MEXICO Trends and Developments Contributed by: Bernardo Martinez-Negrete, Lisandro Herrera Aguilar and Martha Contreras Secchi, Galicia Abogados, SC
Equivalence Agreements and Importation Without Marketing Authorisation Regulation of equivalence agreements in Mexico In Mexico, the Ministry of Health ( Secretaría de Salud ) has the authority to issue general provi- sions recognising that the requirements, tests and evaluation procedures used by foreign health authorities can be equivalent to those required by Mexican law for the approval of health products. These foreign evaluations are considered sufficient if they ensure that the prod- ucts meet the same standards of quality, safety and effectiveness that are mandated in Mexico. As a result, products that have been approved in countries with similar regulatory systems can be fast-tracked for approval in Mexico, avoiding the need for a full re-evaluation. This approach ensures that drugs and medical devices meet the necessary standards while facilitating a more efficient process for obtaining sanitary registra- tion in Mexico (Article 161 bis of the Health Input Regulations ( Reglamento de Insumos para la Salud RIS)). One of the key mechanisms through which this process is facilitated is the equivalence agree- ments established by the Federal Commission for the Protection against Health Risks ( Comisión Federal para la Protección contra Riesgos Sani- tarios COFEPRIS). According to public records, COFEPRIS still has equivalence agreements with the sanitary regulatory agencies of the following countries (as well as the European Medicines Agency; EMA): Germany, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Cyprus, Colombia, Korea, Cuba, Denmark, Slo- vakia, Slovenia, Spain, Estonia, Finland, France, Greece, Netherlands, Hong Kong, Hungary, Ire- land, Italy, Japan, Iceland, Latvia, Lithuania, Mal- ta, Norway, Poland, Portugal, the United King-
dom, the Czech Republic, Romania, Singapore, Sweden, Switzerland and the USA. By leveraging equivalence agreements, COFE- PRIS enables drugs and medical devices that have already been evaluated and approved by these regulatory agencies to be marketed in Mexico without undergoing the entire approval process again, since it is considered that these agencies comply with the same quality, safety and effectiveness standards required in Mexico. The use of equivalence agreements not only reduces the time it takes for products to reach the Mexican market but also reduces the admin- istrative costs for COFEPRIS by avoiding the need to reprocess the technical and scientific information of the products. Regarding the United States, it is important to note that even though – through an executive order from President Donald Trump – the United States withdrew from the World Health Organiza- tion (WHO) on 20 January 2025, this withdrawal has no impact on the equivalence agreements executed between COFEPRIS and the Food and Drug Administration (FDA), since such agree- ments are independent from any international affiliations between both countries. With respect to medical devices, the equivalence agreement between Mexico (COFEPRIS) and the FDA was published in the Official Gazette of the Federa - tion (the “Official Gazette” ) on 26 October 2010, while the equivalence agreement between Mex- ico (COFEPRIS) and the FDA for medicines was published in the Official Gazette on 11 November 2012. Background to importation without marketing authorisations under equivalence agreements The Mexican government has the authority to allow the importation of drugs and medi-
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