Abstract

BECERRIL-RUIZ, Víctor Hugo; ORTIZ-REYNOSO, Mariana  and  SANTILLAN-BENITEZ, Jonnathan Guadalupe. History of the regulation of generic drugs in Mexico. TIP [online]. 2018, vol.21, suppl.1, e20180144.  Epub Dec 02, 2020. ISSN 1405-888X.  https://doi.org/10.22201/fesz.23958723e.2018.0.144.

This is a review of the historical development of the regulatory regarding generic drugs in Mexico, with special emphasis both in the Mexican basic drug formulary since 1975 to present and in the official statutes regarding generics and bioequivalence in the versions of 1998 and 2013. The role of generic drugs within the Mexican economy is also discussed, being this country the main drug exporter in Latin America. The use of the dissolution test as a useful in vitro tool in research & development as well as in industrial drugs production is reviewed as well. Likewise, biopharmaceutical classification system, a base model used to state criteria needed to achieve an in vivo test exemption and its relevance to set up a generic drug, is revised. Generic drugs are an important input for Mexican government because they are a key elemental in reducing public health expenses.

Keywords : generic drugs; biopharmaceutical classification system; dissolution test; pharmaceutical regulatory framework.

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