省药监局相关处室负责人介绍，为切实提高药品监管能力，陕西药品监管"一体化"运行机制全面建 立运行，药品监管党政同责有效落实，省、市、县食品药品安全委员会机制健全，监管机构职能清晰、 运行顺畅。 2月5日，记者从省药监局获悉："十四五"以来，陕西药品监管系统持续深化监管改革，药品安全风 险防控得到有效落实，截至2025年底，陕西药品、疫苗、医疗器械、化妆品监管实现全覆盖。 在推进药品智慧监管建设方面，陕西已建成药品监管综合业务系统、陕西省疫苗（药品）追溯监管 系统、陕西省药品监管大数据中心，实现省、市、县三级药械化监管业务"一网通办"，疫苗、特殊药 品、血液制品、集采中选产品等重点药品实现全链条信息可追溯。全省药品监管各类信息集成共享，风 险识别、风险预警、风险处置实现闭环管理。（记者：周明） 为支持"两品一械"（药品、化妆品、医疗器械）产业高质量发展，"十四五"以来，陕西药监系统持 续深化审评审批制度改革，药械化创新取得显著成效。I类创新药甲磺酸普雷福韦片获批上市，实现陕 西I类创新药零的突破。5个三类医疗器械创新产品获批上市。2种化妆品新原料通过国家药监局备案。 196个品种药品通过或视同通过仿制药一致性评 ...

Core Insights - The meeting on August 28 emphasized the need for a comprehensive approach to drug regulation during the "14th Five-Year Plan" period, focusing on safety and innovation [1] Regulatory Framework - The meeting highlighted the importance of establishing a robust drug safety responsibility system and a full-chain regulatory mechanism to ensure high-level drug safety [1] - It called for the enhancement of law enforcement and case handling mechanisms to improve regulatory effectiveness [1] Reform and Innovation - There is a strong push for deepening reforms in drug review and approval systems, promoting the inheritance and innovation of traditional Chinese medicine, and accelerating the development of high-end medical devices [1] - The meeting also addressed the need to reform the review and approval mechanisms for cosmetics to foster high-quality development [1] Standards and Talent Development - The need to improve the regulatory standards system and strengthen technical support capabilities was emphasized, alongside a commitment to information technology leadership [1] - The meeting stressed the importance of building a high-quality drug regulatory talent team to enhance overall regulatory capabilities [1]

Group 1: Food Safety Regulation - The Market Supervision Administration emphasizes the importance of food safety and is enhancing full-chain supervision during the 14th Five-Year Plan period, focusing on major food categories such as rice, flour, oil, meat, eggs, milk, fruits, vegetables, and tea [1] - Strict regulations are being implemented for new consumption scenarios arising from the rapid development of the platform economy, including online shopping, food delivery, and live-streaming sales, to ensure compliance and mitigate risks [1] Group 2: Drug Safety Regulation - The National Medical Products Administration (NMPA) is strengthening dynamic regulation throughout the entire lifecycle of drugs, focusing on key areas such as online drug sales, entrusted production, and clinical trial management [2] - A zero-tolerance approach is being adopted to combat illegal activities such as adulteration, false advertising, and consumer fraud, resulting in the revocation of 3,072 licenses and restrictions on 238,000 individuals [2] Group 3: Drug Approval and Innovation - The NMPA has established accelerated pathways for breakthrough therapies, conditional approvals, and priority reviews, resulting in the approval of 204 innovative drugs and 265 innovative medical devices since the beginning of the 14th Five-Year Plan [3] - Efforts are being made to optimize the approval process for urgently needed foreign drugs, with a focus on pediatric and rare disease medications, leading to the approval of 387 pediatric drugs and 147 rare disease drugs since the start of the 14th Five-Year Plan [3]

Core Points - The provincial government is implementing reforms to accelerate the approval process for innovative medical devices and drugs, including establishing a green channel for priority reviews and compressing inspection timelines to enhance market access [1][2] Group 1: Approval Process Optimization - The provincial drug regulatory authority has introduced measures to optimize the review and approval mechanism, including a proactive approach with tailored strategies for each product and dedicated support teams [1] - The approval process for drug changes has been streamlined, reducing the minimum processing time for site changes from 195 days to 105 days, achieving an overall time reduction of over 40% [1] Group 2: Inspection and Registration Improvements - The registration inspection for low-risk drug varieties has been optimized, with the required batch quantity for inspection reduced from three times to two times the full inspection quantity [2] - The inspection timeline for registered medical devices has been compressed to 20 working days, and emergency approvals are being implemented to expedite the process for urgently needed medical devices and drugs [2] Group 3: Focus on Rare Diseases and Urgent Needs - The approval process for drugs and medical devices related to rare diseases has been expedited, with the number of required inspection batches reduced from three to one, and the batch quantity requirement also decreased [2] - Clinical urgent medical devices are prioritized in the approval process, with the approval timeline reduced from 58 working days to 30 working days [2]