Washington, DC, 28 July, 2020 (PAHO) - The Central American Mechanism for the Joint Evaluation of Medicines announced it is now open to receive dossiers from companies wanting to register products in Central America, as of August 1, 2020.
The Mechanism seeks to ensure the quality, safety, and effectiveness of medicines and health technologies in the Region. It was launched by the National Regulatory Authorities (NRAs) of Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, and Panama, with the support of the Pan American Health Organization (PAHO), on October 2019.
In a first stage, chemical synthesis medicines can be presented, which are not required to show bioequivalence in any of the Central American countries. The central procedure does not require any payment or user fees, however, local fees must be paid in each country; and it commits the applicants to present the required documentation for registration in all the participating countries.
The mechanism works by respecting the regulations, processes, and administrative procedures of each participating country, and ensures harmonized technical criteria based on the Central American Technical Regulations.
"The Central American Mechanism for the Joint Evaluation of Medicines is an example of synergy and willingness among coutries to work as a team," said Analía Porrás, Head of the PAHO/WHO Medicines and Health Technologies Unit.
The Technical Coordination of the Mechanism will be managed by PAHO. 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.