Perspectives for licensing vaccines in Mexico

Area of Science:

• Public Health
• Regulatory Science
• Vaccinology

Background:

• Vaccines are a critical public health tool, with Mexico ranking second in Latin America for COVID-19 vaccinations.
• Regulatory approval is essential for vaccine accessibility in Mexico, involving an interplay between authorities and applicants.
• Mexico aligns with International Council for Harmonisation (ICH) standards, utilizing the Common Technical Document (CTD) for vaccine submissions.

Purpose of the Study:

• To elucidate the regulatory requirements and processes for vaccine approval in Mexico.
• To provide a comprehensive guide for researchers and manufacturers regarding vaccine licensing and emergency use authorization.
• To specifically address the requirements for COVID-19 vaccines in Mexico.

Main Methods:

• Review of guidelines and regulations published by the Secretariat of Health (SALUD) and COFEPRIS.
• Analysis of the Common Technical Document (CTD) framework adopted by Mexico.
• Description of the processes for vaccine licensing and emergency use authorization (EUA) by COFEPRIS.

Main Results:

• Mexico's regulatory framework for vaccines encompasses GMP, labeling, stability, clinical trials, biocomparability, and pharmacovigilance.
• COFEPRIS, the national regulatory agency, manages vaccine approval through licensing and EUA pathways.
• The study presents up-to-date information on vaccine approval requirements, including those for COVID-19 vaccines.

Conclusions:

• Understanding Mexico's regulatory landscape is crucial for vaccine manufacturers and researchers.
• The adoption of CTD and international harmonization facilitates foreign vaccine evaluation.
• This work offers a comprehensive resource for navigating vaccine approval processes in Mexico, particularly for COVID-19 vaccines.