Mexico: The amendment to the Health Supplies Regulations strengthens the protection of pharmaceutical innovation by introducing patent term compensation and clinical data exclusivity

Mexico - 05 / 07 / 2026

On April 24, an amendment to the Health Supplies Regulations (Reglamento de Insumos para la Salud – RIS) was published, redefining key aspects of Mexico’s pharmaceutical regulatory framework in line with commitments under the USMCA. The changes introduce significant adjustments regarding intellectual property, exclusivity, and regulatory processes, with direct implications for competitiveness between innovative medicines and their generic and biosimilar alternatives.

On April 24, an amendment to the Health Supplies Regulations (RIS) was published in the Official Gazette of the Federation (Diario Oficial de la Federación), mainly aimed at complying with obligations concerning intellectual property rights for pharmaceutical products under the United States-Mexico-Canada Agreement (USMCA).

Below is an overview of the main amendments to the RIS, which are highly relevant to the analysis of exclusivity for innovative products versus market entry for generic and/or biosimilar products:

Definition of new molecule (article 2, section XV). The definition is modified to include references to biopharmaceuticals and combination products already approved. The four definitions of “new molecule” applicable to proceedings before the New Molecules Committee are eliminated; these definitions had been used as grounds for obtaining protection for novel indications in administrative litigation.

Request for technical opinion from the New Molecules Committee (article 166, section III – small molecules, and article 177 bis 2 – biotechnological products). The requirement for a technical meeting between the applicant and the Committee is replaced by a request for an opinion submitted by the Federal Commission for Protection against Sanitary Risks (COFEPRIS), thereby eliminating the preliminary procedure. For products authorized abroad by regulatory agencies recognized by the Ministry of Health, a technical opinion is only required if risks associated with the medicine are identified.

Patent term compensation for approval delays (articles 166 bis 1 to 166 bis 5). The amendment establishes the possibility of requesting that COFEPRIS determine whether unreasonable delays occurred in obtaining marketing authorization, in order to secure patent term extension, subject to the following conditions:

The delay must affect the ability to enjoy exclusivity under a patent protecting the innovative medicine. Such patent must have been identified at the time the marketing authorization application was filed.
Compensation may only be requested with respect to one of the patents listed in the registration.
Compensation will be granted through a supplementary certificate with a term not exceeding five years.
The request must be filed within 60 days following the granting of the marketing authorization for the innovative product.
Delays associated with responses to official actions, judicial proceedings unfavorable to applicants, force majeure events, or acts of God are not considered compensable delays.

Clinical data exclusivity (articles 167 and 167 bis).

A five-year exclusivity period is established as a condition affecting the processing of generic/biosimilar medicines. The exclusivity is linked to the definition of a new molecule.
There are no specific references to exclusivity periods for new indications.

Extension of the term for renewal of marketing authorizations (article 190 bis 1).