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Vaccinations01:51

Vaccinations

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Overview
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Microorganisms in Medicine and Therapeutics01:29

Microorganisms in Medicine and Therapeutics

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Microorganisms play a fundamental role in vaccine development, gene therapy, and therapeutic production. Their biological properties are harnessed to advance medicine and public health. Beyond immunization, microorganisms contribute to gut health, antibiotic synthesis, and genetic disease treatment.Live Attenuated and Inactivated VaccinesLive attenuated vaccines, such as the measles, mumps, and rubella (MMR) vaccine, utilize weakened forms of pathogens to closely resemble natural infections.
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Cancer Vaccines01:30

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Cancer treatment vaccines are a rapidly evolving field that offers a promising approach to immunotherapy. Unlike traditional vaccines that prevent diseases, cancer treatment vaccines are designed to treat existing cancers by stimulating the immune system to recognize and attack cancer cells.
Cancer vaccines come in two categories: preventive (prophylactic) and treatment (active). Preventive vaccines, such as the Human Papillomavirus (HPV) vaccine, protect against viruses that cause certain...
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Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
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Drug Regulation01:25

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Related Experiment Video

Updated: Sep 4, 2025

Cell-Free Scaled Production and Adjuvant Addition to a Recombinant Major Outer Membrane Protein from Chlamydia muridarum for Vaccine Development
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Perspectives for licensing vaccines in Mexico.

Eriko Padron-Regalado1, Emilio Medina-Rivero1

  • 1New Developments Department, Landsteiner Scientific, S.A. de C.V. Prologacion 4 Norte No. 234. Parque Toluca 2000, Toluca, Estado de Mexico P.C. 50200, Mexico.

Vaccine
|July 14, 2022
PubMed
Summary

This study details 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:

Keywords:
ApprovalCOFEPRISCOVID-19CTDICHVaccine

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  • 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.