Brazil Profile Updated
The Brazil profile in ClinRegs has been reviewed and updated with the following information:
- 2025 and 2026 regulations, requirements, and additional resources related to the transition from the National Research Ethics Commission (Comissão Nacional de Ética em Pesquisa (CONEP)) system to the National System of Ethics in Research Involving Human Beings (Sistema Nacional de Ética em Pesquisa com Seres Humanos (SINEP)) framework (See Scope of Assessment, Ethics Committee topic, Clinical Trial Lifecycle topic, Insurance & Compensation, Risk & Quality Management, Vulnerable Populations, and Consent for Specimen)
- 2026 regulation establishing the National Research Ethics Authority (Instância Nacional de Análise Ética em Pesquisa (INAEP)) structure, governance, and administrative processes (See Oversight of Ethics Committee)
- 2025 and 2026 requirements establishing interim SINEP ethical review procedures and standardized ethics committee (Comitê de Ética em Pesquisa (CEP)) bylaws related to ethical review procedures and timelines, multicenter research, and high-risk protocols (See Ethics Committee, Scope of Review, Submission Process, Timeline of Review, Documentation Requirements, and Required Elements)
- 2026 Ministry of Health (MOH) regulation establishing a Technical Monitoring Committee to make recommendations, provide information, and develop proposals to improve the development process of the National Research Platform Involving Human Beings (See Oversight of Ethics Committees)
- 2026 National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) regulation establishing a priority category for clinical research prior approval petitions, as well as registration and post-registration processes (See Scope of Assessment, Submission Process, Timeline of Review, and Manufacturing & Import)
- 2025 and 2026 requirements and related resources outlining ANVISA’s regulatory reliance framework and establishing temporary, reliance-based measures to optimize the clinical research analysis queue (See Scope of Assessment and Timeline of Review)
- 2025 ANVISA regulation adopting a risk-based approach to granting and renewing good manufacturing practice and Good Distribution and/or Storage Practice certificates (See Manufacturing & Import)
- ANVISA requirements and resources related to submission processes and timelines for pre-submission meetings, clinical research petition migration to the Solicita electronic submission system, and substantial investigational product modifications (See Submission Process, Submission Content, Timeline of Review, Manufacturing & Import, and Quality Requirements)
- 2025 ANVISA regulation and related resources on foreign trade controls for health-regulated products within the Integrated Foreign Trade System (SISCOMEX) (See Manufacturing & Import)
- Reference to 2026 National Data Protection Authority (Autoridade Nacional de Proteção de Dados (ANPD)) regulation recognizing the European Union as providing comparable data protection for international transfers (See Personal Data Protection)
- Reference to ANVISA’s electronic contact form for international users (See Regulatory Authority)
- Reference to Vigimed System safety reporting resource (See Safety Reporting)
Sources Added During this Update:
(Circular) Circular Letter No. 51/2024 - Guidance on Aspects Related to the Application of Law No. 14,874, of May 28, 2024 (CLNo51-2024 - Portuguese) (November 26, 2024)
National Research Ethics Commission (CONEP), National Health Council (CNS)
(Guidance) Brazilian Health Regulatory Agency (Anvisa) Import Manual via DUIMP (G-DUIMP - Portuguese) (English-G-DUIMP – Google Translate) (Version 1.9) (June 1, 2026)
Sanitary Control Management for Products and Companies at Ports, Airports, Borders, and Customs Areas (GCPAF)
(Guidance) Questions and Answers - RDC No. 945/2024 and IN No. 338/2024 - Guidelines and Procedures for Conducting Clinical Trials for Registration Purposes (G-ResNo945-FAQs - Portuguese) (English-G-ResNo945-FAQs – Google Translation) (3rd Edition) (December 26, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health
(Order) Order No. 1 – Standardizing the Internal Bylaws and Administrative Procedures to be Used by Research Ethics Committees (CEPs) (OrderNo1 - Portuguese) (Effective April 28, 2026)
National Research Ethics Authority (INAEP), Ministry of Health
(Order) Order No. 2 – Providing Ethical Review Timelines and Procedures to be Used by Research Ethics Committees (CEPs) (OrderNo2 - Portuguese) (Effective April 28, 2026)
National Research Ethics Authority (INAEP), Ministry of Health
(Order) Order No. 3 – Providing Procedures for the Single Ethical Review Process for Multicenter Human Research Studies (OrderNo3 - Portuguese) (Effective June 8, 2026)
National Research Ethics Authority (INAEP), Ministry of Health
(Order) Order No. 5 – Establishing Ethical Guidelines for Pharmacokinetic Studies with Higher Risk Medications (OrderNo5 - Portuguese) (English-OrderNo5 – Google Translation) (Effective July 7, 2026)
National Research Ethics Authority (INAEP), Ministry of Health
(Regulation) Decree No. 12,651, of October 7, 2025 (DecreeNo12.651 - Portuguese) (Effective October 8, 2025)
Federative Republic of Brazil
(Regulation) Normative Instruction No. 457 of July 9, 2026 (RegNo457 - Portuguese) (Effective July 13, 2026)
National Health Surveillance Agency (ANVISA), Ministry of Health
(Regulation) Ordinance No. 54 of January 27, 2021 (OrdNo54 - Portuguese) (Effective February 28, 2021)
National Health Surveillance Agency (ANVISA), Ministry of Health
(Regulation) Resolution CD/ANPD No. 32, of January 26, 2026 (CD-ANPD-No32 - Portuguese) (Effective January 27, 2026)
National Data Protection Authority (ANPD), Ministry of Justice and Public Security
(Regulation) Resolution No. 1, of April 2, 2026 (ResNo1 - Portuguese) (Effective April 6, 2026)
National Ethics Committee for Research (INAEP), Ministry of Health
(Regulation) Resolution of the Collegiate Board - RDC No. 977, of June 5, 2025 (ResNo977 - Portuguese) (Last Amended March 6, 2026)
National Health Surveillance Agency (ANVISA), Ministry of Health
(Regulation) Resolution of the Collegiate Board - RDC No. 982 of July 28, 2025 (ResNo982 - Portuguese) (Effective July 29, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health
(Regulation) Resolution of the Collegiate Board - RDC No. 997 of November 7, 2025 (ResNo997 - Portuguese) (Last Amended May 7, 2026)
National Health Surveillance Agency (ANVISA), Ministry of Health
(Regulation) Resolution of the Collegiate Board - RDC No. 1,001, of December 11, 2025 (ResNo1001 - Portuguese) (Last Rectified February 25, 2026)
National Health Surveillance Agency (ANVISA), Ministry of Health
(Regulation) SCTIE/MS Ordinance No. 8, of February 2, 2026 (OrdNo8 - Portuguese) (Effective February 4, 2026)
Secretariat of Science, Technology and Innovation in Health, Ministry of Health
(Regulation) SCTIE/MS Ordinance No. 85, of October 14, 2025 (OrdNo85 - Portuguese) (Effective October 14, 2025)
Secretariat of Science, Technology and Innovation in Health, Ministry of Health
(Article) Brazil Publishes Decree to Regulate Law on Clinical Trials Involving Human Beings (BRA-89) (October 28, 2025)
Mattos Filho
(Article) Decree Regulates Clinical Research Law and Establishes the National System of Ethics in Research Involving Human Beings (BRA-11 - Portuguese) (October 9, 2025)
Demarest
(Article) Regulatory Reliance (BRA-137) (Last Updated March 8, 2026)
National Health Surveillance Agency (ANVISA), Ministry of Health
(Document) National Research Ethics Authority - Questions and Answers (BRA-141 - Portuguese) (English-BRA-141 – Google Translation) (Version 1.1) (February 19, 2026)
National Research Ethics Authority (INAEP)
(Document) Notification Instruction Manual for Health Services in the VigiMed System (BRA-145 - Portuguese) (English-BRA-145 – Google Translation) (Effective June 1, 2026)
National Health Surveillance Agency (ANVISA)
(Document) Technical Note No. 1/2026 - DECIT/SCTIE/MS (BRA-142 - Portuguese) (English-BRA-142 – Google Translation) (January 16, 2026)
Department of Science and Technology, Secretariat of Science, Technology and Innovation in Health, Ministry of Health
(Document) Technical Note No. 43/2025 - DECIT/SECTICS/MS (BRA-143 - Portuguese) (English-BRA-143 – Google Translation) (November 17, 2025)
Department of Science and Technology, Secretariat of Science, Technology and Innovation in Health, Ministry of Health
(Form) Digital Contact Us Form for International Users (BRA-120 - Portuguese) (Current as of July 29, 2026)
National Health Surveillance Agency (ANVISA), Ministry of Health
(Press Release) Anvisa Publishes List of Abandoned and Replaced Processes According to the Rules of RDC 997/2025 (BRA-136 - Portuguese) (December 4, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health
(Press Release) Anvisa Releases Schedule for Integration into the New Import Process (BRA-144 - Portuguese) (October 2, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health
(Press Release) Migration of Clinical Research Petitions to Solicita Begins on March 16 (BRA-123 - Portuguese) (February 27, 2026)
National Health Surveillance Agency (ANVISA), Ministry of Health
(Press Release) The Pharmaceutical Division of Anvisa (Brazilian Health Regulatory Agency) Adopts Procedures to Comply with RDC 997/2025 (BRA-139 - Portuguese) (Last Updated December 22, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health
(Webpage) Anvisa Launches New System for Scheduling Hearings (BRA-146 - Portuguese) (November 4, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health
(Webpage) Hearings (BRA-147 - Portuguese) (Last Updated June 1, 2026)
National Health Surveillance Agency (ANVISA), Ministry of Health
(Webpage) Questions and Answers - RDC 997/2025 (BRA-138 - Portuguese) (Last Updated December 22, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health
Sources Revised During this Update:
(Guidance) Anvisa Manual for Importing Medicines and Related Products (G-ImprtMeds - Portuguese) (English-G-ImprtMeds – Google Translation) (Version 3.1) (July 2026)
National Health Surveillance Agency (ANVISA), Ministry of Health
(Guidance) Manual for Reporting Suspected Serious and Unexpected Serious Adverse Reactions (SUSARs) and Safety Monitoring in Clinical Trials (G-SUSARs - Portuguese) (English-G-SUSARs – Google Translation) (3rd Edition) (2025)
Coordination of Clinical Research in Medicines and Biological Products (COPEC) Second Board of Directors, National Health Surveillance Agency (ANVISA)
(Document) Annual Activity Report 2025 - Coordination of Clinical Research on Medicines and Biological Products - COPEC (BRA-60 - Portuguese) (English-BRA-60 – Google Translation) (9th Edition) (May 15, 2026)
Coordination of Clinical Research in Medicines and Biological Products (COPEC) Second Board of Directors, National Health Surveillance Agency (ANVISA)
(Document) Solicita User Manual (BRA-47 - Portuguese) (Version 5.3) (Last Updated July 28, 2026)
National Health Surveillance Agency (ANVISA), Ministry of Health