COFEPRIS 2025: Regulatory advances and international alignment
By the close of 2025, the Federal Commission for Protection against Sanitary Risks (COFEPRIS), has consolidated a transformation focused on agility, transparency, and international recognition.
The following are the key milestones that defined the year:
1. Boosting Innovation and Healthcare Access
Clinical Trials: 183 new protocols were authorized, fostering the development of cutting-edge medical treatments in Mexico.
Sanitary Registrations: 312 registrations were granted for medicines (including biotechnologies and vaccines) and 2,450 for medical devices, strengthening the supply of essential health supplies. In our February edition of IPSNews, we will share a detailed analysis of COFEPRIS resolution times throughout 2025. This report will provide key insights into the efficiency and trends of the regulatory process.
Vaccines: Over 127 million doses were approved, with their safety and efficacy guaranteed through analysis by the National Reference Laboratory.
2. Administrative Efficiency and Legal Reform
Streamlining Procedures: Following the publication of 11 agreements in the Official Gazette of the Federation (DOF), COFEPRIS reduced its administrative burden from 287 to just 106 procedures, eliminating unnecessary bureaucracy.
Registration Validity: The reform to the General Health Law was approved to extend the validity of sanitary registrations from 5 to 10 years, providing greater certainty to the industry.
Digitalization: Implementation of digital verifications and the coordination of the new Federal Sanitary System.
3. Sanitary Surveillance and Safety
Operations: More than 259,000 verification visits were conducted, resulting in the seizure of 105,000 irregular medicines and medical devices.
Alerts: 112 sanitary alerts were issued to protect the population from deceptive advertising and high-risk products.
4. Leadership and Internationalization
Path to WLA: In just six months, COFEPRIS increased its implementation of international standards from 10% to 90%, allowing it to formally apply for recognition as a WHO Listed Authority (WLA).
Global Alliances: Ties were strengthened with elite agencies such as the EMA (Europe), ANVISA (Brazil), and the Danish Medicines Agency, seeking mutual recognition schemes to expedite the registration of innovative products in Mexico.
The year 2025 marks a transition toward an updated technical framework for COFEPRIS, characterized by increased administrative efficiency and closer alignment with international standards. However, the consolidation of this system remains an ongoing process, with key initiatives, such as the full implementation of reliance pathways, still pending. These developments establish a new regulatory baseline while highlighting the areas of opportunity that will define the agenda for the coming year.
