Increasing access to safe and effective products for the prevention, diagnosis and treatment of priority diseases, especially for use in low-and middle-income countries.

RFA-FD-16 - 044：项目总结 在加强监管制度和标准化活动方面开展合作， 获得安全有效的生物制品。 该项目的总体长期目标是增加获得优质、安全和有效生物制品的机会， 用于预防、诊断和治疗重点疾病的产品，特别是用于低 中等收入国家（LMIC）。该项目旨在确定监管的现状， 加强优先的中低收入国家;建立全球发展所需的国际框架 加强监管系统的协调;促进和确保科学合作， 加强国家监管机构和网络的监管能力，以推动全球 获得安全有效的疫苗和其他生物制品;支持开发基于科学和 数据驱动的规范、标准、指南和方法，以指导国家监管机构;以及 与美国食品和药物管理局建立牢固的关系，共同努力， 加强生物制品领域的监管制度和标准化活动。在 根据《资助机会公告》，世卫组织建议在四个目标下开展活动： 为疫苗监管现状的知识库做出贡献， 生物制品; 2）为监管体系提供技术支持; 3）制定全球规范， 支持监管科学和其他活动，以促进 开发和增加获得安全有效生物产品的机会。该项目将 在60个月内实施，分12个月的阶段;由一个项目管理和实施 世卫组织总部、区域和国家办事处的管理团队和技术人员， 卫生部、国家监管机构、国家和专业协会、联合国 机构和其他相关合作伙伴。世卫组织利用广泛的世卫组织合作中心网络， 非政府组织和世界各地卫生部的50名本国专业干事。需求增加 监管体系不断加强，全球监管环境日益复杂，等等 全球卫生竞技场的参与者促使世卫组织制定新的运作模式， 通过伙伴组织联盟和区域合作概念加强监管体系 卓越中心，本项目将利用这些中心。新方法受到了强烈的政治影响， 来自全球卫生机构/伙伴关系的支持，以及与美国食品和药物管理局的合作努力， 药物管理在这方面至关重要。

RFA-FD-16-044: PROJECT SUMMARY Collaboration in regulatory systems strengthening and standardization activities to increase access to safe and effective biological products. The project's overall long-term goal is to increase access to quality, safe and effective biological products for the prevention, diagnosis and treatment of priority diseases, especially for use in low- and middle-income countries (LMICs). The project aims to establish the current status of regulatory strengthening in priority LMICs; generate the required international framework for global coordination of regulatory systems strengthening; facilitate and ensure scientific collaboration and enhance regulatory capacities of National Regulatory Authorities and networks to advance global access to safe and effective vaccines and other biologicals; support development of science-based and data-driven norms, standards, guidance and approaches to guide national regulatory authorities; and build a strong relationship with the US Food and Drug Administration for collaborative efforts in regulatory systems strengthening and standardization activities in the area of biological products. In line with the Funding Opportunity Announcement, WHO proposes activities under four objectives: 1) Contribute to the knowledge base of the current state of regulatory oversight of vaccines and biologicals; 2) Provide technical support to regulatory systems; 3) Develop global norms and standards for biological products; and 4) Support regulatory science and other activities to promote the development and increased access to safe and effective biological products. The project will be implemented over 60 months, through 12-months's phases; managed and implemented by a Project Management Team and technical staff in WHO Headquarters, regional and country offices, with ministries of health, national regulatory authorities, national and professional associations, UN agencies and other relevant partners. WHO draws on a wide network of WHO Collaborating Centres, NGOs and 50 National Professional Officers in ministries of health worldwide. Increasing demand for regulatory systems strengthening, increasingly complex global regulatory environments and more players in the global health arena have prompted WHO to elaborate a new operational model for regulatory systems strengthening with a Coalition of partner organisations and the concept of regional Centres of Excellence, on which this project will draw. The new approach is receiving strong political support from global health agencies/partnerships, and collaborative efforts with the US Food and Drug Administration is crucial in this respect.