Building Research Capacity in Global Tobacco Product Regulation Program

项目摘要： 全球10亿吸烟者消费的烟草产品都是经过高度改造的， 精心营销，对于大约50%的用户来说，是致命的。比许多其他危险的东西更危险 产品，管理烟草制造、标签、销售、分销、广告和促销 事实证明，在许多情况下，即使有像家庭这样强有力的立法，也特别具有挑战性 《吸烟预防和烟草控制法》(《烟草控制法》)，P.L.111-31。通过这件事 项目，世卫组织将利用其在国际烟草领域的独特历史、地位、网络和联系 控制和烟草产品监管努力，以支持食品和药物管理局(The FDA)在减少烟草使用、危害和成瘾方面的方法。谁在这方面有经验 领域包括管理烟草产品监管研究小组， 烟草实验室网络(TobNet)及其烟草产品合作中心 法规，全球烟草监管论坛(GTRF)，以及在过去三年中， 世卫组织-FDA合作协议《建设全球烟草产品研究能力》 监管方案“。在吸取经验教训和这些广泛的网络的基础上，该项目 该提案列出了在未来五年内开展的一些以科学为基础的活动。这些措施包括 发展和协调科学、法律、政策和公共领域的多边研究工作 健康传播。由于健全的数据是良好监管的基石，活动将 还扩大数据收集和信息共享机制、管理和报告 协议。单独的报告活动将确保世卫组织认真监测和评估 计划活动、过程和结果。作为FDA的烟草产品中心(CTP) 审议其对烟草产品的销售和分销施加限制的任务， 执行烟草产品标准，审查新烟草产品的申请，以及 考虑修改风险产品的申请，这个项目的信息将使美国 监管机构考虑全球趋势、现有和新的科学文献以及相关 来自其他国家的证据/信息。由于CTP现在有权对所有烟草进行监管 产品，包括可能还没有在美国市场上上市的新产品，特别是 向具有相关经验的其他监管机构和研究人员学习非常重要。

Project abstract: The tobacco products consumed by the world's one billion smokers are highly engineered, meticulously marketed and, for about 50% of users, lethal. More so than many other dangerous products, regulating tobacco manufacture, labeling, sale, distribution, advertising and promotion has proven particularly challenging in many contexts, even with strong legislation like the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), P.L. 111-31. Through this project, WHO will use its unique history, position, networks and contacts in international tobacco control and tobacco product regulation efforts to support the Food and Drug Administration (the FDA) in its approaches to reducing tobacco use, harm and addiction. WHO's experience in this area includes managing the Study Group in Tobacco Product Regulation (TobReg), the Tobacco Laboratory Network (TobLabNet), its Collaborating Centres in Tobacco Product Regulation, the Global Tobacco Regulators Forum (GTRF), and, for the past three years, the WHO-FDA Cooperative Agreement “Building Research Capacity in Global Tobacco Product Regulation Program”. Building on lessons learned and these extensive networks, this project proposal sets out a number of science-based activities over the next five years. These include development and coordination of multilateral research efforts in science, law, policy and public health communications. Because sound data is the cornerstone of good regulation, activities will also expand data collection and information sharing mechanisms, management and reporting protocol. A separate reporting activity will ensure that WHO carefully monitors and evaluates program activities, processes and outcomes. As the FDA's Center for Tobacco Products (CTP) considers its mandate to place restrictions on the sale and distribution of tobacco products, implement tobacco product standards, review applications for new tobacco products, and consider applications for modified risk products, the information from this project will enable US regulators to consider global trends, existing and new scientific literature, and relevant evidence/information from other countries. Since CTP now has authority to regulate all tobacco products, including novel products that may not be on the U.S. market yet, it is particularly important to learn from other regulators and researchers with relevant experience.