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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 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.
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