The volume of generic drug products consumed by the Mexican population grew from 54% to 84% in the last three years, was announced by Mikel Arriola, Commissioner for the COFEPRIS, the Mexican regulatory agency. The announcement was made at the opening of a training session on marketing authorization of allopathic medicines of the Interchangeable Generic Drug Product Manufacturers Mexican Association (Asociación Mexicana de Fabricantes de Medicamentos Genéricos Intercambiables – AMEGI).
Dr. Arriola highlighted that Mexico is a the world leader in generic drug consumption, and that the Mexican people has overcome the myth that generic products are of poorer quality, safety and efficacy profile than those offered by innovative brands. He also mentioned that, thanks to expedite approval of these products, considerable savings are possible, both of out-of-pocket medicines expenditure, and public healthcare costs. Generic products now represent 52% of market share, the remaining 48% corresponding to innovatives.
In the last 29 months COFEPRIS has approved 261 generics of 29 APIs that lost market exclusivity of intellectual property protection.
Regarding administrative streamlining, on February 7th a new “Documental Checklist” system was implemented for marketing authorization applications, in which the content of the dossier is quickly inspected at the moment of submission to assure completion of information and documents. The need for this system was evidenced at noticing that 90% of the applications produced deficiency letters for lack of information. Now dossiers have to “tick all the boxes” to be admitted for revision.
In the last couple of years, COFEPRIS hasn’t speared efforts to increase the market share of generic drug products in Mexico. Actions included strengthening and clarification of the understanding of intellectual property rights, collaborations with the industry, administrative streamlining and education of the population. To illustrate this last point, here are some videos aimed to promote the choice of generics at the time of buying generics. (in Spanish)
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