COFEPRIS review times. First half 2026
OVERVIEW
At IPS, we continuously monitor COFEPRIS processing times to identify regulatory trends that help companies better plan their market entry strategies in Mexico. This report compares the agency's performance during the first half of 2026 with 2025.
During 2025, we observed a significant acceleration in processing times, consistent with the regulatory initiatives introduced under Plan México. More recently, we have also seen a considerable number of applications submitted in 2024 and 2025 finally receive resolutions, suggesting a positive shift in COFEPRIS's overall processing capacity.
The exceptionally fast approvals seen in early 2025, when some registrations were granted in less than two months, have not continued. Instead, current data may indicate that approval timelines are stabilizing at more consistent and sustainable levels.
MEASURES
Our analysis considers the time elapsed between COFEPRIS’s official receipt of an application and its final decision. Data is presented as the average time in months per type of application.
FINDINGS
During the first half of 2026, we observed a moderation in COFEPRIS's processing pace compared with the beginning of the year. Nevertheless, the overall regulatory outlook remains positive. Of the 134 applications submitted during this period, more than one-third have already been approved or otherwise finalized. In addition, a significant share of the resolutions issued in 2026 corresponds to applications originally submitted in previous years, suggesting that COFEPRIS continues to reduce its backlog. This trend points toward a more sustainable stabilization of approval timelines rather than the exceptionally short processing times observed in early 2025.
About IPS
At IPS, we simplify the regulatory process for companies entering and growing in the Mexican healthcare market.
Through regulatory expertise and market intelligence, we monitor COFEPRIS activity and transform regulatory data into actionable insights that help companies better plan their market entry strategies. Contact us for more information info@insumosparasalud.com