• The new regulatory agency would boost self-sufficiency in strategic supplies; reduce the gap in technological and organizational capabilities; and promote the development of raw materials, pharmaceutical products and health technologies.

The National Institute for Food and Drug Surveillance (Invima) of Colombia; the Cuban Center for the State Control of Medicines, Medical Equipment and Devices (Cecmed); and the Federal Commission for Protection against Health Risks (Cofepris) of Mexico met to advance the creation of a Latin American and Caribbean Medicines Agency (AMLAC).

This initiative promoted by Colombia, Cuba and Mexico seeks to strengthen the public health capacities of Latin America and the Caribbean and contribute to the process of authorizing medicines and vaccines in health emergencies, which would benefit the region's health self-sufficiency plan.

Officials of the health agencies and foreign ministries of the three countries discussed coordinating the work of regulatory convergence that would allow for regional self-sufficiency in strategic supplies and would close the gap in the technological and organizational capacities needed for the development of the raw materials, pharmaceuticals and health technologies that best meet the public health needs of the region.

The initiative also aims to eliminate barriers to the trade of the raw materials needed for medicines and vaccines and would allow for the unified and expedited authorization of medicines and medical devices in health emergencies.

The agencies said that that convergence and recognition of norms and standards in the field of health regulation is a must in a globalized world.

This project was announced in January 2023 at the 7th Summit of Heads of State and Government of the Community of Latin American and Caribbean States (Celac) and will be a regional model of effective regulation, including the inspection of factories and laboratories.

The heads of Invima, Cecmed and Cofepris agreed that the next meetings would be held in Acapulco, Mexico in April and then later in Bogotá, Colombia and Havana, Cuba.

This project contributes to regional integration in health matters. In addition to facilitating the trade of these products in the region, it also helps to ensure access to safe, effective and quality products for the Latin American and Caribbean people.

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