# Support Regulatory Systems Strengthening in Latin America and the Caribbean

> **NIH FDA U01** · PAN AMERICAN HEALTH ORGANIZATION · 2020 · $300,000

## Abstract

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.

## Key facts

- **NIH application ID:** 10260771
- **Project number:** 3U01FD005329-05S1
- **Recipient organization:** PAN AMERICAN HEALTH ORGANIZATION
- **Principal Investigator:** James Fitzgerald
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $300,000
- **Award type:** 3
- **Project period:** 2014-09-15 → 2021-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10260771

## Citation

> US National Institutes of Health, RePORTER application 10260771, Support Regulatory Systems Strengthening in Latin America and the Caribbean (3U01FD005329-05S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10260771. Licensed CC0.

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