RFA-FD-15-002: Fostering cooperation and Strengthening Medical Product Regulatory Systems in the Americas Project Summary Access to safe, efficacious and quality-assured medical products constitutes one of the pillars of health systems. There is growing global consensus on the importance of regulation as an essential public health function to promote and protect health and to facilitate access to essential medicines. Effective regulatory systems promote and protect population health by supporting the development, manufacturing, storage, distribution and management of health technologies throughout the product life cycle. As globalization advances, national regulatory authorities (NRAs) face new challenges to oversee pharmaceutical markets and enforce regulations. Despite evidence that regulatory capacity for medicines and medical products is significantly improving throughout the Americas, asymmetries still persist. A weak regulatory capacity for medical products may have a negative impact in public health outcomes and hinder the goal of achieving Universal Health Coverage in developing countries. Guided by Member State mandates, the Pan American Health Organization (PAHO) provides technical cooperation to its 35 Member States in the Americas to strengthen regulatory capacities and to expand access to critical public health commodities. The main goal of this cooperative agreement is to support regulatory systems development in Latin America and the Caribbean by fostering regulatory cooperation and the strengthening of regional regulatory systems. Furthermore, by improving cooperation among Regional and out-of-the-Region NRAs, by developing regulatory systems appropriate for the national health system and by improving efficiencies in the use of scarce resources, this project will contribute to the establishment of competent national regulatory systems with increased levels of integration within the region and global level. The innovative approaches proposed will support the efforts of NRAs to oversee the quality, safety and efficacy of medical products throughout the region, protecting and promoting health, and contributing to a more secure global supply chain in ways that provide benefit and contribution to the U.S. FDA regulatory and public health mission.

Public Health Relevance

RFA-FD-15-002: Fostering cooperation and Strengthening Medical Product Regulatory Systems in the Americas Project Narrative Access to safe, efficacious and quality-assured medical products constitutes one of the pillars of health systems. Effective regulatory systems promote and protect population health by supporting the development, manufacturing, storage, management and dispending of health technologies throughout the product life cycle. Guided by Member State mandates, the Pan American Health Organization (PAHO) provides technical cooperation to countries in the Americas to strengthen regulatory capacities and to expand access to critical public health commodities. The main goal of this cooperative agreement is to support regulatory systems development in Latin America and the Caribbean by fostering regulatory cooperation and strengthening medical product regulatory capacities in ways that provide benefit and contributes to the U.S. FDA regulatory and public health mission.

Agency
National Institute of Health (NIH)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01FD005329-01
Application #
8908624
Study Section
Special Emphasis Panel (ZFD1)
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Pan American Health Organization
Department
Type
DUNS #
City
Washington
State
DC
Country
United States
Zip Code
20037