Mexico City. The Federal Commission for the Protection against Health Risks (Cofepris) reported that as part of the progress in the process to obtain health records for vaccines against covid-19, which maintain the authorization for emergency use, to date it has been attended to. to three companies.
This is the case of Pfizer SA de CV, which requested health registration for the Comirnaty vaccine (BNT162b2 monovalent XBB 1.5) and has a dossier entered with considerable progress in its evaluation.
ModernaTx was also attended to. Inc. (through its legal representative in Mexico, Asofarma SA de CV) that requested health registration for the monovalent Spikevax vaccine XBB1.5, for which the submission of the dossier for evaluation is pending; and AstraZeneca SA de CV, with which the technical session was completed.
As part of the aforementioned process, he indicated that a program of technical sessions was established for the requesting companies, in order to resolve observations and move towards resolution. This involves the case of vaccines that received a favorable and unfavorable opinion from the Committee on New Molecules (CMN), since Cofepris considers that the vaccines that currently have authorization for emergency use are quality, safe and effective products, which need complete the route with the update of technical and administrative information.
He indicated that companies seeking authorization for the commercialization of said biologicals received advice to structure the documentation and technical requirements; Once completed, they will be evaluated by examiners from the Health Authorization Commission (CAS).
Cofepris highlighted that, as the World Health Organization (WHO) points out, guidance is essential for the adequate interpretation of the regulation, which is why the provisions of international organizations are complied with through the implementation of non-regulatory measures aimed at clarifying : the authorization requirements and their definition, the internal evaluation process, and the time associated with each of the ruling stages.
He explained that technical sessions are a mechanism through which the regulated sector receives guidance on the regulatory provisions of products and services subject to evaluation and surveillance. Likewise, these sessions are part of the New Strategy for Linking with the Regulated Industry created by this authority.
He affirmed that this user orientation model is attached to the Good Regulatory Practices of the WHO, specifically to the principles of clarity, efficiency and transparency expressed in Annex 11 of Good regulatory practices in the regulation of medical products.
2023-11-03 18:52:04
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