Mexico has issued several official communications recognizing that requisites imposed by certain foreign agencies to approve pharmaceutical products and medical devices are equivalent to those established under national laws and regulations.  

These communications include recognition of approvals by:

• The WHO prequalification program
• Swissmed
• The FDA
• EMA
• Health Canada 
• The Australian Therapeutic Goods Administration.
• WHO/PAHO reference regulatory agencies

Whereas some of these communications have existed for many years, their use had not been widespread, specifically because applicants did not receive a clear advantage from them on regulatory timelines; products submitted for approval under these communications would be studied on a first in-first out basis, along with all other submissions. 

This situation changed –at least on paper- on November of 2020, as the Ministry of Health Issued a communication that included a significant reduction to regulatory timelines, as it established:

• A 5 working day term to issue product marketing authorizations filed under equivalency agreements, and
• A 3 working day term to issue requirements to applicant, in case the information was not complete, and 
• A tacit affirmative response –meaning that the approvals would be considered as granted if the terms expire.

In spite of this communication the Mexican Regulatory Agency – COFEPRIS- has not observed the shortened deadlines; marketing authorizations have not been issued, for what has now been several months, and the regulator has publicly recognized that they are facing severe backlog.

As a way to counter the inactivity of COFPRIS, - and at the request of one of our clients in the pharmaceutical industry-  we designed a regulatory/litigation strategy.

In the corresponding trial, we have secured favorable injunctions for our client. In the decision, the Court has established:

• That the likelihood of a favorable decision on the merits favors our client, based on legal arguments derived from the above-mentioned expedited approval communications. 
• That COFEPRIS must allow our client to undertake all activities associated to a granted marketing authorization. 

We are confident that we will be able to obtain an eventual favorable decision on the merits, which will further solidify the positive effects derived from this injunction.

Furthermore, the legal strategy can be replicated to benefit other clients and expedite their marketing authorization processes, when facing similar situations. 

At Sánchez Devanny we have substantial experience representing companies in the life sciences industries, including advisory on regulatory scenarios, administrative litigation, and crossover with IP rights.

This newsletter was jointly prepared by Juan Luis Serrano ([email protected]),  Mariajosé Ayala ([email protected]) and Rodrigo Calderón ([email protected]).