##  [Guide to CTD Registration & Modification for Medicinal Products and Biologics (Annexes)](/mandate/guide-to-ctd-registration-modification-for-medicinal-products-and-biologics-annexes) 

April 3, 2026

The document outlines requirements, formats, and procedures for the application, modification, documentation, labeling, and regulatory compliance involved in the sanitary registration of medicines and biological products in Mexico. It covers CTD structure (5 modules), label projects, regional information, reference drug documentation, WHO prequalification, and guidance from FDA, EMA, and WHO.



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