On July 11, 2025, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) published a landmark Agreement in the Official Gazette of the Federation, marking a decisive step toward the nationwide simplification and modernization of sanitary procedures. This transformative measure reflects COFEPRIS’s ongoing efforts to streamline regulatory processes and reduce administrative burdens across the health sector.
Update
This regulatory move aims to reduce administrative burdens, accelerate processing times, and foster a more agile environment that balances public health protection and national economic development. The reform is expected to benefit businesses and professionals operating in regulated sectors by streamlining their interactions with the health authority and promoting greater regulatory efficiency.
Regulatory Framework
This Agreement is grounded in various legal frameworks, reaffirming the Mexican State’s commitment to regulatory improvement and the constitutional right to health protection. Its legal foundation is primarily supported by the following instruments:
Political Constitution of the United Mexican States – Specifically, Article 4, which establishes the right to health protection, and Article 25, which promotes the implementation of regulatory improvement policies.
General Law of Regulatory Improvement – Enables the simplification of administrative procedures through the issuance of general agreements.
General Health Law and the Internal Regulations of the Ministry of Health – Provide the legal and administrative basis for health-related procedures and institutional actions.
Effects from the RA update
This regulatory update introduces significant operational enhancements aimed at streamlining COFEPRIS procedures, promoting greater agility, transparency, and efficiency. Key improvements include:
Streamlined Procedure Classification
Immediate Resolution: Minor administrative updates—such as changes to address or company name—will be processed swiftly.
In-depth Assessment (Dictamination): Applications requiring detailed regulatory review will undergo a comprehensive technical evaluation by COFEPRIS.
Transition from Permits to Notices or Reports
Reduced Response Times
Elimination of Physical Documentation Requirements
Abolition of Certain Procedures
These measures are expected to convert previously complex and time-consuming procedures into more efficient and user-friendly processes, ultimately benefiting both stakeholders and the health authority through better time and resource management.
Written By:
Abigail López
About ips
The implementation of these new provisions may raise questions about their impact on your specific operations. To ensure compliance with the updated regulations and fully capitalize on the opportunities these simplifications offer, we encourage you to seek specialized guidance. At IPS, our team is ready to help you understand the regulatory changes, answer your questions, and support the effective implementation of these measures.
For expert support, contact us at info@insumosparasalud.com