Collaboration in Regulatory Systems Strengthening and Standardization Activities to Increase Global Access to Safe and Effective Biological Products.

RFA-FD-21-031：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。 这项持续合作协定的总体目标是增加全球人口的准入 用于预防、诊断和治疗重点疾病的安全有效的生物制品， 尤其是在LMIC中使用。该项目旨在实现对监管机构现状的监督 加强优先小岛屿发展中国家；为全球协调制定必要的国际框架 加强监管制度；促进和确保科学合作并加强 国家监管当局和网络的监管能力，以促进全球获得SAFE 以及有效的疫苗和其他生物制品；支持以科学为基础和数据驱动的发展 指导国家监管当局的规范、标准、指导方针和方法；并建立强有力的 与美国食品和药物管理局在监管系统方面的合作关系 加强和规范生物制品领域的活动。与资金相一致 机会公告，世卫组织提出了四项目标下的活动：1：促进 加强低收入和中等收入国家的监管系统；2：加强上市后 疫苗安全监测；3)制定全球规范和标准；4)支持 监管使团相关研究和其他活动，以促进和增加 获得安全有效的生物制品。 该项目将在60个月内分12个月实施；管理和 由世卫组织总部的项目管理小组和技术人员实施，区域和 国家办事处，设有卫生部、国家监管机构、国家和专业机构 协会、联合国机构和其他相关伙伴。世卫组织利用世卫组织的广泛网络 世界各地卫生部的合作中心、非政府组织和50名国家专业人员。 对加强监管系统的需求日益增加，全球监管日益复杂 环境和全球卫生舞台上更多的参与者促使世卫组织制定一项新的 与伙伴组织联盟加强监管系统的业务模式 区域英才中心、信实中心和世卫组织列出的权力机构的概念。这些新的 这些方法得到了世卫组织成员国和全球卫生组织的大力政治支持 机构/伙伴关系。

RFA-FD-21-031: PROJECT SUMMARY Collaboration in regulatory systems strengthening and standardization activities to increase access to safe and effective biological products. The overall goal of this continued Cooperative Agreement is to increase access of the global population to safe and effective biological products for the prevention, diagnosis, and treatment of priority diseases, especially for use in LMICs. The project aims to achieve oversight of 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: Contributing to regulatory systems strengthening in low- and middle-income countries; 2: Enhancing post-market surveillance of vaccines safety; 3: Development of global norms and standards; and 4) Supporting regulatory mission relevant research and other activities to promote development of 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 concepts of regional Centres of Excellence, reliance and WHO Listed Authorities. These new approaches are receiving strong political support from WHO Member States and global health agencies/partnerships.