COFEPRIS Sets Four-Year Validity for Third-Party Authorizations

Mexico's Ministry of Health published updated operating guidelines for Authorized Third Parties on Sept. 2, 2026, setting a four-year validity period for authorizations and formally separating administrative modifications from technical ones that require evaluation. The measure completes a component left pending from a May 2026 simplification package that cut COFEPRIS procedures from 340 to 125 and reduced resolution times from 100 days to 24 days. It affects pharmaceutical, medical device, and diagnostics companies that rely on certified test laboratories and interchangeability and biocomparability units for regulatory filings in Mexico. 

Mexico's Ministry of Health published new operating guidelines governing Authorized Third Parties, the private and academic entities that support the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) in verifying compliance across pharmaceuticals, medical devices, and other health products. The agreement took effect Sept. 3, 2026, one day after its publication in the Official Gazette of the Federation (DOF), and fixes a four-year validity period for authorizations while separating future modifications into administrative and technical categories. The guidelines complete a component left pending from a broader simplification package the ministry issued on May 4, 2026.

The reform extends a wider regulatory simplification drive that Mexican authorities have pursued since presenting an updated Plan Mexico investment strategy in May. Under that package, COFEPRIS reduced its procedures from 340 to 125, cut requirements by half, and shortened resolution times from 100 days to 24 days, according to Víctor Borja, Federal Commissioner, COFEPRIS. Business groups welcomed the broader push at the time: Altagracia Gómez, Head, Advisory Council for Regional Economic Development and Relocation, described the measures as "a hug of trust" for investors weighing capital deployment in Mexico.

An Authorized Third Party is a physical or corporate entity certified by COFEPRIS to issue technical opinions or conduct studies that support sanitary procedures, without replacing the commission's authority to evaluate, grant, or revoke authorizations. The guidelines group these entities into three categories: Test Laboratories, which analyze methodologies applied to consumer and health products; Interchangeability Units, which develop bioavailability, bioequivalence, and dissolution profile studies; and Biocomparability Units, which run preclinical, clinical, and analytical tests for biotechnological medicines.

The Sept. 2 guidelines build directly on the May 4 agreement, which reduced requirements and response times across numerous COFEPRIS procedures. The new alignments arrive as COFEPRIS pursues a broader modernization agenda under Borja, who took office in January 2026 and has already introduced an international recognition pathway for medical device registration and a revised set of priorities for the Federal Sanitary System centered on harmonization, digitalization, and risk-based oversight.

The guidelines distinguish two types of modifications. Administrative modifications, such as a name change or a street address correction that does not involve physical relocation, require only a documentary review, with no evaluation visit. Technical modifications, such as expanding the analytical scope or updating a referenced standard in ways that change methodology, require a supporting application and, when the change adds new capabilities, may be referred case by case to the Technical Evaluation Committee for Authorization of Third Parties (CTEAT) for a technical opinion. Test Laboratories continue to be evaluated against the NMX-EC-17025-IMNC-2018 standard for testing and calibration competence, and Interchangeability and Biocomparability Units against NOM-177-SSA1-2013.

COFEPRIS keeps the three-month resolution period set under the May decree for both new authorizations and extensions, though the guidelines clarify that missing that deadline does not automatically grant the request; the Federal Law of Administrative Procedure applies instead. Extensions, filed under homoclave COFEPRIS-07-005 between three and six months before expiration, can renew an authorization for another four-year term if the holder met its obligations, submitted required productivity reports, and carries no sanitary measures imposed by the ministry. If COFEPRIS misses its own deadline to resolve a properly filed extension, the existing authorization remains valid until a decision is issued, though this does not equate to automatic approval.

This  also add obligations on confidentiality and conflicts of interest, requiring Authorized Third Parties to protect technical, scientific, and commercial information they access and to disclose and manage any situation that could compromise their objectivity. COFEPRIS retains full supervisory power, including document reviews, verification visits, and the ability to revoke an authorization under the General Health Law. Pending applications filed before Sept. 3 will be resolved under the rules in force when they were submitted.

For pharmaceutical, medical device, and diagnostics companies that depend on these certified laboratories and units for regulatory filings, the update offers a clearer, time-bound framework for a process that had previously lacked defined categories for modifications. Companies operating Test Laboratories, Interchangeability Units, or Biocomparability Units now have a fixed four-year planning horizon for renewals and a documented path for distinguishing routine administrative updates from changes that require a new technical review, reducing the uncertainty that previously surrounded how COFEPRIS would classify a given modification.