Improving regulatory systems for medical products and technologies
The FDA and PAHO work together to strengthen national regulatory authorities by sharing information, standards, and guidelines
Access to safe, effective, and quality-assured medical products constitutes one of the pillars of healthcare systems. The Food and Drug Administration (FDA), a U.S. governmental agency, and the Pan American Health Organization (PAHO) are partners that help countries across the Region of the Americas achieve that goal.
In the United States, the FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. And because many products are manufactured abroad, the FDA enters into arrangements that make it easier for countries’ regulatory agencies to share information with their regulatory counterparts around the world, and to coordinate standards with other countries.
The FDA uses varied approaches as part of its strategy to address issues related to medical products and foods—developing new enforcement and regulatory tools, increasing collaboration with foreign regulators and other stakeholders, helping develop internationally compatible standards, and increasing transparency and accountability in the supply chain. One of those approaches has been partnering with multilateral organizations like PAHO to facilitate the sharing of information with other national regulatory agencies.
Access to safe, efficacious, and quality-assured medical products
Since 2010, the FDA’s s Office of International Programs has collaborated with PAHO on strengthening regulatory systems in Latin American and the Caribbean by providing financial support and technical cooperation. The collaboration has helped countries in Latin America and the Caribbean to better understand how others regulatory system work and to coordinate their standards and guidelines to make them more compatible. This project has also made it possible for countries to respond more quickly if there is a problem with a medical product or the supply chain.
Initially, the collaboration between PAHO and the FDA focused on assessing regulatory functions—evaluating countries’ strengths and as well as ways they could improve their systems for regulating medical products in the Americas by employing a standardized methodology that contributes to better access to safe, effective, and high-quality medical technologies. This partnership has also included creating communities of practice and an electronic platform for knowledge-sharing. Results of the evaluation in the Region have been shared using the Regional Platform for Access and Innovation of Health Technologies (PRAIS), an electronic platform with virtual tools designed to improve transparency, information flow, and collaboration among different sectors involved in developing, using and regulating essential medicines, biological products and public health diagnostics.
More recently, with the FDA’s support, PAHO released a new report that reviewed lessons learned from National Regulatory Authorities of Regional Reference, which are ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), INVIMA (Colombia), CECMED (Cuba), and COFEPRIS (Mexico). The report highlighted that COVID-19 pandemic has demonstrated the urgent need for strengthening national regulatory authorities in Latin America and the Caribbean to ensure the safety and effectiveness of new medicines and medical products, and it showed that national regulatory authorities vary dramatically in their capacity to evaluate medicines and medical products, among other points.
The FDA is a key partner for PAHO, as both organizations are working together with countries in Latin America and the Caribbean to strengthen the countries’ national regulatory systems that oversee the use of medicines, medical products and health technologies.
More information
FDA- Office of Global Policy and Strategy
FDA awards $904,000 to Pan American Health Organization for information 'hub'
PAHO launches Regional Platform on Access and Innovation for Health Technologies