2025 NATIONAL QUALITY INFRASTRUCTURE PROGRAM

On February 17, 2025, the National Quality Infrastructure Program 2025 (hereinafter, the “Program”) was published in the Official Federal Gazette. The Program aims to plan, coordinate, and inform the public about the standardization, metrology, and normalization activities that will take place nationwide during 2025.

The Program includes the creation and modification of various Official Mexican Standards (hereinafter, the “NOMs”), which could have significant implications for multiple sectors, including the pharmaceutical, medical device, and healthcare services sectors, as well as consumer protection and other areas related to health safety, surveillance, and quality control of health products. The NOMs that the Program considers for modification during 2025 include the following: 

1. Medicines.

• NOM-177-SSA1-2013, Establishing the tests and procedures to demonstrate that a medicine is interchangeable. Requirements applicable to Authorized Third Parties conducting interchangeability tests. Requirements for conducting biocomparability studies. Requirements applicable to Authorized Third Parties, Research Centers, or Hospital Institutions conducting biocomparability tests.

• NOM-059-SSA1-2015, Good manufacturing practices for medicines.

• NOM-073-SSA1-2015, Stability of drugs and medicines, as well as herbal remedies.

• NOM-249-SSA1-2010, Sterile mixtures: nutritional and medicinal, and facilities for their preparation.

2. Health.

• PROY-NOM-262-SSA1-2024, Good clinical practices.

• NOM-004-SSA3-2012, Medical records.

• NOM-253-SSA1-2024, Provision of human blood and its components for therapeutic purposes.

• NOM-036-SSA2-2012, Disease prevention and control. Administration of vaccines, toxoids, fabotherapeutics (sera), and immunoglobulins in humans.

• PROY-NOM-220-SSA1-2024, Installation and operation of Pharmacovigilance.

• NOM-210-SSA1-2014, Products and Services. Microbiological testing methods. Determination of indicator microorganisms. Determination of pathogenic microorganisms.

• NOM-048-SSA1-1993, Establishing the standardized method for health risk assessment due to environmental agents.

• NOM-199-SSA1-2000, Environmental health. Blood lead levels and actions as criteria to protect the health of the non-occupationally exposed population.

• NOM-230-SSA1-2002, Environmental health. Water for human use and consumption, sanitary requirements to be met by public and private supply systems during water management. Sanitary sampling procedures.

3. Medical devices.

• PROY-NOM-241-SSA1-2024, Good manufacturing practices for medical devices.

• PROY-NOM-137-SSA1-2024, Labeling of medical devices.

• PROY-NOM-240-SSA1-2024, Implementation and operation of technovigilance.

4. Prepackaged food and non-alcoholic beverages.

• NOM-051-SCFI/SSA1-2010, General labeling specifications for prepackaged food and non-alcoholic beverages – Commercial and health information.

• NOM-218-SSA1-2011, Products and services. Non-alcoholic flavored beverages, their frozen counterparts, concentrated products for their preparation, and caffeine-added beverages. Specifications and sanitary provisions. Testing methods.

The Program provides a preliminary justification for the creation and modification of the NOMs referenced in its content, whose implementation will be subject to the respective public consultation processes and formal publication in the Official Gazette of the Federation. The publication can be found at the following link: https://www.dof.gob.mx/nota_detalle.php?codigo=5749334&fecha=17/02/2025#gsc.tab=0

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