Founded in 2001, the Federal Commission for the Protection against Sanitary Risks (Cofepris) has positioned itself as the highest authority on sanitary control and regulation throughout the country. Since then she has been in charge of analyze and authorize the operation of all products, devices and establishments related to health. It ranges from pharmaceutical laboratories, medicines, pharmacies and clinics of all kinds. In sum, all of them are equivalent to almost 10 percent of the Gross Domestic Product (GDP).
While a fairly recurring complaint that you receive is the delay of your bureaucratic procedures. The situation has become even more complicated since the start of the pandemic due to the risk posed by face-to-face meetings. As a solution, through Haste Scheme to Knock Down the Lag (ECAR), launched in May this year, has managed to clear more than 1,400 backlogs, some since 2017.
How does it work?
ECAR facilitates the joint work of Cofepris with manufacturers, importers or laboratories of medicines and medical devices in the attention of historically lagged procedures with priority in those that have the greatest impact on health, which has facilitated the resolution of procedures in 2017, 2018 , 2019 and 2020.
The initiative of the Sanitary Authorization Commission (CAS) consists of a new form of collaboration between the regulated industry and the authority, since pharmaceutical companies and companies transcribe files for a more efficient validation by specialized opinion-makers. This process constitutes the first step in the digitalization process of the regulatory authority.
At the launch of ECAR, 685 pending administrative modifications were contemplated, of which more than 600 have been ruled, that is, almost the total.
Work done so far
This first phase, announced on May 18, 2021, focused on addressing the backlog of administrative modifications to medications, prioritizing drug procedures for the nervous and digestive system, as well as anti-infectives in general for systemic use, in order to facilitate their access to patients.
A month after launching it, the program also included administrative modifications to medical devices. Up to this date, almost 80 percent of the 1,994 procedures registered in this phase have been resolved.
With the most recent expansion of the scheme, Cofepris promotes clinical research in the country, implementing it in 57 new protocols or clinical trials and 809 amendments and inclusions, concluding its ruling this month.
The executive director of Authorization of Products and Establishments, Iván Calderón Lojero, explained that this is the most ambitious phase of the implementation of the scheme.
Calderón Lojero also emphasized that ECAR optimizes processes and speeds up service without losing scientific rigor in the review of lagged files, which determines whether a procedure is approved, prevented or rejected.
Through innovative initiatives such as ECAR, Cofepris advances in addressing the backwardness of past administrations, streamlining bureaucratic processes to facilitate access to quality, safe and effective health supplies, for the benefit of people’s health.