2024-01-08 18:00:47
One of the objectives of the Federal Commission for the Protection against Health Risks (Cofepris) is to achieve a transition towards Digital world. With this in mind, the regulatory agency works on implementing best practices to optimize its processes through the use of technological tools.
Cofepris says goodbye to paper to be a digital agency
Based on the above, it makes a constant investment in resources aimed at reducing paper procedures, eliminating lines and reducing the need for physical presence in the offices. In fact, it is expected that the consolidation of its digital transformation occur in the first months of this year.
One of the pillars of this transformation is the launch and operation of the platform Digipris. Its objective is to facilitate procedures and services in a more agile way, based on the best regulatory practices.
How many procedures have been carried out online?
This tool, which has processed 270 thousand procedures completely digitally, not only increases management efficiency but also contributes to the internal transformation of Cofepris towards sustainability, aspiring to become a completely paper-free institution. In addition, it contributes to transparency, accountability and the fight against corruption by guaranteeing the traceability of each procedure.
Prior to entering applications on said platform, each procedure consumed 40 minutes of attention, so thanks to Digipris The equivalent of 180 thousand hours or 20.5 years of continuous work of an adjudicator have been saved.
Furthermore, these 270 thousand procedures would be equivalent to a continuous line of 330 km of users, that is, a line from the headquarters of Cofepris in the Nápoles neighborhood of Mexico City, to the city of León, Guanajuato. Finally, it is estimated that users have saved more than 500 thousand hours of transportation.
As part of this innovation process, the new version of Digipris, Digital Platform for Research and Clinical Trials. It is aimed at specialists from the public and private sectors involved in clinical research in human beings.
New procedures that can now be done online
This platform allows you to request new protocols and modifications to those already authorized. It also makes it possible to carry out entry procedures, review the status and receive resolutions in a digital environment without intermediaries, in a direct and agile manner. In addition, it optimizes the evaluation times of the procedures, so that all of them are on time and without delays.
Based on international standards to streamline the management of Modifications to Health Registration Conditions (MCRS) procedures, Cofepris’ digitalization strategy now includes new classification criteria, simplifying them and dividing them into the categories: minor, moderate and major, for procedures related to biotechnological and biological medicines, vaccines, allopathic, herbal, homeopathic and vitamin drugs, as well as medical devices.
These modifications, implemented since August 2023, have made it possible to efficiently handle 3,264 procedures, thanks to the fact that, in the first phase of the strategy, the Immediate Resolution Window was enabled in the Comprehensive Services Center (CIS) for the reception of MCRS by appointment, with the aim of avoiding waiting times. This window is responsible for managing minor and moderate changes for allopathic, herbal, homeopathic and vitamin medications without narcotics and/or psychotropics.
The implementation of these criteria reduces the administrative burden in the evaluation of each procedure. The purpose of this care model is to gradually expand to the other two categories.
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