New Mexican Pharmaceutical Regulation in the Face of the USMCA

June 01, 2026

The reforms published on April 24 regarding pharmaceutical regulation in the country, although technical in nature, have direct implications on matters of high public interest: the protection of innovation, competition among medicines, the entry of generics and biosimilars, and access to safe and effective treatments.

In this context, two relevant reforms were published which, foreseeably, respond to commitments undertaken by the Mexican government within the framework of the formal tripartite negotiations of the USMCA that began on May 27, 2026. The first is an amendment to the Health Supplies Regulation; the second is an amendment that adds various articles to the Regulation for Registrations, Import and Export Authorizations, and Export Certificates for Pesticides, Plant Nutrients, and Toxic or Hazardous Substances and Materials. This publication outlines the key points of the amendment to the Health Supplies Regulations.

Among the amendments and additions to the Health Supplies Regulation (RIS), several changes impacting access to medicines stand out, including the modification of the definition of “new molecule”; the incorporation of patent term adjustments to compensate for unjustified delays in the granting of health registrations attributable to COFEPRIS; the regulation of data protection for clinical or test data under the terms provided by the USMCA; and adjustments to the mechanism linking patents to health registrations.

DEFINITION OF NEW MOLECULE

The definition of “new molecule”, which is an important concept in multiple legal contexts, has been modified to help reduce strategic litigation intended to have (and has had) a significant impact on multiple exclusive rights in the market and providing greater regulatory clarity.

ADJUSTMENT OF PATENT TERMS

The inclusion in the RIS of this new legal concept fulfills one of Mexico´s outstanding obligations to the USMCA regarding industrial property rights, whose implementation was required within 4.5 years of the Agreement’s entry into force.

Requirements

The main requirements for obtaining an extension of the patent term are as follows:

1. That the delay in issuing the health registration is attributable to the COFEPRIS.
2. The patent for which compensation is sought must have been designated by its owner when the application for health registration was filed.
3. The delay must affect the exclusivity conferred on the selected patent from the time of filing the registration application.
4. The holder must file a request for compensation within 60 days of being notified that the registration has been granted, in which a calculation of the new period and justification for the adjustment is proposed.
5. That the holder has not previously requested an adjustment for a different patent for the same drug, and that it has not been registered or commercialized in advance.

Characteristics of the adjusted term

• Only one patent may be compensated per drug, even if the patent holder owns more than one patent in relation to the drug.
• Calculation of the new term will be done by COFEPRIS, who will notify the IMPI so that the Institute may issue a corresponding supplementary certificate.
• The maximum extension of the patent term is 5 years.

PROTECTION OF CLINICAL AND TEST DATA

Clinical and test data refers to the data provided by the owner of a drug that includes a new molecule in order to demonstrate its safety, quality, and efficacy when registered for the first time in Mexico.  The rationale and justification for this protection is based on the cost and effort presumably involved in creating the supporting clinical data.

The essential characteristics of the protection of clinical data are as follows:

• The protected information is the technical and scientific information provided by the developer that supports the safety, quality, and efficacy of the drug.
• This information will only be protected for products containing a new molecule; this excludes, for example, modifications to the originally registered product and new indications.
• Protection granted in Mexico for the first registration of a new molecule is unique, automatic, and valid for a period of 5 years starting from the date the holder is notified that the health registration has been granted, which will provide long-awaited transparency and legal certainty in this area.

LINKAGE

There are only a few changes regarding linkage as a result of the amendments to the RIS. The second paragraph specifically refers to applications for generic or biosimilar drugs to clarify that the COFERPIS-IMPI linkage mechanism applies to registration procedures that do not involve new molecules; it also specifies that IMPI’s response will be based on the list it maintains in the official gazette which was created for the mechanism’s operation.

With these reforms, progress has been made in implementing USMCA provisions that had been delayed. It is commendable that the Mexican government has incorporated certain flexible measures permitted by the Agreement, possibly for the first time, which is a relevant adjustment in the design of the regulatory framework.

In this regard, the changes could have positive effects on the population’s access to generic and biosimilar medicines, which must comply with the same standards of safety, efficacy, and quality as the reference “innovator medicines”.