Cofepris: procedures and digitalization in Mexico

Mexico‘s Federal Commission for Protection against Health Risks (Cofepris) is undergoing a transformation process, one of the strategic axes of which is digitalization.

According to the Mexican government, this process is designed under a paperless government policy, which eliminates the discretional nature of the procedures handled by this institution.

This initiative speeds up legal response times, reduces the administrative burden on citizens and consolidates a digital platform that promotes transparency, accountability and the fight against corruption.

Thus, 52% more new generic drug registrations were granted from January to August 2022 compared to the same period of the previous year.

With this, it went from 160 to 243 authorizations, highlighting that the number of procedures attended in 2022 represents an increase of 228% compared to 2018.


Indeed, in 2018, 5,028 entries and 1,741 exits were obtained, while in 2022, 5,537 entries and 5,720 exits were obtained, a result that shows the progress in addressing the backlog that had been inherited.

For this reason, and in order to advance towards effectiveness and efficiency in the handling of procedures, the Virtual Ruling Unit was developed, made up of 18 ruling officers specialized in digital procedures, managing to handle more than 1,000 procedures in less than three months, representing a milestone in the digitalization of sanitary regulation in Mexico.


For its part, every Monday, Cofepris updates the list published electronically with applications for Health Registrations for generic and biocomparable medicines. The list is published electronically.

The updated list includes applications received during the previous week from Monday to Friday.

At the end of the list, the date of update is indicated as a reference to determine the origin of the Opposition Form.

The holder, licensee or sublicensee of a patent that wishes to express its opinion on a potential infringement has 10 working days from the day following the publication to notify the Cofepris through the «Opposition Form of third party affected by an application for Health Registration of generic or biocomparable drugs», which can be downloaded from the web page.


Redacción Opportimes