Strengthen regulatory systems to ensure the safety and quality of food and medical products.

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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 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.