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：项目摘要 加强监管系统方面的协作和标准化活动，以增加 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高质量、安全和有效的生物 预防、诊断和治疗重点疾病的产品，特别是用于低血压病和 中等收入国家(LMIC)。该项目旨在确定监管机构的现状 加强优先考虑的低收入国家；制定必要的国际框架 协调加强监管系统；促进和确保科学协作和 加强国家监管机构和网络的监管能力，推动全球 获得安全有效的疫苗和其他生物制品；支持发展以科学为基础的 以数据为导向的规范、标准、指南和方法，以指导国家监管当局；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……里面 根据供资机会公告，世卫组织提出了四项目标下的活动：1) 促进疫苗和疫苗监管的当前状态的知识库 生物制品；2)为监管系统提供技术支持；3)制定全球规范和 生物制品标准；以及4)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制品的机会。该项目将是 通过12个月的阶段在60个月内实施；由项目管理和实施 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 各机构和其他相关合作伙伴。世卫组织利用世卫组织合作中心的广泛网络， 非政府组织和世界各国卫生部的50名国家专业人员。不断增长的需求 不断加强的监管制度、日益复杂的全球监管环境等 全球卫生领域的参与者促使世卫组织为以下目标制定新的业务模式 通过伙伴组织联盟和区域组织概念加强监管系统 英才中心，本项目将借鉴这一点。新方法在政治上受到强烈反响。 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 在这方面，药品监督管理局至关重要。

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.