The Federal Commission for the Protection against Sanitary Risks (COFEPRIS), under Mexico’s Ministry of Health (Secretaría de Salud), is responsible for regulating the market authorization, compliance review, and post-market surveillance of products such as cosmetics, pharmaceuticals, medical devices, food, and dietary supplements. With regard to cosmetics, COFEPRIS oversees the entire lifecycle of products-including manufacturing, importation, distribution, and commercialization-to ensure that all products placed on the market meet established safety standards.
On July 11, 2025, COFEPRIS officially published in the Official Gazette a landmark agreement aimed at modernizing and streamlining sanitary regulatory procedures, marking a new phase in the transformation of Mexico’s health regulatory framework.
Highlights of the Agreement
1. Elimination of Redundant Procedures and Forms
Several duplicative forms and procedures have been consolidated or eliminated to prevent companies from submitting the same information across multiple regulatory processes.
2. Simplification of Procedure Types
Activities that previously required a full marketing authorization application may now be processed through simplified mechanisms such as a Notice or Report, significantly improving administrative efficiency.
3. Full Digitalization of Processes
All related procedures will be 100% digitalized. Applications, follow-ups, and approvals will now be conducted entirely online through a centralized electronic platform.
4. Faster Response Times and Greater Transparency
COFEPRIS has committed to significantly reducing processing times. Certain notification-based procedures may be confirmed immediately or resolved within a few days. In parallel, the regulatory process will become more transparent and less susceptible to discretionary intervention, thereby strengthening public trust.
Significance of the Agreement
1. For Regulated Industries (e.g., Cosmetics, Pharmaceuticals, Medical Devices):
- The elimination of redundant forms and the full digitalization of submission processes reduce administrative burden and waiting times.
- A faster regulatory response mechanism facilitates quicker product registrations, licensing, and other compliance procedures, thereby improving operational efficiency.
- Standardized procedures and enhanced transparency make it easier for companies to understand and comply with regulatory requirements, minimizing the risk of non-compliance due to misinterpretation of the rules.
2. For Manufacturers and Distributors
- Accelerated approval timelines allow new products to reach the market more quickly, enhancing companies’ responsiveness and competitiveness.
- The unified and digitalized system reduces opportunities for discretionary intervention and strengthens consistency and transparency in regulatory enforcement.
3. For Mexico
This reform represents a major step toward digital governance in the field of health regulation and contributes to the modernization of the national regulatory framework.
The changes are aligned with international best practices and standards established by the World Health Organization (WHO), the Organisation for Economic Co-operation and Development (OECD), and the Pan American Health Organization (PAHO), reinforcing Mexico’s commitment to global regulatory harmonization.
Our Services
- Mexico Cosmetic Product Notification
- Mexico Formula Review for Cosmetic Products
- Mexico Cosmetics Labeling and Claims Compliance Assessment
- Mexico Local Responsible Person Service
- Importer's License Application
- Importation, Storage, and Distribution Setup
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
Further Information
https://www.dof.gob.mx/nota_detalle.php?codigo=5762739&fecha=11/07/2025#gsc.tab=0
