May 7th, 2026
On April 24, 2026, two significant amendments were published in the Official Gazette of the Federation (Diario Oficial de la Federación): one to the Regulations on Health Supplies (Reglamento de Insumos para la Salud, “RIS”), and another to the Regulations on the Registration, Import and Export Authorizations and Export Certificates for Pesticides, Plant Nutrients, and Toxic or Hazardous Substances and Materials (“PLAFEST”).
I. Regulations on Health Supplies
- Patent term compensation for regulatory procedures
A patent term compensation procedure for “unreasonable delays” occurring during the granting of a sanitary registration was introduced. This procedure must be initiated at the request of the interested party. It is worth noting that this mechanism had already been incorporated through the amendments to the Federal Law for the Protection of Industrial Property (Ley Federal de Protección a la Propiedad Industrial, “FLPIP”).
Eligibility for compensation is contingent upon the existence of “unreasonable delays attributable to COFEPRIS.” Although the regulation does not specify when an unreasonable delay attributable to the authority arises, it does identify certain reasonable delays that must be excluded from the calculation, such as time periods to respond to official requests for information, the processing of judicial proceedings or adverse legal challenges, as well as periods resulting from force majeure or acts of God. This framework -particularly due to the breadth of this last exception- grants the authority wide and discretionary latitude to determine which periods should be excluded, which could be grounds for a challenge on the grounds of unconstitutionality, since the individual is unaware of the meaning of the term “unreasonable delay”:
Finally, as with the amendment to the FLPIP, COFEPRIS is designated as the authority responsible for determining the eligibility of the compensation and for requesting the Mexican Institute of Industrial Property (IMPI) to issue the supplementary certificate, which raises potential issues regarding the allocation of powers between the two authorities.
To request the compensation, the application must be filed within sixty days following notification of the sanitary registration, and compensation may only be granted in relation to one patent per product. Importantly, for compensation to apply, the patent must have been expressly cited in the sanitary registration application. Compensation will be deemed inadmissible where: the patent relates to an allopathic medicine that previously obtained a sanitary registration; it was previously included in another sanitary registration; it was not identified at the initiation of the procedure; or the product was commercialized prior to obtaining the sanitary registration.
It is also important to note that any potential compensation is capped at a maximum of five years.
According to the transitory provisions, these rules are intended to apply to sanitary registrations filed after their entry into force, which occurred on April 25, 2026.
- Definition of “new molecule”
The definition of “new molecule” set forth in Article 2, Section XV was amended. Previously, it was defined as a substance of natural or synthetic origin not previously used in the country and whose efficacy, safety, and therapeutic purposes were not fully documented in the scientific literature. The new definition limits the concept to drugs, biologics, or substances with therapeutic, preventive, or rehabilitative activity that do not hold a sanitary registration in Mexico, thereby clarifying and, in practice, narrowing its regulatory scope.
- New requirements for obtaining sanitary registrations
With respect to Article 167, which governs the requirements for obtaining a sanitary registration, the obligation to include the document issued by the Mexican Institute of Industrial Property (IMPI) evidencing ownership of the relevant patents or, as applicable, the corresponding license, is now expressly added.
Regarding generic medicines, when the interchangeability report relies on safety and efficacy information of a new molecule, the express written consent of the holder of such information must be submitted, provided that no more than five years have elapsed since notification of the sanitary registration.
- Protection of clinical data
Another significant addition is the express recognition of clinical data protection. Pursuant to Article 167 Bis, where an allopathic medicine contains a new molecule, the technical and scientific information submitted regarding its safety, quality, and efficacy will be protected for a period of five years from the notification of the sanitary registration. During this period, such information may not be used by third parties without the express authorization of the holder. Although this protection could be interpreted as operating automatically, in our view, obtaining express recognition from the authority remains advisable in order to clearly delimit the right and ensure its enforceability against third parties.
An open question remains as to whether this protection extends to second therapeutic uses, which the legislation treats as “new molecules” and which require the submission of safety, quality, and efficacy information. The inclusion or exclusion of such cases within the scope of the protection is not expressly resolved and is therefore likely to be defined in future contentious proceedings.
- Biotechnological Products and Biosimilars
Likewise, it is established that, in the case of comparable biotechnological medicines whose manufacturing and studies were conducted abroad, eligibility may be determined based on the opinion of the New Molecules Committee, which must consult the Subcommittee for the Evaluation of Biotechnological Products when a risk associated with the medicine is identified.
For purposes of obtaining the sanitary registration for these biotechnological medicines, it was added that, in applications supported by a prior authorization issued by a foreign regulatory authority recognized by the Ministry, the opinion of the New Molecules Committee will only be requested when a risk associated with the comparable biotechnological medicine is identified.
With respect to preclinical and clinical studies for comparable biotechnological medicines, it is clarified that the corresponding reference product must be used. In addition, it is no longer necessary for the Ministry to rely on the opinion of the New Molecules Committee to require in vitro studies, and the requirements for preclinical and clinical animal studies are now general requirements, without the need for conformity with the opinion of the New Molecules Committee.
- Extension of the Term of Sanitary Registrations
Finally, the term of sanitary registrations is extended from five to ten years, which is undoubtedly a positive development for the pharmaceutical industry.
- Application
The reform entered into force on April 25, 2026. However, the decree itself provides that matters pending at the time of its entry into force will continue to be governed by the provisions in effect at the time they were filed. In addition, the Ministry is required to carry out the necessary regulatory and administrative adjustments for the proper implementation of the reform. Until such adjustments are made, the decree establishes that the previously applicable provisions will continue to apply to the extent they do not conflict with the decree, and that the provisions of the decree will apply only in the event of a conflict. This creates uncertainty regarding its implementation, particularly with respect to sanitary registrations that were granted prior to the entry into force of the reform.
II. Regulations on the Registration, Import and Export Authorizations and Export Certificates for Pesticides, Plant Nutrients, and Toxic or Hazardous Substances and Materials.
- New requirements for sanitary registrations
New requirements are established to obtain the sanitary registration of a pesticide, including: (i) the consent of the data holder when prior studies are relied upon; and (ii) evidence of ownership or a license to an intellectual property right, where a patent exists.
- Data protection
A ten-year data protection period is provided: information on the safety and efficacy of new products will enjoy exclusivity during that period, throughout which third parties may not use such information, without authorization, to register similar products.
As with clinical data protection, this protection could be interpreted as operating automatically. Nevertheless, for the proper delimitation of the right and its enforceability against third parties, in our view it remains advisable to obtain express recognition from the authority.
- Transparency
COFEPRIS is also required to publish and update, every 30 days, the applications filed and the registrations granted.
- Term and renewal of registrations
Finally, the term and renewal of registrations in this area are established at ten years.
All of the foregoing changes are aimed at complying with the provisions of the USMCA (T-MEC), which, it should be noted, is currently undergoing a renegotiation process.
At Basham, we will continue to monitor these changes and related criteria with the aim of providing useful advice to our clients and strengthening the protection of their intellectual property rights even by enforcing the rights of individuals before the Competent Courts.
We remain at your service.
SINCERELY,
Adolfo Athié Cervantes
Claudio Ulloa Escobedo
Mariana González Vargas
Erika Rodríguez Kushelevich
José Eduardo Peña Cabral