In this paper are discussed essential issues about the concept, characteristics and general functions of sanitary regulation, as well as the principles and main lines of action contained in the Program of Modernization of the Sanitary Regulation, which is being implemented by the Ministry of Health of Mexico. In addition, some considerations are offered regarding the supporting role of such a program, in the context of the free trade era that Mexico is undergoing. After 40 years of an outdated sanitary regulation based in a non-functional licensing concept, the new and improved scheme relies on several amendments to the General Health Law. Thus, the present approach, focuses on a set of flexible, simple and efficient rules, strengthened by proven scientific and technical procedures.