Mexico, Colombia and Cuba, are moving ahead with plans to create a new Latin American and Caribbean Medicines Agency that would work towards regulatory convergence as a means of improving access to medicines and stimulating innovation, said regulators from the three countries. The pharmaceutical industry is in support of a new agency and says it would like to see a new regional body follow in the model of the European Medicines Agency.
Latin America Sets Sights On Creating New Regional Medicines Regulator
Centralized Marketing Authorization Should Be Priority, Says Industry
Regulators in Mexico, Colombia and Cuba have affirmed plans to create a new Latin American and Caribbean Medicines Agency.
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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 Two companies have withdrawn their marketing authorization applications.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.