- A delegation from the United States was a witness of honor before a milestone in the digitization of health regulation in Mexico.
- In less than three months, more than a thousand procedures for health supplies have been attended to.
- The Virtual Judgment Unit was created in response to the success of the summons to the regulated industry to submit procedures via the Internet.
One of the biggest advantages of technology is that it reduces geographical distances. Now everything is just a click away and even paperwork can now be done remotely. With this in mind the Federal Commission for the Protection against Sanitary Risks (Cofepris) announced an important change that will have many implications.
With the presence of a delegation from the Embassy of the United States, the new Virtual Judgment Unit. It is an unprecedented effort to attend to the procedures presented to the health authority with digital tools.
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 Environment. While the objective of this event was to strengthen the working ties between both countries.
What does it consist of?
During the tour of the new unit, the head of Cofepris, Alexander Svarch Perezcelebrated 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 It 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.
How were the procedures in the past?
Previously, the Processing 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 because reviewers reviewed files in redundant processes for products with years of evidence in the market. This caused five-year cycles of shortages.
During the visit, heads of the various commissions of Cofepris presented seven strategic activities. Among them, the installation of the Committee of Good Regulatory Practices stands out, with which it is sought to ensure that all changes in the regulatory framework have coherence and viability; 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 treatments.
Also read:
16 mandatory requirements that a medical office must meet according to Cofepris
Cofepris prepares the first recertification in its history to be at the level of the FDA
Cofepris presents a new magazine and you can download it here