Clinical Trial Applications in Mexico: decentralization and acceleration of protocol approval

Regulatory Affairs in Latin America

With the goals of accelerating the development of new molecules that improve the healthcare and quality of life of Mexicans, and of stimulating clinical investigation, pharmaceutical innovation and foreign investment in the country, on the 5th of March 2014, the COFEPRIS has authorized the eight National Institutes of Health and the High-Specialty Hospitals Coordinating Commission to pre-approve clinical investigation protocols.

clinical trial phases

Once the Institutes pre-revise the clinical protocol, it would take the COFEPRIS about 20 working days to grant the final approval. This decentralizing action is expected to reduce the total approval timelines to just a month: a third of what it takes today.

During the official designation of the entities, Mikel Arriola, head of the COFEPRIS said: “This is a great window of opportunity. We want more investigation in Mexico, in Mexican patients, we want more and better treatments to be developed and we wantbig pharma companies to invest more in…

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