Mexico's healthcare system faces a strategic choice: to persist in a predominantly administrative model focused on formalities and document verification, or to transition to a modern approach to comprehensive health risk management. Since its creation, the Federal Commission for the Protection against Health Risks (Cofepris) has operated under a paradigm inherited from classical administrative law, which allowed for the establishment of formal controls but is today insufficient in the face of a complex health environment, accelerated technological innovation, and an epidemiological transition dominated by chronic diseases and profound inequalities in access. The problem is not legal, as the legal framework exists. Its performance should not be measured by the number of procedures resolved, but by its ability to anticipate threats, reduce real harm, promote innovation, and the adoption of affordable technologies. Mexico has the legal framework; what is now required is a technical and strategic reinterpretation that places public health at the center, with metrics oriented to health outcomes, institutional leadership, and a regulatory culture based on evidence, transparency, and continuous improvement. In line with the recommendations of the World Health Organization, it is necessary to advance towards a new social contract between the public and private sectors that balances innovation, the production of generics, and affordability. Health regulation must be conceived as a living system. That is, files are reviewed, but the robustness of the processes that generate the information or its correspondence with the potential harm to public health is rarely analyzed. This leads to an inefficient allocation of institutional resources and limits the State's ability to exercise health stewardship based on results. From a public health perspective, it is essential to redirect the model towards comprehensive risk management based on scientific evidence and epidemiological analysis. Sanitary inspections must be scheduled based on explicit criteria derived from the emergence of outbreaks, complaints, or strategic supervision, and supported by statistically representative market sampling. This is not random surveillance, but scientific sampling based on risk. The underreporting of adverse events without knowing the batch number, the origin of the prescription, and its dispensation, and the limited use of available data prevent transforming real-world market experience into institutional learning that supports regulatory improvement plans. Digitizing reports, integrating near real-time analysis, and feeding back to healthcare professionals would allow for the early detection of signals and the adjustment of regulatory decisions, incorporating relevant pharmacogenomic and pharmacogenetic information for the Mexican population. The pre-marketing authorization provided for in the General Health Law should be used strategically according to the national epidemiological profile, particularly for products with components associated with chronic risks. Treating products, services, and establishments with different risk profiles as equivalents dilutes the preventive impact of state action. The rationalization of procedures should be conceived as a mechanism for institutional strengthening. This implies prioritizing regulatory interventions based on three critical variables: the magnitude of potential harm, the probability of occurrence, and the vulnerability of the exposed population. Eliminating requirements without sanitary value, replacing purely administrative notices with focused post-verification schemes, and moving towards one hundred percent digital files would free up technical capacities currently absorbed by bureaucratic tasks. Comprehensive digitization, accompanied by standardized formats with protection and real-time traceability, constitutes an enabling condition for building regulatory intelligence and improving transparency. A central component of this paradigm is risk-based verification. This does not imply automatic prohibitions, but the progressive application of instruments such as voluntary reformulation or conditional authorizations. Finally, it is necessary to incorporate economic accessibility as a complementary regulatory dimension. For products subject to prior authorization, the systematic post-marketing sampling is indispensable to corroborate the veracity of the information presented and to ensure the maintenance of the conditions under which the authorization was granted. Similarly, the strengthening of pharmacovigilance and technovigilance is imperative. Visits to emergency rooms to identify incidents is a good source of information. What is required is a change in criteria. An effective drug loses its social value if it is unreachable for the majority. The challenge is more of a conceptual and operational nature.
