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Regulatory Pathway for Licensing Biotherapeutics in Mexico.

Carlos A López-Morales1, Alejandra Tenorio-Calvo1, Rodolfo Cruz-Rodríguez2

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Mexico

Keywords:
Common Technical Documentbiotherapeutic productsharmonizationlicensingregistrationregulation

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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.