药物警戒服务
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我省药物警戒工作 再受国家药监局通报表扬
Xin Lang Cai Jing· 2026-02-26 16:38
Core Viewpoint - The Anhui Provincial Drug Administration has been recognized by the National Medical Products Administration for its outstanding performance in drug vigilance work in 2025, marking the third time it has received such acknowledgment [1]. Group 1: Drug Vigilance Work - The Anhui Provincial Drug Administration has implemented comprehensive measures to enhance the drug vigilance system, including clearer regulatory guidelines and internal audit guidelines for drug license holders [2]. - The coverage rate of drug vigilance inspections in the region exceeds 40%, with a focus on addressing common deficiencies found during inspections [2]. - The establishment of adverse drug reaction monitoring points has improved risk monitoring and response measures, including timely communication and production suspension when necessary [2]. Group 2: Training and Capacity Building - The provincial drug administration has organized online training for drug vigilance inspectors and conducted competitions to foster a competitive learning environment, significantly enhancing the capabilities of regulatory personnel [2]. Group 3: Future Directions - The Anhui Provincial Drug Administration plans to continue implementing the National Medical Products Administration's requirements for drug vigilance, aiming to improve risk prevention accuracy and regulatory efficiency with stricter standards and practical measures [3].
自贸区数据出境负面清单实践交流活动举行
Guo Ji Jin Rong Bao· 2025-09-17 09:33
Core Viewpoint - The implementation of the negative list for data export in free trade zones presents both opportunities and challenges for enterprises, facilitating cross-border data flow while ensuring compliance with regulations [1] Group 1: Policy Implementation and Impact - The Shanghai Free Trade Zone (FTZ) has initiated the first national practice exchange event for the negative list of data export, involving various departments and over 50 key enterprises [1] - The negative list allows enterprises to report data export activities after usage, eliminating prior approval processes and potentially exempting them from evaluations or filings [2] - The introduction of the negative list has significantly reduced compliance costs for enterprises, with thresholds for sensitive personal information raised from 10,000 to 100,000 individuals [2] Group 2: Support and Guidance for Enterprises - A data cross-border service center has been established in the Shanghai FTZ, conducting nearly 20 policy briefings and providing one-on-one consultations for over 1,000 enterprises [3] - An expert group has been formed to support data cross-border facilitation, including professionals from various organizations to assist enterprises in expanding overseas markets [3] - The city and district data cross-border teams are continuously updating operational guidelines and providing professional training to better address enterprise needs [3] Group 3: Events and Activities - During the National Cybersecurity Awareness Week, seven district-level activities will be held, including policy practice exchanges and cybersecurity competitions [4]