Snapshot

The The Central American Mechanism for the Joint Evaluation of Medicines pathway has been developed by the Pan American Health Organization (PAHO) of Central American Mechanism.

This pathway can be used where The Central American Mechanism for the Joint Evaluation of Medicines (Mecanismo de Evaluacion Conjunta de Expedientes de Medicamentos de Consumo Humano de Sintesis Quimica) is open to receive dossiers from companies wanting to register products in Central America, as of August 1, 2020. In a first stage, chemical synthesis medicines can be presented, which are not required to show bioequivalence in any of the Central American countries. However, the goal is to expand the complexity of the products that can be reviewed in this mechanism..

It is an abridged review (a reliance pathway).

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: Costa Rica El Salvador Guatemala Honduras Nicaragua Panama

While respecting the regulations, processes, and administrative procedures of each participating country, the mechanism ensures a unique technical review that will reduce registration times in the subregion, completing the procedure in less than three months.