In Mexico, the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) within the Ministry of Health, is charged with protecting the public against health risks. COFEPRIS' regulatory responsibilities span from health-related drugs and technologies (e.g. pharmaceutical drugs, medical devices, blood, and organ transplants), toxic substances, food, tobacco, and other environmental factors and conditions. The General Health Law of 1984 grants COFEPRIS the aforementioned authority. COFEPRIS is also responsible for the oversight of clinical trials in Mexico including research involving cellular therapy products. Chapter 14 of the General Health Law was recently amended and requires all establishments obtain a license and authorization from COFEPRIS if it is involved in the collection, analysis, preparation, and disposition of organs, tissues, and cells.
At the time of this writing (January 2014), current legislation and official Mexican norms (commonly referred to as NOMs) do not address cellular therapy-specific requirements. However, cellular therapy-related regulations are planned for Mexico. It is envisioned that secondary legislation will be developed that stipulates the conditions required to perform clinical trials, the quality framework for establishments, and other requirements for human cell and tissue-based products and organs.