Navigating the ANVISA Clinical Trial Review Timeline

By Daniel — Founder, Samba Trials (a BioAlma company). Published 2026-04-20. This piece synthesizes public regulation (RDC 9/2015, Lei 14.874/2024, CNS Resolução 466/2012) with observed operational timelines from sponsor engagements in 2024-2026.

For years, "Brazil" was a feasibility-deck line item that meant "long review timeline." That's changing. Lei 14.874/2024 — the new Brazilian clinical-trial law, signed in mid-2024 and now in implementation — sets a statutory target of roughly six months from submission to authorization for a first-in-country industry protocol. Sponsors who wrote off Brazil two or three years ago because of regulatory latency are, reasonably, re-evaluating.

This article walks through what the law actually requires, what we're seeing operationally in 2025-2026 activations, and how to structure your submission so the theoretical timeline matches your actual one.

The three-track system

Brazilian clinical-trial authorization for an industry-sponsored drug protocol runs on three tracks that must all land before the first patient can be enrolled:

Each track has its own submission portal, its own reviewer pool, and its own internal clock. Historically, sponsors and CROs often submitted them sequentially — wait for CEP, then submit to CONEP, then submit to ANVISA — which is the single most common reason end-to-end timelines ran 9-12 months. The modern, and Lei-14.874-aligned, approach is parallel submission from day one.

Historical timelines (RDC 9/2015 regime)

Under RDC 9/2015 — the previous ANVISA regulation — the typical end-to-end timeline for a first-in-country multinational Phase 3 protocol looked like this:

• CEP (first site): 4-8 weeks for initial review, often with one round of stipulations that added another 2-4 weeks.
• CONEP: 60-120 days from submission, with variance driven by reviewer bandwidth and dossier completeness. 4-6 month timelines were common.
• ANVISA (Comunicado Especial): Historical statutory target of 180 days; real-world medians closer to 270 days for complex protocols.
• Parallel additional CEPs (additional sites): 4-8 weeks each, usually handled after CONEP is positive.

When run serially, 9-12 months was the norm. When run in parallel with an experienced local regulatory consultancy, 7-9 months was achievable. That's the baseline that gave Brazil its slow-market reputation.

What Lei 14.874/2024 changed

Lei 14.874/2024 — the Marco Regulatório da Pesquisa Clínica com Seres Humanos — was signed in June 2024 after years of legislative work. The law does several things at once:

• Statutory review windows. ANVISA's review target is now set in law rather than regulation, with specific timeline commitments (generally 180 days total, with shorter windows for oncology and rare disease).
• Parallel CEP/CONEP/ANVISA submission is explicitly enabled and encouraged. Previous practice already allowed this, but the law formalizes it.
• CONEP's role is narrowed. The law redirects CONEP toward its original oversight-and-guidance function, reducing its routine review bottleneck.
• Post-trial access obligations formalized. Sponsors must describe post-trial continuation-of-access plans for investigational therapies that demonstrate benefit.
• Clearer biobanking and biospecimen-export rules — especially relevant for genetic substudies, biomarker arms, and oncology protocols requiring central sequencing.

What to submit in parallel, from day one

Here's the practical structure we use for an industry-sponsored Phase 3 protocol aiming for a 6-8 month activation:

Day 0: simultaneous filings

• Lead-CEP submission. File at the principal investigator's institution's ethics committee. Choose a site with a high-volume, responsive CEP (HCPA, Moinhos de Vento, Hospital Alemão Oswaldo Cruz all run fast, experienced CEPs).
• CONEP dossier upload. Via Plataforma Brasil. Complete protocol package, Brazilian Portuguese ICF (fully translated and adapted), biospecimen-export strategy (Termo de Transferência de Material Biológico), post-trial access statement.
• ANVISA CE dossier. Investigator's Brochure, protocol synopsis and full protocol, CMC package, risk-management plan, and the import license request (DUIMP) for investigational product.

Weeks 4-8: secondary-CEP cascade

As lead-CEP returns stipulations or approval, begin additional-site CEP submissions. Each adds 4-8 weeks to that site's activation, not to the overall program — sites come online as they approve.

Months 3-6: responses and staged activation

CONEP and ANVISA typically return stipulations in months 2-4. Budget for one, occasionally two, response rounds. First-site activation commonly lands in months 6-8; full site footprint by months 10-14 depending on program size.

TA-specific nuances that affect the timeline

Not all protocols review equally. Specific features extend or compress the timeline:

What extends the timeline

• Biospecimen export to third countries — adds CONEP scrutiny, sometimes adds a round. Especially common for genomic sub-studies. Address with a clean Termo de Transferência document at filing.
• Pediatric protocols — CONEP pediatric-research review is stricter; assent procedures and parental-consent workflow need to match CNS 466/2012 expectations exactly.
• First-in-class mechanism — ANVISA reviewers may request additional nonclinical data, particularly for novel pathway-modulators.
• Comparator access questions — if your active comparator isn't SUS-accessible post-study, expect questions about participant access plans.
• Radiopharmaceuticals — add CNEN (nuclear energy regulator) coordination on top of ANVISA.

What compresses the timeline

• Oncology protocols — Lei 14.874/2024 explicitly sets shorter windows for oncology and rare disease.
• Orphan-drug designation via RDC 205/2017 — for qualifying rare-disease programs, priority review further compresses ANVISA's clock.
• Reference-country prior approval — prior FDA, EMA, or PMDA authorization materially speeds ANVISA review when included in the dossier.
• Experienced Brazilian regulatory counsel — the right local consultancy can shave 30-60 days off the median by ensuring the first submission is complete rather than triggering a Letter of Findings.

Parallel submission strategy: the common mistakes

Three common mistakes we see sponsors make on their first Brazilian program:

1. Waiting for CEP before filing ANVISA. There is no regulatory reason to do this. The tracks are independent. Serial filing adds 2-3 months unnecessarily.
2. ICF translated but not adapted. A literal translation from English is not a compliant Brazilian Portuguese ICF. The adaptation must be readable by lay Brazilian adults at an 8th-grade reading level and include specific cultural and access-language required by CNS 466/2012. CEPs reject ICFs on this ground routinely.
3. Biospecimen-export strategy written after the fact. If your protocol exports genetic, serum, tissue, or microbiome samples, the Termo de Transferência de Material Biológico must be in the original CONEP filing. Retrofitting it as an amendment can add 60-90 days.