Countries from Latin America and the Caribbean have this year formally started talks on creating a new regional medicines and devices regulator. The initiative has the potential to bring benefits for companies and patients, including reduced regulatory burden, an easier route to market and increased safety, quality and efficacy for products. However, experts warn that it could harm competitiveness of the region with increased bureaucracy and costs if the initiative is poorly managed.
Cofepris, Invima and Cecmed, regulators from Mexico, Colombia and Cuba respectively, formalized talks for a new Latin American and Caribbean Medicines Agency (AMLAC) in April 2023 when they signed the Acapulco Declaration