Fostering Cooperation and Strengthening Medical Product Regulatory Systems in the Americas

The Food and Drug Administration (FDA) is announcing its intent to accept a single source application for RFA-FD-15-002 to award a Cooperative Agreement to the Pan American Health Organization. The goal of the funding is to foster regulatory cooperation and strengthen regional regulatory systems in the Americas through activities that may include:Developing and applying regional/global norms and standards in the Americas for medical product regulation;research involving generating and analyzing evidence on regulatory systems gaps and opportunities; their performance; and emerging challenges and trends that may impact system performance; and,providing technical support to regulatory systems strengthening efforts: including, developing strategies to expand the knowledge about the criticality of regulatory systems within the broader global health context.Research ObjectivesThe Cooperative Agreement would represent the further expansion of well-established collaborations between OIP/FDA and PAHO in support of data-driven and science-based public health strategies and approaches. The objective is to build upon existing cooperation to foster regulatory collaboration and strengthen regulatory capacity throughout the Americas in ways that provide benefit and contribution to the FDA regulatory and public health mission. This partnership aligns with FDA's domestic and global goals of addressing medical product safety and quality challenges.This Cooperative Agreement would support collaboration and investigation in the following areas: Developing and applying regional/global norms and standards• Enable the sharing of scientific findings and data through expert meetings and technical consultations; • Assist Member States in the implementation and subsequent evaluation of internationally-recognized standards and guidelines, e.g. WHO guidelines and standards and those emerging from standards development venues such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH);• Utilize PAHO’s convening power to engage with relevant stakeholders on science-based norms and standards;• Facilitate the alignment and convergence of standards between PAHO, other regions, and/or global bodies.Generating and analyzing evidence of regulatory systems performance• Contribute to the knowledge base of the current state of medical product regulation globally, including challenges, risks, and emerging trends, and making the business case for investments in regulatory systems;• Enable and/or further strengthen the development of data/information systems as sources of inputs for evidence-based regulatory decisions and actions and enhanced knowledge management systems, coalitions, and networks;Providing technical support to regulatory systems strengthening efforts and expanding awareness of the role of regulatory systems in the broader global health development framework • Enable the strengthening of regulatory systems at the regional and global levels in such critical domains as: regulatory frameworks; marketing authorization; import/export control and postmarket surveillance; inspections; laboratories; pharmacovigilance; clinical trials; and vaccine lot release; staff development and training, including the professionalization of the regulatory workforce; monitoring and evaluation of product quality; inspection and surveillance of products throughout the supply chain; risk assessment, analysis, and management. • Contribute strategies to expand the knowledge and awareness of the essential role of regulatory systems within the broader global health and development frameworks, including ways that can leverage existing initiatives, investments and partnerships or catalyze new ones.