COFEPRIS’ New Administration: Main Challenges for 2025

In Mexico, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is the key regulatory body responsible for overseeing health-related products, including pharmaceuticals, medical devices, and food safety. As a consequence of the change in the federal administration, a new head commissioner – Armida Zuñiga – was recently designated. The agency faces several challenges as it prepares for 2025:

1. Tackling Backlog- Streamlining Regulatory Processes for Pharmaceutical Products

A major challenge for COFEPRIS is improving the efficiency and speed of its regulatory approval processes. While there have been significant efforts to modernize the system, delays in the approval of drugs and medical devices remain a persistent issue. This is problematic for both the innovator and generic markets. 

To address this, COFEPRIS has started implementing a series of reforms designed to reduce bureaucratic hurdles and shorten the approval timeline for health products, including digitalization and automatic approvals. Additionally, COFEPRIS will establish specialized committees to expedite the evaluation of novel products, focusing on biopharmaceuticals and medical devices, which require specific expertise.

The implementation of tacit affirmative approvals is still pending. Several key stakeholders have discussed it with the authority, supported by different judicial precedents. 

2. Addressing the Growing Demand for Biosimilar Products

Mexico is experiencing increasing demand for advanced medical products, particularly biologics and biosimilars, as the healthcare needs of its population evolve. While the country has attempted to improve approval processes for biosimilars, market penetration remains low compared to other regions like the United States and Europe.

The new COFEPRIS administration has recognized the need for a more robust framework to support the development and approval of these products. In 2025, the agency is expected to focus on incentivizing domestic manufacturing in biologics by offering regulatory clarity and financial incentives to local manufacturers. COFEPRIS will also work to enhance collaboration between industry players, research institutions, and international organizations to encourage the development of biopharmaceuticals in Mexico.

3. New Regulations of Health Supplies

One of COFEPRIS' most relevant challenges will be the issuance of a broad reform to the Regulations of Health Supplies, which govern the approval, modification, assignment and cancellation of authorizations. The review process has been ongoing for several months, and careful implementation will be necessary to avoid product shortages. 

4. Navigating Intellectual Property (IP) and Patent Challenges

Intellectual property issues will remain a key area of focus for COFEPRIS in 2025. The agency must balance the need to protect IP rights for innovative companies with the necessity of ensuring that affordable medicines are available to the Mexican population. The application of patent laws is expected to be a contentious issue.

A key challenge lies in the review of the linkage system, intended to include a patent review prior to approval of pharmaceutical products. COFEPRIS is expected to continue working closely with the Mexican Institute of Industrial Property (IMPI) and industry associations to refine the patent linkage system, ensuring that regulatory approvals are not unduly delayed by patent disputes.

6. Adapting to New Public Health Challenges

The COVID-19 pandemic has underscored the importance of having a flexible and responsive regulatory agency capable of adapting quickly to new health threats. In 2025, COFEPRIS will need to remain agile in responding to emerging diseases, including potential pandemics and the growing threat of antimicrobial resistance.

To strengthen its preparedness, COFEPRIS should enhance its surveillance systems, improve data sharing and communication with international health organizations, and streamline emergency regulatory pathways for vaccines, therapeutics, and diagnostics.

Looking Ahead

As COFEPRIS prepares for 2025, the new administration faces a complex set of challenges that require careful planning, coordination, and implementation. Addressing issues such as regulatory delays, intellectual property disputes, and new regulations will be essential to modernizing Mexico’s healthcare landscape and ensuring that the benefits of innovation reach the population.

Moving forward, effective collaboration with industry stakeholders, transparent decision-making, and a focus on public health will be key to achieving these goals. By prioritizing regulatory efficiency, COFEPRIS can contribute significantly to the advancement of Mexico’s healthcare system and its ability to address the needs of a growing and diverse population.