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)

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.