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.
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.
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Brazil’s drug regulator ANVISA has also published its first post-marketing authorization monitoring reports on advanced therapies Yescarta, Zolgenma, Kymriah, Carvykti and Luxturna.
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Health technology assessment bodies in England, the US, Canada, Australia, the Netherlands and Colombia have joined forces to produce guidance for drug developers on using surrogate endpoints for cost-effectiveness analyses.
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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.
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Mexico is to establish a new regulatory framework that is in line with international standards to encourage domestic production of biosimilar medicines.
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.