In Mexico, the Federal Commission for Protection against Health Risk (COFEPRIS) within the Ministry of Health is responsible for protecting the population against health risks. COFEPRIS regulatory responsibilities span from health-related drugs and technologies (e.g. pharmaceutical drugs, medical devices, blood transfusion and organ transplants, toxic substances, food, tobacco and other environmental factors and conditions). In 1991 the Decree creating COFEPRIS was published, this organism is also responsible for the supervision of clinical trials in Mexico, including research related to cell therapy products. Article 315 of the General Health Law was modified in November 2015 and requires that all establishments obtain a license and authorization from COFEPRIS if they participate in the collection, conservation, analysis, preparation, supply and disposal of organs, tissues and cells.
Current legislation does not address the specific requirements of cell therapy. There is currently (2019) no Official Mexican Norms (referred as NOM) on the use of human stem and progenitor cells for therapeutic and research purposes. However, regulation related to cell therapy has been developed for Mexico by the National Center of Blood Transfusion. If the legislation is approved (Regulation and NOM) it would stipulate among other things: profiles (e.g. training, degrees, certification, etc.) of the medical care personnel involved, source of cell procurement, selection processes of donors, Good Manufacturing Practices, unit processing, analytical determinations, tests and histocompatibility criteria for transplantation, Transplant Committee and registry of clinical trials, among others.
July 21, 2021
July 21, 2021
July 20, 2021