The week that closed June saw three Latin American regulators move to compress timelines, demonstrate authorization throughput, and stabilize leadership at the units sponsors
first-in-human · FIH · clinical research · regulatory · ANVISA · ANMAT
The week that closed June saw three Latin American regulators move to compress timelines, demonstrate authorization throughput, and stabilize leadership at the units sponsors care about most. Mexico confirmed a 30-day clinical-trial approval target. Brazil's ANVISA cleared twelve experimental molecules in one resolution. Argentina formalized leadership of its clinical trials department. Colombia's regulatory backlog became measurable for the first time in months.
Here is what bioaccess® is tracking this week:
Mexico moves from "120 days" to "30 days" on clinical-trial protocol authorization Brazil's ANVISA clears twelve sponsor petitions in one DOU resolution Argentina names a permanent head of clinical trials at ANMAT after 22 months in transitory status Colombia's INVIMA backlog now sits at ~12,700 trámites — oncology decisions are running ~2.5 years A Brazilian benznidazole analogue clears T. cruzi in 78% of chronic Chagas patients across a tri-country Phase III Roche Mexico commits 1.2 billion pesos to clinical research for 2025–2026, citing a 55-day COFEPRIS authorization Three LATAM-positioned CROs documented with multi-year operational silence
Take a closer look at the four regulators that defined the week.
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Why It Matters: Sponsors who priced Mexico's regulatory friction into their LATAM site selection a year ago should re-run their decision matrices. A 30-day Mexican pathway changes how Mexico competes against Argentina, Colombia, and Brazil for multi-site Phase II and Phase III placements — and it materially improves the case for COFEPRIS-led reliance-based approvals once Mexico and Korea's new 45-business-day fast track is operating.
ANVISA published Resolução-RE nº 2.501 in the Diário Oficial da União on June 22, 2026, authorizing investigations on twelve experimental molecules across eleven sponsors: OTP-01 (Medpace do Brasil), Amivantamabe, Guselcumabe and JNJ-78934804 (Janssen-Cilag), Neladalkib (PPD do Brasil), Atirmociclib (Pfizer), Mosunetuzumabe (IQVIA), and Mocertatug Rezetecan (GlaxoSmithKline). Most are protocol amendments to active studies; OTP-01 is a fresh biologic-development-dossier approval.
Bottom Line: Brazil's weekly throughput is the strongest single-resolution evidence yet that the operational improvements promised under Law 14.874/2024 are landing in practice. For sponsors evaluating Brazil for protocol amendments or amendment-heavy mid-trial pivots, the path of least resistance is now ANVISA's weekly resolution cycle rather than the slower bilateral query-response track.
Argentina's Ministerio de Salud confirmed in Resolución 706/2026, published in the Boletín Oficial on June 24, 2026, the formal designation of Médica Laura Giselle Traversi as Jefa del Departamento de Ensayos Clínicos at the Dirección de Investigación Clínica y Gestión del Registro de Medicamentos within INAME-ANMAT. The appointment is back-dated to August 1, 2024, formalizing a 22-month acting arrangement with Suplemento por Función Directiva Nivel V.
What to Focus On: The unit that processes Argentine FIH and Phase 1 authorizations now has stable, documented leadership for the first time since 2024. Sponsors who had been routing around Argentina because of perceived uncertainty in the queue should reconsider — this is the kind of regulatory-personnel signal that precedes faster turnaround on subsequent submissions.
Diario Occidente, citing INVIMA's most recent published figures from May 2026, reported on June 23 that the agency is carrying approximately 12,700 pending trámites. Oncology medicines are running an average of ~2.5 years for a regulatory decision against a statutory target near nine months. The figures mix commercial registrations with clinical-trial authorizations, but the queue affects both. INVIMA's modernization program — which includes reliance pathways with FDA, EMA, ANVISA and COFEPRIS — has not yet drawn down the backlog at scale.
Why It Matters: This is the freshest published bottleneck datum from any LATAM regulator. Sponsors planning Q4 2026 Colombian submissions should now build in queue-position risk explicitly, and consider whether parallel ANMAT or COFEPRIS submissions can de-risk the program timeline.
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Two other items reinforce the regional trend. Roche Mexico published its 2026 outlook on June 26, citing 81 clinical studies completed in 22 Mexican states in 2025, approximately 1,400 enrolled patients, and a planned 1.2 billion peso clinical-research investment across 2025–2026. The company highlighted a 55-day COFEPRIS authorization for a Phase III Parkinson's program — public confirmation that the new 30-day target reflects already-improving practice, not aspirational policy. Separately, researchers at Instituto do Coração in São Paulo and Federal University of Minas Gerais reported their benznidazole analogue cleared Trypanosoma cruzi infection in 78% of chronic indeterminate Chagas patients in a Phase III trial of 2,000 participants conducted across Brazil, Bolivia and Colombia.
What to Focus On: The Chagas program is the first antiparasitic in fifty years to demonstrate efficacy in the chronic phase of the disease. It is also a high-visibility demonstration that multi-country LATAM Phase III designs can deliver primary endpoint data on the same calendar as US- or EU-anchored programs.
LinkedIn monitoring through June 27, 2026 confirms continued multi-year operational silence at three LATAM-positioned CROs: ReSolution Latin America (no public content since 2017), Activa CRO (no public content since December 2020), and IPSUM Clinical (no public content since May 2021). The pattern is consistent with operator turnover, financing constraints, or quiet wind-downs. Sponsors using LATAM CRO RFPs to triangulate operational viability should treat extended LinkedIn silence as a leading-indicator red flag rather than a neutral data point.
Bottom Line: The bar for what counts as an "active" LATAM CRO is moving. Public-facing communication, ICH E6(R3) literacy and demonstrable hiring activity are now table stakes — not differentiators.
Mexico's 30-day COFEPRIS authorization target moves the country from regulatory laggard to operationally competitive in a single announcement ANVISA's June 22 resolution authorizing twelve experimental molecules in a single DOU edition is the strongest single-week evidence of Brazilian throughput under Law 14.874/2024 Argentina's formalization of clinical trials department leadership removes a 22-month uncertainty for ANMAT-track sponsors Colombia's INVIMA backlog of ~12,700 trámites and 2.5-year oncology decision time should be modeled explicitly into any Q4 2026 Colombian submission plan A tri-country Brazil–Bolivia–Colombia Phase III in chronic Chagas demonstrates that multi-country LATAM trial designs can deliver primary endpoint data competitively Roche Mexico's 55-day COFEPRIS Phase III Parkinson approval confirms the new 30-day target reflects practice, not aspiration Three LATAM CROs with multi-year LinkedIn silence reinforce the sponsor due diligence value of public-activity monitoring
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