MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
On 11 June 2025, COFEPRIS published its newest fast track equivalency decree, pursuant to which the requirements set forth in Articles 167, 170, 177, 177 Bis 2, 179 and 180 of the Regulation of Health Sup- plies (Reglamento de Insumos para la Salud , or RIS), as well as the technical evaluation procedures carried out by COFEPRIS for granting MA for health supplies, are recognised as equivalent to: • the requirements of, and the tests and evaluation procedures carried out by, reference regulatory authorities to allow, in their jurisdictions, the sale, distribution and use of health supplies; • evaluations conducted under the WHO Prequalifi- cation Program; and • the criteria applicable to the importation of health supplies intended for the care and treatment of emerging or neglected diseases, or in cases of national emergency. This new fast-track equivalency decree renders invalid the 2019, 2020 and 2021 equivalency decrees with members of PIC/S with respect to WHO-prequalified medicines and vaccines. 4.2 Regulatory Reliance Regulatory reliance refers to the practice of relying on regulatory decisions made by other jurisdictions, which are recognised as trusted regulatory authorities, to approve new medical products. Regulatory reliance can be applied to the extent deter- mined by the health regulator, either through an abbre- viated process for medical products already author- ised by another regulatory authority or by directly recognising the regulatory decision. COFEPRIS aims to use reliance as a method to improve efficiency in supervising medical products. It has adopted the concept of reliance to achieve regula- tory alignment with other regional authorities by col- laborating with the Pan American Health Organization (PAHO). On June 2025, COFEPRIS issued an Official Decree. This effort resulted in strategies for regulatory certain- ty for medicines and medical devices, as well as the modernisation of technical regulations such as NOM-
241-SSA1-2025 on good manufacturing practices for medical devices, which recognises Medical Device Single Audit Program (MDSAP) audits, certifications and verfications as valid, and NOM-177-SSA1-2013 on the interchangeability of medicines. Additionally, several other existing technical regulations are being modified, including NOM-059-SSA1-2015 on good manufacturing practices for medicines. As mentioned, COFEPRIS can legally expedite market authorisations if a company has approvals from rec- ognised jurisdictions. However, expedited resolutions for such applications are rarely seen in practice. Similarly, for clinical trials on 24 March 2025, COFE- PRIS issued the Decree that Establishes the Criteria to Authorize Clinical Trial Protocols Previously Author- ized by a Foreign Regulatory Authority. This Decree broadly applies to clinical trial authorisations issued by: • the European Medicinal Agency; • the Food and Drug Administration (FDA); • the Medicines and Healthcare products Regulatory Agency; and • Health Canada. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants A pharmaceutical manufacturing plant is subject to a licence, and a medical device manufacturing plant must submit a notice of operation. COFEPRIS is the authority responsible for granting the manufacturing licence and receiving the notice of operation. To secure a manufacturing licence, a certificate of good manufacturing practices (“GMP certificate”) must be obtained. For that purpose, a COFEPRIS inspection visit to the manufacturing plant must first be requested, to review whether the plant complies with Technical Standard NOM-059-SSA1-2015 on good manufacturing practice for pharmaceuticals. If COFEPRIS determines in the inspection visit that the facility is in compliance, it will grant a certifi-
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