Brazil Profile Updated

The Brazil profile in ClinRegs has been reviewed and updated with the following information:

• National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA))’s 2024 clinical trial regulation has been incorporated into the profile (See the Regulatory Authority, Clinical Trial Lifecycle, Sponsorship, Informed Consent, and Investigational Products topics and Scope of Review)
• Updated ANVISA clinical trial application guidance manual and related clinical trial submission forms (See the Clinical Trial Lifecycle and Investigational Products topics, Scope of Assessment, and Risk & Quality Management)
• International transfer of personal data requirements and additional guidance for data processing agents from the National Data Protection Authority (Autoridade Nacional de Proteção de Dados (ANPD)) (See Personal Data Protection)
• Additional and updated ANVISA requirements on importing medicines subject to special control and good manufacturing practices for investigational products (See Manufacturing & Import and Labeling)
• Updated ANVISA regulation on sponsor/company transfer of responsibility for clinical trials (See Submission Process, Submission Content, Definition of Sponsor, and Insurance & Compensation)
• Requirements, guidelines, and related form for complying with ANVISA’s optimized analysis procedure reviews (See Scope of Assessment, Submission Process, Timeline of Review, and Manufacturing & Import)
• Updated ANVISA organizational structure requirements (See Regulatory Authority and Scope of Assessment)
• Additional details on ANVISA electronic document filing requirements (See Submission Process)
• Additional ANVISA clinical trial safety reporting and data safety and monitoring committee guidelines and related form (See Safety Reporting and Site/Investigator Selection)
• Additional ANVISA resource on submitting an advanced therapy product clinical trial application (See Scope of Assessment)
• Updated ANVISA contact information (See Regulatory Authority)
• References to additional regulations related to bioavailability/bioequivalence studies (see Submission Process)
• Updated guideline related to ANVISA’s import petition process, which underwent minor revisions (See Manufacturing & Import) 

Sources Added During this Update:

(Legislation) Law No. 6,437, of August 20, 1977 (LawNo6.437 - Portuguese) (Effective August 24, 1977)
Federative Republic of Brazil

(Regulation) CD/ANPD Resolution No. 19, of August 23, 2024 (CD-ANPD-No19 - Portuguese) (Effective August 23, 2024)
National Data Protection Authority (ANPD), Ministry of Justice and Public Security

(Regulation) Regulatory Instruction No. 136 of March 30, 2022 (RegNo136 - Portuguese) (Effective May 2, 2022)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Regulatory Instruction No. 338 of November 29, 2024 (RegNo338 - Portuguese) (Effective January 1, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Regulatory Instruction No. 345 of February 20, 2025 (RegNo345 - Portuguese) (Effective February 24, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Resolution of the Collegiate Board – RDC No. 585 of December 10, 2021 (ResNo585 - Portuguese) (Effective December 20, 2021)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Resolution of the Collegiate Board - RDC No. 659, of March 30, 2022 (ResNo659 - Portuguese) (Effective May 2, 2022)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Resolution of the Collegiate Board - RDC No. 705 of June 14, 2022 (ResNo705 - Portuguese) (Effective June 20, 2022)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Resolution of the Collegiate Board - RDC No. 800 of June 6, 2023 (ResNo800 - Portuguese) (Effective July 3, 2023)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Resolution of the Collegiate Board - RDC No. 903 of September 6, 2024 (ResNo903 - Portuguese) (Effective September 9, 2024)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Resolution of the Collegiate Board - RDC No. 926, of September 20, 2024 (ResNo926 - Portuguese) (Effective September 24, 2024)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Resolution of the Collegiate Board - RDC No. 931, of October 9, 2024 (ResNo931 - Portuguese) (Effective October 14, 2024)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Resolution of the Collegiate Board - RDC No. 942, of November 18, 2024 (ResNo942 - Portuguese) (Effective November 19, 2024)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Resolution of the Collegiate Board – RDC No. 945, of November 29, 2024 (ResNo945 - Portuguese) (Effective January 1, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Resolution of the Collegiate Board - RDC No. 947 of December 12, 2024 (ResNo947 - Portuguese) (Effective March 13, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Guidance) Anvisa Manual for Importing Medicines and Related Products (G-ImprtMeds - Portuguese) (English-G-ImprtMeds – Google Translation) (Version 1.1) (September 2024)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Guidance) Guideline: Performance of the Person Responsible for the Processing of Personal Data ((Guidance) Guideline: Performance of the Person Responsible for the Processing of Personal Data (G-CD-ANPD-No18 - Portuguese) (English-G-CD-ANPD-No18 – Google Translation) (December 2024)
National Data Protection Authority (ANPD), Ministry of Justice and Public Security

(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) (2nd Edition) (2025)
Coordination of Clinical Research in Medicines and Biological Products (COPEC) Second Board of Directors, National Health Surveillance Agency (ANVISA)

(Guidance) Operational Guidelines for the Establishment and Operation of Data and Safety Monitoring Committees (G-DSMB-BRA - Portuguese) (English-G-DSMB-BRA – Official Translation) (2008)
Ministry of Health; World Health Organization (WHO)

(Article) ANPD Launches Guide on the Role of the Person in Charge (BRA-119 - Portuguese) (Last Updated December 19, 2024)
National Data Protection Authority (ANPD), Ministry of Justice and Public Security

(Document) Instruction Manual for Using the Authorized Clinical Trials Consultation System (BRA-129 - Portuguese) (English-BRA-129 – Google Translation) (Version 1.0) (June 12, 2023)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Document) Technical Note No. 17/2024: Guidelines for Submitting Optimized Analysis Procedure Requests Based on Regulatory Trust (Reliance) for DDCM Petitions and DEEC Investigational Product Modifications and Clinical Protocol Amendments, Under the Terms of RDC No. 945/2024 and IN No. 338/2024 (BRA-122 - Portuguese) (English-BRA-122 - Google Translation) (January 28, 2022)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Document) VigiMed Company User Manual - Clinical Research (BRA-130 - Portuguese) (English-BRA-130 – Google Translation) (2nd Edition) (February 2025)
Coordination of Clinical Research in Medicines and Biological Products (COPEC) Second Board of Directors, National Health Surveillance Agency (ANVISA)

(Form) Form for Declaration of Compliance with the Requirements for the Admissibility of the Optimized Analysis Procedure by Regulatory Trust (Reliance) (Version 2) (BRA-124 - Portuguese) (English-BRA-124 – Google Translation) (March 19, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Form) Form for Registration/Change of Registration - VigiMed (BRA-131 - Portuguese) (English-BRA-131 – Google Translation) (Date Unavailable)
Coordination of Clinical Research in Medicines and Biological Products (COPEC), National Health Surveillance Agency (ANVISA)

(Form) Investigational Drug Development Plan (PDME) (BRA-128 - Portuguese) (English-BRA-128 – Google Translation) (Version 3) (December 2024)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Form) Petition Form for Substantial Amendment to Clinical Trial Protocol (BRA-125 - Portuguese) (English-BRA-125 – Google Translation) (Version 2.0) (Date Unavailable)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Form) Petition Form for Substantial Modification to the Investigational Product (Annex I) (BRA-127 - Portuguese) (English-BRA-127 – Google Translation) (Version 2.0) (Date Unavailable)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Form) Sponsor Statement of Responsibility and Commitment Form for Expanded Access, Compassionate Use, or Post-Study Drug Delivery Programs - (Annex VI of Resolution No. 38) (BRA-126 - Portuguese) (English-BRA-126 – Google Translation) (2013)
National Health Surveillance Agency (ANVISA), Ministry of Health

(International Guidance) ICH Harmonised Guideline: Guideline for Good Clinical Practice E6(R3) (BRA-121) (Final Version) (Adopted January 6, 2025)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(International Guidance) ICH Harmonised Guideline: The Common Technical Document for the Registration of Pharmaceuticals for Human Use (M4) (BRA-133) (Step 5 Versions) (Modules range from 2002-2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(Webpage) ANVISA – Telephone (BRA-135 - Portuguese) (Last Updated July 30, 2024)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Webpage) Health Surveillance: Contacts for ANVISA and State Health Surveillance Agencies and their Respective Capitals (BRA-132 - Portuguese) (Last Updated June 11, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Webpage) International Data Transfer (BRA-118 - Portuguese) (Current as of June 27, 2025)
National Data Protection Authority (ANPD), Ministry of Justice and Public Security

(Webpage) Prioritization of Drug Analysis (BRA-82 - Portuguese) (Last Updated February 20, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Webpage) Request Approval for Clinical Development Dossier for Advanced Therapies (DDCTA) (BRA-134 - Portuguese) (Last Updated December 16, 2024)
Ministry of Health

Sources Revised During this Update:

(Guidance) Manual: Petition for Import License through LPCO (G-LPCOImprtPetition - Portuguese) (English-G-LPCOImprtPetition - Google Translation) (Version 2.17) (Last Updated February 12, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Guidance) Manual for Submission of Clinical Drug Development Dossier (DDCM) and Specific Clinical Trial Dossier (DEEC) (G-DDCMManual - Portuguese) (English-G-DDCMManual - Google Translation) (4th Edition) (2025)
General Management of Medicines (GGMED), Coordination of Clinical Research in Medicines and Biological Products (COPEC), National Health Surveillance Agency (ANVISA)

(Document) Plataforma Brasil - Investigator's Manual (BRA-91 - Portuguese) (Version 3.8) (Last Updated August 8, 2023)
National Health Council (CNS), Ministry of Health

(Document) Solicita User Manual (BRA-47 - Portuguese) (English-BRA-47 – Google Translation) (Version 4.4) (Last Updated April 9, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Form) Clinical Trial Start Date Form in Brazil (BRA-25 - Portuguese) (English-BRA-25 – Google Translation) (Version 3.0) (Date Unavailable)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Form) Clinical Trial Submission Form (FAEC) (BRA-22 - Portuguese) (English-BRA-22 – Google Translation) (Version 6.0) (February 24, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Form) End of Clinical Trial Notification Form in Brazil (BRA-24 - Portuguese) (English-BRA-24 – Google Translation) (Version 3.0) (Date Unavailable)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Form) Petition Form for Approval in the Clinical Drug Development (DDCM) Dossier Process (BRA-21 - Portuguese) (English-BRA-21 – Google Translation) (Version 2) (December 19, 2024)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Webpage) Electronic Petition for Import (PEI) (BRA-108 - Portuguese) (Last Updated June 6, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Webpage) General Management of Medicines (GGMED) (BRA-12 - Portuguese) (Last Updated January 21, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Webpage) Integrated Foreign Trade System (Siscomex) (BRA-106 - Portuguese) (Last Updated June 6, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Webpage) Issue DARF for Payment of Federal Taxes (BRA-111 - Portuguese) (Last Updated May 16, 2025)
Federal Revenue Service, Government of Brazil

(Webpage) National Health Council - About the Council (BRA-49 - Portuguese) (Current as of June 27, 2025)
National Health Council (CNS), Ministry of Health

(Webpage) National Health Council - Plataforma Brazil (BRA-33 - Portuguese) (Current as of June 27, 2025)
National Health Council (CNS), Ministry of Health

(Webpage) National Research Ethics Commission (CONEP) (BRA-50 - Portuguese) (Current as of June 27, 2025)
National Health Council (CNS), Ministry of Health

(Webpage) Protocol Documents - General Information (BRA-42 - Portuguese) (Last Updated March 24, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Webpage) Registration of New and Innovative Medicines (BRA-40 - Portuguese) (Last Updated January 31, 2025)
National Health Surveillance Agency (ANVISA), Ministry of Health