Mexico: New Criteria for Recognition of Equivalence in Marketing Authorizations for Medicines and Medical Devices

On July 18, 2025, was published in the Mexican Official Gazette the Agreement by which are issued the general Guidelines for the application of the abbreviated regulatory route for the granting of marketing authorizations of health supplies in which the requested requirements, tests and evaluation procedures issued by reference regulatory authorities and the prequalification program of the World Health Organization are recognized as equivalent.

The objective of the agreement is to optimize and simplify the procedure for granting marketing authorizations through the recognition of international standards, in order to:

• Accelerate access to medicines and medical devices of quality.
• Strengthen trust in regulatory decisions based on evidence.
• Application of Good Regulatory Practices (reliance) recommended by the WHO.

Background

In Mexico, various regulatory harmonization efforts have been carried out, in compliance with the constitutional mandate to preserve and promote the right to health. In this regard, the General Health Law and the Health Supplies Regulations contain different provisions associated with the control, surveillance and sanitary authorization of health supplies, raw materials and additives that comprise them, ranging from their obtention, preparation, marketing and distribution to their import and export.

Health supplies include medicines, biotechnological products and medical devices that require authorization through "marketing authorization", except for those low-risk devices determined by COFEPRIS. To obtain the marketing authorization, health supplies must meet the requirements of quality, safety and efficacy.

In this regard, since 2010, the Ministry of Health has promoted various agreements that allow the requirements and procedures carried out by reference health authorities such as the Swiss Agency for Therapeutic Products-Swissmed, the European Commission, the Food and Drug Administration of the United States of America, Health Canada, the Australian Therapeutic Products Administration or the PAHO/WHO Reference Regulatory Agencies; as well as the medicaments prequalified by the World Health Organization's Prequalification Program for Drugs and Vaccines or Regulatory Agencies member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

These equivalence agreements are fundamental tools to expand timely access to medicines and other health supplies, through the good regulatory practices (reliance) recommended by the WHO. The implementation of these agreements will also speed up the process for the granting of the marketing authorization in Mexico for medicines and other health supplies based on the requirements and evaluation procedures of other national or reference regulatory authorities, simplifying, updating and providing regulatory certainty to the industry.

General aspects of the agreement

The guidelines included in the agreement will enter into force 30 business days after its publication in the Mexican Official Gazette, that is, on August 29, 2025.

The marketing authorization applications for medicines and medical devices made in terms of the previous equivalence agreements, which have been submitted before the entry into force of the Guidelines included in this agreement and, which are pending of resolution, must be concluded in accordance with the provisions in force at the time of entry of the application.

With the entry into force of these Guidelines, the equivalence agreements published between October 5, 2012 and June 11, 2025, related to individual regulatory equivalences with agencies such as the FDA (USA), Swissmedic (Switzerland), EMA (European Union), Health Canada, TGA (Australia) and WHO (Prequalification Program) are abrogated.

Relevant provisions of the agreement 

• These Guidelines are public and mandatory for COFEPRIS in the granting of marketing authorizations for medicines and medical devices based on the recognition as equivalent of the requirements, tests and evaluation procedures applied by other Regulatory Reference Authorities (ARRs) including the Medicines Prequalification Program of WHO.
• The Guidelines are applicable to the following health supplies:
  • Medicines:
    • Classified as new molecules.
    • Generics.
    • Innovative biotechnology products.
    • Biosimilar biotechnology products.
    • Vaccines and Biological products.
  • Medical devices: medical equipment, prostheses, orthoses, functional aids, diagnostic agents, dental supplies, surgical and healing material, hygienic products and other devices for medical use.
• The recognition made by COFEPRIS of the authorizations issued by an ARR will have the same legal effects as those made in accordance with an ordinary procedure for the marketing authorization of health supplies.
• COFEPRIS may cancel or revoke the marketing authorization granted in accordance with these guidelines, in accordance with articles 376 and 380 of the General Health Law and other applicable legal provisions.
• COFEPRIS may exercise its powers on matters of health surveillance and control at any time.
• The holders of marketing authorizations, distributors or marketers of the supplies registered under these Guidelines must comply with the applicable provisions on pharmacovigilance and technovigilance.
• COFEPRIS will adopt the good reliance practices issued by WHO to consider the decisions made by any ARR so that it is recognized that the requirements, tests, evaluation procedures and other requirements that said authorities request to allow, in their respective countries, the sale, distribution and use of health supplies, are equivalent to those that the General Health Law,  the Health Supplies Regulations and other applicable provisions require to guarantee the quality, safety, efficacy and performance that must be met to obtain their marketing authorization in the country.
• The application for marketing authorization that is intended to be made through the recognition of other ARR must be submitted in accordance with the Guidelines indicated in the agreement, with the complete legal and technical information that applies according to the classification of the health supply object of the application.
• The health supplies for which marketing authorizations are requested, under the terms of the guidelines of the agreement, must have essential basic characteristics identical to those authorized by the ARR abroad.
• The authorization document issued by the ARR must be valid from the moment the applicant submits the application and during the validity of the marketing authorization.
• ARR approvals that are different from an ordinary approval may not be used to support an application for authorization submitted through this abbreviated route.
• Any regulatory decision of another jurisdiction used by COFEPRIS must be guided by the principles of universality, sovereignty in decision-making, transparency, respect for national and regional legal bases, coherence, simplification, cooperation and competition.
• The ARR that COFEPRIS recognizes in its regulatory decisions for medicines are: i) founding members of ICH or permanent regulatory members; and ii) WLAs included in the WLA list with the function "Authorization for registration and marketing" for medicines.
• For generic medicines, the evaluations carried out by WHO, through its Medicines Prequalification Program, may also be used.
• For medical devices, COFEPRIS recognizes the decisions of the Regulatory Reference Authorities of: a) member countries of the Management Committee of the International Medical Device Regulators Forum (IMDRF); b) full members of the Single Medical Device Audit Program (MDSAP), for Good Manufacturing Practice Certificates.
• The application for Marketing authorization by recognition of equivalence with another ARR will be applicable to the following inputs: a) for medicines and b) for medical devices.
• When there are changes in the quality aspects of the drug, in the manufacturing or primary packaging sites with respect to those approved by the ARR, or in case additional manufacturing sites are required, the application for marketing authorization may not be made in accordance with the guidelines of the agreement.
• The marketing authorization granted by an ARR must have been issued within a period of no more than 5 years.
• Regardless of the classification of medical devices in accordance with the regulations and documents mentioned in the guidelines of the agreement, COFEPRIS will classify the medical devices defined by the Secretariat according to the criteria established in Article 83 of the Health Supplies Regulations.
• The abbreviated assessment procedure will consist of considering the decisions of other ARRs and compliance with the applicable legal provisions. Through this procedure, COFEPRIS can grant a marketing authorization by carrying out a more agile evaluation, provided that the applicant certifies that the health input in question is the same as one already evaluated and approved by an ARR.
• The equivalent use of regulatory decisions of other jurisdictions does not imply dependence, that is, COFEPRIS will retain its administrative, technical and operational autonomy, which adheres at all times to the applicable legislation in force.
• COFEPRIS, through the abbreviated regulatory route to guarantee the quality, safety and efficacy of health supplies, will only review that all the documentation requested is complete and duly required, without making a greater evaluation scrutiny, as has already been carried out by an ARR previously, so no additional documentation and information will be necessary.
• The accelerated mechanism will also include a consultation with the IMPI to verify the non-infringement of patents. Surely, the times established in the COFEPRIS-IMPI collaboration agreement will have to be reduced for these purposes.
• COFEPRIS will have a maximum term of 45 business days to issue the resolution corresponding to the Application for Marketing authorization of Medicines by Equivalence of Regulatory Reference Authorities and a maximum term of 30 business days to issue the resolution corresponding to the Application for Marketing authorization of Medical Devices by Equivalence of Regulatory Reference Authorities.