Commercial Law

New Decree Boosts Domestic Pharmaceutical Investment

On June 2, 2025, a key decree was published aiming to strengthen Mexico’s domestic production of medicines, healthcare supplies, and medical devices, while also promoting scientific research in the country. This measure is part of the federal government's broader effort to reduce reliance on imports, ensure supply stability, and trigger investment within national territory.

Starting in fiscal year 2026, consolidated public procurement processes in the healthcare sector will favor — through a points-based evaluation system — companies with proven investments in Mexico. This includes both existing infrastructure (factories, laboratories, warehouses) and projects under development, as well as scientific research and innovation initiatives.

For Mexican pharmaceutical companies, this represents an immediate competitive advantage in public procurement. Companies with local production capabilities or R&D operations will receive higher scores in federal bidding processes — including for generic medicines, medical devices, and patented or single-source products.

In addition, the decree mandates COFEPRIS (Mexico’s health regulatory agency) to streamline key regulatory procedures such as sanitary registrations, export certificates, raw material import permits, and research protocol authorizations. This long-awaited administrative simplification could significantly reduce time to market.

Another important feature is the creation of the Pharmaceutical Investment Promotion Committee, which will serve as an institutional platform to assess investment proposals with national impact. This committee will allow companies to present concrete projects that may be linked to future government purchases through cooperation agreements.

The decree presents a clear opportunity for both Mexican and foreign companies seeking to establish production or research operations in Mexico. Local investment will not only level the playing field but become a decisive factor for access to the public healthcare procurement market.

At García Barragán Abogados, we assist our clients in designing and executing legal and regulatory strategies to take full advantage of this new framework. From investment structuring to public tender participation, our team supports pharmaceutical companies through every stage of the process.

en_USEnglish