Mexico admits delays in permit authorizations from Cofepris

The Mexican government acknowledged delays incurred by the Federal Commission for the Protection against Sanitary Risks (Cofepris) in granting registrations or permits for imports of products under its control, such as fertilizers, medical devices, medicines, and food supplements.

Through the World Trade Organization (WTO), the European Commission consulted Mexico about the fact that exports from that block face obstacles due to the “big delays” of Cofepris since 2019 and, above all, from 2020.

The Mexican government responded that it is currently aware of delays in authorizations and that it is intended to improve automated processes and reduce response times at a general level in government entities that manage foreign trade procedures.

Within Cofepris, he added, a paradigm shift has been developed in the approach for timely attention to procedures related to obtaining a sanitary registry for drugs, medicines, food supplements, medical devices, pesticides, and plant nutrients.

To this end, strategies have been established aimed at speed, efficiency and actions aimed at organizing the personnel dedicated to the evaluation of the files.

Among some of the strategies aimed at the search for an agile, fair and transparent regulation is digitization, through the implementation of self-management and electronic procedures submitted through the procedures portal (Digipris), especially in the attention of various notices. and in the effective implementation of digital extensions (medical drugs and devices) under a new legal and regulatory framework.

The government also has the objective of implementing a model unit, focused on the executive sub-directorate of drugs and medicines. The goal is to guarantee the quality, safety, and efficacy of authorized medicines, improve processing times, and reduce the backlog.

The attention of the procedures has been assigned based on priorities (national supply, UNOPS (United Nations Office for Project Services), orphan drugs, recognition days, among the main ones) oriented towards sanitary registries, modifications to the conditions of the Sanitary registration and extensions.

At the same time, a strategy has been drawn up to optimize the care of clinical trial procedures, both phases and bioequivalence.

According to Cofepris, there is an effort to attend to procedures with digital tools and there is a physical space and trained personnel to attend to these procedures, thus reaffirming the commitment to have an agile and digital health regulation.

For products that require prior import permission, it is required to present a sanitary certificate issued by the competent authority of the country of origin and notify Cofepris at the Ministry of Health of the arrival and destination of the merchandise.

Cofepris applies, monitors and certifies compliance with health provisions (for the production, distribution, import and export of products for human use and consumption). It also prepares and issues Official Mexican Standards (NOM).

Likewise, the commercialization, import and processing of Genetically Modified Organisms (GMOs) destined for human use or consumption require the endorsement of Cofepris.

roberto.morales@eleconomista.mx