Representatives of leading regulatory agencies in the Americas met last week at the Pan American Health Organization/World Health Organization (PAHO/WHO) to take stock of recent cooperation aimed at strengthening drug regulatory systems and to discuss ways of expanding these efforts to further benefit countries in Latin America and the Caribbean.
Washington, D.C., 8 December 2014 (PAHO/WHO) — Representatives of leading regulatory agencies in the Americas met last week at the Pan American Health Organization/World Health Organization (PAHO/WHO) to take stock of recent cooperation aimed at strengthening drug regulatory systems and to discuss ways of expanding these efforts to further benefit countries in Latin America and the Caribbean.
Participants included representatives from the regulatory agencies of Brazil, Canada, Colombia, Cuba, Mexico, and the United States, which have all been designated as Regulatory Authorities of Regional Reference (NRArr) in the Americas. Together with PAHO/WHO experts they reviewed recent progress in sharing experiences, expertise, standards, and procedures to strengthen the ability of regulatory authorities throughout the region to ensure the safety, effectiveness, and accessibility of medicines and health technologies for their populations.
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PAHO/WHO has been working with countries since 2000 to build drug regulatory capacity by identifying and assessing regulatory functions—which range from licensing of drug manufacturers and approval of new medical products to combatting counterfeit drugs—and facilitating country-to-country cooperation. PAHO/WHO established the Regional Platform on Access and Innovation for Health Technologies (PRAIS) to serve as a platform for regulatory authorities to exchange information and best practices.
PRAIS has allowed regulatory authorities from throughout the region to utilize methods and criteria developed by larger, stronger NRArs. Among the most recent examples of cooperation between some NRArs and other regulatory agencies are shared inspection reports and shared approvals and registration of pharmaceutical products and medical devices.
Participants in the meeting said future efforts should include supporting the development of a Caribbean Regulatory System (CRS) and providing technical expertise on the product registration process and post-market surveillance of medicines. NRAr representatives agreed to continue to cooperating with PAHO/WHO and countries throughout the Region to develop regulatory capacity regionwide.
PAHO Assistant Director Francisco Becerra said the leadership, commitment and coordination of the Regulatory Authorities of Regional Reference has been and will continue to be critical to improving access to safe, effective, and high-quality medicines and health technologies for their populations, as part of larger efforts to achieve universal health coverage.
Meeting participants included representatives of Brazil's Health Surveillance Agency (ANVISA), Colombia's National Institute for Surveillance of Medicines and Food (INVIMA), Cuba's Center for State Control of Medicines and Medical Devices (CECMED), Mexico's Federal Commission for the Protection against Sanitary Risk (COFEPRIS), Health Canada, and the U.S. FDA.
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