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Mexican Pharmaceutical Companies Submit Vaccine Registration Requests to Cofepris: Latest Updates and Evaluation Process

Editorial/Quadratín México

MEXICO CITY, October 13, 2023.- The Federal Commission for the Protection against Health Risks (Cofepris) reported that to date it has received four requests from pharmaceutical companies to obtain the health registration for the marketing of vaccines against Covid 19 in the national market.

This action derives from the call issued by Cofepris on September 22 and in compliance with our total commitment to transparency, under the glass box principle,” he stressed in a statement.

Requests: Comirnaty of Pfizer Vaxzevria of AstraZeneca Spikevax of ModernaTx Bivalent spikevax of ModernaTx

Also, he announced the scheduling of the evaluation sessions of these biologicals in the New Molecules Committee (CMN), as part of the transition process from the Emergency Use Authorization to the Health Registry. These sessions will be focused mainly on the evaluation of the clinical performance of the vaccines and will be public through the social networks of this health authority:

“It is important to mention that the CMN is the consultation body that issues the technical opinion on the safety, quality and effectiveness of different health supplies. However, these opinions are not binding for the final authorization granted by Cofepris.

“Through this regulatory process, a pioneer in the world, Cofepris reaffirms its commitment to being an agile, fair and transparent health authority, focused on protecting health and guaranteeing health access with high quality standards,” he stressed.

2023-10-14 00:31:00
#Cofepris #receives #applications #market #vaccines #Covid

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