RAUpdate: Creation of the CENAFyT and its impact on the health sector.
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has formalized the transition from the former National Pharmacovigilance Center (CNFV) to the new National Center for Pharmacovigilance and Post-Market Surveillance (CENAFyT). This institutional update, derived from reforms to the General Health Law (LGS), centralizes the supervision of the safety of medicines and medical devices into a single, highly specialized technical entity. This content is essential for sanitary registration holders, pharmacovigilance units, and medical technology manufacturers, as it establishes a new standard for reporting and regulatory coordination aimed at mitigating sanitary risks in a preventive and unified manner.
Update
On March 9, 2026, COFEPRIS officially announced the creation of the National Center for Pharmacovigilance and Post-Market Surveillance (CENAFyT). This body emerges not as an isolated entity, but as the strategic evolution of the former National Pharmacovigilance Center (CNFV), following the legal modifications made to the General Health Law at the beginning of 2026.
The Secretariat of Health (SA), COFEPRIS itself as the regulatory body, and all members of the National Health System are involved in this process. The importance of this update lies in the unification of surveillance criteria. Historically, pharmacovigilance and post-market surveillance operated under structures that, although coordinated, maintained an administrative separation that could slow down the management of massive data. With CENAFyT, Mexico aligns its regulatory infrastructure with the standards of international reference agencies (such as IMDRF or FDA), consolidating a technical authority that supervises the complete life cycle of health supplies, from their approval to their clinical post-commercialization use.
Regulatory Framework
The regulatory framework that supports CENAFyT is based on a legal hierarchy that guarantees its authority and operational capacity. The analysis of the regulatory impact is divided into the following key areas:
Reforms to the LGS (January 2026): These constitute the legal basis that grants CENAFyT legal existence, elevating its administrative status and providing it with express powers to coordinate both surveillance systems (drugs and medical devices).
Technical Update of Mexican Official Standards (NOM): CENAFyT assumes the responsibility of supervising and, where appropriate, proposing updates to the current standards:
NOM-220-SSA1-2016: The update implies a more rigorous monitoring of Adverse Drug Reactions (ADR) and Events Supposedly Attributable to Vaccination or Immunization (ESAVI).
NOM-240-SSA1-2012: The reporting of adverse incidents related to medical devices, in vitro diagnostic devices, and software as a medical device is strengthened.
Effects from RAUpdate
The transition to CENAFyT generates immediate and long-term effects on the pharmaceutical and medical device industries:
Optimization in signal management: By concentrating information in a single technical center, greater efficiency is expected in the detection and evaluation of alert signals associated with adverse incidents. For the industry, this could translate into more structured communication with the authority and a potential reduction in response times to regulatory safety inquiries.
Rigor in compliance: Companies must review and, where appropriate, update their standard operating procedures (SOPs) to ensure that institutional references, as well as reporting channels, are aligned with CENAFyT as the central point of reception and evaluation.
Trend towards data-driven surveillance: CENAFyT is expected to promote the use of digital tools and integrated databases for the management of safety information. In this context, organizations may be obliged to strengthen the digitization of their surveillance processes and adopt international standards for information exchange.
Real-world scenario: In the case of drug-device combinations, the reporting of an incident could previously be located in an area of intersection between pharmacovigilance and post-market surveillance. With CENAFyT, a clearer path is expected for the comprehensive evaluation of the event, allowing for a more precise determination of whether the origin corresponds to the drug, the device, or their interaction, which could streamline decision-making aimed at patient protection.
Platform unification: Holders of sanitary registrations must migrate their reporting flows towards an integral structure managed by CENAFyT, which implies operational harmonization in the management of safety information. This unification could have direct impacts on:
Reporting deadlines: Although the NOMs establish the applicable regulatory timelines, centralization in CENAFyT could favor a more agile and homogeneous reception and evaluation of reports, reducing the variability in analysis times by the authority.
Risk management: The integration of information into a single platform could facilitate the implementation of more dynamic and integral Risk Management Plans, by allowing a more complete evaluation of incidents based on the risk profile and the context of use of the Medical Device.
These effects will be subject to the degree of operational and technological maturity that CENAFyT achieves in its implementation.
Written By:
Gabriela Pedraza
Expert in the Post-Market Surveillance of medical devices, including the management and notification of adverse incidents, as well as compliance with applicable regulatory requirements. Provides strategic consulting to health sector companies to ensure regulatory compliance in Post-Market Surveillance matters, strengthening patient safety and product traceability in the market.
About IPS
At IPS, we understand that the regulatory evolution toward CENAFyT demands precise technical adaptation from the regulated sectors. We have an expert team to support your organization in updating its Post-Market Surveillance Units, developing risk management plans, and strictly complying with the new provisions of the General Health Law. Contact us for more information: info@insumosparasalud.com