ANVISA Clinical Trial Approval in Brazil

Brazil runs a dual-track clinical trial approval process: a drug or biologic trial cannot begin until it has been cleared on both a regulatory track, led by ANVISA (Agência Nacional de Vigilância Sanitária, the National Health Surveillance Agency), and an ethics track, led by a local Research Ethics Committee (CEP) with national oversight from CONEP (Comissão Nacional de Ética em Pesquisa). Neither approval substitutes for the other, and as of RDC 945/2024 the two tracks are formally independent of each other’s timeline, so sponsors can and should submit to both in parallel rather than waiting for one to clear before starting the other. This guide walks through who reviews what, the regulations that currently govern the process, realistic timelines, and where international sponsors most often lose time.

Who regulates clinical trials in Brazil

Three bodies matter for a drug or biologic trial in Brazil:

ANVISA is Brazil’s national health surveillance agency, linked to the Ministry of Health. Within ANVISA, the Coordination of Clinical Research in Medicines and Biological Products (COPEC) is the unit that conducts the technical, sanitary review of a trial application and issues the regulatory authorization, submitted electronically through ANVISA’s Solicita petition system.
CEP (Comitê de Ética em Pesquisa) is the local, institution-level research ethics committee that performs the first-line ethical review of a study protocol and its informed consent materials, functionally comparable to a US IRB or a REC in other jurisdictions.
CONEP (Comissão Nacional de Ética em Pesquisa) is the national ethics commission that sits above the CEP system. Higher-risk or specific categories of research (certain new drugs, genetic research, populations covered by special protections, and other categories CONEP designates) require CONEP’s additional review on top of the local CEP’s opinion.

Both the CEP and CONEP operate under the framework set by Brazil’s National Health Council (CNS) Resolution 466/2012, the foundational ethics-review standard for human-subjects research in Brazil, and submissions to the CEP/CONEP system are made electronically through Plataforma Brasil, the national platform for registering and tracking human-subjects research protocols. A 2024 law, Law 14.874/2024, established a National System of Ethics in Research, a further legislative layer to the ethics-oversight structure sponsors should be aware of even though CEP/CONEP review remains the operative mechanism day to day.

RDC 945/2024: the current regulatory framework

ANVISA’s clinical trial regulation was substantially updated by Resolution RDC No. 945/2024, published by ANVISA in late 2024 and in effect since January 1, 2025. RDC 945/2024 sets out the guidelines and procedures for clinical trials of synthetic and semi-synthetic drugs, herbal medicines, radiopharmaceuticals, biologics, and biosimilars conducted wholly or partly in Brazil for registration purposes, succeeding the prior clinical trial framework. It was accompanied by Normative Instruction (IN) No. 338/2024, which governs an optimized review pathway described below.

Two structural points in RDC 945/2024 matter most for planning purposes:

Ethical and regulatory approvals are independent. A sponsor may submit to ANVISA and to the CEP/CONEP system at the same time rather than sequentially — but the trial can still only start once both the ethics approval and the ANVISA sanitary authorization are in hand.
A fixed maximum review deadline. RDC 945/2024 sets a 90-business-day maximum for ANVISA to complete analysis of a primary petition (the initial trial-authorization request) and a defined deadline for secondary petitions (post-authorization amendments), replacing the more variable timelines under the earlier framework.

Step by step: from protocol to first patient in

Prepare the dossier. ANVISA’s technical dossier for a drug trial is generally referred to as the DDCM (Dossiê de Desenvolvimento Clínico de Medicamento — Drug Clinical Development Dossier), broadly analogous in function to a US IND submission or an EU clinical trial application, though structured to ANVISA’s own requirements rather than the ICH Common Technical Document format used elsewhere. In parallel, the clinical trial protocol, investigator’s brochure, and informed consent materials are prepared for the CEP/CONEP ethics submission.
Submit in parallel. The regulatory dossier goes to ANVISA through the Solicita system as a primary petition; the ethics dossier goes to the CEP of record (and, if the study falls into a CONEP-reviewed category, onward to CONEP) through Plataforma Brasil. Submitting both tracks at or near the same time is what actually compresses the overall timeline — sponsors who wait for one approval before starting the other add the second track’s full review period onto the end of the first.
Respond to queries. Either track can come back with a request for clarification or additional information (a “pending” or exigency status) before a final opinion is issued; the review clock in each system generally pauses while the sponsor’s response is outstanding.
Obtain both approvals. ANVISA issues its sanitary authorization once its technical review is satisfied; the CEP (and CONEP, where applicable) issues a final favorable ethical opinion. A trial cannot enroll its first participant, or import investigational product for use in Brazil, until both are in hand.
Register the trial. Brazilian trials are registered in ReBEC (Registro Brasileiro de Ensaios Clínicos), Brazil’s national clinical trial registry, which participates in the WHO International Clinical Trials Registry Platform (ICTRP) network alongside registries such as ClinicalTrials.gov and the EU’s CTIS — see CASRAI’s guide to clinical trial registration and reporting compliance for the general principles that apply across registries.

Timelines: what to expect

Published deadlines describe maximums, not typical or guaranteed outcomes — actual time-to-approval depends heavily on dossier completeness and how quickly a sponsor turns around any information requests. As a planning frame:

ANVISA (primary petition): up to 90 business days for a complete technical review under RDC 945/2024, though straightforward, well-prepared submissions are often resolved faster.
CEP: an initial completeness check is typically fast, with substantive review taking roughly 30 days from acceptance of a complete protocol.
CONEP (for studies requiring it): review adds further time beyond the CEP’s own review, since CONEP’s assessment follows the CEP’s opinion.

Because the two tracks run independently, the realistic end-to-end timeline for a new trial is generally set by whichever track — regulatory or ethics — finishes last, not by either one alone. Sponsors experienced in other ICH-aligned jurisdictions should plan for a longer aggregate approval window in Brazil than a single-authority market, precisely because of the dual-track structure, and should budget review-response time into the project timeline rather than treating the maximum deadline as the expected date.

A faster path for trials already reviewed by a recognized foreign authority

IN No. 338/2024, issued alongside RDC 945/2024, defines an optimized analysis procedure available when a trial has already been authorized by a regulatory authority on ANVISA’s list of Equivalent Foreign Regulatory Authorities. In practice this is a reliance-style mechanism: rather than ANVISA repeating a full independent technical review from first principles, a trial with an existing authorization from a recognized peer agency can qualify for a streamlined ANVISA review, provided the Brazilian submission meets the criteria IN 338/2024 sets out. This does not remove the requirement for CEP/CONEP ethics review, and it does not apply automatically — sponsors should confirm current eligibility criteria and the current list of recognized authorities directly with ANVISA (gov.br/anvisa) before relying on it in a submission plan, since both the list and the criteria are maintained and updated by ANVISA rather than fixed in the base regulation text.

Medical devices follow a separate track

The pathway above applies to drug, biologic, and biosimilar trials. Clinical investigations of medical devices in Brazil are governed by a distinct regulation, RDC No. 10/2015, rather than RDC 945/2024 — a common point of confusion for sponsors running combination programs. Device trials still require both ANVISA and CEP/CONEP clearance following the same dual-track logic, but the technical dossier requirements and applicable regulation differ from the drug pathway described in this guide.

Common pitfalls for international sponsors

Treating the two tracks as sequential. Waiting for ANVISA authorization before submitting to the CEP/CONEP system (or vice versa) is the single most common source of avoidable delay — RDC 945/2024’s independence of the two tracks is a feature meant to be used, not a default sponsors fall into by accident.
Underestimating CONEP-triggering categories. Assuming local CEP approval alone is sufficient without checking whether the protocol falls into a category requiring CONEP review adds an unplanned review layer late in the process.
Assuming ANVISA’s dossier maps directly onto an ICH CTD. The DDCM has its own structure; a submission built by simply repackaging a CTD or a US IND without adapting to ANVISA’s own requirements is a frequent source of completeness-related delay at intake.
Missing the ReBEC registration step. Registration is a distinct action from either approval and has its own timing expectations (comparable in spirit to the prospective-registration norms enforced elsewhere, per prospective clinical trial registration) — it is not a byproduct that happens automatically once ANVISA and CEP/CONEP approvals are issued.
Not verifying current guidance directly. Because RDC 945/2024 and IN 338/2024 are recent, and ANVISA continues to publish clarifying Q&A and manuals interpreting them, sponsors should check gov.br/anvisa for the current guidance documents rather than relying solely on secondary summaries, including this one, for submission-critical details.

How Brazil compares to other jurisdictions

The dual-approval logic — a national regulator plus an independent ethics body, both required before enrollment — is not unique to Brazil; it is broadly the same structural pattern used in Canada’s Health Canada / REB framework and, in different forms, across most ICH-aligned jurisdictions, including the EMA and FDA pathways. What differs by country is the specific agency names, submission systems, review deadlines, and the degree to which ethics and regulatory review are formally coupled or run independently. For sponsors managing a multi-country trial, the practical implication is the same lesson that applies across jurisdictions covered in CASRAI’s Good Clinical Practice guide: build country-specific regulatory and ethics timelines into the master trial plan individually rather than assuming one jurisdiction’s approval cadence for another.

Frequently asked questions

Does a foreign sponsor need a Brazilian legal representative to submit to ANVISA?

Sponsors without a Brazilian legal presence typically work through a local sponsor representative or CRO to handle in-country regulatory and ethics submissions, import logistics, and communication with ANVISA and the CEP/CONEP system — confirm current representation requirements directly with ANVISA or Brazilian regulatory counsel before finalizing a country-level operating plan.

Can ANVISA and CEP/CONEP review happen at the same time?

Yes. Under RDC 945/2024 the two tracks are independent, and submitting in parallel is the standard way to avoid adding one track’s full review period onto the other’s.

What is the difference between a primary and a secondary petition?

A primary petition is the initial request to authorize a new trial; a secondary petition covers post-authorization changes, such as protocol amendments, that require ANVISA sign-off once a trial is already underway.

Is there a faster pathway if a trial already has FDA or EMA approval?

Potentially. IN 338/2024 defines an optimized review procedure for trials already authorized by an agency on ANVISA’s list of Equivalent Foreign Regulatory Authorities, though eligibility and the current agency list should be confirmed directly with ANVISA rather than assumed.

Do medical device trials use the same ANVISA pathway as drug trials?

No. Device trials are governed by RDC No. 10/2015, a separate regulation from RDC 945/2024, though the same dual-track (ANVISA plus CEP/CONEP) logic applies.

Where must a Brazilian clinical trial be registered?

In ReBEC, the Registro Brasileiro de Ensaios Clínicos, Brazil’s WHO ICTRP-participating national trial registry.