On June 11, 2026, it was published Technical Note No. 60/2026, issued by Anvisa through its General Management of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs and Advanced Therapy Products (GGBIO).

By means of this Technical Note, Anvisa established that it is safe to perform multiple switches between a comparator biological drug and its biosimilars, as well as between biosimilars of a comparator biological drug. In order to issue this opinion, Anvisa analysed national and international pharmacovigilance data, highlighting that:

Based on such data, Anvisa understands that multiple switching is safe and effective provided that such switching is accompanied by:

Why this matters

Although it does not promote substantial changes in the regulatory framework applicable to biological products and their biosimilars – currently governed by RDC 55/2010 and RDC 875/2024 – the Technical Note represents progress from the perspective of public procurement. This is because it objectively mitigates the argument that separate tenders would be necessary for patients already in treatment and for new (naive) patients, by recognizing the safety and efficacy of multiple switches between the comparator biologic and biosimilars.

Furthermore, the document reinforces regulatory predictability and confidence in the healthcare environment by indicating that prescribing healthcare professionals do not need to link the prescription to a specific brand. In practice, this enables the exchange of a comparator biologic for its biosimilar or between biosimilars, provided that there is proper authorization in the prescription, increasing operational flexibility and efficiency in the acquisition and dispensing of these medications in the Unified Health System.

The Life Sciences & Healthcare team at Souto Correa Advogados remains available to answer questions on this topic.

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Harmonization of the Treatment of Fragrances in SisGen (Technical Guidance No. 6/2018)

The main item for which supporting documents have already been made available is the proposal to amend CGen Technical Guidance No. 6/2018, applicable to the fragrance sector, in order to align it with CGen Resolution No. 40/2023.

The proposal arises from the identification of a regulatory inconsistency: whereas the Technical Guidance allows certain products to be addressed by means of notification, the Resolution provides that such cases must be reported in the access registration in SisGen.

This inconsistency applies to products resulting from access to genetic heritage or associated traditional knowledge in which such components are not one of the key elements adding value to the product.

The Statement of Reasons resolves this conflict based on the interpretation of Law No. 13,123/2015, emphasizing that such products:

The proposal therefore seeks to harmonize the applicable regime by consolidating the understanding that such cases must be treated in SisGen as results obtained from access, within the scope of the access registration, including under the “Resultados obtidos” field (“results obtained”).

Although presented as a low-impact regulatory measure, the amendment is likely to produce relevant operational effects, especially for the fragrance and cosmetics sectors (which are the actual scope of the Technical Guidance), with a possible need to revisit regulatory classifications and update existing registrations accordingly.

Updates on the request for review submitted by the Ministry of Agriculture regarding the proposed Resolution approving the Reference List of Associated Traditional Knowledge of Non-Identifiable Origin

Within the scope of regulatory harmonization, the report on the request for review submitted by the Ministry of Agriculture regarding the proposed Resolution approving the Reference List of Associated Traditional Knowledge of Non-Identifiable Origin will also be presented. This list stems from CGen Resolution No. 47/2025, which mandated the creation of a reference database on associated traditional knowledge, encompassing both identifiable and non-identifiable origins, with the aim of enhancing legal certainty for all stakeholders working with Brazilian biodiversity. Once approved, the list will be made available on the CGen website.

Updates on the new version of SisGen

The agenda also includes discussion of the new version of SisGen, a recurring topic on the CGen agenda with a direct impact on users’ operational routines. The most anticipated update is likely the inclusion of the international module, which is already in the testing phase.

Digital Sequence Information (DSI)

The agenda also includes updates on discussions related to digital sequence information (“DSI”), a topic under development at both the domestic and international levels. During the meeting of the Academic Sectoral Chamber, discussions will also address options for non-monetary benefit-sharing arising from the use of DSI.

In this context, the proposed amendment to OT No. 6/2018 represents the most concrete advancement from a regulatory standpoint, while the remaining items indicate relevant trends for the future development of the regulation of access to genetic heritage in Brazil.

The Life Sciences & Healthcare team at Souto Correa Advogados remains available to address any questions on the matter.

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What the SPA/MF communicated

The Technical Note reaffirms the set of duties already established under Law No. 14,790/2023 (notably Articles 16, 17 and 27, and the penalty regime of Article 39) and SPA/MF Ordinance No. 1,231/2024, in addition to the Consumer Protection Code (Law No. 8,078/1990) and Annex “X” of the Brazilian Advertising Self-Regulation Code (CONAR). The core message is one of enforcement priority: during the 39 days of the World Cup, the SPA/MF, consumer protection agencies (Procons), the Public Prosecutor’s Office, Public Defenders and CONAR will, according to the Note itself, pay “heightened attention” to advertising in the sector.

Points requiring immediate review

• Mandatory warnings. The “18+” notice and the gambling-disorder risk warning must be clear, legible and occupy at least 10% of the size or length of the advertisement (Article 13, §1, of Ordinance 1,231/2024), preferably in both spoken and written form.
• Authorization number. Every advertising piece must display the number of the SPA/MF ordinance that authorized the operator (Article 15, §3).
• Liability for affiliates and influencers. The operator is jointly and severally liable for the actions of its affiliates (Articles 21 and 22), which requires a written contract in Portuguese and active monitoring of the content disseminated.
• Prohibited content. Appeals to easy gains, “calls to action” prompting immediate betting, associating betting with personal/financial success or with celebrities suggesting such success, and any targeting of children and adolescents are prohibited (Article 12).
• Apparent age. Individuals shown betting in advertising must be and appear to be over 21 years of age.
• Cross-border campaigns. Global content accessible or residually directed to Brazilian consumers must comply with national rules; offers from operators not authorized in Brazil must be blocked to local bettors.

Why this increases risk

Although the Technical Note is a guidance instrument — penalties arise from Law No. 14,790/2023 and Ordinance No. 1,231/2024, not from the Note itself —, it documents unequivocal awareness of the requirements by market participants. This element is legally relevant to the administrative offenses under Article 39, items X and XII, of Law No. 14,790/2023, which penalize maintaining a relationship with, or disseminating, boosting or monetizing content associated with, an unauthorized operator where there is awareness of the irregularity.

Recommendations

• Immediately review the entire World Cup campaign pipeline — both own and affiliate/influencer campaigns — before June 11.
• Audit pieces for warnings (≥10%), the authorization number, and the absence of “calls to action” and easy-gain appeals.
• Strengthen contractual clauses and processes for prior approval and monitoring of affiliates and influencers.
• Retain factual support for advertising messages — the burden of proving truthfulness lies with the sponsor (Article 38 of the Consumer Protection Code).
• Maintain reinforced customer service and ombudsman channels throughout the event.

The Gaming & Betting team at Souto Correa Advogados remains available to clarify any questions.

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A proximidade temporal entre os atos normativos evidencia uma atuação coordenada na Receita Federal e sinaliza uma clara diretriz de aceleração da modernização do OEA, com impactos diretos sobre a cadeia logística e portuária.

O que é o Programa OEA

O Programa OEA consiste em um modelo de certificação aduaneira que reconhece operadores com elevado nível de conformidade, segurança e confiabilidade na cadeia de suprimentos internacional. Os intervenientes elegíveis à certificação estão previstos no art. 6º da Instrução Normativa RFB nº 2.318/2026, incluindo importadores, exportadores, transportadores, agentes de carga, agências marítimas, depositários em recintos alfandegados e em Recintos Especiais para Despacho Aduaneiro de Exportação (Redex), operadores portuários e operadores aeroportuários.

Uma vez certificados, os operadores passam a usufruir de benefícios como redução de inspeções, maior previsibilidade nos fluxos aduaneiros, tratamento prioritário e potencial reconhecimento internacional, chegando até ao diferimento de tributos devidos na importação, a depender da modalidade de certificação.

Em especial, no contexto portuário e logístico, o OEA consolida-se como um instrumento central de eficiência operacional, gestão de riscos e competitividade.

IN nº 2.318/2026: reestruturação das modalidades e níveis de certificação

A Instrução Normativa promove alterações estruturais relevantes no OEA, com destaque para a reorganização das modalidades de certificação.

Nos termos do art. 7º, o programa passa a contemplar: (i) a modalidade OEA-Segurança (OEA-S); e (ii) a modalidade OEA-Conformidade (OEA-C), subdividida em três níveis progressivos: OEA-C Nível 1 (Essencial), OEA-C Nível 2 (Qualificado) e OEA-C Nível 3 (Referência).

A estruturação em níveis no âmbito do OEA-C reforça uma lógica evolutiva de certificação, permitindo que os operadores ingressem no programa com requisitos iniciais e avancem conforme o grau de maturidade de seus controles internos e de conformidade. Ademais, essa nova estrutura visa atender a uma demanda decorrente das alterações trazidas pela Reforma Tributária, considerando determinadas situações de certificação OEA para a fruição de desonerações tributárias.

A IN também aprimora a sistemática de benefícios, ao estabelecer a diferenciação entre benefícios gerais — aplicáveis aos operadores certificados — e benefícios específicos, vinculados à modalidade e ao nível de certificação, conforme previsto no art. 8º.

Na prática, tais benefícios se traduzem em ganhos relevantes de eficiência operacional, especialmente para operadores com cadeias logísticas complexas.

Adicionalmente, a Instrução Normativa detalha o processo de certificação (arts. 18 a 27), que passa a observar etapas estruturadas que envolvem o protocolo do requerimento, a análise documental, a validação pela Receita Federal e, quando aplicável, a realização de diligências, deixando claro que a certificação está sujeita a monitoramento contínuo quanto à manutenção dos requisitos.

Nesse contexto, a norma também disciplina hipóteses de exclusão do operador certificado (art. 34 e seguintes), especialmente em casos de descumprimento de requisitos, inconsistências nos controles, prestação de informações inexatas ou ocorrência de irregularidades que comprometam sua confiabilidade, evidenciando que o OEA exige a manutenção permanente de elevados padrões de governança e compliance.

Portaria Coana nº 187/2026: o principal marco operacional

A Portaria assume papel central ao regulamentar a aplicação prática do novo OEA, ao mesmo tempo em que estrutura regimes distintos conforme a data de protocolo dos requerimentos de certificação, assegurando tratamento adequado tanto para processos em curso quanto para novos pedidos.

Especificamente, a norma prevê três marcos temporais:

Ademais, a Portaria também prevê prazo para a conclusão do procedimento de validação (até 120 dias). Embora se trate de prazo já estabelecido anteriormente, espera-se que a previsão na nova Portaria seja observado e resolva a problemática relativa ao elevado tempo que o procedimento de validação apresentava, o que era objeto de críticas e é evidenciado pela própria Portaria ao tratar de requerimentos protocolados ainda antes de julho de 2024.

É importante destacar que, para requerimentos protocolados a partir de 15 de abril de 2026, a norma dispensa a apresentação de informações e documentos já disponíveis nas bases da Receita Federal — como CNPJ, regularidade fiscal e adesão ao DTE.

Considerações finais

A Instrução Normativa RFB nº 2.318/2026 também estabelece disposições específicas de adequação ao novo modelo do Programa OEA, com efeitos práticos relevantes para os operadores. Nos termos do art. 51, a certificação anteriormente concedida na modalidade OEA-Conformidade (OEA-C) passa, desde a publicação da norma, a ser automaticamente denominada OEA-C Qualificado, refletindo a nova estrutura em níveis e promovendo o enquadramento imediato dos operadores já certificados no novo regime, sem necessidade de novo requerimento.

Ademais, o art. 53 fixa marco temporal relevante para a operacionalização das novas categorias, ao estabelecer que os requerimentos de certificação nas modalidades OEA-C Essencial e OEA-C Referência somente poderão ser formalizados a partir de 15 de abril de 2026, o que delimita o início efetivo da aplicação prática da nova arquitetura do programa.

Por fim, o art. 57 dispõe que ficam revogadas: a Instrução Normativa RFB nº 2.154, de 26 de julho de 2023; e a Instrução Normativa RFB nº 2.200, de 12 de julho de 2024.

Nossas equipes de Aduaneiro e Marítimo & Portuário estão à disposição para esclarecer dúvidas sobre as recentes mudanças no Programa OEA e seus impactos práticos na cadeia logística e portuária.

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This initiative (i) is part of the implementation of Brazil’s new regulatory framework for research involving human participants, established by Law No. 14,874/2024 and Decree No. 12,651/2025, which transferred to INAEP competencies previously held by the National Commission for Research Ethics (Comissão Nacional de Ética em Pesquisa – “CONEP”) and (ii) seek to consolidate and update previously fragmented regulations, particularly National Health Council’s Resolution No. 441/2011 and Ministry of Health’s Ordinance No. 2,201/2011, in alignment with the new legal framework.

The draft resolution submitted for public consultation represents the continuation of a process initiated in 2023 under CONEP. The text was initially approved unanimously by CONEP’s board in 2024 and was subsequently reviewed and resubmitted by INAEP under the new institutional arrangement.

The draft addresses, in a structured manner, key issues such as:

The proposal introduces the concept of an accredited Research Ethics Committee (Comitê de Ética em Pesquisa – “CEP”), concentrating the ethical review of biobanks within committees that demonstrate adequate technical and operational capacity. It also expressly aligns the regulatory framework with the principles of the Brazilian General Data Protection Law and with international ethical standards, such as the World Medical Association’s Declaration of Taipei, thereby enhancing regulatory predictability and harmonization.

Contributions may be submitted until June 1, 2026, exclusively through the government platform.

Impacts on Industry and Research Institutions

If approved, the resolution is expected to have significant implications for sponsors, research institutions, biobank managers, and companies in the pharmaceutical, biotechnology, and medical devices sectors.

Key anticipated effects include greater specialization in ethical review, increased governance and transparency requirements, and enhanced clarity regarding conditions for future use, international transfer of human biological material, and cost reimbursement mechanisms. At the same time, the new regulatory framework has the potential to strengthen legal certainty and support the sustainability of large-scale research initiatives, particularly in fields involving innovation and international scientific cooperation.

The Life Sciences & Healthcare team at Souto Correa Advogados is available to address any questions you may have at lifesciences@soutocorrea.com.br.

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In the ruling published on Tuesday (10), the STF held that the TCU exceeded the limits of its constitutional authority by replacing ANTAQ in a regulatory decision that falls within the agency’s exclusive competence. In the leading opinion, Justice Dias Toffoli emphasized that courts of accounts cannot, under the guise of exercising their supervisory functions, assume the role of regulatory agencies. According to the rapporteur, it is not for the courts of accounts “to step into the shoes of regulatory agencies, making decisions on regulatory matters that have been entrusted to those agencies and not to the courts themselves,” also noting that ANTAQ has greater institutional and technical capacity to address the matter, having conducted a broad, transparent regulatory process based on public hearings, which resulted in Resolutions 2,864/12, 34/19, and 72/22.

The decision further highlighted that, over the past years, ANTAQ has consolidated consistent regulatory parameters for the sector, including mechanisms for competition protection and provisions enabling the agency to set maximum prices for the SSE in the event of indications of abusive practices. The Court observed that, by invalidating the possibility of charging the SSE, the TCU encroached upon powers belonging not only to ANTAQ, but also to CADE, whose mission includes safeguarding competition. The opinion adds that CADE itself considers that charging the SSE is not inherently unlawful in the abstract, with assessments of potential abuse requiring a case-by-case analysis.

The Shipping & Port team at Souto Correa Advogados is closely monitoring the developments related to the decision and remains available to address any questions on the matter.

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This report brings together analyses on nutrivigilance, medical device innovation, pricing of advanced therapies, health‑sector litigation, veterinary pharmacovigilance, and other highly relevant themes for regulated industries.

Explore the 17 topics we have identified for 2026:

Click here to download the full report and prepare for the key regulatory challenges ahead.

The Life Sciences & Healthcare team at Souto Correa Advogados is available for any questions on these topics via email: lifesciences@soutocorrea.com.br.

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The deadline for submitting contributions is 60 days and will end on March 9, 2026.

The draft resolution and other supporting documents can be accessed through this link.

The Life Sciences & Healthcare team at Souto Correa Advogados is available to answer any questions regarding the proposed resolution via email: lifesciences@soutocorrea.com.br.

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The final text of Resolution 3/2025 can be accessed at this link.

Hot Topics

Resolution 3/2025:

On the other hand, pricing criteria for advanced therapies and radiopharmaceutical products will be addressed in a specific resolution and, for the time being, such products will be considered omitted cases. In addition, the criteria for extraordinary price adjustments for medicines were not covered in the new framework and are expected to be defined in 2026.

The resolution provides for a 120‑day transition period and, during this interval, CMED’s Executive Secretary, Mateus Amâncio, stated that CMED “will act to clarify any questions and provide the necessary guidance for a safe and transparent implementation of the new rules.”

I. Preliminary Provisions of the New Framework

Resolution 3/2025 standardizes the concept of incremental innovation as a change relative to an originator medicine resulting from innovative activity, not considering as such mere variations in simple product characteristics, such as:

In this sense, the new framework also introduces the concept of a medicine with incremental innovation as a medicine that demonstrates innovative activity in relation to an originator medicine already registered in the country, consisting of a new combination, new monodrug, new route of administration, new strength, new dosage form, new packaging, or other incremental innovation, according to the following definitions:

i. New chronological sequence for price submission

The new framework determines that holders of the marketing authorization must submit a price request to CMED after submitting the marketing authorization application and before its publication. It will be the company’s responsibility to monitor the progress of the marketing authorization process with Anvisa and take the necessary steps to comply with Article 6 of Resolution 3/2025. If the marketing authorization holder does not submit the DIP by the time Anvisa publishes the marketing authorization, CMED must initiate ex officio proceedings to define the medicine’s Factory Price (“PF”).

This obligation was included in the regulation to comply with what was determined by the Federal Supreme Court under Theme 1234.

ii. Pre‑submission meeting

Resolution 3/2025 provides that interested parties may request a pre‑submission meeting with CMED for the presentation of the DIP.

iii. Criteria for Price Determination

iv. Categories of Medicines and Criteria for Setting the PF by Category

The table below summarizes the categories of medicines provided in the new framework and the respective criteria for defining the PF by category, without prejudice to the detailed explanation throughout the text:

The new framework provides eight (8) categories for classifying new products, namely:

To detail the table above, Resolution 3/2025 provides the following criteria for setting the PF:

v. Marketing Authorization Conditional Upon Submission of Additional Data and Evidence & Provisional Price

CMED may set a provisional price in cases where the marketing authorization is conditional upon the submission of additional data and evidence after the authorization has been granted, when the information necessary for the product’s definitive pricing is not yet available at the time the DIP is submitted.

In such cases:

vi. Documents in a Foreign Language

Documents accompanying the DIP must be submitted in Portuguese, but the new framework also states that documents in English and Spanish will be accepted.

If translation of documents originally submitted in English and Spanish is necessary, a request for clarification will be issued asking for the translation of the documents. Where a translation is required, and in the absence of a specific rule requiring sworn translation, a free (non‑sworn) translation may be accepted.

Documents accompanying the DIP, when submitted in a language other than Portuguese, English, or Spanish, must be submitted via sworn translation referring to the identification of the price or to the lack of a price in the reference countries.

vii. First‑Instance Decision and Deadlines

CMED’s Executive Secretariat (“SCMED”) is responsible for issuing first‑instance decisions on price requests for new products and new presentations submitted, and must observe the following deadlines, counted from the date of publication of the marketing authorization:

These deadlines may be extended once, for an equivalent period. In addition, SCMED must prioritize the analysis of DIPs whenever there is a formal and duly substantiated request from the Ministry of Health.

viii. Administrative Appeal

An appeal may be filed with the Technical‑Executive Committee (“CTE”) against SCMED’s decision within 30 (thirty) days from the notification of the decision. The appeal will be addressed to SCMED, which may reconsider the first‑instance decision within 90 (ninety) days.

If there is no reconsideration of the decision, or upon expiry of the reconsideration period, the case will be sent to the CTE for a decision on the appeal. If SCMED’s reconsideration only partially accepts the grounds of the appeal, the company will be notified so that, if it wishes, it may file an appeal with the CTE within 30 (thirty) days from the notification.

ix. Mandatory Reexamination

SCMED decisions will be subject to mandatory reexamination by the CTE when the company does not file an appeal, in the following cases:

The CTE’s decision in the mandatory reexamination may confirm the first‑instance decision or modify it to set a higher or lower price than that calculated by SCMED. In situations where the mandatory reexamination results in the definition of a price lower than that established by SCMED, a request for reconsideration may be filed with the CTE itself within 30 (thirty) days, and the case will be assigned to a new rapporteur.
CMED may review its decisions when it identifies:

X. Disclosure of Prices

CMED decisions on DIPs, at any level, will result in the disclosure of the approved prices in a list published monthly on its website and on Anvisa’s website, which may be amended if the decision is modified in reconsideration or appeal proceedings. The price list published on Anvisa’s website will include an indicator showing cases pending judgment by CMED.

XI. Final and Transitional Provisions

The PF obtained from the calculations provided for in the new framework will be expressed with two decimal places, with rounding from the third decimal place, as set out in item “7. Rounding of Numerical Data” of the publication Standards for Tabular Presentation of the IBGE (Brazilian Institute of Geography and Statistics).
Failure to comply with the provisions of Resolution 3/2025 will subject the violator to the sanctions set out in Law 10,742/2003. Doubts arising from the application of Resolution 3/2025 will be resolved by the CTE, after hearing SCMED.

XII. Five‑Year Review of the New Medicine Pricing Framework

The CTE will periodically coordinate evaluation processes of Resolution 3/2025, observing good regulatory practices, to assess the need for its amendment by the Council of Ministers. The evaluation processes will be carried out at intervals no longer than five (5) years.

XIII. Omitted Cases: Advanced Therapies and Radiopharmaceutical Products

The criteria for setting prices for advanced therapy products and radiopharmaceutical products will be regulated in specific acts of the Council of Ministers. Thus, advanced therapy products and radiopharmaceutical products will be considered omitted cases until the specific acts of the Council of Ministers are issued.

XIV. Transition Regime

The new regulatory framework for medicine pricing applies to:

Companies requesting pricing for medicines that fall under the situations above must submit the supplementary documentation required by Resolution 3/2025 within 30 (thirty) days from its effective date. In cases where the supplementary documentation is not submitted within the specified period, SCMED must notify the applicant company to comply with the determination within 30 (thirty) days. Failure to observe the 30‑day period will result in the initiation of ex officio proceedings to define the initial PF for the medicine.

Administrative appeals and mandatory reexaminations that are under review at the CTE, as well as appeals pending judgment by the Council of Ministers, will continue their course before those instances until judgment, observing the rules set out in Resolution 2/2004.

XV. Revoked Rules

The following Resolutions are revoked:

The Life Sciences & Healthcare team at Souto Correa is available to answer any questions about the new medicine pricing framework, its transition period, and its possible developments at lifesciences@soutocorrea.com.br.

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Dividend Taxation and High-Income Taxation:

Important Notes:

It is therefore advisable for companies to assess the existence of accumulated profits and consider distribution, in accordance with the law, to avoid additional taxation.

How to Prepare for 2026

With dividend taxation scheduled for 2026, it is essential for taxpayers and companies to evaluate tax optimization strategies, such as:

The Tax Law team at Souto Correa Advogados is available to clarify any questions related to this matter.

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