The new AMLAC agency would promote the self-sufficiency of strategic inputs and the reduction of the gap in technological and organizational capacities for the development of raw materials, pharmaceutical products and health technologies.

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 Federal Commission for the Protection against Sanitary Risks (Cofepris) of Mexico, have taken the first steps to foster the creation of the Latin American and Caribbean Medicines Agency (AMLAC).

This initiative seeks to strengthen health capacities and support the authorization process for medicines and vaccines in health emergencies, contributing to the region's health self-sufficiency plan.

Regulatory convergence towards self-sufficiency of strategic inputs

During the meeting of the directors of these agencies, the basis was discussed to initiate an articulated work of regulatory convergence that allows the self-sufficiency of strategic inputs in the region, covering the gap in technological and organizational capacities for the development of raw materials, pharmaceutical products and health technologies that better respond to public health needs.

Elimination of barriers of raw materials for medicines

In addition, the initiative seeks to eliminate barriers to the trade of raw materials for medicines and vaccines and will allow convergence in the expedited authorization routes for medicines and medical devices in health emergencies.

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.

AMLAC will be a regional model

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)

and will be a regional model to show the effectiveness 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, Bogotá - Colombia and Havana - Cuba.

This project contributes to health integration, not only to facilitate the trade of these products in the region, but also to guarantee access to safe, effective and quality products for the Latin American and Caribbean population.

(Taken from consultorsalud.com)