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, the numbers had increased to 5,537 entries and 5,720 exits. This shows significant progress in addressing the backlog that had been inherited.
To continue improving efficiency in handling procedures, the Virtual Ruling Unit was created. This unit consists of 18 ruling officers specialized in digital procedures. In less than three months, the team managed over 1,000 procedures. This achievement marks a key milestone in the digitalization of sanitary regulation in Mexico.
Medicines
Every Monday, Cofepris updates the list of Health Registration applications for generic and biocomparable medicines. This 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 update date is provided for reference. This helps determine the origin of the Opposition Form.
If the holder, licensee, or sublicensee of a patent wishes to express concerns about a potential infringement, they have 10 working days from the day after publication. To notify Cofepris, they must use the «Opposition Form of third party affected by an application for Health Registration of generic or biocomparable drugs,» which is available for download on the website.