Currently it is widely known that the Latin American markets operate with their respective regulatory health bodies, varying from having dedicated agencies in some nations to entrusting responsibilities like drug approval and post-marketing surveillance to their health ministries in others. The Pan American Health Organization (“PAHO”) extends technical assistance and collaboration to these regulatory authorities, as well as fosters regional collaboration and synchronization efforts to promote greater cohesion in healthcare regulatory practices across the region.
Nevertheless, there has been a growing discussion recently regarding a potential shift in this model.
In April this year, regulatory authorities from Mexico (i.e., Cofepris), Colombia (i.e., Invima), and Cuba (i.e., Cecmed) endorsed the Acapulco Declaration[1], initiating discussions to establish a novel regional regulatory body responsible for overseeing medicines in Latin America and the Caribbean, named the Latin American and Caribbean Medicines Agency, or simply “AMLAC”. Additionally, several other nations including Bolivia, Dominica, Ecuador, El Salvador, Honduras, Jamaica, and the Dominican Republic have shown interest in participating in this initiative.
