Group 1 - The core theme of the article is "Drug Safety and Regulation for the People," focusing on integrating drug safety knowledge dissemination with drug safety rectification efforts [1] - The initiative includes outreach to schools, communities, and enterprises to enhance public awareness of drug safety [1] - The approach involves interactive methods such as storytelling and Q&A sessions in schools, practical examples in communities, and integrating safety education into regulatory inspections in enterprises [1] Group 2 - The next steps involve deepening the integration of drug safety promotion with daily regulatory practices, ensuring that supervision and public education are synchronized [1] - The goal is to extend the reach of drug safety education to all areas where regulation occurs, reinforcing the message that "where regulation extends, promotion will cover" [1] - This strategy aims to strengthen drug safety measures and create a solid foundation for maintaining a good drug safety environment [1]

省药监局出台《首次轻微违法行为不予行政处罚清单》，推进包容审慎监管，全面推行服务型执 法，采取预防为主、轻微免罚、重违严惩、过罚相当、事后回访等措施，将服务贯穿于药品行政执法事 前、事中、事后全过程。 上述《清单》对违法情节轻微，不影响药品、医疗器械、化妆品的安全性、有效性的初次违法行 为，在符合相关规定情形下，应当不予处罚的行为作出了具体规定。初次违法是指当事人五年内在其全 部生产经营地域范围内第一次实施同一性质违法行为。但当事人被处以五年以上职业禁止处罚的除外。 省药监局政策法规处负责人介绍，今年以来，省药监局审评人员赴17家企业开展注册现场指导，变 被动受理为主动服务，完成涉企行政检查1060家次，对20余家企业开展点对点帮扶，产业发展环境持续 改善。（记者：周明 见习记者：马瑜） 9月4日，记者从省药监局获悉：陕西实行药品领域行政审批全程网办、一网通办和发放电子许可证 书，实现服务对象办事"零跑腿"。 "十四五"以来，陕西深入开展药品监管政务服务提质增效专项行动，精减政务服务流程节点7个， 优化12个事项的办事流程。积极推动零售药店开办"一件事"改革，将多个相关联的"单项事"合理归集、 一并办理，申报 ...

Core Viewpoint - The article highlights the importance of drug safety education for young people, emphasizing the need for awareness regarding the risks associated with certain medications and the proper use of drugs in a school setting [1] Group 1: Event Overview - The event titled "Safe Medication in Schools" was organized by the Market Supervision Administration of Luntai County at the Sixth Primary School [1] - The activity aimed to strengthen the drug safety defense for teenagers by providing practical lessons on medication safety [1] Group 2: Educational Content - Law enforcement personnel acted as "safety mentors," using engaging formats like cartoons and short dramas to explain the potential risks of "internet-famous drugs" and "overseas purchased drugs" [1] - Students received a "Drug Safety Handbook" that outlined the principles of "following medical advice, reading instructions, and avoiding misuse" [1] Group 3: Interactive Engagement - The interactive area featured a "medication scenario simulation" that sparked lively discussions among students about topics such as "how to organize a family medicine cabinet" and "the difference between prescription and over-the-counter drugs" [1] - Real-life cases were used to illustrate the dangers of repeated medication use, and students were taught how to verify the authenticity of drugs using traceability codes [1] Group 4: Future Initiatives - The Market Supervision Administration of Luntai County plans to continue the "Drug Safety in Schools" initiative, aiming to involve families and the broader community in building a comprehensive drug safety network [1]

人民财讯9月10日电，9月10日，国家药监局局长李利在京会见了来访的新加坡卫生科学局局长蔡瑞文一 行。双方围绕推动中新两国药品和医疗器械监管互信、中药监管等内容进行交流。双方同意，进一步深 化药品监管领域务实合作，共同提升药品监管质效，更好增进两国人民健康福祉。 ...

Core Viewpoint - The National Medical Products Administration emphasizes the importance of formulating the "14th Five-Year" drug planning to enhance drug regulation capabilities and promote high-quality development of the pharmaceutical industry, aiming to transition China from a major pharmaceutical country to a strong pharmaceutical nation [1] Group 1: Drug Regulation Development - The meeting highlighted the need to develop an overall strategy for drug regulation during the "14th Five-Year" period [1] - It aims to address deep-seated contradictions and issues in drug regulation, enhancing governance capabilities [1] - The focus is on creating a comprehensive drug safety responsibility system and a full-chain regulatory mechanism [1] Group 2: Reform and Innovation - There is a call for comprehensive deepening of drug review and approval system reforms [1] - The meeting encourages the innovation and development of traditional Chinese medicine and high-end medical devices [1] - It also emphasizes the need to reform the review and approval mechanisms for cosmetics to promote high-quality development [1] Group 3: Regulatory Capacity Building - The meeting stresses the importance of improving the regulatory standards and legal framework [1] - It highlights the need for strengthening technical support capabilities and leading with information technology [1] - The goal is to build a high-quality team of drug regulatory professionals to enhance overall regulatory capabilities [1]

Core Viewpoint - The FDA is planning to appoint biotechnology executive Macari as the Chief Drug Regulator [1] Group 1 - The appointment of Macari is expected to influence drug regulation policies and practices within the FDA [1] - Macari's background in biotechnology may bring a new perspective to the FDA's approach to drug approvals and oversight [1] - This move reflects the FDA's ongoing efforts to enhance its regulatory framework in response to the evolving pharmaceutical landscape [1]

Core Viewpoint - The FDA has announced a new regulation that requires all imported products to undergo review, regardless of their value or size, following the cancellation of the small package exemption policy [2][3][4]. Group 1: Regulatory Changes - The previous exemption for products valued under $800 has been eliminated, meaning all products will now be subject to full review [3]. - This policy took effect on July 9 and aims to enhance the FDA's oversight of the U.S. supply chain and improve the identification of repeat violators [4]. - The new regulation applies to all product categories regulated by the FDA, including drugs, food, beverages, dietary supplements, cosmetics, medical devices, and biological samples [6]. Group 2: Impact on Imports - The FDA can now review all imported products declared through electronic systems, including those purchased online and transported across borders [5]. - Even small packages must adhere to the same regulatory standards as larger shipments, which may affect the circulation of weight-loss drugs in the "gray market" [8]. - A study indicated that in January, shipments of active ingredients from unregistered Chinese suppliers increased by 44% compared to the previous month [8]. Group 3: Implications of the Policy - The data does not account for packages that previously entered the U.S. under the exemption policy, suggesting that the actual import volume may be significantly higher than current statistics indicate [9]. - This policy adjustment is part of the FDA's efforts to close regulatory loopholes and strengthen comprehensive import reviews [10].

Core Insights - The FDA is revising its drug approval process to accelerate the approval speed of certain medications and increase the application of artificial intelligence [1] Group 1 - The FDA's adjustments aim to enhance the efficiency of drug approvals [1] - The incorporation of artificial intelligence is expected to streamline the evaluation process for new drugs [1]