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April 27, 2023
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Cuba, Colombia and Mexico agree to create the Medicines Regulatory Agency

Cuba, Colombia and Mexico agree to create the Medicines Regulatory Agency

(EFE) the creation of the Regulatory Agency for Medicines and Medical Devices of Latin America and the Caribbean (Amlac).

Through a statement, the Federal Commission for the Protection against Sanitary Risks (Cofepris) of Mexico reported that together with the National Institute for Food and Drug Surveillance (Invima) of Colombia, and the Center for State Control of Medicines, Equipment and Devices Doctors (Cecmed) from Cuba signed the agreement.

“It was agreed to keep the pro-tempore presidency of the Community of Latin American and Caribbean States (PPT-Celac) duly informed about the process of establishing Amlac”

According to Cofepris, the Acapulco Declaration “recognizes the challenges that Latin America and the Caribbean face in the health, productive, economic and social fields, especially in times of emergency such as the Sars-CoV-2 pandemic.”

For this reason, the creation of Amlac was proposed “as a mechanism to contribute to regional integration through harmonization and convergence in health regulations, in favor of access to safe, effective and quality medicines and medical devices.”

The Declaration also invited the regulatory authorities of Argentina, Brazil and Chile to join this initiative and summoned the South Centre, an intergovernmental organization of developing countries to which Colombia and Cuba belong, to add its technical and political support on the international stage. .

“It was agreed to keep the pro-tempore presidency of the Community of Latin American and Caribbean States (PPT-Celac) duly informed about the Amlac constitution process, in order to promote a broad exchange of knowledge and receive contributions from the countries interested members,” the note stated.

It was also noted that one of Amlac’s main strategies is to “implement the health self-sufficiency plan” designed by the Economic Commission for Latin America and the Caribbean (Cepal), which was announced during the Celac 2021 summit, through a solidarity alliance between Invima, Cecmed and Cofepris.

At the time, the Secretary of Health of Mexico, Jorge Alcocer, described the signing of the agreement as a milestone that will contribute to achieving the goals of sanitary self-sufficiency among the nations of Latin America and the Caribbean.

In addition, it was established that the next face-to-face meetings will be in May 2023 in Bogotá, Colombia, and in June 2023 in Havana, Cuba.

While the head of Cofepris, Alejandro Svarch, pointed out that when talking about health regulation, a vision generally prevails that conceives it as an instrument to solve market failures and an intervention mechanism to promote economic competitiveness.

In addition, it was established that the next face-to-face meetings will be in May 2023 in Bogotá, Colombia, and in June 2023 in Havana, Cuba.

The results of the work for the constitution of the agency will be presented to the rest of the members of Celac, under the coordination of the Pro Tempore Presidency of Celac.

At the meeting, the representatives of the three countries pledged to work together to promote health self-sufficiency in the region.

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