Mexico, Colombia and Cuba Formalize Talks On New Latin American Regulator

Medicines regulators from Mexico, Colombia and Cuba have pledged to create a new agency for medicines and medical devices of Latin America and the Caribbean.

collaboration
Latin American Regulators Commit To Creating New Regional Agency • Source: Shutterstock

Cofepris, Invima and Cecmed, the medicine regulators in Mexico, Colombia and Cuba respectively, have signed a declaration to formalize talks on creating a new regional medicines regulator for Latin America and the Caribbean. The Acapulco Declaration represents a “major milestone” in the journey to establish the agency, make the region more self-sufficient in health care and bring safe, effective and quality medicines more swiftly to patients, said Alejandro Svarch Pérez, director of Cofepris.

The declaration was signed in Acapulco, Mexico, on 26 April and follows proposals made earlier this year on creating a...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

More from Latin America

Brazil Issues Guidance On Regulatory Reliance & Equivalent Authorities

 

Brazilian regulator Anvisa is relying on the decisions of its foreign counterparts as a means of ensuring more quality medicines are made available in the country.

Anvisa To Access US FDA-Reviewed Data For More Robust Evaluations In Brazil

 

Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.

Colombia Signs Agreement With PAHO To Strengthen Regulatory Capacity

 

The deal comes at a time when Latin American countries are increasingly looking to improve the regulatory environment for pharmaceuticals and move towards greater convergence.

Mexico Launches ‘Regulatory Certainty Strategy’ For Biosimilars

 

Mexico is to establish a new regulatory framework that is in line with international standards to encourage domestic production of biosimilar medicines. 

More from Geography

Canada Cuts Red Tape With Single Ethics Review For Trials

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

Nancy Test Circulable Section Geography

 

This is a short description

Diversity Action Plans: What To Submit And When

 
• By 

With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.