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Vol. 25. Issue 3.
Pages 424-427 (July - September 2024)
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Vol. 25. Issue 3.
Pages 424-427 (July - September 2024)
Special article
Importance of national regulatory agencies and national control laboratories in the face of the COVID-19 pandemic: Experience of Federal Commission for the Protection against Sanitary Risks (COFEPRIS)
Importancia de las agencias reguladoras nacionales y los laboratorios nacionales de control ante la pandemia de COVID-19: experiencia de la Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
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Imelda Rocío Guzmán-Cervantesa,
Corresponding author
irguzman@cofepris.gob.mx

Corresponding author.
, Elías Parra-Hernándeza, Alejandro Ernesto Svarch-Pérezb, Armida Zúñiga-Estradac, Jorge C. Alcocer-Varelad
a Dirección Ejecutiva, Comisión de Control Analítico y Ampliación de Cobertura, Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), Mexico
b Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), Mexico
c Comisión de Control Analítico y Ampliación de Cobertura, Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), Mexico
d Secretaria de Salud de México, Mexico City, Mexico
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Table 1. Analytical methods transferred to the Commission for Analytical Control and Expansion of Coverage (CCAYAC).
Abstract

COVID-19 pandemic has challenged the National Regulatory Agencies (NRAs). One of these challenges is the transfer and validation of new vaccine methodologies so that they are safe, quality, and effective in protecting the population. In this article, we review the process that the Mexican NRA followed for the Vaxzevria and Convidecia vaccines; where communication between manufacturers and NRA allowed the methodological transfer and validation to be carried out before the first batch for application was ready in compliance with WHO guidelines. In this way, the importance of the relationship that must exist between manufacturers and NRAs is manifested to provide an immediate response and provide the population with a means of protection in the event of a public health emergency.

Keywords:
National Regulatory Agency
COVID-19
COFEPRIS
Resumen

La pandemia de COVID-19 ha desafiado las Agencias Nacionales Reguladoras (ARN). Uno de estos desafíos es la transferencia y validación de metodologías de vacunas nuevas para que sean seguras, de calidad y efectivas para proteger a la población. En este artículo, revisamos el proceso que siguió la ARN de México para las vacunas Vaxzevria y Convidecia; en donde la comunicación entre fabricantes y ARN permitió que la transferencia y validación metodológica se realizara antes de que el primer lote para aplicación estuviera listo dando cumplimiento a las directrices de la OMS. De esta manera, se manifiesta la importancia de la relación que debe existir entre los fabricantes y las ARN para dar una respuesta inmediata y brindar a la población un medio de protección ante una emergencia de salud pública.

Palabras claves:
Agencia Reguladora Nacional
COVID-19
COFEPRIS

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