Mexico:
Mexican Health Ministry Establishes Requirements For Approving Biotech And Biosimilars
17 February 2015
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 reference drug qualifications.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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