Mexico’s regulator, Cofepris, wants to drive local production and development of biosimilar medicines to increase access through a new regulatory and operational framework for these products. The plans include the creation of several new bodies, including a new Council for National Pharmaceutical Development.
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.
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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 Two companies have withdrawn their marketing authorization applications.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.