Support Regulatory Systems Strengthening in Latin America and the Caribbean

RFA-FD-15-002：促进合作，加强医疗 美洲的产品监管体系 项目摘要 获得安全、有效和有质量保证的医疗产品是支柱之一 卫生系统的。全球越来越多地达成共识，认为监管作为一种 基本的公共卫生职能，以促进和保护健康并便利获得 基本药物。有效的监管体系通过以下方式促进和保护人口健康 支持开发、制造、储存、分销和管理 在整个产品生命周期中使用健康技术。随着全球化的推进，国家 监管机构(NRAS)面临新的挑战，以监督药品市场和 执行法规。尽管有证据表明，药品和医疗保健的监管能力 产品在整个美洲都有显著改善，但不对称现象仍然存在。一个 医疗产品监管能力薄弱可能对公共健康产生负面影响 结果并阻碍在发展中实现全民健康覆盖的目标 国家。在成员国授权的指导下，泛美卫生组织 泛美卫生组织向其在美洲的35个成员国提供技术合作 加强监管能力，扩大获得关键公共卫生商品的机会。 这项合作协议的主要目标是支持 拉丁美洲和加勒比，促进监管合作和加强 地区性监管体系。此外，通过改善区域和区域之间的合作， 区域外NRAS，通过开发适合国家的监管系统 通过提高稀缺资源的使用效率，该项目将 促进建立有能力的国家监管制度，增加 区域内和全球层面的一体化程度。建议的创新方法 将支持NRAS监督医疗服务的质量、安全性和有效性的努力 整个地区的产品，保护和促进健康，并为 更安全的全球供应链，为美国带来利益和贡献。 FDA监管和公共卫生使命。

RFA-FD-15-002: Fostering cooperation and Strengthening Medical Product Regulatory Systems in the Americas Project Summary Access to safe, efficacious and quality-assured medical products constitutes one of the pillars of health systems. There is growing global consensus on the importance of regulation as an essential public health function to promote and protect health and to facilitate access to essential medicines. Effective regulatory systems promote and protect population health by supporting the development, manufacturing, storage, distribution and management of health technologies throughout the product life cycle. As globalization advances, national regulatory authorities (NRAs) face new challenges to oversee pharmaceutical markets and enforce regulations. Despite evidence that regulatory capacity for medicines and medical products is significantly improving throughout the Americas, asymmetries still persist. A weak regulatory capacity for medical products may have a negative impact in public health outcomes and hinder the goal of achieving Universal Health Coverage in developing countries. Guided by Member State mandates, the Pan American Health Organization (PAHO) provides technical cooperation to its 35 Member States in the Americas to strengthen regulatory capacities and to expand access to critical public health commodities. The main goal of this cooperative agreement is to support regulatory systems development in Latin America and the Caribbean by fostering regulatory cooperation and the strengthening of regional regulatory systems. Furthermore, by improving cooperation among Regional and out-of-the-Region NRAs, by developing regulatory systems appropriate for the national health system and by improving efficiencies in the use of scarce resources, this project will contribute to the establishment of competent national regulatory systems with increased levels of integration within the region and global level. The innovative approaches proposed will support the efforts of NRAs to oversee the quality, safety and efficacy of medical products throughout the region, protecting and promoting health, and contributing to a more secure global supply chain in ways that provide benefit and contribution to the U.S. FDA regulatory and public health mission.