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

加强监管系统和标准化活动方面的合作,以增加全球获得安全有效的生物产品的机会。

基本信息

  • 批准号:
    10675535
  • 负责人:
  • 金额:
    $ 200万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2021
  • 资助国家:
    美国
  • 起止时间:
    2021-09-01 至 2026-08-31
  • 项目状态:
    未结题

项目摘要

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.
Rfa-fd-21-031:项目总结

项目成果

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Hiiti Sillo其他文献

Hiiti Sillo的其他文献

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{{ truncateString('Hiiti Sillo', 18)}}的其他基金

Collaboration in Regulatory Systems Strengthening and Standardization Activities to Increase Global Access to Safe and Effective Biological Products.
加强监管系统和标准化活动方面的合作,以增加全球获得安全有效的生物产品的机会。
  • 批准号:
    10448926
  • 财政年份:
    2021
  • 资助金额:
    $ 200万
  • 项目类别:
Collaboration in Regulatory Systems Strengthening and Standardization Activities to Increase Global Access to Safe and Effective Biological Products.
加强监管系统和标准化活动方面的合作,以增加全球获得安全有效的生物产品的机会。
  • 批准号:
    10491861
  • 财政年份:
    2021
  • 资助金额:
    $ 200万
  • 项目类别:
Strengthen regulatory systems to ensure the safety and quality of food and medical products.
加强监管体系,确保食品和医疗产品的安全和质量。
  • 批准号:
    10473511
  • 财政年份:
    2018
  • 资助金额:
    $ 200万
  • 项目类别:

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