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数据或成“生物炸弹”原料,国安部提醒:跨国合作谨防生物数据泄露
Xin Lang Cai Jing· 2026-01-26 23:11
《中华人民共和国生物安全法》对"人类遗传资源与生物资源安全"有严格规定。境外组织、个人及其设 立或者实际控制的机构不得在我国境内采集、保藏我国人类遗传资源,不得向境外提供我国人类遗传资 源。将我国人类遗传资源信息向境外组织、个人及其设立或者实际控制的机构提供或者开放使用的,应 当向国务院卫生健康主管部门事先报告并提交信息备份。境外组织、个人及其设立或者实际控制的机构 获取和利用我国生物资源,应当依法取得批准。利用我国生物资源开展国际科学研究合作,应当依法取 得批准。利用我国人类遗传资源和生物资源开展国际科学研究合作,应当保证中方单位及其研究人员全 过程、实质性地参与研究,依法分享相关权益。 ——遗传资源潜藏危机隐患。基因数据被广泛应用于临床疾病诊治、医学药物研究等方面,具有重要的 学术、商业和社会价值,堪称人类"生命说明书"。大量的人群基因数据一旦泄露,可能被别有用心之人 用于分析我国人口的健康状况、遗传弱点和族群结构,甚至绘制我国人群的"生物地图",为研发针对性 的生物技术手段提供依据。 ——生物代码后藏"隐形通道"。生物研究高度依赖信息化、自动化,测序仪、数据分析软件、云平台等 都是生物研究领域的必要设备 ...
速递|打击中国减肥药?FDA将对所有进口商品进行筛查
GLP1减重宝典· 2025-07-18 04:15
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].