A convergence of regulatory reform, real-world approvals, and shifting capital is redefining where early-phase clinical research happens — and Colombia is at the center of it. This week: • Colombia’s Proyecto de Ley 191
first-in-human · FIH · clinical trial · clinical research · regulatory · ANVISA
A convergence of regulatory reform, real-world approvals, and shifting capital is redefining where early-phase clinical research happens — and Colombia is at the center of it.
This week:
• Colombia’s Proyecto de Ley 191 proposes the most significant overhaul of the country’s clinical trial framework in 33 years
• A rare disease biotech received INVIMA approval and began dosing patients in Medellín — demonstrating that speed from concept to execution is real
• Market access dynamics across Argentina, Brazil, Colombia, and Mexico are forcing sponsors to rethink one-size-fits-all LATAM strategies
• Peer-reviewed data confirms emerging regions are outperforming traditional markets on startup timelines, cost, and patient diversity
• A $60 million oversubscribed raise signals that neuropsychiatric FIH pipelines are gaining institutional momentum
Take a closer look at what is reshaping the future of first-in-human research. 👇
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Colombia’s Proyecto de Ley 191 would replace Resolution 8430 — the 33-year-old regulatory backbone of Colombian clinical research — with a modern framework designed explicitly for first-in-human and early feasibility studies. The proposed legislation introduces a 30-day INVIMA objection window (versus the current open-ended process), risk-stratified approval tiers, and a dedicated Phase I pathway that does not yet formally exist in Colombian law.
The bill is currently before the Comisión Séptima of the Cámara de Representantes. If enacted, it would represent the most substantive structural change to Colombia’s clinical research environment since 1993 — and one of the most ambitious regulatory modernization efforts in the region.
Why It Matters: Sponsors planning Phase I and early feasibility studies in LATAM need to track this legislation closely. A successful passage would place Colombia’s approval speed in the same tier as Argentina’s newly enacted 62-day cap — making Colombia a dual-site option for multi-country FIH strategies rather than an alternative to them.
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While Proyecto de Ley 191 works through the legislative process, Unravel Biosciences is already treating patients in Colombia. The Boston-based clinical-stage company received INVIMA authorization in December 2025 under a priority review pilot for orphan and high unmet-need diseases, and began dosing patients with RVL-001 — an investigational therapy with a first-in-class mechanism — in January 2026.
The program targets two rare pediatric neurological disorders: Rett syndrome (15 patients) and Pitt-Hopkins syndrome (5 patients) at the Universidad de Antioquia’s PECET research center in Medellín. The authorization came through a dedicated rare disease fast-track channel that INVIMA has maintained in parallel with its broader registration backlog of more than 12,800 pending applications.
Bottom Line: This is not a hypothetical. A U.S. biotech is dosing patients with a novel therapeutic mechanism in Colombia today, under a regulatory authorization granted in under 90 days. The fast-track rare disease pathway functions — even as general INVIMA registration timelines stretch toward 29 months in some categories. Sponsors with orphan indications have a differentiated option available now.
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As clinical trials increasingly move into Latin America, sponsors are discovering that regulatory approval is only the first step. Market access in Argentina, Brazil, Colombia, and Mexico operates through distinct HTA bodies — ANEFiTS, CONITEC, IETS, and CENETEC respectively — each with different evidence standards, reimbursement logic, and pricing expectations.
A sponsor that has navigated ANVISA’s approval pathway in Brazil cannot assume that the same data package will satisfy CONITEC’s reimbursement review, let alone translate to Colombia’s IETS or Mexico’s CENETEC. Country-specific strategies, built from the beginning of the development process rather than appended at launch, are becoming the distinguishing factor between efficient and delayed commercialization.
What to Focus On: Sponsors targeting LATAM commercialization post-FIH should begin HTA alignment conversations at the study design phase — not at regulatory submission. The countries where trial data is generated will shape reimbursement dossier requirements. Integrating this logic early can reduce the gap between approval and patient access, which currently averages 5.6 years across the region.
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A February 2026 study in Cureus (PMC) quantified what experienced trial sponsors have observed operationally: emerging regions including Latin America consistently outperform traditional markets on early-phase trial fundamentals. Faster study startup timelines, lower per-patient costs, access to treatment-naïve and ethnically diverse populations, and growing regulatory infrastructure are cited as the primary drivers.
Latin America accounts for more than 8 percent of the global population but hosts only 3.6 to 5 percent of global oncology trials — a gap the study attributes not to site quality or scientific capacity but to governance models and regulatory alignment. The study explicitly identifies Argentina’s Disposición 7516/2025 and Brazil’s Law 14.874/2024 as evidence that targeted regulatory reform can close this gap rapidly.
Why It Matters: For sponsors still evaluating whether LATAM is ready for early-phase trials, peer-reviewed evidence now supports what bioaccess® has demonstrated operationally across 20+ years: the fundamentals are in place, and the regulatory reforms of 2025–2026 have removed the most significant structural barriers.
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Gilgamesh Pharma, an AbbVie spinout developing next-generation neuropsychiatric therapies, closed a $60 million Series A in March 2026 — oversubscribed. The company is advancing GM-3009, a cardio-safe ibogaine analog targeting depression, PTSD, and addiction, toward a first-in-human Phase 1 study targeted for Q3–Q4 2026.
The raise reflects a broader capital shift: institutional investors are backing novel mechanism FIH programs with compressed timelines and differentiated safety profiles — exactly the profile of companies that have historically benefited from LATAM regulatory speed and cost efficiency for Phase I execution.
Bottom Line: A well-funded ibogaine analog program targeting FIH in under 12 months represents an active opportunity in a therapeutic area where LATAM regulatory agencies have demonstrated flexibility. The compressed timeline between funding and FIH initiation makes site selection decisions imminent.
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• Colombia’s Proyecto de Ley 191 proposes a 30-day INVIMA objection window and a dedicated FIH pathway — the most significant clinical trial reform bill in 33 years
• Unravel Biosciences began dosing patients with RVL-001 in Medellín in January 2026 under INVIMA’s rare disease fast-track, proving execution speed is real
• LATAM market access requires country-specific evidence strategies from study design onward — Argentina, Brazil, Colombia, and Mexico operate entirely distinct HTA frameworks
• Peer-reviewed data in Cureus (Feb 2026) confirms LATAM’s structural advantages in FIH fundamentals and attributes underrepresentation to governance gaps now being addressed by reform
• Gilgamesh Pharma’s oversubscribed $60M Series A and Q3–Q4 2026 FIH timeline signal active demand for LATAM-eligible early-phase execution
• Digital health tools — remote monitoring, AI analytics, connected devices — are compressing trial timelines and expanding patient access across hybrid and decentralized models in the region
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