Brazil opened a fast track for global trials, and it belongs to whoever arrives already in compliance. In May 2024, Lei 14.874 rewrote clinical research in Brazil. In October 2025, Decreto 12.651 put it into force. The stated goal is to double the country’s clinical research volume and move it into the world’s top ten. The timelines were shortened for real: ethics review by a Research Ethics Committee dropped from up to 180 days to up to 30, and ANVISA’s review of primary clinical trial petitions is now up to 90 business days. A short deadline is only short for a protocol that enters already aligned. For everyone else, the clock restarts on every pendency.
The reliance route: how a prior FDA or EMA assessment accelerates ANVISA review
For a biotech with a dossier already aligned to the FDA or EMA, there is an additional route. RDC 945/2024, with IN 338/2024, created an optimized analysis procedure based on regulatory reliance, in which ANVISA can rely on the assessment of an Equivalent Foreign Regulatory Authority instead of repeating it from scratch. A portable proof certificate is what an assessment needs to look like to travel between authorities. Celina is built to feed the procedure ANVISA already operates.
Reliance accelerates review; it does not mean automatic approval. The dossier still has to be well-formed, jurisdiction-aware, and internally consistent before ANVISA will lean on a foreign assessment. That is the work that decides whether a short deadline stays short. It is the work the proof certificate is designed to carry, and the mechanism behind it is the three-gate verification architecture.
What SINEP changed, and why old guidance is now wrong
Lei 14.874/2024 created the National System of Ethics in Research with Human Beings (SINEP), and Decreto 12.651/2025 regulates it. SINEP runs on two instances: the National Instance of Ethics in Research (INAEP) and the Research Ethics Committees (CEP). CONEP now acts as an appeals instance during the transition.
This matters for a practical reason. Content that still describes a CEP/CONEP dual-review system as the operating rule is citing a framework that has already changed. A submission built to the old map coordinates against instances that no longer hold the same authority. The full architecture behind compliant, inspection-ready submissions is set out in the regulatory validation framework.
Gate 2 — Formal Proof
The output carries a formal, mathematical proof that its structure is sound, one anyone can independently re-verify without trusting us. It proves the document is well-formed. It does not claim to prove the document is clinically correct, and it states that boundary plainly. This gate is in production and in first validation with a launch sponsor.
Frequently asked questions
- What is Brazil's new clinical trial law?
- Lei 14.874/2024 rewrote Brazil’s clinical research framework and created the National System of Ethics in Research with Human Beings (SINEP). Decreto 12.651/2025 regulates it and sets the new timelines.
- What are the new ANVISA and ethics review timelines?
- Ethics review by a Research Ethics Committee is now up to 30 days, ANVISA review of primary clinical trial petitions is up to 90 business days, and strategic research for the public health system and health emergencies is up to 15 business days.
- What is SINEP, and what happened to CONEP?
- SINEP is Brazil’s current ethics-in-research system under Lei 14.874/2024. It runs on two instances: the National Instance of Ethics in Research (INAEP) and the Research Ethics Committees (CEP). CONEP now acts as an appeals instance during the transition. Content still referencing the old CEP/CONEP system is citing a rule that has already changed.
- Can prior FDA or EMA approval speed up ANVISA review?
- Yes. RDC 945/2024 with IN 338/2024 created an optimized analysis based on regulatory reliance, letting ANVISA rely on the assessment of an Equivalent Foreign Regulatory Authority. Reliance accelerates review; it does not mean automatic approval.
- Does Brazil regulate AI in clinical decisions?
- Yes. CFM Resolution 2.454/2026 governs the use of AI in medicine and takes effect on 26 August 2026. Its core rule is that the clinical decision is always human and AI is support, never substitution.
Read next
For the architecture behind compliant submissions, read the regulatory validation framework and the three-gate verification architecture.
Planning a Brazil entry? See how Celina prepares an ANVISA- and SINEP-ready dossier.
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A note on posture
This is a methodology contribution offered under an engagement, not endorsement, posture. Nothing here claims regulatory approval, certification, or agency agreement. We cite Brazilian and foreign frameworks to show design alignment, not conformance. Regulatory status can change; verify against the current text of Lei 14.874/2024, Decreto 12.651/2025, and the cited ANVISA and CFM instruments before relying on any timeline.