- The new regulatory mechanism would promote self-sufficiency of strategic inputs and reduce the gap in technological and organizational capabilities.
- It would also boost the development of raw materials, pharmaceuticals and health technologies.
- The following meetings to create the first Medicines Agency in Latin America and the Caribbean will be in the cities of Acapulco, Bogotá and Havana.
Using Europe as an example, in the past the Federal Commission for Protection against Sanitary Risks (Cofepris) proposed creating the first Medicines Agency of Latin America and the Caribbean. Through the union and common objectives, it was intended to create a block that would allow more power. The difference is that now it is not only a proposal but a reality.
In this case, the first institutions to confirm their participation are the National Institute for Food and Drug Surveillance (Invima) of Colombia; the Center for the State Control of Medicines, Equipment and Medical Devices of the Republic of Cuba (Cecmed); and the aforementioned Cofepris.
Objectives of the first Medicines Agency in Latin America and the Caribbean
This initiative promoted by Colombia, Cuba and Mexico seeks to strengthen the health capacities of Latin America and the Caribbean. Also support the authorization process for medicines and vaccines in health emergencies, contributing to the health self-sufficiency in the region.
During the meeting of the directors of the health agencies and their respective foreign ministries, the bases were analyzed to initiate an articulated work of regulatory convergence that allows the self-sufficiency of strategic supplies in the region. The idea is to cover the technological and organizational capacity gap for the development of raw materials, pharmaceuticals and health technologies that better respond to the public health needs of these nations.
Drug-free transit between countries
In addition, the initiative seeks remove barriers to trade in raw materials for medicines and vaccines. With this, the unification of the expedited authorization routes for medicines and medical devices in health emergencies will be allowed.
Faced with this proposal, the directors of the agencies in question pointed out that the convergence and recognition of norms and standards in the field of health regulation is necessary in a globalized world.
This project was announced in January 2023 during the VII Summit of Heads of State and Government of the Community of Latin American and Caribbean States (Celac). From the beginning it was said that it would be a regional model to show the efficiency in the performance of regulatory functions, including the inspection process of factories and laboratories, as well as representing an opportunity to respond to clinical research.
The heads of Invima, Cecmed and Cofepris determined that the next technical-operational meetings will be in Acapulco, Mexico in April and later in the cities of Bogotá, Colombia and Havana, Cuba.
This project contributes to the regional integration in health. In addition to facilitating trade in these products in the region, it also helps guarantee access to safe, effective, and quality products for the Latin American and Caribbean population.
Also read:
Pharmaceutical Regulatory Certainty Plan 2022-2030: These are the Cofepris plans
Cofepris proposes to create the Latin American Medicines Agency
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