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: 9770842
• 负责人: Diana Lee
• 金额: $ 93.23万
• 依托单位: WORLD HEALTH ORGANIZATION
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9770842
• 关键词: Strengthen; regulatory; systems; ensure; safety

RFA-FD-18-022: Project Summary/Abstract Strengthen Regulatory Systems to Ensure the Safety and Quality of Food and Medical Products (U01) The project’s overall long-term goal is to strengthen global regulatory systems to ensure the safety and quality of food and medical products. The project aims to achieve three research objectives: 1) develop global norms and standards; 2) articulate evidence- and science-based policy options, including those relating to regulatory systems and regulatory systems performance; and 3) provide technical, scientific, and research-based support to national regulatory authorities and governments through systems strengthening efforts. The research project seeks to build upon and expand well-established collaborations between the WHO and FDA, aligned with mutual global goals on product safety and quality and better and more secured product supply chains. This is critical for achieving the health-related Sustainable Development Goals and other targets set by the global health community. As the international authority on public health, WHO is tasked to lead and coordinate global action to strengthen drug and food regulatory capacities. In line with the Funding Opportunity Announcement, WHO proposes the following activities under the three aforementioned research objectives; 1) Aligned with Objective 1, developing norms and standards; Aligned to Objective 2, tackling substandard and falsified medical products; and Aligned to Objective 3, ensuring food safety. The project will be implemented over 60 months, through 12 month phases; managed and implemented by project management and technical staff at WHO, with key relevant stakeholders such as ministries of health, national regulatory authorities, and others as required. WHO draws on a wide international network of partners and contacts, including WHO Collaborating Centres, NGOs, and National Professional officers. With regulatory systems strengthening as an international priority, increasingly complex global regulatory environments for food and medical products, and requests from countries for support to strengthen their ability to ensure access to safe and quality products is prompting WHO to shift the paradigm and embark on a novel science-based opportunities for public health collaboration and research development. This approach will contribute to the regulatory knowledge base and fill the gaps in research, public health and scientific efforts. Strong political support from global health agencies/partnerships, and collaborative efforts with the US Food and Drug Administration is crucial in this respect.

RFA-FD-18-022：项目总结/摘要 加强监管体系，确保食品和医疗安全和质量 产品（U 01） 该项目的总体长期目标是加强全球监管体系，以确保 食品和医疗产品的安全和质量。该项目旨在实现三项研究 目标：1）制定全球规范和标准; 2）阐明基于证据和科学的 政策选择，包括与监管制度和监管制度有关的政策选择 （3）为国家提供技术、科学和研究支持。 监管机构和政府通过加强系统的努力。研究 该项目旨在建立和扩大世卫组织与 FDA，与产品安全和质量的共同全球目标保持一致， 安全的产品供应链。这对于实现与健康有关的可持续发展至关重要。 发展目标和全球卫生界设定的其他目标。国际 作为公共卫生的权威，世卫组织的任务是领导和协调全球行动，加强药物管制， 食品监管能力。根据筹资机会公告，世卫组织 根据上述三个研究目标，提出以下活动：1） 目标1，制定规范和标准;与目标2保持一致，解决不符合标准的问题 与目标3保持一致，确保食品安全。该项目将 在60个月内实施，分12个月阶段;由 世卫组织的项目管理和技术人员，与关键的相关利益攸关方， 卫生部、国家监管机构和其他必要机构。世卫组织借鉴了 广泛的国际合作伙伴和联系人网络，包括世卫组织合作中心， 非政府组织和国家专业官员。随着监管制度的加强， 国际优先事项，日益复杂的全球食品和医疗监管环境 产品，以及各国要求提供支持以加强其确保获得 安全和高质量的产品正在促使世卫组织转变模式， 以科学为基础的公共卫生合作和研究发展机会。这 方法将有助于监管知识库，并填补研究，公共 健康和科学的努力。来自全球卫生机构/伙伴关系的强有力的政治支持， 在这方面，与美国食品和药物管理局的合作至关重要。