems, and several key applications [2] Group 2: Information System Development - The province is focusing on the coordinated development of regulatory information systems to create practical and user-friendly digital platforms [3] - An online service hall has been established for drug licensing and filing, enabling a "one-stop" online process for application, approval, technical review, and feedback [3] - A comprehensive drug regulatory system has been launched to facilitate real-time data collection and entry for inspections, administrative penalties, and sampling, enhancing cross-regional regulatory collaboration [3] Group 3: Data-Driven Regulation - A provincial drug regulatory data center is being built to consolidate various regulatory data, including licensing, inspections, and complaints, to support data governance and public access [3] - The establishment of drug safety credit files and product archives will allow for risk warning analysis and scientific regulation, ensuring transparency in drug regulation [3] Group 4: Traditional Chinese Medicine (TCM) Initiatives - The province has pioneered an information traceability platform for TCM pieces, collecting traceability data to connect the production, circulation, and regulatory chains, contributing over 20 replicable results [4] - This platform has been recognized as a model project by the National Medical Products Administration, showcasing the province's experience in TCM traceability [4] Group 5: Future Directions - The provincial drug regulatory authority plans to leverage new technologies such as artificial intelligence, big data, and machine vision to accelerate the digital transformation of drug regulation [4] - The goal is to transition from "machine assistance" to "intelligent operations," enhancing the convenience of government services, efficiency of data governance, and robustness of the traceability system [4]