COFEPRIS and IMPI issue new mechanisms to encourage the production of generic drugs
18 noviembre 2020


The head of the Federal Commission for Protection against Health Risks (COFEPRIS, in Spanish) José Báez, and the general director of the Mexican Institute of Industrial Property (IMPI, in Spanish) Juan Lozano, on November 13 announced a work process between both organizations to boost the production of generic medicines and promote a competitive environment in the pharmaceutical sector

The cooperation between COFEPRIS and IMPI will make it easier for natural and legal persons to patent registrations of products with industrial and intellectual protection, as well as those due to expire in the next 10 years where it is expected that there will be a generic product at a more accessible price (once the industrial property right has concluded).

As explained by the authorities of both organizations, the work is being developed on the following axes:

Registration of medicines: application and response formats were modified both in COFEPRIS and in IMPI to provide greater clarity about the registration procedures for generic medicines.

Opportunities for new actors in the market: with the coming into force last November 5th of the new Federal Law of Protection to the Industrial Property, the possibility for those interested in producing generic medicines to carry out studies, researches and tests before the expiration of a patent was materialized.

On-line information: from the IMPI’s web page will enable consultation on: a) the list of patents due to expire in the next 10 years; b) patents associated with allopathic medicines (alternative medicine); c) the IMPI’s answers to the COFEPRIS on patents.

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