Washington DC, 15 October 2019 (PAHO/WHO) - National Regulatory Authorities (NRAs) of Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, and Panama launched the Central American Mechanism for the Joint Evaluation of Medicines Records, with the support of the Pan American Health Organization (PAHO). The Mechanism seeks to ensure the quality, safety, and effectiveness of medicines and health technologies in the Region.
The Mechanism was launched in San José de Costa Rica, Costa Rica, on 9 October, 2019, with the presence of the Vice President of the Republic of Costa Rica, Espy Cambell, PAHO/WHO Representative in Costa Rica, María Dolores Perez-Rosales, and the Director of the National Directorate of Medicines of El Salvador, Mario Melendez, who will be the General Coordinator of the Mechanism.
“This initiative seeks to optimize results and strengthen regulatory systems in States with limited resources to perform the essential regulatory functions of medicines and other technologies,” said Analía Porrás, Chief of the Medicines and Health Technologies Unit at PAHO.
The Mechanism will carry out the joint review of new medicines registries, which will allow optimizing technical resources and regional expertise. It can be used by manufacturers and distributors worldwide who wish to market their products in Central America. PAHO has collaborated with the countries´ NRAs in the development of the Central American Mechanism, which, respecting the regulations, processes, and administrative procedures of each participating country, ensures a unique technical review using criteria for applying the Central American Technical Regulations. This will reduce registration times in the Subregion since the procedure requires the process to be completed in less than three months.
The Technical Coordination of the Mechanism will be in charge of the Medicines and Health Technologies Unit of the Department of Health Systems and Services at PAHO.
“The Organization will continue to collaborate with this initiative by facilitating the participation of experts to make sure that the mechanism ensures that the products are reviewed with the highest demands of international standards, and in accordance with the regulations in the Central American Subregion,” said María Dolores Perez -Rosales, PAHO/WHO Representative in Costa Rica.
The initiative is part of the joint efforts of PAHO and countries to improve access to safe, effective, and quality medicines and health technologies in the Central American Region.