MEXICO Trends and Developments Contributed by: Bernardo Martinez-Negrete, Lisandro Herrera Aguilar and Martha Contreras Secchi, Galicia Abogados, SC
Conclusion In conclusion, Mexico has implemented equiva- lence agreements to streamline the process of importing drugs and medical devices. These agreements recognise the regulatory standards of agencies whose requirements align with Mex- ico’s safety, efficacy and quality standards, thus expediting market entry and reducing COFE- PRIS’s administrative burden. The 2024 Equivalence Agreement issued by COFEPRIS represents the most recent devel- opment in the regulation of the importation of drugs and medical devices without marketing authorisation (although such products will need to obtain a marketing authorisation in order to be commercialised in Mexico). It encourages greater participation in consolidated public pro- curement, providing foreign suppliers with a clear pathway to engage in Mexico’s healthcare system while ensuring that imported products comply with COFEPRIS’s regulatory standards.
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