COFEPRIS Opens Public Consultation on Five Draft NOMs

Mexico’s health regulator has opened a public consultation on five draft Official Mexican Standards (NOMs) as part of the regulatory commitments outlined in the federal Plan México for the pharmaceutical sector.

The Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) published the draft standards in the Official Gazette of the Federation (DOF), initiating a review process aimed at updating regulatory requirements for medicines, herbal remedies, sterile mixtures, and selected environmental health issues.

Three of the draft NOMs focus directly on pharmaceutical regulation. PROY-NOM-072-SSA1-2025 addresses labeling requirements for medicines and herbal remedies, while PROY-NOM-177-SSA1-2025 establishes criteria for conducting bioequivalence, comparative bioavailability, biowaivers, and comparative dissolution profile studies. A third proposal, PROY-NOM-249-SSA1-2025, covers the preparation and dispensing of sterile nutritional and medicinal mixtures.

In parallel, COFEPRIS released two additional draft standards related to environmental health. PROY-NOM-003-SSA1-2025 focuses on labeling requirements for paints and related products, and PROY-NOM-199-SSA1-2025 sets parameters for blood lead concentration levels.

The publication of these drafts marks the start of a 60-day public consultation period, during which stakeholders may submit technical and regulatory comments. The consultation period will conclude on March 5, 2026, according to the notices published in the DOF.

COFEPRIS says that comments must be submitted in Spanish to the National Advisory Committee for Standardization on Regulation and Sanitary Promotion. Submissions may be delivered in person at the committee’s offices in Mexico City or sent electronically via the agency’s designated email address.

The commission also made available a standardized format for submitting comments on draft NOMs, which can be downloaded through its official channels.

Through this process, COFEPRIS reiterated its commitment to regulatory improvement in the areas of health supplies and environmental health. The agency says the proposed updates seek to align technical criteria, regulatory requirements, and compliance obligations with a risk-based public health protection approach, while also strengthening transparency and participation from authorities, industry, academia, and civil society.

The scope and timing of the proposed updates also coincide with a leadership transition at COFEPRIS, placing added attention on how the next phase of regulatory implementation and oversight will be managed. 

Last week, President Claudia Sheinbaum named Víctor Hugo Borja as the new head of COFEPRIS. Borja replaces Armida Zúñiga and assumes the role as part of a transition the Ministry of Health says will prioritize continuity in regulatory work and public health protection. The Ministry of Health says the leadership change aims to ensure an orderly transition and maintain ongoing efforts to safeguard the population from sanitary risks

The Ministry of Health says Borja’s technical background, management experience, and academic trajectory position him to further strengthen COFEPRIS’ regulatory role. The ministry reiterated its commitment to ensuring continuity in COFEPRIS’ work during the transition, underscoring the agency’s relevance for public health outcomes and regulatory certainty for industry.

In 2025, COFEPRIS authorized 183 clinical trials, representing potential pathways for the development of new medical treatments for a range of diseases. The agency also granted 312 sanitary registrations for medicines, including allopathic, homeopathic, herbal, biotechnological, vitamin-based products, nutrition formulas, and vaccines, covering a total of 127 million authorized doses, as well as 2,450 registrations for medical devices.