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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 thesafety and quality of food and medical products. The project aims to achieve three researchobjectives: 1) develop global norms and standards; 2) articulate evidence- and science-basedpolicy options, including those relating to regulatory systems and regulatory systemsperformance; and 3) provide technical, scientific, and research-based support to nationalregulatory authorities and governments through systems strengthening efforts. The researchproject seeks to build upon and expand well-established collaborations between the WHO andFDA, aligned with mutual global goals on product safety and quality and better and moresecured product supply chains. This is critical for achieving the health-related SustainableDevelopment Goals and other targets set by the global health community. As the internationalauthority on public health, WHO is tasked to lead and coordinate global action to strengthen drugand food regulatory capacities. In line with the Funding Opportunity Announcement, WHOproposes the following activities under the three aforementioned research objectives; 1) Alignedwith Objective 1, developing norms and standards; Aligned to Objective 2, tackling substandardand falsified medical products; and Aligned to Objective 3, ensuring food safety. The project willbe implemented over 60 months, through 12 month phases; managed and implemented byproject management and technical staff at WHO, with key relevant stakeholders such asministries of health, national regulatory authorities, and others as required. WHO draws on awide international network of partners and contacts, including WHO Collaborating Centres,NGOs, and National Professional officers. With regulatory systems strengthening as aninternational priority, increasingly complex global regulatory environments for food and medicalproducts, and requests from countries for support to strengthen their ability to ensure access tosafe and quality products is prompting WHO to shift the paradigm and embark on a novelscience-based opportunities for public health collaboration and research development. Thisapproach will contribute to the regulatory knowledge base and fill the gaps in research, publichealth 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.

Deats, Michael Charles
World Health Organization
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