Amendment to the Regulations for Health Supplies

On April 24th 2026, was published in the Official Gazette of the Federation (“DOF”) on “Decree reforming and adding various provisions to the Regulations for Health Supplies” (he "Decree“), which introduces relevant modifications in matters of health registration, data protection, linkage of patents and biotechnological medicines.

The changes are of particular relevance to pharmaceutical companies, developers of innovative medicines, manufacturers of generics and biosimilars, as well as patent holders in the health supplies sector.

Fundamental aspects

New definition of New Molecule.  The Decree updates the definition of “New Molecule” to refer to any drug, biopharmaceutical or substance with therapeutic, preventive or rehabilitative activity, alone or in combination, contained in a medicine or biological product, that does not have prior health registration in national territory.

Evaluation of new molecules.  For medications containing new molecules, the Ministry of Health, through the Federal Commission for Protection against Sanitary Risks (“COFEPRIS”), will request the technical opinion of Committee on New Molecules as part of the sanitary registration evaluation process. This opinion will not be required when the application already has prior authorization issued by a foreign regulatory authority recognized by the Ministry, unless a risk associated with the drug is identified. The Committee will be composed of heads of COFEPRIS departments and external experts with scientific, technical, academic, and regulatory experience. The resolution must be issued within a maximum term of 180 days from the submission of the application.

Supplementary patent certificates

One of the most relevant new features of the Decree is the introduction of the supplementary certificates, a mechanism by which the holder of a health registration may request compensation when there are delays unreasonable attributable to the Secretariat in the processing of the registration, provided that said delay affects the exploitation of the exclusivity of a patent indicated from the filing of the application.

The supplementary certificate will be issued by the Mexican Institute of Industrial Property (“IMPI”) and will adjust the validity of one of the drug's patents, without being able to exceed five yearsCompensation may only be requested for one patent per delay, and the request must be submitted within the within 60 business days. counted from the date of notification of the health registration.

The compensation request is unfounded when, among other assumptions: (i) the patent is part of a drug that has already obtained a prior registration; (ii) the patent grant number has not been indicated in the original application; or (iii) the drug has been marketed before obtaining the sanitary registration.

Data protection and generic medicines

Data protection for new molecules.  Technical and scientific information on the safety, quality, and efficacy of medicines containing a novel molecule will be subject to protection for a period of five years counted from the date of notification of the sanitary registration. During that period, no third party may use said information to obtain a sanitary registration without the express written consent of the holder.

Generic medicines and interchangeability.  For generic drugs, instead of submitting the safety and efficacy information of the innovator drug, the following must be submitted: interchangeability test reportHowever, when such a report uses—in whole or in part—information concerning the safety and efficacy of a New Molecule, it will be necessary to submit the express written consent of the holder of that information, if no more than five years have passed since the notification of the innovator's health registration.

Biotechnology drugs

The Decree strengthens the regulatory framework applicable to innovative and biosimilar biotechnological medicines. innovative biotechnologicalCOFEPRIS will request the opinion of the Committee on New Molecules and of Subcommittee on the Evaluation of Biotechnology Products, unless authorization is obtained from a foreign authority recognized by the Secretariat and no risk is identified.

For biosimilarsThe registration process requires the submission of biocomparability and immunogenicity studies, adverse event reports, and standard technical documentation. COFEPRIS will request the opinion of the New Molecules Committee, except when the aforementioned foreign authorization recognition criterion applies.

Extensions of health registration

The Decree establishes that the first extension The sanitary registration of medicines, medical equipment, prostheses, orthoses, diagnostic agents and other medical supplies will be granted for a period of ten yearssimplifying the requirements that must be submitted for processing. For the second extension and subsequent extensionsthe application must be submitted no later than 150 calendar days before that the registration expires.

Transitory dispositions

Executive Summary

The Decree published on April 24, 2026 introduces reforms of great relevance to the pharmaceutical and medical device industry in Mexico. The main new features are: (i) the creation of supplementary patent certificates to compensate for delays in the processing of health registration; (ii) the protection of data of new molecules for five years; (iii) the strengthening of the biotechnology assessment process; (iv) the simplification of requirements for registration extensions; and (v) the new requirement of consent for the use of data of new molecules in generic applications.

Reference Links: https://dof.gob.mx/nota_detalle.php?codigo=5785957&fecha=24/04/2026

For more information on the impact of these reforms on the pharmaceutical and healthcare supplies sector, please contact: