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Mexican Health Ministry Establishes Requirements For Approving Biotech And Biosimilars

Author:Mr Mark Mansour, Laurie A. Clarke, Colleen Heisey, Christopher M. Mikson, Emily K. Strunk, Stephanie L. Resnik, Brigid C. DeCoursey, Matthew R. Bowles, Joseph M. Cardosi and Laura E. Malament
Profession:Jones Day
 
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The Mexican Ministry of Health recently completed a regulatory framework for registering biosimilar drugs and biotechnologies used in treating common chronic conditions like diabetes, arthritis, and hypertension. The regulation establishing the guidelines and requirements for approval takes effect this month. Requirements include manufacturing process controls, clinical trial procedures, and...

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