Mexico, Cuba, and Colombia signed the “Acapulco Declaration” on Wednesday to establish the Latin American and Caribbean Regulatory Agency for Medicines and Medical Devices (AMLAC).
Mexican Alejandro Svarch, director of the Federal Commission for Protection Against Sanitary Risks (COFEPRIS), Cuban Olga Jacobo, director of the Center for State Control of Medicines, Medical Equipment, and Devices (CECMED), and Colombian Mariela Pardo, director of the National Institute for Food and Drug Surveillance (INVIMA), signed the agreement.
AMLAC will serve as a regional integration mechanism, promoting access to safe, effective, and high-quality medications and medical equipment through harmonization and convergence in health regulations.
“If Latin America and the Caribbean remain fragmented, our region will continue to rely on trade with the great powers, which seek low-cost raw materials but sell their finished goods at prices that ensure them large profits,” Svarch said.
AMLAC “will bring us closer to health self-sufficiency and guarantee access to medicines and medical devices in our region,” said Mexican Health Minister Jorge Alcocer.
“It will strengthen the mechanisms for the harmonization and recognition of regulations, to ensure that the registration of a drug or medical device approved by the agency is recognized by the rest of the countries,” said CECMED director.
“We call on all Latin American and Caribbean countries to join this initiative, to work together for the region’s health security,” INVIMA director said, adding that representatives from the countries will meet in Bogotá in May and Havana in June to consolidate the new regional agency.