The document is a press release issued by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) on May 22, 2025, reporting a significant improvement in the efficiency of the clinical research protocol approval process in Mexico.

The commissioner announced that, thanks to the digitalization and optimization of internal processes, the approval time for these protocols was reduced by 60%, from 90 days in 2024 to 45 days between January and April 2025. This reduction even exceeds the established legal deadline. Furthermore, the average processing time for amendments was 57 days, representing a 37% decrease.

One of the key advances was the publication of an agreement in the Official Gazette of the Federation on March 24, 2025, allowing for the authorization of protocols previously approved by international agencies recognized by the WHO. This reliance scheme facilitates the harmonization of international standards without compromising national regulation, especially for Phase III clinical studies.

WHOM DOES THIS IMPACT?

The direct impact is felt by patients, researchers and clinical centers, pharmaceutical and biotechnology companies, and the Mexican healthcare system.

CONCLUSION:

The digitalization of COFEPRIS represents a strategic advance that strengthens clinical research in Mexico, improves access to treatments, and positions the country as a regulatory benchmark in the region.