COFEPRIS presents a new Virtual Judgment Unit

Authorities of the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) received a delegation from the Embassy of the United States, before whom they presented the new Virtual Judgment Unit, an unprecedented effort to attend with digital tools the procedures presented before the health authority.

The North American delegation was led by the Embassy’s Health Attaché, María Julia Marinossen, and representatives of the Food and Drug Administration (FDA), the United States Agency for International Development (USAID, for its acronym in English), the Foreign Commercial Service, as well as the Departments of Agriculture and the Environment, to strengthen working ties between the two countries.

During the tour of the new unit, the head of COFEPRIS, Alejandro Svarch Pérez, celebrated the incorporation of 18 adjudicators specialized in digital procedures, who in less than three months have already attended to more than a thousand procedures.

The Virtual Judgment Unit was created in response to the success of the call to the regulated industry to submit procedures via the Internet, announced in February of this year. With a physical space and trained personnel to attend to these procedures, COFEPRIS reaffirms its commitment to having an agile and digital health regulation.

Previously, the process of extensions for health supplies had to be carried out at the headquarters of this regulatory entity every five years, the documentation was received on paper, and the response could mean a wait of weeks or months since adjudicators reviewed files in processes redundant for products with years of evidence in the market. This caused five-year cycles of shortages.

During the visit, heads of the various COFEPRIS commissions presented seven strategic activities, among which the installation of the Good Regulatory Practices Committee stands out, with which it seeks to ensure that all changes in the regulatory framework are consistent and viable; implementation of digital solutions that optimize the evaluation of pharmaceutical products; In addition, reduction of trade barriers for the importation of biotechnological drugs, thereby guaranteeing access to safe, effective and quality treatment.

The major issues for the further development of the pharmaceutical market will be discussed at the Mexican Pharmaceutical Forum that will be organized by the Global Pharmaceutical Leaders’ Club on the 29-30th November 2022 in Mexico City. Secure your delegate place ASAP! Registration is here:

Mexican Pharmaceutical Forum

No Comment.