Amendment to the regulation of health supplies

The amendments primarily respond to three main pillars:

• Protection of innovation (patents and clinical data),
• Regulatory efficiency (timelines and simplification), and
• Technical strengthening in the evaluation of medicines, particularly biotechnological products.

Taken together, these changes imply a more sophisticated regulatory system, but also impose a greater compliance burden, especially for generic and biosimilar medicines.

These changes are also aligned with the agreements contained in the former NAFTA and now the USMCA (T-MEC), as well as with agreements and criteria issued by various local industry chambers involved.

The reform can be analyzed in light of Chapter 12 of the USMCA (Technical Barriers to Trade), particularly Annexes 12-F (pharmaceutical products) and 12-E (medical devices). These establish principles of transparency, non-discrimination, efficiency, and international regulatory cooperation applicable to regulatory frameworks such as the Regulation on Health Supplies.

Annex 12-F governs aspects related to the marketing authorization of pharmaceutical products, which in Mexico is implemented through the sanitary registration provided for in the General Health Law and the Regulation itself. For its part, Annex 12-E sets out similar guidelines for medical devices, strengthening regulatory compatibility and the recognition of international standards.

Thus, the reform to the Regulation on Health Supplies can be seen as an adjustment of the Mexican regulatory framework to comply with international commitments regarding trade facilitation, regulatory harmonization, and regulatory improvement under the USMCA.

The most relevant changes mainly include:

A. New molecules and strengthening of the evaluation process

Articles: 2, section XV; 166, section III

The concept of “New Molecule” (“Mólecula Nueva”) is redefined, specifying that it refers to any substance with a therapeutic effect that does not have a sanitary registration in Mexico. This provides greater clarity in delimiting which products must undergo a more rigorous review process.

• The role of the New Molecules Committee (Comité de Moléculas Nuevas) is strengthened, and its technical opinion becomes a structural component of the evaluation process.
• The Committee is composed of key regulatory authorities and external experts, aiming to raise the scientific standard of decision-making.

A regulatory flexibility element is introduced:

• When prior authorization from a recognized foreign authority exists, the intervention of the Committee is limited to cases where a potential risk is identified.

Additionally:

• A maximum period of 180 days is established for resolving applications for sanitary registration, thereby reducing uncertainty for applicants and placing pressure on the authority to comply with defined timelines.

✔ This seeks to balance technical rigor with regulatory agility, particularly to facilitate the entry of innovation already validated in other markets.

B. Compensation for regulatory delays and patent term extension

Articles: 166 Bis 1 to 166 Bis 5

The possibility of compensating unjustified delays by the authority in the sanitary registration process is incorporated.

• If the delay is attributable to the authority and affects the effective term of patent exploitation, the patent holder may request an adjustment to the patent term through a supplementary certificate issued by the Mexican Institute of Industrial Property (IMPI).
• This adjustment is capped at up to five years.

The framework establishes:

• A formal procedure with specific requirements and a 60-business-day period to request compensation.
• Clear grounds for inadmissibility (for example, when the applicant itself caused the delay or when the product had already been previously registered).
• The exclusion of “reasonable delays,” such as those arising from requests for additional information, legal challenges, or force majeure.

✔ This mechanism creates an incentive for the authority to issue timely decisions while simultaneously protecting innovators against administrative delays that may erode the value of their patents.

C. Comprehensive system: patent-linkage, data protection, and generic regime

Articles: 167, sections I Bis and V; 167 Bis

A comprehensive system for the protection of innovative medicines is established, operating through three complementary mechanisms:

Patent–sanitary registration linkage

It is established as a mandatory requirement that the applicant demonstrate:

• Ownership of the patent, or
• Holding an exploitation license duly recorded with the IMPI.

For generic or biosimilar medicines:

• Applicants are allowed to declare, under oath, that no patent infringement occurs.
• In such cases, the authority requests an opinion from the IMPI, which must respond within 10 business days.
• If the IMPI does not respond, it is presumed that no conflict exists (affirmative ficta/ afirmativa ficta).

If a potential infringement is identified:

• The applicant must demonstrate the corresponding rights; otherwise, the application will be rejected.

✔ A preliminary review of patent conflicts is incorporated into the sanitary procedure, which may delay or block registrations.

Data exclusivity protection

A five-year protection period is established for technical information (safety, quality, and efficacy) submitted for medicines containing new molecules.

During this period:

• Third parties may not rely on such information to obtain sanitary registrations.
• They may do so only with the express authorization of the rights holder.

This protection applies even if the data originates from registrations obtained abroad.

It prevents competitors from “free-riding” on the innovator’s dossier, thereby reinforcing regulatory exclusivity.

Previously, this protection was addressed through the process colloquially known as “Data Protection,” primarily derived from NAFTA and now from the USMCA (T-MEC).

Restrictions on generics

Requirements for generics are tightened:

• Mandatory submission of interchangeability studies.
• Prohibition on the use of protected data without consent during the exclusivity period.

✔ This raises both the technical and legal threshold for the entry of generics, particularly in the early stages of a medicine’s lifecycle.

Systemic interpretation

The system creates a dual barrier to market entry:

• Patents (IMPI) → prevent infringement of rights.
• Clinical data (COFEPRIS) → prevent the use of technical information.

Both operate independently, meaning that:

• A product may be blocked even in the absence of a patent (due to data protection), or
• Even after data exclusivity expires, the product may remain protected by patent rights.

D. Regulation of biotechnological medicines

Articles: 177, section IX; 177 Bis 1, section II; 177 Bis 2; 177 Bis 4; 177 Bis 5

The regulatory framework applicable to biotechnological medicines is significantly strengthened:

• A risk management plan is incorporated, requiring applicants to anticipate and manage potential adverse effects.
• The participation of specialized technical bodies in the evaluation process is reinforced.

For biosimilars:

• A robust evidence package is required, including:
  • Preclinical studies
  • Clinical studies
  • Immunogenicity assessments
  • Comparability analyses

Additionally:

• The expansion of therapeutic indications is permitted, provided there is scientific support validated by the authority.

✔ This significantly raises the technical standard, bringing Mexico closer to more stringent regulatory models in biotechnology.

E. Renewal of sanitary registrations

Articles: 190 Bis 1; 190 Bis 3; 190 Bis 7

The validity of sanitary registrations is standardized:

• The first renewal is granted for a period of 10 years.
• Subsequent renewals must be requested:
  • At least 150 calendar days in advance, and
  • Shall each have a duration of 10 years.

✔ This simplifies regulatory portfolio management, while requiring stricter timeline control to avoid expirations.

Key Points

• New definition of “new molecule” (Art. 2).
• Maximum 180-day timeframe for sanitary registrations (Art. 166).
• Introduction of patent term extensions due to regulatory delays (Arts. 166 Bis).
• Strengthening of the COFEPRIS–IMPI linkage system (Arts. 167 and 167 Bis).
• Five-year protection of clinical data.
• Increased regulatory burden for generics and biosimilars.
• Stricter standards for biotechnological products.
• Ten-year validity for sanitary registration renewals.

Practical Implications

For innovators:

• Greater legal protection (patents + data exclusivity).
• Recovery of value in the event of regulatory delays.
• Increased certainty regarding approval timelines.

For generics/biosimilars:

• Increased costs and longer timelines for market entry.
• Risk of regulatory blocking through dual mechanisms.
• Need for a more sophisticated legal and regulatory strategy.

At the system level:

• Greater coordination between health regulatory authorities and industrial property authorities.
• Alignment with international standards.
• Increased complexity, but also enhanced legal certainty.

The aforementioned changes will enter into force as of April 25, 2026. In this regard, we consider that these changes will have an impact on the industry (whether for innovative or generic medicines), making it advisable to anticipate and develop a strategic plan to mitigate potential adverse effects. Should you have any questions, please do not hesitate to contact us.