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.

Cofepris

In 2018, there were 5,028 entries and 1,741 exits. By 2022, these figures increased to 5,537 entries and 5,720 exits. This reflects substantial progress in addressing the inherited backlog.

To enhance efficiency in handling procedures, the Virtual Ruling Unit was established. This unit comprises 18 officers specialized in digital processes. Within just three months, the team successfully managed over 1,000 procedures. This milestone represents a significant step in the digitalization of sanitary regulation in Mexico.

Medicines

Every Monday, Cofepris updates its list of Health Registration applications for generic and biocomparable medicines. This list is published online for easy access.

The updated document includes applications received during the previous week, from Monday to Friday. At the end of the list, the publication date is clearly stated. This date is essential to determine the origin of the Opposition Form.

Patent holders, licensees, or sublicensees who identify potential infringements have 10 working days to raise concerns. This period begins the day after the publication of the list. To notify Cofepris, they must complete the «Opposition Form of third party affected by an application for Health Registration of generic or biocomparable drugs.» This form is available for download on the Cofepris website.