Global Regulatory Training Needs Assessment & Stakeholder Engagement

The contract encompasses a global needs assessment focused on National Regulatory Authorities in low- and middle-income countries to uncover critical gaps in the regulation of generic drugs and the use of regulatory reliance mechanisms. The work involves designing a comprehensive survey, deploying multilingual data collection tools to ensure broad accessibility, conducting in-depth stakeholder interviews with regulatory officials, and synthesizing findings into actionable insights. The goal is to understand the current capacity, challenges, and barriers faced by these authorities in ensuring the safety, efficacy, and quality of generic medicines. Building on the assessment, the project requires the development of a detailed curriculum roadmap to guide future training and capacity-building initiatives. This roadmap will be informed by the data gathered and tailored to address identified gaps, supporting stronger regulatory systems through targeted education and knowledge transfer. The effort is led by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services, with performance centered in Silver Spring, Maryland. The engagement timeline is tightly scheduled, with responses due by July 28, 2026, and the work is structured as a subcontract within the broader framework of global health and regulatory strengthening efforts.