Regulatory Pathway for Licensing Biotherapeutics in Mexico

Area of Science:

• Biotherapeutics and recombinant DNA technology advancements.
• Global biopharmaceutical market growth and regional impact, particularly in Mexico.

Background:

• Biotherapeutics are crucial for treating severe diseases, with a significant global market share.
• Mexico represents a substantial market for biotherapeutics, especially monoclonal antibodies.
• Regulatory approval is key for market access, necessitating clear guidelines for product registration.

Purpose of the Study:

• To elucidate the regulatory process for biotherapeutics in Mexico.
• To bridge the gap between regulatory requirements and technical-scientific knowledge for industry applicants.
• To enhance communication between industry stakeholders and regulatory agencies.

Main Methods:

• Adoption of the Common Technical Document (CTD) structure aligned with International Council on Harmonisation (ICH) guidelines.
• Compliance with Mexican regulation NOM-257-SSA1-2014 for biotherapeutic registration.
• Inclusion of Good Manufacturing Practices, labeling, stability, clinical trials, biocomparability studies, and pharmacovigilance in the evaluation framework.

Main Results:

• Mexico utilizes the CTD format for dossier organization, mirroring international standards.
• NOM-257-SSA1-2014 outlines comprehensive requirements for biotherapeutic registration.
• COFEPRIS provides specific guidelines to streamline the application process, supported by expert technical evaluations.

Conclusions:

• The Mexican regulatory framework for biotherapeutics is structured yet requires clearer technical guidance.
• Understanding COFEPRIS's process is vital for successful biotherapeutic registration in Mexico.
• This article provides essential insights into the technical-scientific information required for biotherapeutic applications in Mexico.