AMLAC, a regional body for Latin America and the Caribbean, is being set-up to promote greater access to safe, effective medical equipment and medicines through a combination of regional regulations.
On 26 April 2023, the heads of the health agencies of Colombia, Cuba and Mexico, specifically the National Institute for Surveillance of Drugs and Food (INVIMA) of Colombia, the Center for the State Control of Medicines, Equipment, and Medical Devices (CECMED) of Cuba, and Federal Commission for the Protection against Sanitary Risks (COFEPRIS) of Mexico, signed the Acapulco Declaration for the creation of AMLAC (Agencia Reguladora de Medicamentos y Dispositivos Médicos de Latinoamérica y el Caribe), the Latin America and Caribbean Medicines and Medical Devices Regulatory Agency,
The declaration acknowledges the challenges faced by Latin America and the Caribbean in the health, productive, economic and social spheres, especially in times of emergency such as the COVID-19 pandemic, which revealed the existing health inequalities and healthcare system shortcomings in the region during such a magnitude emergency.
Cuba’s Ministry of Foreign Affairs said that: ‘The establishment of AMLAC seeks to achieve health self-sufficiency in Latin America and the Caribbean.’ The Agency will be a mechanism ‘to contribute to regional integration through harmonization and convergence in health regulation, facilitating timely access to safe, effective and quality medicines and medical devices.’
AMLAC’s objective is to join forces for the health security in Latin America and to address health emergencies, particularly when there is a context of systemic inequity that becomes alarming when it comes to access to health supplies, according to the head of COFEPRIS.
The Declaration was signed by representatives of the regulatory bodies for health control and surveillance of the signing countries: Alejandro Search, Head of COFEPRIS in Mexico, Mariela Pardo, who leads INVIMA in Colombia, and Olga Lidia Jacobo Casanueva, Director of CECMED in Cuba.
Also present at the signing of the Declaration were the ambassadors of Colombia, Cuba and Honduras, as well as the Coordinator of the Pro Tempore Presidency of the Community of Latin American and Caribbean States (PPT-CELAC), among others.
The heads of the health agencies of Mexico, Colombia and Cuba have established the commitment to inform and present the progress of their work to CELAC – Community of Latin American and Caribbean States – where the initiative was launched in January 2023.
Currently, 10 nations have joined this new mechanism of regional cooperation, while Argentina, Brazil and Chile have thus far declined to join it. The last face-to-face meetings was held in May 2023 in Bogota, Colombia, and the next one will be held in June 2023 in Havana, Cuba.
The development of biological and biotechnological products in Latin America is very diverse due to the particularities related to numerous factors such as cultural, economic, political and regulatory factors. Therefore, each Latin American country has a unique market and regulatory landscape .
The establishment of AMLAC will ultimately help strengthen mechanisms for harmonization and recognition of regulations, aiming to ensure that the registration of a drug or medical device approved by the agency is recognized by the rest of the member countries.
Regulatory landscape for similar biotherapeutic products in Latin America
Collaboration between regulatory authorities for biosimilars
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1. GaBI Online - Generics and Biosimilars Initiative. Regulation of the registration of biological drugs in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jun 12]. Available from: www.gabionline.net/biosimilars/research/regulation-of-the-registration-of-biological-drugs-in-latin-america
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