Mexico’s medicines regulator, COFEPRIS, says it is streamlining the registration of generic medicines and biosimilars by recognizing registration studies conducted in other countries. The move is part of Mexico’s shift towards greater regulatory reliance.
Mexico Continues Reliance Strategy To Expand Drug Access
Mexico aims to speed up the registration of generics and biosimilars.
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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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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.