COFEPRIS Clinical Trial Authorization: Mexico’s Regulatory Pathway and the 2025-2026 Reforms

Mexico regulates clinical trials through a single federal health authority working alongside a decentralized network of research and bioethics committees — a structure closer to India’s CDSCO model than to the European Union’s centralized CTIS. The Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), Mexico’s federal sanitary risk regulator, must authorize a clinical trial protocol before a sponsor may enroll a single participant, and that authorization only comes after a registered research ethics committee has already issued a favorable opinion. Since 2025, COFEPRIS has been the subject of a sustained set of reforms aimed at cutting protocol review times that had made Mexico a comparatively slow market for multinational trial sponsors. This guide covers COFEPRIS’s role and structure, the step-by-step authorization pathway, and what the 2025–2026 reforms specifically changed — and what they didn’t.

What COFEPRIS Is and Where It Sits

COFEPRIS is a decentralized administrative body of Mexico’s Secretariat of Health (Secretaría de Salud), operating with technical, administrative, and operational autonomy under the Ley General de Salud (General Health Law) — the primary statute that grants the Secretariat, and by extension COFEPRIS, authority to regulate products, services, and research activities that could pose a health risk. Within its broader mandate covering drugs, biologics, medical devices, cosmetics, and sanitary risk generally, COFEPRIS is the competent authority for authorizing clinical research protocols involving investigational drugs and biologics in Mexico.

COFEPRIS does not review clinical trial protocols in isolation. Mexican clinical research operates on a sequential, not parallel, review model:

• Comité de Ética en Investigación (Research Ethics Committee, or REC/CEI) — a registered site or institutional ethics committee must issue a favorable opinion on the protocol and informed consent materials before the file goes to COFEPRIS. Committee registration and operation fall under the Reglamento de la Ley General de Salud en Materia de Investigación para la Salud (the health-research regulation implementing the General Health Law).
• Comité de Investigación (site-level Research Committee) — approves the protocol’s scientific and operational feasibility at the institution where the trial will run.
• Comité de Bioseguridad (Biosafety Committee) — required when the investigational product or study procedures raise biosafety considerations (recombinant products, certain biologics, infectious-agent handling).
• COFEPRIS — issues the final sanitary authorization. Because REC review must precede COFEPRIS submission rather than run in parallel with it, the ethics review effectively sits on the critical path for how quickly a protocol can start.

For trials conducted at Mexico’s National Institutes of Health and high-specialty hospitals, the Comisión Coordinadora de Institutos Nacionales de Salud y Hospitales de Alta Especialidad (CCINSHAE) also plays a coordinating role, and Mexico’s National Bioethics Commission (Comisión Nacional de Bioética, CONBIOÉTICA) oversees the broader ethics-committee registration system that RECs operate within.

Step by Step: From Protocol to First Patient In

1. Confirm or register the site’s ethics committee. The REC reviewing the protocol must be registered under Mexico’s health-research regulation; an unregistered or lapsed committee cannot issue a valid opinion for COFEPRIS purposes.
2. Submit the protocol for REC review. The sponsor (directly or through a local legal representative/CRO) submits the protocol, investigator’s brochure, and informed consent documents to the site’s REC. The committee’s favorable opinion is a precondition for the next step, not a parallel track.
3. File with COFEPRIS via DIGIPRiS. Once the REC opinion is in hand, the sponsor submits the clinical trial authorization request through DIGIPRiS, COFEPRIS’s digital regulatory-submission platform, including the REC-approved protocol, investigator’s brochure, informed consent/assent forms, proof of the applicable regulatory fee payment, and legal authorization documents (power of attorney or public instrument for the sponsor’s local representative).
4. COFEPRIS technical review. COFEPRIS’s Health Authorization Commission processes the request through defined internal stages — intake, evaluation, verification, sign-off, and resolution — and may issue queries (prevenciones) that pause the review clock until the sponsor responds.
5. Authorization and trial registration. Once satisfied, COFEPRIS issues the sanitary authorization to conduct the trial. Enrollment cannot legally begin before this authorization and the REC’s favorable opinion are both in place. As with most jurisdictions CASRAI covers in this series, sponsors should also register the trial on a WHO ICTRP-linked registry as part of standard clinical trial registration and reporting compliance.

Timelines: The Baseline and What Changed

Historically, COFEPRIS clinical-protocol review was widely cited by sponsors and CROs as one of the slower authorization pathways among major Latin American markets, with review periods commonly running around 115–120 calendar days. That baseline is the reference point for the 2025–2026 reform trajectory below.

In May 2025, COFEPRIS publicly reported a roughly 65% reduction in response times for clinical protocol applications — from approximately 115 days down to around 40 days — with a stated longer-term goal of moving toward a two-week turnaround for straightforward files. By mid-2026, regulatory-affairs press coverage (including reporting tied to COFEPRIS’s own Scientific Conference 2026) described further compression, with authorization timelines characterized as having moved from roughly 120 days to roughly 30 days for a meaningful share of protocols. Sponsors should treat these figures as reported directional targets and recent trend data, not statutory ceilings guaranteed for every submission — a complete, query-free file with an already-registered, responsive REC will track much closer to the fast end of that range than a file that draws prevenciones.

The 2025–2026 Reforms in Detail

Several distinct threads make up what sponsors typically shorthand as “the COFEPRIS reforms”:

• Protocol review acceleration (2025–2026). The timeline compression described above — process re-engineering inside COFEPRIS’s Health Authorization Commission rather than a change to the underlying legal requirements for REC review, biosafety review, or the documentation set required under the General Health Law and its health-research regulation.
• A permanent interinstitutional coordination structure. Since January 2026, Mexican regulatory-affairs reporting describes a Permanent Interinstitutional Board for Clinical Protocols coordinating COFEPRIS, CCINSHAE, and Mexico’s National Bioethics Commission — aimed at reducing the handoff friction between the sanitary-authorization track and the ethics/institutional-coordination track described above, rather than eliminating either review.
• Reliance on foreign regulatory evaluations. Regulatory-news reporting describes COFEPRIS moving toward greater use of evaluations already completed by reference regulators — the EMA, FDA, MHRA, and Health Canada — to expedite Mexican review of protocols for products with an existing favorable assessment elsewhere. This follows a broader global pattern of regulatory reliance rather than a Mexico-specific mechanism; sponsors should confirm the current scope and eligibility criteria directly with COFEPRIS or local regulatory counsel before assuming a given product qualifies, since public reporting on the exact operational criteria remains limited.
• Risk-classification and device-adjacent changes. COFEPRIS also published 2025 updates affecting medical-device risk classification and review pathways (including a September 2025 abbreviated pathway leveraging IMDRF/MDSAP recognition). These are primarily device-registration reforms rather than drug/biologic clinical-trial-protocol reforms, but they matter for device and combination-product trials, where device registration and trial authorization can intersect.

Industry response to the 2025 reforms has been publicly visible: Bayer announced in August 2025 that it would triple its planned investment in clinical studies in Mexico, citing improved regulatory collaboration with COFEPRIS, and other multinational sponsors have expanded academic-institution partnerships (for example with UNAM, IPN, and IMSS) for clinical research. Mexico’s Secretariat of Health, under Secretary David Kershenobich, has framed the faster protocol pathway as part of a broader push to grow Mexico’s share of multinational trial activity.

What This Means for Sponsors and Research Administrators

• Get REC registration status right first. Because REC approval is a strict precondition, not a parallel track, an unregistered or lapsed ethics committee is the single most common avoidable delay in the Mexican pathway — verify registration status before finalizing site selection.
• Build a complete DIGIPRiS submission the first time. Reform-driven timeline compression assumes a clean file; COFEPRIS’s query (prevención) process still pauses the clock, so incomplete investigator’s brochures, inconsistent consent documents, or missing legal-representative documentation erode the benefit of the faster baseline.
• Confirm reliance-pathway eligibility directly with COFEPRIS. Don’t assume a prior EMA, FDA, MHRA, or Health Canada approval automatically shortens Mexican review — confirm current criteria with COFEPRIS or local counsel rather than relying on secondary reporting.
• Treat device-adjacent reforms separately from drug/biologic trial reforms. The 2025 device risk-classification and abbreviated-pathway changes are a distinct regulatory track from clinical-protocol authorization; don’t conflate the two when scoping a combination-product trial.

How COFEPRIS Compares to Other National Regulators

COFEPRIS’s sequential ethics-then-regulator model has real parallels elsewhere in CASRAI’s national-regulator series: it resembles ANVISA’s dual-track process in Brazil and CDSCO’s Ethics Committee-plus-DCGI model in India more closely than it resembles single-portal systems. For sponsors running multi-country Latin American programs, it’s also worth reviewing Health Canada’s CTA and REB framework and, for broader north-south comparison, CASRAI’s EMA vs. FDA comparison. Sponsors running trials across multiple Latin American and Asian markets simultaneously should also see CASRAI’s guides to MFDS’s pathway in South Korea and NMPA’s process in China for comparison points on committee structure and review sequencing.

Across all of these jurisdictions, the underlying scientific and ethical expectations trace back to the same international reference point: ICH E6(R3) Good Clinical Practice. COFEPRIS’s own guidance and Mexico’s health-research regulation are broadly consistent with ICH GCP principles, even though the procedural mechanics (REC-then-COFEPRIS sequencing, DIGIPRiS submission, CCINSHAE coordination for national institutes) are Mexico-specific. Research staff working across jurisdictions may also find CASRAI’s guide to GCP certification useful as a baseline credential that travels across these national frameworks.

Frequently Asked Questions

What is COFEPRIS?

COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) is Mexico’s federal sanitary risk regulator, a decentralized body of the Secretariat of Health responsible for authorizing drugs, biologics, medical devices, and clinical trial protocols, among other sanitary-risk categories.

How long does COFEPRIS clinical trial approval take in 2026?

Publicly reported timelines have compressed substantially since 2025, moving from a historical baseline around 115–120 days toward figures in the roughly 30–40 day range for many protocols, per COFEPRIS’s own public reporting and Mexican regulatory-affairs press coverage. Treat any specific figure as a recent trend indicator rather than a guaranteed turnaround, since complete files with a registered, responsive REC move faster than files that draw review queries.

Does a trial need ethics committee approval before COFEPRIS review, or can they run in parallel?

Sequentially, not in parallel. A registered Research Ethics Committee (REC) must issue a favorable opinion on the protocol before the sponsor submits the COFEPRIS authorization request.

What is DIGIPRiS?

DIGIPRiS is COFEPRIS’s digital platform for regulatory submissions, including clinical trial authorization requests, sanitary registrations, and related filings.

Do the 2025–2026 reforms change the documentation a sponsor must submit?

Not materially. The reforms reported publicly to date are primarily about internal review-process speed and interinstitutional coordination (COFEPRIS, CCINSHAE, and Mexico’s National Bioethics Commission), not a reduction in the underlying protocol, informed consent, investigator’s brochure, or ethics-committee documentation requirements under the General Health Law and its implementing health-research regulation.