- Cofepris presumed that during 2022 it closed 79 irregular surgical clinics for the first time and imposed a total of 23 million pesos in fines.
- This strategy guarantees the safety, quality, and efficacy of medicines in Mexico and the United States.
- Both authorities work on food safety for the benefit of the health of the populations of both nations.
The Federal Commission for Protection against Sanitary Risks (Cofepris) and the Food and Drug Administration of the United States government (FDA) held their first high-level meeting in 2023. The objective was to establish the execution plan for this year and thus guarantee the safety, quality and efficacy of medicines, as well as food safety for the benefit of the health of the populations of both nations.
The holder of cofepris, Alejandro Svarch Pérez, presented to the US delegation, led by the director of the FDA’s Latin America Office, Katherine Serrano, the progress of this commission during 2022 in different areas. For example, in terms of health surveillance The Mexican regulatory agency closed for the first time 79 irregular surgical clinics and imposed a total of 23 million pesos in fines.
Results of digitization in Mexico
In addition, Svarch Pérez announced the advances and benefits of digitization that the health authority has implemented, through the DIGIPRiS platform. In this modality, 44,000 procedures have been handled, including three types of notices. These procedures, called self-management, receive an answer automatically and can be carried out 365 days a year, 24 hours a day from anywhere.
Regarding the New Linkage Strategy with the Regulated Industry, established by the federal commissioner of Cofepris, and which consists of more direct contact with representatives of the different sectors, the implementation of EducaPris was obtained as a result, which registers more than 70 sessions broadcast live.
Regarding the achievements made during 2022, Alejandro Svarch highlighted that Cofepris managed to reduce the backlog in terms of clinical trials. With this, he managed to go from 20 to 80 new records per month, which means bringing patients closer to future therapeutic options.
Likewise, the meeting shared the three priorities of the Mexican health agency for 2023, which are in terms of food, pharmaceuticals and medical devices.
Collaborative work between the United States and Mexico
Katherine Serrano recognized the advances presented by the Mexican authority and specified those issues in which there is interest in continuing to work together for the benefit of the health of the populations of the United States and Mexico.
The areas where collaboration will be deepened are: medical devices, where it is intended to align regulatory frameworks and participate in the International Medical Device Regulators Forum (IMDRF); and the Medical Device Audit Program (MDSAP).
In terms of medicines, support will continue for the implementation of the guidelines of the International Council for the Harmonization of Technical Requirements for Pharmaceutical Products for Human Use (I).
future goals
These activities will promote the implementation of recognition mechanisms that increase access to safe, quality medical products, and the strengthening of their supply chain for the benefit of thousands of patients.
Additionally, the analysis of genomic sequences of pathogens isolated from food will be promoted; training in traceability in cases of outbreaks to strengthen collaboration in the attention of those that are related to priority products; as well as training in the safety of agri-food products.
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