药械监管
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李家超:于2026年内成立“香港药物及医疗器械监督管理中心”
Zheng Quan Shi Bao Wang· 2025-09-17 04:13
Core Points - The Hong Kong government plans to establish the "Hong Kong Drug and Medical Device Regulatory Center" by 2026 to become an internationally recognized authority in drug and medical device regulation [1] - The government will accelerate the "1+" new drug approval mechanism, prioritizing the approval of innovative drugs that can treat serious or rare diseases as recommended by the Hospital Authority [1] - Hong Kong aims to standardize clinical data within the Greater Bay Area and build a real-world data platform to facilitate faster market access for innovative drugs to mainland China and international markets [1]
组织市民走进药企考察,北京“药品安全宣传周”系列宣传活动启动
Xin Jing Bao· 2025-09-02 06:09
Group 1 - The "National Drug Safety Publicity Week" will be held from September 1 to 7, 2025, with a series of themed promotional activities organized by the Beijing Drug Administration [1] - Activities will include laboratory open days, public open days, and services delivered to parks and enterprises, aimed at showcasing drug regulation achievements and promoting safety knowledge of drugs, cosmetics, and medical devices [1] - The initiative will involve cross-regional collaboration in the Beijing-Tianjin-Hebei biopharmaceutical sector, exploring innovative regulatory models and hosting national laboratory open day events [1] Group 2 - The "Pharmacist Walks with You" initiative will conduct public lectures in commercial areas and communities, addressing medication safety and management [2] - Over the past five years, Beijing has conducted an average of 13,000 batch inspections annually for drugs, medical devices, and cosmetics, maintaining a drug inspection pass rate of over 99.8% [2] - The "Risk + Credit" classification and grading regulatory system has been upgraded, evaluating 47,000 regulatory entities and identifying over 300 potential risk points [2] Group 3 - Pilot policies for innovative drug clinical review and approval, as well as segmented production of biological products, have been implemented in Beijing [3] - In the innovative drug clinical review pilot, 12 projects have been approved for clinical trials, with the fastest approval taking 18 working days [3] - A green channel for urgently needed imported drugs and devices has been established, benefiting approximately 4,900 patients through the approval of 25 temporary import drug specifications [3]