Last Monday, the Ministry of Health and COFEPRIS published new criteria that expedite the authorization of research protocols in humans.

In the agreement published in the Official Journal of the Federation (DOF), it is stated that the evaluations made by the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA), the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom and the Canadian Health Agency (Health Canada), may be recognized by COFEPRIS as decisions that comply with the quality and ethical standards established in the Mexican regulation and thus speed up the research process in Mexico.

These new criteria represent a greater opportunity to enter the Mexican market with facility.

The trials eligible for the announced reliance must meet the following requirements:

– Be Phase III clinical trials (comparative study to measure safety and efficacy between the new treatment and the standard treatment).

– The drug, biologic and biotechnology will have to be used in key areas such as oncology, pulmonology and cardiology, as well as in others that address pathologies of high epidemiological impact in Mexico, such as diabetes.

– Be active, follow regular regulatory evaluations and not present safety alerts from the AERs or WHO.

COFEPRIS will be in charge of the approval of the protocols and may request additional information or the redesign of the research if it is considered inefficient or does not comply with the established quality and safety standards.

If your clinical trial has the approval of the AERs recognized in the agreement, do not miss the opportunity to take the next step for the expansion of your pharmaceutical development to the Mexican market since these provisions will be implemented as of June 17, 2025.

Authors: Katy Adame and Sabrina Barrientos

Source: Official Journal of the Federation (DOF): https://dof.gob.mx/nota_detalle.php?codigo=5752676&fecha=24/03/2025#gsc.tab=0