Brazil has quietly become one of the most improved places in the world to run a clinical trial — and most of the field hasn't looked. Roughly 950 industry sponsors run US Phase 2/3 trials with no Brazilian footprint at all, overwhelmingly mid-cap biotechs that haven't revisited the country since the 2024 reforms. The honest pitch isn't "no downsides" — it's that the downsides are a different kind of problem than the upsides. The advantages are structural: scale, cost, a transformed regulatory clock. The disadvantages are operational: importation, depots, lab logistics. You can't manufacture the first list somewhere else — and you can plan your way through the second. Here's both sides, straight.
The case for Brazil
1. Massive scale, in a single country
212 million people under one regulator, one language, and one currency — which means large, accessible, often treatment-naïve patient pools and high per-site enrollment, in sharp contrast to the saturated, heavily-competed sites of the US and Western Europe. And it's a mature ecosystem, not a frontier: as of Q3 2026, 585 industry-sponsored trials are actively recruiting across 144 sponsors.
2. A cost advantage that's real — and widening
In IQVIA's cross-country analysis, Brazil came in as the lowest-cost option in every category compared — a neurology indication, an infectious-disease indication, and three separate oncology baskets — landing between roughly 31 and 67 on an index where the most expensive comparator country is set to 100, and consistently below Korea, Mexico, Argentina, China, and the major Western markets. No trade-off in GCP quality or data integrity. On a large Phase 2/3 enrollment tranche, that per-patient delta is material to the program budget.
3. A genuinely transformed regulatory clock
This is the reason to relook at Brazil now. Lei 14.874/2024 — the Marco Legal da Pesquisa Clínica — put ethics review (a single CEP, ≤30 business days) and ANVISA (≤90 business days) on parallel statutory clocks, with decurso de prazo: if the agency misses its deadline, the study is automatically authorized. Ninety business days is roughly four to five calendar months of ANVISA review; add the parallel ethics track and normal submission and query-response overhead, and well-prepared programs are now reaching authorization in about six months — against a historical nine to twelve. (We walk through the mechanics in our ANVISA timeline piece.)
Three further provisions compound the effect: investigational product can be imported during the review, so material is in-country when approvals land rather than sourced afterward; ANVISA can lean on FDA and EMA decisions through regulatory reliance to shorten its analysis of a multi-country package; and the post-study drug-supply obligation is now capped at five years, removing a previously open-ended liability. ANVISA is itself an ICH member and sits on the WHO's list of Listed Authorities — credibility that carries weight when a multi-country protocol team decides where to place sites.
4. Population diversity as a scientific asset
Brazil is one of the most genetically admixed populations on earth — Indigenous, European, African, and Asian ancestry, frequently within a single family tree. For sponsors facing diversity-enrollment expectations (such as FDA diversity action plans) or seeking pharmacogenomic generalizability, that representativeness is available in one jurisdiction.
5. World-class sites and investigators
Brazil offers 800+ research sites, anchored by high-throughput academic centers — HCPA in Porto Alegre, Barretos, Sírio-Libanês — with deep GCP track records and experienced principal investigators. The strength is concentrated, which is itself an advantage: a handful of centers can carry a large share of your enrollment.
6. Time-zone alignment with the US
Brazil overlaps the US Eastern time zone, so monitoring, oversight calls, and sponsor–site collaboration happen inside a shared working day — a practical edge over Asia-Pacific or European alternatives when your program team sits in North America.
The honest cons — and how you plan around each
Here's the part the brochure skips. Notice that none of these is regulatory, and none is a reason to rule Brazil out — they're operational: logistics, infrastructure, and the import mechanics around them. Every one has a known mitigation, and every mitigation is the same shape: decide it before first-patient-in, not after.
Not every lab assay is available — or trial-ready — in-country
Routine chemistry and hematology are well covered, but specialized central-lab and esoteric assays — certain biomarkers, flow panels, companion diagnostics — may not be locally validated or readily available for clinical-trial use. Discovering that after protocol lock forces awkward, expensive workarounds.
Plan ahead — Map your full assay list against local capability during protocol design; pre-qualify central-lab routing and the sample-shipping logistics that go with it, so no assay is a surprise at activation.
Importation is per-shipment — and each clearance takes time
Investigational product, ancillary supplies, lab kits, and comparators each move through Brazil's importation process on their own — and a given shipment can take on the order of ten days to clear. Teams used to intra-EU or domestic-US logistics routinely underestimate this and build timelines that don't survive contact with the first shipment.
Plan ahead — Front-load import licensing, then batch and schedule shipments against the enrollment plan with buffer stock in-country. Use the Marco Legal provision that lets you import investigational product during the review — so drug is in-country when approval lands, not sourced afterward — and an importer-of-record who does this every week turns a recurring ten-day question into a routine line on the calendar.
Your CRO may not have the depots you need
Depot coverage isn't uniform. The cold-chain, cryopreservation, and specialized storage your protocol depends on — for lab kits, biologics, cell products — may sit outside your CRO's standard Brazilian footprint. Assuming it's covered is how a cryopreserved shipment ends up without a home.
Plan ahead — Confirm depot and cold-chain capability explicitly at CRO selection, and line up specialized depot partners for cryo and biologics rather than assuming the default network covers them.
Customs — historically the bottleneck, now much less so
For years, customs clearance was the delay everyone warned you about. It has quietly improved: biologics now clear in roughly two days when the documentation is in order. The remaining risk is almost entirely paperwork — not the process itself.
Plan ahead — Get the documentation right the first time and work with an experienced broker. Do that, and customs is a two-day step — not the multi-week gamble it used to be.
The symbolic-import-pricing trap
To trim import taxes on investigational product, teams are often tempted to declare a nominal customs value — a dollar, ten dollars a unit. It's a false economy. An implausible value invites customs scrutiny and undervaluation penalties, and — more costly down the line — it puts a rock-bottom figure on the official record, exactly the wrong anchor when you later need to establish and defend a commercial price.
Plan ahead — Declare a defensible, documented value now, on a real basis — cost of goods, or a fair-market reference for clinical supply. It clears customs cleanly today, and because it is explicitly a pre-commercial supply price, it leaves your commercial pricing free to be set — higher — at launch. A documented basis you can transparently step up from beats a symbolic one you would later have to explain away.
The pattern: plan before first-patient-in
Look at what every con has in common. None is regulatory, and none is a reason to rule Brazil out — they're operational. That's the whole point. The pros are structural: you cannot source Brazil's scale, diversity, or cost advantage anywhere else. The cons are executional — and executional problems yield to preparation. Brazil rewards the sponsor who plans the supply chain, the assays, the valuation, and the logistics before enrollment starts — with someone who has done it before owning it from day one.
One honest note on fit: Brazil pays off at scale, not at the margin. A large Phase 2/3 multi-country tranche over the next 12–24 months is the sweet spot; a marginal six-week gain on a single site probably is not worth the activation lag. And if Brazil or Latin-American market entry is itself a goal, running the trial there starts building the ANVISA and access relationship early — the trial becomes a market-entry asset, not just enrollment.
Start with your sites and PIs
If there is one place to spend your planning energy, it's here — and there's a number that proves it. Of trials authorized in Brazil in 2025, 31% still had not enrolled a single patient six months after approval. The regulatory clock is now fixed and fast; site contracting and operational readiness have become the real critical path. Competing-trial load, principal-investigator bandwidth, and site readiness decide your timeline far more than the paperwork does, and the programs that slip are almost always the ones that chose sites after approval instead of before. Identify and qualify your sites and PIs in advance, while the protocol is still taking shape — not once the clock is already running.
SambaTrials runs the site side, end to end
That's exactly the work we take off your plate: site and PI search, feasibility, site assessment and selection, study initiation, and investigator meetings — then full management of every site interaction through the trial, including monitoring and patient finding. If Brazil is on the map for an upcoming program, start a conversation with us. The earlier we talk, the more directed the guidance we can give for your indication, timeline, and site strategy.
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